Medical Plastics Data Service Magazine July - August 2018 by Medical Plastics Data Service

Table of

Contents Vol. 26

No. 4

July - August 2018

COVER STORY Clean Room Environment For Medical Devices – ISO 14644 - Sanjay Shah, CEO, Unikal Consultants The Need for Clean Rooms; The Attributes to Create and use a Clean-Room; What keeps Cleanroom “Clean”?; Designing Air Handling Units; Clean Room Certification; ISO 14644. Injectionnique Moulding Machines For Clean Room Applications - Ankur Agarwal, Marketing Communications, Milacron India All-Electric Injection Moulding Machine is developed to comply with clean room standards. Ma chine eliminates hydraulic components and circuits thereby enhancing the degree of transmission efficiency and reduced losses. Removal of hydraulic oil also results in No Contamination of product. Simplifying Setting-up Of Plastic Processing Clean Room By : Medline Department, The Conair Group, USA Depending on the products being manufactured, medical plastic processors have adopted several different configurations for clean environments. Each requires a different level of cleanliness.

41 43

45 46 16 39 July-August 2018

MATERIALS Polymer Compounds For Medical Devices R C Gupta, Sr. General Manager, KLJ Polymers & Chemicals Ltd. The use of PVC compounds in medical device manufacture for more than 50 years has demonstrated its great ability to satisfy the demanding requirements of the medical health care industry.

MANUFACTURING Design Control : Importance and Regulatory Aspects. Anil Chaudhary, CEO, Operon Strategist The Design and Development of the product play vital role in total life cycle of product and to ensure the effective and safe product in market. The well-planned and documented approach is expected while conducting the design and development (D and D) activity. The design control initiates at.....

Global Market Insights : Snapshots Medical Polymers, Medical Injection Molding , Medical Device Contract Manufacturing. PVC Hospital Waste Recycling

AiMeD & REGULATORY UPDATES • • • •

Rs.100 Crore Central Aid Package To Help Medical Device Parks To Set Up Common Facilities Indian Pharmacopoeia Commission ( PC ) issues first 'Standards for Medical Devices Govt amends Medical Devices Rules : all NABL-accredited labs can issue performance report on IVDs Use Auto-Disable Syringes to Prevent Infection : Medical devices industry official

INDUSTRY NEWS • Mitsubishi expanding Indian footprint with PVC business acquisition • Covestro Strengthens its Global Film Production • AMTZ sets up Centre for Bio-Materials Testing • India, US move a step closer : Trade Issues including Medical Devices.

PRODUCT GALLERY • New Closed Male Luer Lock Valves / New Line of Tyvek® Sterilization Supplies

DID YOU KNOW? • Why Clean Room Is Important For Medical Plastics Manufacturing

EVENTS CALENDER • Medicall : 21-23 September, 2018 / Medica / Compamed : 12 - 15 Nov. 2018 • IMDI 2018 / 15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 : 26-27 October, 2018 • Medical Fair India 2019 : 21-23 February, 2019 / K 2019 : 16 – 23 Oct., 2019

Flashback Select Article Index

Jan. 2009 to June. 2009 • Marketing : A Marketing Approach To Overcome Recession (January – February 2009)

Did You Know ?

• Market Research : Medical Plastics – Future Needs From The Perspective Of The Medical Device Manufacturing (January – February 2009) Dr.VinnySastri, President, WINOVIA (R) LLC, USA

Why Clean Room Is Important For Medical Plastics Manufacturing

• Manufacturing : Needle Bonding with Epoxy Adhesives (January – February 2009) Timothy E. Zack, Engineered Materials Systems, Inc., USA

Clean rooms are classified by International Organization for Standardization (ISO). Clean rooms are enclosed and environmentally-controlled spaces in which temperature, humidity, pressure and contaminant levels are kept within strict limits. It helps to ensure that products remain under controlled contamination levels throughout the production process, thereby reducing potential risks to patients. Therefore, appropriate clean room designs, and the implementation of personnel policies and procedures that control work within the clean room environment, are critical for the production of safe devices.

• Global Trends : CBI Export Guidelines (January – February 2009) • Did You Know ? : About Paediatric Medical Device Institute (January – February 2009) • Cover Story : Changing Scenario For Medical Device Industry Regulations In India (March – April 2009) Mr. Rajiv Nath, Forum Coordinator - Association of Indian Medical Device Industry (AIMED) and Managing Director, Hindustan Syringes & Medical Devices Ltd. • Quality : Quality Assurance Concept in Medical Devices (March – April 2009) Dr. G. L. Jain, Centre for Active Learning, Guidance & Solutions • Quality : Safety Assessment of Medical Devices and GLP Complaint Studies (March – April 2009) Mr.NarendraDeshmukh, Director, Intox Pvt. Ltd. • Global Trends : Medical Device Regulations: Quality System Requirements (March – April 2009) • Did You Know ? : About Shared responsibility for medical device safety and performance (March – April 2009) • Cover Story : A General Overview Of Silicones Used In Medical Devices (May – June 2009) Mr. Bill Riegler, General Manager - Asia, Nusil Technology LLC, USA • Cover Story : Non-Woven Medical Disposable Products And Its Disposable Techniques (May – June 2009)

Unlike other industrial sectors, Medical Device components manufacturing is highly specialized , carrying specific requirements for sterility and regulatory accountability .This makes it essential for the Medical Device Manufacturers to have clean room manufacturing for their molded plastic parts/components.

Particles found in the clean room include those created by the manufacturing equipment, as well as particles already in the room. In regards to plastics manufacturing for medical devices, injection moulds are a source of contaminants, especially if the moulds are not properly maintained. Other clean room contamination sources specific to plastics are dust that is released during production and contaminated raw materials. Basic clean room practices include : • Developing a thorough clean room gowning requirements and procedures. • Ensuring the correct clean room supplies are present and they are used properly. • Instituting clean room housekeeping procedures and schedules. Preventative maintenance is very useful, especially for plastic mould injection equipment to reduce contaminants that are produced during the process. • Training personnel on behavioral standards within the clean room environment. • Continuously auditing and assessing clean room procedures and making improvements as needed. Micro-organisms, dust/smoke, unapproved equipment, inadequate environmental controls and human error are among leading causes of contamination in clean rooms. Research has shown that clean room personnel contribute to approximately 80% of all contamination that is found within the clean room.

In a Nutshell.... “If facts are the seeds that later produce knowledge and wisdom, then the emotions and the impressions of the senses are the fertile soil in which the seeds must grow.” - Rachel Carson

July-August 2018

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.

However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

July-August 2018

Editor’s Desk

From the

Growing Importance Of Clean Room Manufacturing In Medical Device Industry The focus of this issue along with other important Medical Device Manufacturing aspects is on “Clean Room Manufacturing” - be it end products, raw materials or components. There are many factors responsible for growing importance of clean including stringent healthcare / medical device industry regulations and demand for quality products. The issue is very elaborately explained by experts covering different stages of manufacturing. To start with, Mr Sanjay Shah of Unikal Consultants has given a very thorough overview on the Purpose / need for clean rooms, the sources responsible for generation of particles and other impurities, how clean rooms work, effective ways of maintaining air quality, international standards and clean room certifications. Injection moulding is an integral part of Medical Device manufacturing. In a very detailed article , Mr Ankur Agarwal of Milakron India, has given explanation of clean room systems with focus on various technologies with respect to Injection Moulding. In another informative article by Medline Department of Conair Group, USA, a very analytical detailing of process of specifying, buying, installing, qualifying and operating Plastics Auxiliary Equipment in a clean room. Extending to the materials aspect, Mr R C Gupta of KLJ Polymers & Chemicals Ltd, introduces the unique position the versatile material, PVC in compounded form has achieved for the benefit of Medical Device Industry. Further, Mr Anil Chaudhary of Operon Strategist has contributed a very well researched article on Importance and Regulatory aspects related to Design Control in order to ensure effective and safe product in the market. This issue also highlights regular features including ,”AiMED & Regulatory Updates”, Industry News, Global Trends, Events and more. We Invites all stake holders of the Industry to participate in IMDI 2018 (www.imdiconferences.com) - The 15th National Conference and Technology Exhibition on “Indian Medical Devices & Plastics Disposables / Implants Industry 2018” to be held on October 26-27, 2018 at Ahmedabad. This annual event, being organized since 2001, is widely supported by leading Industry Associations in Medical Devices, Pharma and Plastics sectors has been organized with a mission to create a platform for the Indian Medical Device Industry for sharing knowledge , Brain Storm and Network. I has also proved to be an effective media for the Industry to interact with Technology / Products / Service Providers. The participation of students of life science courses in this event is an effort to create Industry – Institute Interaction. The “SUSHRUTA INNOVATION AWARD” (SIA) competition being organized as part of this event is an attempt to recognize and appreciate students with innovative ideas and concepts having wider applicability to the Society for development of Medical Technology Products.

Cover Story

Clean Room Environment For Medical Devices - ISO 14644

Sanjay Shah, Managing Director Unikal Consultants, Ahmedabad

Introduction What is the purpose of a clean room? The purpose of every clean room is to control an environment by limiting the presence of sub-micron particles and modifying inadequate environmental conditions. The level to whichthe environment is controlled is what separates one clean room from another. For instance, a Class 10 clean room has 10 particles of size 0.5 microns per cubic foot of air, where as a Class 100,000 clean room has 100,000 particles of size 0.5 micron per cubic foot of air. The need for clean rooms : The electronic, high-tech, semiconductor, pharmaceutical, aerospace, medical and many other industries depend on clean room technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical and medical device manufacturing companies, clean, safe and contaminant-free products are imperative to manufacturing and distributing a viable product. What are the attributes to create and use a clean-room : The largest threat to contaminate devices is personnel working on processing them! Why? The following statistics have been taken from "The Austin Index" to illustrate personnel contamination. Personnel sampled were fully clothed in clean room garments and engaged in one of the following: 1.

Standing or sitting with no movement resulted in 100,000 particles/minute 0.3 microns or larger 2. Sitting or standing, light head, hand and forearm movement resulted in 500,000 particles/minute, 0.3 microns and larger 3. Sitting or standing, average body and arm movement, toe tapping, resulted in 1,000,000 particles / minute, 0.3 microns and larger 4. Changing positions, sitting to standing, resulted in 2,500,000 particles/minute, 0.3 microns or larger. 5a. Slow walking (2 mph), 5,000,000 particles/minute, 0.3 microns and larger. 5b. Average walking (3.57 mph), 7,500,000 particles/minute, 0.3 micron and larger. 5c. Fast walking (5 mph) 10,000,000 particles/minute, 0.3 microns and larger 6. Climbing stairs, 10,000,000 particles/minute, 0.3 microns and larger Let’s see how clean room works to maintain defined standards:

Like anything technical, how a cleanroom works is essentially basic, but wrapped up in a whole lot of jargon, standards, rules and regulations. The basic principles are actually perfectly understandable. Cleanrooms do not eliminate contamination altogether. They control it to an acceptable level. How do they do this? There are three things that keep a cleanroom “clean”: 1. The internal surfaces of the cleanroom and the equipment within; 2. The control of air through the cleanroom; 3. The way the cleanroom is operated. Each of the three things above is as important as the other. Let’s look at them in more detail. Everything in a cleanroom should be “smooth and impervious”. The whole idea is to have surfaces that: • Don’t generate their own contamination ie, don’t create dust, or peel, flake, corrode or provide a nice place for bugs to grow • Are easy to clean i.e., all surfaces are easily accessible and are easily decontaminated • Are rigid and robust and won’t crease, crack, shatter or dent easily. This means that a painted wall is better than a bare brick wall; a stainless steel bench is better than a wooden one. Cleanrooms need a lot of air. As a general rule of thumb, the cleaner the cleanroom needs to be, the more air it will need to use. Air handling systems are designed to circulate air through the room, removing contamination as air is generated and keeping the temperature and humidity stable. Particles (contamination) in the air tend to either float around or slowly settle to the ground, depending on how big they are. The air handling system delivers air into the room in such a way that it captures any particles and sweeps them out of the room. The air taken out of the room and is usually re-circulated through the air handling system where filters remove the contamination. Typically, the air is then recycled back into the room. The amount of air we put into the room is important as well. As noted earlier, generally the cleaner the cleanroom the more clean air you will need to put in. The more air that goes in, the faster the room cleans itself. This can be important for rooms that occasionally experience high amounts of contamination, or something like a sampling room or dispensary where the room needs to be cleaned quickly between operations. So, as the amount of air introduced into a cleanroom is tightly controlled, so is the amount of air that is taken out. Generally cleanrooms are pressurized, which is achieved by taking out slightly less air than is July-August 2018

Cover Story put in. The extra air then leaks out under the door or through the tiny cracks or gaps that are inevitably in any cleanroom. As a rule, within a facility the area you need to be the cleanest operates at the highest pressure. The flow of air out of the cleanroom helps to stop any external contamination from getting in. A good air handling system makes sure that air is kept moving throughout the cleanroom. The properly locating where the air is brought in and taken out is the key to good cleanroom design. The location of the supply and return air should take the highest priority when laying out the room. The most effective way of maintaining the air quality in a cleanroom is to operate it properly. This involves : • minimizing the amount of contamination that escapes from your manufacturing operations • strictly controlling access to the cleanroom to trained personnel – people are the largest source of cleanroom contamination • regularly cleaning your cleanroom to strictly controlled procedures • regular maintenance of equipment • regular monitoring of the filters and air flows and frequent recertification of the cleanroom. This requires defining the number of times the air is changed within a cleanroom. It is simply calculated by taking the total volume of air introduced into the cleanroom over an hour and dividing it by the volume of the room. HEPA is one of the most important elements of a cleanroom. They are large, box shaped filters that remove contamination very efficiently, but they take quite a bit of energy to push the air through them. They must also be monitored and tested regularly to make sure they are still integral. DOP testing or integrity testing is a testing procedure to ensure that a HEPA filter has no holes and is properly sealed in its frame. A micron is a millionth of a metre. A human hair is around 100 microns thick. Bacteria are 1 or 2 microns wide. Particles less than 50 microns cannot be seen by a naked eye. An airlock is a room where personnel, materials or equipment are transferred to a cleaner environment. It can be the size of a small box, through to a large room where personnel change into and out of cleanroom garments. Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry for European, Australian and some Asian countries. Grade A is the cleanest, for sterile operations, through to Grade D for packing or support operations. These Grades can be related to the ISO Classes. Thus there is a need to use clean room technology to reduce the contamination which will ultimately affect cleanliness of the product and in our case medical device being manufactured in the environment. Cleanliness level is classified under specific conditions. The cleanliness of a clean room is measured by the size and number of dust particles in a given volume of air. The rating or classification by the number of particles in a given volume of air and under specific conditions is called cleanliness level class.

CLEANROOM AND CLEAN ZONE CERTIFICATION Regulations vary from country to country, but in most places, the national rule is established by referring to US Federal standard 209E and now ISO 14644. New series of standards ISO 14644-1 have derived its structure July-August 2018

from Federal Standard 209 E, at the same time there are some significant differences that affects medical device and pharmaceutical manufacturers. ISO 14644-1 primarily addresses the cleanroom classification system and the ISO 14644-2 contains specifics on "how" to test and monitor clean-rooms or clean zones for compliance. ISO 14644 International clean-room standard:Part 1 was first published in 1999. It is a 12 part standard. It is applicable to Electronics, healthcare, biotechnology, pharmaceuticals. It replaced FS 209E in 2001 and this was Accepted by EU GMP in 2003 for classification but not monitoring of clean room and FDA aseptic filling guide in 2004. What is the content of these standards series? ISO 14644-1 - Classification of air cleanliness ISO 14644-2 - Specifications for testing and monitoring to prove continued compliance by ACP. Both parts deal with particles only Details are given below with reference to each of these parts. They are divided in two # 1 & 2 ISO 14644-1:2015 - Part 1: Classification of air cleanliness Explanation: Classification is the process of qualifying cleanroom environment by number of particles using a standard method. This was we can determine classification of clean-room according to standards e.g. Room x is ISO class y. This is distinct from routine environmental monitoring and also distinct from process monitoring e.g. ongoing assessment of aseptic filling. ISO 14644-2:2015 - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644 ISO 14644-3:2005 - Part 3: Test methods ISO 14644-4:2001 - Part 4: Design, construction and start-up ISO 14644-5:2004 - Part 5: Operations ISO 14644 – parts #2 : ISO 14644-6: 2004 - Vocabulary ISO 14644-7:2004 - Part 7: Separative devices (clean air hoods, glove-boxes, isolators and mini-environments) ISO 14644-8:2013 - Part 8: Classification of air cleanliness by chemical concentration (ACC) ISO 14644-9:2012 - Part 9: Classification of surface cleanliness by particle concentration ISO 14644-10:2013 - Part 10: Classification of surface cleanliness by chemical concentration No part 11 in draft ISO 14644-12:draft - Part 12: Classification of air cleanliness by nanoscale particle concentration ISO 14644-13:draft - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications ISO 14644-14:draft - Part 14: Assessment of suitability for use of equipment by airborne particle concentration ISO 14644 Became live in December 2015. Thus it forms the latest guideline standard/s for clean rooms. The clean room environment is defined further with its Occupancy states If it is as built: condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present Before the use but at rest: condition where the installation is complete with equipment installed and operation in a manner agree upon by the customer and supplier, but with no personnel present. We will discuss more in future article/s on aspects of maintaining and monitoring clean rooms.

Cover Story Selected airborne particulate cleanliness classes for cleanrooms and clean zones ISO classification number (N)

CLASS LIMITS (particles/m3) Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes shown below 0.1 um

0.2 um

0.3 um

0.5 um

1 um

5 um

ISO Class 1

ISO Class 2

100

ISO Class 3

1000

237

102

ISO Class 4

10000

2370

1020

352

ISO Class 5

100000

23700

10200

3520

832

ISO Class 6

1000000

237000

102000

35200

8320

293

ISO Class 7

352000

83200

2930

ISO Class 8

3520000

832000

29300

ISO Class 9

35200000

8320000

293000

Note: Uncertainties related to the measurement process require that concentration data with no more than three significant figures be used in determining the classification level. Following applicable rules for the manufacture of notified Medical Devices in India, from January 01, 2018 are described briefly.

ENVIRONMENTAL REQUIREMENTS FOR NOTIFIED DEVICES Name of Device

Type of Operation

Grade

ISO Class (At rest)

Cardiac stent/Drug Eluting Stent

Primary Packing and Crimping Washing, Ultrasonic cleaning & Drug coating Assembly, Wrapping & Packaging Laser cutting, Descaling, Annealing & Electro polishing

A C D Well ventilated area

5 7 8 9

Heart Valve

Valve Packing Ultrasonic Cleaning & Visual Inspection Frame & Disc Assembly

A C C

5 7 7

Intra Ocular Lenses

Primary Packing & Sealing Final Inspection Power Checking & Final Cleaning Tumble Polishing & Lathe Cutting

A C D Well Ventilated Area

5 7 8 9

Bone Cements

Final Product Filling Sieving & Calcinations Powder Preparation, Granulation & Drying

A C D

5 7 8

Internal Prosthetic Replacement

Primary Packing Product Preparation Component Preparation

A C D

5 7 8

Orthopedic Implants

Cleaning & packaging (to be sterilized in factory premises) C 7 Cleaning & packaging (Non Sterile- to be sterilized in Hospital) D 8 Cutting, lathing and Polishing Well Ventilated Area 9

Catheters/ Ablation Devices/ Assembly, Coating, Wrapping & Packing I V Cannulae/Scalp Vein Set Component Preparation & Cleaning Hypodermic Syringes/HypoMolding dermic Needles/Perfusion Set

C D Ventilated Area

7 8 9

Also included are IUD, Tubal Rings, Blood Bags, Suture, Staplers, Ligatures, Surgical Dressings & IVD Medical devices (kit/reagents) Specific details are given in Medical Device Rules GSR78E on pages 200-201 of English version.

July-August 2018

Cover Story

All Electric Injection Moulding Machines for Clean Room Applications

Mr Ankur Agarwal, Marketing Communications Milacron India The world of medical manufacturing is considered one with the most stringent requirements. To avoid contamination, the concept of clean room is devised. A clean room for a medical process is a controlled environment with low / negligible level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. Cleanrooms can be classified to a number of standards, the most common being ISO 14644, which is an international metric standard with classification based on the maximum allowable concentration of particles greater than 0.1 µm per cubic meter of air. Compliance to a specific class can be made at particle sizes between 0.1 and 5.0 µm depending on cleanroom class, design, and process requirements. Particulate cleanliness classification is normally determined using a discrete particle counter (DPC) and a specified sampling protocol, with sampling sites located on an evenly distributed grid at a height determined by the work activity. A cleanroom is considered compliant if the average concentration at each location, and the 95% upper confidence limit (required if there

are fewer than 10 locations), do not exceed the particle concentration limits of the specified ISO class at the considered particle size. Clean room varies in size and complexity, and are used in industries such as • Biotech, medical device, • Pharmaceuticals, • Food & Packaging and • Life sciences, As well as critical process manufacturing common in • Aerospace • Optics • Military and Department of Energy • The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. • Some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.

Clean room air flow principles • Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. • Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. • Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-6 classified cleanrooms. • Personnel selected to work in clean rooms, they enter and exit the cleanroom through airlocks, air showers, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body. July-August 2018

Cover Story

Injection Moulding Machine To comply with the clean room standards, MILACRON has developed Elektron – an all-Electric Injection Moulding Machine. This machine eliminates the hydraulic components and circuits thereby enhancing the degree of transmission efficiency and reduced losses. Removal of hydraulic oil also results in No Contamination of the product. The Elektron machine is built with enclosed covers to minimize any accumulation of dust particles in the clean room. The Elektron provides extreme reproducibility, prolonged accuracy and instant repeatability. The low energy consumption results in 40 – 80% energy savings for the manufacturing unit. It has a narrow processing window for thin walled components in engineering polymers. High uptime, smaller shot size utilization, low emissions, water savings, noiseless environment need are the features of Elektra for a clean room necessity.

July-August 2018

Cover Story Cycle time reduction respect to hydraulic machine T1: Clamp tonnage & pre-injection T2: Tonnage Breakaway T3: Clamp Open & Refilling (NSOV / Mould gate) T4: Clamp Open & Ejector Forward T5: Clamp Close & Ejector Retract

Clean Air Module – CAM is also available to achieve clean environment in moulding area. The basic working principle of the CAM module is described below:

Schematic Drawing of Clean Air Module

Reading Points

Environment at Moulding area

Environment at Part drop area

The various parts of CAM are as follows: Operating Unit Preliminary Filter Ventilator Main Filter Illumination Ionisation Unit

Classification Filtering

• Clean room classification 3 at air outlet possible • Clean room classification 7 in the mould area in production (according to ISO 14 644) • • • •

Preliminary filter, type F 5 High performance filter for suspended matter, type H 14 Main filter monitoring via differential pressure transmitter Signal lamp for filter exchange and display on machine screen

Ionisation

• DC high voltage • Simultaneous positive and negative electric charge • Plastic frame system with electrode strips

Overpressure

• Against environment

Ventilators

• Radial ventilator with backward curved blades

Air Flow

• Variable pre-adjustable ventilator rotation speed

• Control of function Ventilator monitoring • Limit switch • Indication of function and display on machine screen Illumination

• Energy saving lamps

Mold change

• Moveable along the machine axis above mould mounting area

July-August 2018

About Milacron Milacron is a global leader in the manufacture, distribution and service of highly engineered and customized systems within the plastic technology and processing industry. Milacron is the only global company with a full – line product portfolio that includes hot runner systems, injection molding, blow molding and extrusion equipment plus a wide market range of advanced fluid technologies. Visit Milacron at www.milacronindia.com For more information, contact: Ankur Agarwal, Marketing Communications, Milacron India Ankur_Agarwal@milacron.com

Cover Story

Simplifying Set-Up of Plastics Clean-Rooms By : Medline Department, The Conair Group, USA

Navigating the highly regulated world of medical manufacturing and clean room operations can be a daunting, time-consuming task. Regulations and standards, developed by such organizations as the U.S. Food & Drug Administration, the International Organization for Standardization (ISO) and others, are many and complex. For those who want to begin manufacturing medical plastic products and components, understanding the regulatory requirements is only the first hurdle to be overcome. Then specialized facilities, including cleanrooms (Figure 1), white rooms and hybrid rooms, need to be designed and built, and processing equipment needs to be sourced with special attention not only to performance, efficiency and quality, but also to cleanliness, calibration, maintenance and record-keeping. Mistakes can result in delayed start-up, lost production, quarantined parts, rework and lack of process validation.

Figure 1 To simplify the process of specifying, buying, installing, qualifying and operating plastics auxiliary equipment in a clean environment, Conair has introduced a line of products – 170 units in all – for molding and extrusion of medical products (Figure 2). The new MedLine® product line includes equipment for conveying and storage, resin drying, blending, heat transfer and downstream extrusion. All are based on proven Conair designs, but they have been specially sized, configured, documented and supported for use in cleanrooms and other controlled environments. Here is why that’s important: REGULATORY SITUATION The regulations that govern today’s cleanrooms were first developed in the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. As cleanrooms became more sophisticated, the industry recognized a need for more wide-ranging standards for cleanroom classification and testing. This led to the formation of ISO Technical Committee 209, which was tasked with the "standardization of equipment, facilities, and operational methods for cleanrooms and associated controlled environments." Today, the most common standards governing “the methods, facilities, and controls” used in manufacturing, processing, and packing of plastics medical devices are : • ISO 9001 – based on a number of quality management process approach and continual improvement and aimed at enhancing customer satisfaction through continual improvement of systems and processes, and conformity to customer and regulatory require ments. • ISO 14644 - a tiered structure that allows a specific maximum number of particles per cubic foot of air cleanliness in various classifications of cleanrooms

and other controlled environments. (Similar to US Fed Std 209E.) • ISO 13485 – a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. • ISO 17025 – the single most important standard for calibration and testing • FDA 21CFR – current good manufacturing practices (CGMP) for medical devices and pharmaceutical packaging. These standards and regulations provide the checks and balances that lead to consistent and predictable outcomes in reduced product variation. Following their guidelines, and using good cleanroom management techniques, will help ensure quality and reduce costly mistakes in the production of medical plastics components. In developing the MedLine family of equipment, Conair carefully considered each of these standards. Then they identified equipment features, calibration standards and documentation that can help processors get to a state of compliance faster and more easily, whether they need a single piece of equipment or a complete system DIFFERENT LEVELS OF CLEAN Depending on the products being manufactured, medical plastic processors have adopted several different configurations for clean environments. Each requires a different level of clean. See Tables I and II. A White Room is a typical entry-level clean environment meeting ISO 9 standards. Although a white room is typically air-conditioned, there is no attempt made to control particulate or air change-over. Otherwise, it is treated like a cleanroom, with gowning, hairnets and shoe covers. Typical applications would include lip-balm tubes, pill holders, medical cases, thermometer housings and the like. Although standard equipment has been used in white room environments for many years, there is increasing focus on the cleanliness and compliance. Calibration, preventive- maintenance, and installation qualification procedures are becoming more commonplace. ISO 8 or Class 100,000 cleanroom applications – for instance, pumps, auto-injectors, blood-bag components, diagnostic and testing devices – require an approach that limits particulate generation by equipment and per July-August 2018

Cover Story sonnel working in the room. These rooms generally have air turnover rates of 5 to 48 times per hour in order to keep particulate levels in compliance with the standards. The equipment used in ISO 8 environments must be designed and manufactured to minimize generation of particulate, chemical vapors and airborne microbes. ISO 13485, which governs the manufacture of medical devices, generally requires this or more stringent levels of cleanliness. Equipment used in an ISO 8 environment usually is made with anodized aluminum, certain acceptable powder coatings, chemical resistant HMIs (to allow antiseptic wipe down of surfaces), and even urethane casters that allow machines to be moved for cleaning without generating rubber or vinyl particulate.

ISO 7 (Class 10,000) cleanrooms have more stringent requirements. These rooms generally have air turnover rates of greater than 60 to 90 times per hour. Humidity control is an important factor in controlling static electricity and bacteria growth. Because of this, many of these rooms also require bio-burden testing (to measure the number of micro-organisms on surfaces), antimicrobial-coated materials on room wall panels, equipment coverings and other surfaces. Room air ionization also becomes more important. This much-cleaner environment is much more suitable for pharmaceutical and sterile device packaging, syringes, vials and implantable devices. Equipment, then, needs to be designed and manufactured with consideration for these more stringent requirements. That means stainless-steel housings,

Table I: ISO 14644-1 cleanroom standards Class

Maximum Particles/ft3 =0.1 µm

=0.2 µm

=0.3 µm

=0.5 µm

=1 µm

=5 µm

ISO 1

2.37

1.02

0.35

0.083

0.0029

ISO 2

100

23.7

10.2

3.5

0.83

0.029

ISO 3

1,000

237

102

8.3

0.29

Fed Std 209E equivalent

Class 1

ISO 4

10,000

2,370

1,020

352

2.9

Class 10

ISO 5

100,000

23,700

10,200

3,520

832

Class 100

ISO 6

1.0×106

237,000

102,000

35,200

8,320

293

Class 1,000

ISO 7

1.0×107

2.37×106

1,020,000

352,000

83,200

2,930

Class 10,000

ISO 8

1.0×108

2.37×107

1.02×107

3,520,000

832,000

29,300

Class 100,000

ISO 9

1.0×109

2.37×108

1.02×108

35,200,000

8,320,000

293,000

Room air

Table II Fed. Std. Class

ISO Equivalent

Air Change Rate per Hr.

Class 1

ISO 3

360 – 540

Class 10

ISO 4

300 - 540

Class 100

ISO 5

240 - 480

Class 1,000

ISO 6

150 - 240

Class 10,000

ISO 7

60 - 90

Class 100,000

ISO 8

5 - 48

Examples of equipment being offered as part of the expanded MedLine® family of products include (from L-R) a Carousel® Plus desiccant-wheel dryer, a ResinWorks central drying system, MedLine MicroReceiver and a redesigned MedLine puller/cutter with integral conveyor. July-August 2018

Cover Story castings, and covers instead of anodized aluminum, as well as FDA-complaint gasket materials and plenum-rated cabling. Particulate control is much more important and so equipment typically will be cooling-fan-free, using water cooling or remote exhaust valves. These are just a few things that need to be considered for an ISO 7 environment. Hybrid Cleanrooms are typically installed to minimize costs or to adapt to building design constraints. The cost to build, run and maintain true cleanroom conditions can be high and so the smaller they are, the less they cost and the easier it is to maintain the necessary cleanliness. Hybrid rooms are designed so that most of the particulate-generating equipment is kept outside the clean environment. Polymer dryers, blenders, and vacuum conveyers, for instance, would be installed outside and plumbed or connected to processing equipment inside the cleanroom. Thus, standard equipment can be spec’d without cleanliness concerns. In some cases, even the processing machines operate outside of the room and only molded or extruded components enter the room under controlled conditions for final processing. This arrangement can pose a design and installation challenge but considerable money can be saved by not having to buy or maintain special equipment. PEACE OF MIND Conair has used the MedLine trade name previously to cover downstream extrusion equipment designed especially for producing precision tubing including multi-lumen heart and brain catheters. Now the registered trademark has been extended to encompass the full range of medical auxiliaries, including not only downstream extrusion, but also material-handling, drying, blending/feeding and heat-transfer equipment.

AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026.Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

In all, Conair offers over 40 models across the five equipment families with 170 fully configurable variations to match the complexity of the environment and/or regulatory standards. Machines are factory calibrated to meet regulatory requirements, labeled and certified. Installation qualification forms are supplied, ready to be filled out and filed. Preventive maintenance procedures required for regulatory compliance are also detailed and reporting forms are provided. This documentation significantly reduces the paperwork processors typically need to generate in order to validate compliance of their cleanroom facilities and processes. Besides the mechanical and finishing features like non-ferrous fittings, powder coating of cabinets, stainless-steel components, HEPA filters and chemical-resistant HMI screens, many MedLine products also have control and data-gathering capabilities that are indispensable to clean-room operation and documentation. For instance, a Material Vision Proofing or MVP system provides critical verification in central resin distribution systems. The Drying Monitor 3 delivers early alert notification should drying conditions drift beyond critical set-points. Blenders can be equipped with SQL data-gathering packages and the FLX conveying control has an alarm history log. What the MedLine label signifies to the medical plastics industry is peace-of-mind. When a processor selects a piece equipment with a MedLine label on it, whether it is designed from the ground up for cleanroom applications or it is a part of a standard product line, they can be sure it has been pre-evaluated, pre-configured, pre-calibrated and is suitable to meet the requirements necessary for compliance with applicable standards.

AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 pawantiwari1978@gmail.com

July-August 2018

Materials

Polymer Compounds For Medical Devices

R C GUPTA, Sr. General Manager KLJ Polymers & Chemicals Ltd. SILVASSA

The use of PVC compounds in medical device manufacture for more than 50 years has demonstrated its great ability to satisfy the demanding requirements of the medical health care industry. Before PVC can be made into products, it has to be modified by adding a range of additives like plasticizers, stabilizers, lubricants, processing aid, impact modifiers, antioxidants, UV stabilizer and pigments. Various grades of PVC compounds meet national & international standards like USP, ISO, heavy metal free, kink resistant, ESD protection etc. India is among the fastest growing economy of the world. With the Government of India’s thrust on health care, sector grew at a rate of 17% from 2010 to 2016 and is expected to grow by more than 15% during 2016 to 2020. That means, requirement of medical devices increases by same percentage. One of the most versatile & popular polymer used for medical devices is Polyvinyl chloride. It has widest range of applications from rigid to flexible, opaque to transparent, colored and insulating or conducting.

KLJ is manufacturing medical grade compound in dust free clean room area on automatic plant, where human touch is minimal.

The use of PVC compounds in medical device manufacture for more than 50 years has demonstrated its great ability to satisfy the demanding requirements of the medical health care industry. PVC was originally developed to replace natural rubber and glass. Medical devices made from these traditional materials need cleaning and re-sterilization before reuse. High performance of PVC material at a reasonable cost advantage made it possible to manufacture single use devices, replacing glass and rubber products.

Various grades of PVC compounds meet national & international standards like USP, ISO, heavy metal free, kink resistant, ESD protection etc.

Before PVC can be made into products, it has to be modified by adding a range of additives like plasticizers, stabilizers, lubricants, processing aid, impact modifiers, antioxidants, UV stabilizer and pigments. Additives will influence or determine the mechanical properties, light and thermal stability, color, clarity and electrical properties of the product.

Complete analysis is carried out periodically by approved external laboratory according to USP class VI and ISO 10993-1.

KLJ is into medical compounding business for the last 50 years. KLJ compounds can be sterilized by ETO , gamma rays and steam. We are known for offering a wide range of PVC compounds for medical applications that are rigid and extra soft both for molding and extrusion applications. July-August 2018

PVC compounds are manufactured with premium grade of plasticizers, phthalate & non phthalate Kanatol-800FG, Kanatol-8080 and DINCH. These plasticizers are also manufactured by KLJ at their KLJ plasticizer plant. In addition to phthalate, KLJ also supply adipates, malleate, epoxy and other plasticizers. Following the medical sector requirements our company developed a range of DEHP free products.

Our compounds are formulated using raw materials, which complies to REACH, ROHS and USP requirements. KLJ Quality Assurance is able to perform chemical and toxicological analysis, appearance, ox disable substance, acidity, alkanity & UV spectrum), to measure hardness of compound, thermal stability, and to carry out an extrudability test on each product batch.

Main applications of KLJ compounds are blood bags, soft medical tubing, heart/lung bypass kits, blood tubing, IV sets tubing, drip chambers, stiff medical tubing,, catheters, disposable syringes, Soft molding components face masks, enema nozzles, transfusion & dialysis components, urine bottles, etc. Another versatile polymer used in medical devices is TPE, Thermo Plastic Elastomers, pure & safe material. TPE for medical devices offer many advantages: • Minimum of potential extractable and leach-able

Materials • • • • • • • •

FDA compliance and sterlizability. Silicon, latex & PVC free Offer excellent ceiling and adhesion performance. Soft-touch appeal 40 Shore A to 40 Shore D Transparent & crystal clear Anti kinking Sterlizable with gamma, ETO and steam

KLJ is one of the renowned manufacturers of Thermoplastic Elastomer for injection molding and extrusion products. KLJ has separate R&D departments attached to each plant, which are well equipped with modern equipments like Brabender Plasicorder, FTIR, UTM, MFI, Spectrophotometer, mini twin screw extruders etc. Our experienced R&D group is able to custom formulate unique TPE Alloys & PVC compounds and incorporate functional additives in support of any most demanding product developments. KLJ offers customized solutions manufactured at their High capacity automated plants. Research & Development is at the centre of developing innovative solutions & is recognized by DSIR. To ensure consistent quality and high performance, all products undergo extensive R&D and Application Testing before entering the market. KLJ Group manufactures the widest range of Plasticizers of consistent quality and reliable performance for standard and special applications, along with dedicated lines for non-phthalate Reach compliant plasticizers.

National Healthcare An ISO 9001 : 2008 Company

Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in

July-August 2018

Manufacturing

Design Control: Importance And Regulatory Aspects

Anil Chaudhari, CEO Operon Strategist

The Design and Development of the product play vital role in total life cycle of product and to ensure the effective and safe product in market. The well-planned and documented approach is expected while conducting the design and development (D and D) activity.

The Design and Development of the product play vital role in total life cycle of product and to ensure the effective and safe product in market. The adequate design documentation helps to improvise the product performance while product remains in market. As per FDA data, significant portion at about 44 % percent of the recalls of medical devices are due to lack of the adequate Design Controls. The minimum expectations are clearly laid down in 21 CFR part 820.30 and Clause 7.3, ISO 13485:2016. As per expectations design and development activity has to be performed and evidenced through DHF at the contract manufacturing site, Legal manufacturers site, design and development firm as per the business module and it shall be continually maintained and upgraded. The design control initiates at the stage, where the manufacturer decides to make a product and start finding the marketed products already available in the market, we can call them as a “Predicated devices”. The manufacturer is expected to create the “ Design Team” which shall have the Product designers, Regulatory expert, QA experts, representative of the user, manufacturing expert, marketing representative, the internal reviewer and the peer reviewer. The representation and hierarchies of the activities are given in Figure 1:

Design Control Overview DEFINATION

DEVELOPMENT AND VERIFICATION

VALIDATION

COMMERCIALIZATION

Product Life Cycle

Research

Risk Mgmt

Design Change

Design Transfer

Design Velidation

Design Verification

Design Output

Design Input

CONCEPT / FESIBILITY

Clinical Study

Prototype

Pilot

Design Input Review System Phase Review Definition

July-August 2018

Design Input Review Sub-System Phase Review Development & Verification

Pre-Production Design Review Design Freeze

Design Review Pre-Clinical

Production

Design Review Pre-Submission

Phase Review Design Validation

Design Validation Review

Phase Review Commercialization

Manufacturing The well-planned and documented approach is expected while conducting the design and development (D and D) activity. The adequate “design plans” are shall be available during all stages of the Design and development, defining the roles and responsibility in timed manner for of all team members. The design plans are continually updated as the activity progresses. The study of the marketed products and data collected about the characteristics of the products can be used as design inputs. The design inputs are also collected from the Initial risk analysis as per ISO 14971, “Medical devices — Application of risk management to medical devices”. By Performing the usability Engineering studies as per standards, like ISO 62366 “Application o f usability Engineering to medical devices”. The recalls happened before on the similar devices is also a important study to get away from the similar design flaws. All the data collected from the available studies and resources are used as “Design Inputs”. The manufacturer shall always try to establish as much as possible the available data to create the design inputs. The design inputs shall not be ambiguous and shall be clearly defined, which helps to create the adequate design outputs. It follows the philosophy of “Garbage in..Garbage out” poor design inputs create the poor design outputs. The product characteristics required to achieve the design input expectations are called as “Design outputs”. The design outputs are normally in form the raw material specifications, finished good specifications, drawings, in-process controls, machineries and equipment required, process flow charts, vendor details etc. The “traceability matrix” shall be created to demonstrate the linkage between design input and the design outputs.

the “Summary report” The report shall be reviewed to check if the design output is giving the expected design input expectations. In case, design output attributes fails to achieve the desired expectations laid down in design inputs, then it may call up for the changes in the design. All the changes shall be documented through the “design change requests” which shall be approved by all the team members. Once the change request is approved, then design outputs and/or design is changed with the aim to achieve the expectations given in the design inputs. The repeat verification is performed to recheck if the expected design inputs are being achieved. It is necessary to verify if the device achieves the user needs before launch of the device in market for commercial use. The activity is called as “Design Validation”. The typical example of the validation studies may be simulated product study, clinical trials, bench testing, Animal studies, reliability studies, usability studies, market surveys etc. The studies are carried out on the production equivalent. The validation plan shall be approved and studies conducted. The studies carried out are adequately documented and reports are prepared. The data collected during the validation activities are used for 510 (k) submission, Technical File, Device Master File etc. The risk analysis and usability studies on final product shall be performed to know, the exact status of the designed product going and suitability of the same for commercial purpose. The output of the risk analysis and usability studies can contribute to make the “Instruction for use” (IFU). The relation ship between design verification and validation can be determined in Figure 2 : The design verification determines “If we design the product right” and design validation determines “If we design the right product”.

During all the stages of the development, the “Design reviews” of the activities shall be performed by the team members and the peer reviewers to check if the project is being moved to achieve the user needs. The comment from the reviews will determine the changes in the plan or the design and shall be circulated to all the team members.

The compilation of all documentation done during the design and development activity is called as “Design History File” (DHF). The DHF is the dynamic document and shall be amended as the changes in the design happen based on the market performance of product. The Corrective and preventive actions arising from the various sources related to product performance may lead to design changes and the activity performed is amended in the DHF.

The adequacy of the design output against each of the design input shall be demonstrated. It can be achieved through the set of experimentation and the activity is called as “ Design Verification”. The design verification activity shall be done by creating the test cases for each of the design output and corresponding input. The typical example of the verification studies may be technical, physical, chemical characterization or other engineering analysis, bench testing etc. The test protocols are approved before execution and are executed and data collected. The compilation of the data shall be done to interpret the results in

The design transfer shall be performed to the commercial manufacturing site, the activity is called as “ Design Transfer”. It is the effort to transfer the “know-how” and experience gained during the design and development activity. The design transfer involves the transfer of the Raw material specification, Finished goods specifications and test methods, Test equipment, Process flow charts, manufacturing machines and utilities specifications, In-process test parameters, release parameters, vendor details, labeling details, Instruction for use, Primary and secondary packaging material details etc. The document in which this is

July-August 2018

Manufacturing

Events Calender

mentioned is called as “Device Master record” (DMR). The relationship between DHF, DMR and DHR is shown on figure 3: Figure 3: The relationship of the DHF, DMR and DHR can be shown in below schematics:

Medicall India’s Larges B2B Medical Equipment Exhibition 21-23 September, 2018 Venue : Pragati Maidan, New Delhi, India

The DMR becomes the basis to formalize the “ Device History record” (DHR). The DHR provides the adequate traceability for the commercial batches manufactured. In case of the customer complaint or any adverse events, the complete batch history can be traced through DHR. The continual and deliberate efforts shall be made to collect data from users about the performance of the product and to evaluate the impact of the residual risks posed to the customer the activity is called as “Post market surveillance” (PMS). The adequate post market surveillance will help to “Fine tune” the design of the product and put added features to the device to improvise the device.

15th National Conference And Technology Exhibition On Indian Medical Devices & Plastics Disposables / Implants Industry 2018 Date : 26-27 October, 2018 Venue : Ahmedabad Management Association, Ahmedabad, Gujarat Medical Fair India 2019 25th International Exhibition and Conference Pragati Maidan, New Delhi, India 21-23 February, 2019 K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber Date : October 16 - 23, 2019 Venue : Dusseldofr, Germany

The design and development activity plays a vital role in the total lifecycle of the device. This necessitates the regulators and certifying bodies to have the detailed review of the design and development documentation to ensure compliance.

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • Urine Container • Adaptors (PP) • All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures • And many other Surgical Medical Components Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 SANIDHYA ENTERPRISE Office : 29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (M) 9825474789 E-mail : sanidhya.ent@gmail.com July-August 2018

Alpha Medicare and Devices Ltd.

(taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com

0434

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com 40

July-August 2018

Global Trends Global Market Insights : Snapshots • Medical Polymers • Medical Injection Molding • Medical Device Contract Manufacturing • PVC Hospital Waste Recycling • The global Medical Nonwovens market is valued at million US$ in 2017 and will reach million US$ by the end of 2025, growing at a CAGR of during 2018-2025. (https://thefreenewsman.com) • The global medical device contract manufacturing market was valued at $70 bn in 2017. Visiongain forecasts this market to increase to $115 bn in 2022. The market will grow at a CAGR of 9.5% throughout the forecast period. (https://markets.businessi nsider.com)

• Medical Plastics : Market Scenario : The polypropylene raw material is anticipated to dominate the market, which is followed by the ABS segment. The growing application of ABS in consumer appliances, medical devices, electronic housing and others is attributed to the growth of this segment. On the basis of the application, the packaging is expected to register over 30% of total market share during the forecasted years. (http://www.digitaljournal.com/pr/3893275#ixzz5O17NNYnL)

• Global plastic injection molding market expected to reach $233 billion by 2023 In 2017, the global market for plastic injection molding was valued at $117 billion; it is expected to reach $233 billion in 2023, reflecting a 10.9% compound annual growth rate, according to a new report from BCC Research , Injection Molding: Global Markets and Technologies through 2023.

Rising demand across several vertical industries such as packaging and food and beverages is expected to drive growth. One robust segment is the medical device space, which accounts for 18.7% of the plastic injection molding market and is expected to see strong growth over the forecast period as healthcare becomes an increasingly integral part of household expenditures, especially in more • 150 hospitals in Australia developed countries with aging populations, and New Zealand to recycle PVC said the report. medical waste by end of 2018

The PVC Recycling in Hospitals programme has diverted over 200 tonnes of high-grade PVC waste from landfill to recycling sites since its launch in 2009. The programme helps redirect material to reprocessors in Australia and New Zealand, enabling manufacturers to use the recycled polymer in goods such as garden hoses or outdoor playground matting. By collecting IV bags, face masks and oxygen tubing for recycling, hospitals can help contribute to carbon and energy savings; especially considering that PVC is 100% recyclable. Now the programme, which is managed by the Vinyl Council of Australia and its member partners, is aiming to reach 150 hospitals by the end of 2018. “Thanks to great support and enthusiasm from healthcare professionals, the PVC Recycling in Hospitals program is now operating in every state in Australia except the Northern Territory. “It’s a great example of how the healthcare sector can demonstrate leadership in PVC sustainability and recover high quality material that can be genuinely recycled locally for use in new products. We are currently looking at further end product applications for the recyclate,” MacMillan added. In the UK a similar project is currently in its pilot phase and is being financed by the European’s PVC industry’s sustainable development programme. https://www.medicalplasticsnews.com/news/150-hospitalsin-australia-and-new-zealand-to-recycle-pvc-me/

July-August 2018

An ISO & CE certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.

Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.

July-August 2018

Central Aid Package To Help Medical Device Parks To Set Up Common Facilities; Rs.100 Crore Budgeted For 2018-20 New medical device parks coming up in various states can avail a one-time financial assistance of up to Rs.25 crore to set up common facilities such as component testing units, electro-magnetic interference laboratories and radiation and sterilisation checking centres under a new scheme proposed by the Central government.

approval.

According to official sources, the scheme will be implemented through a one-time grant-in-aid to be released to a state implementing agency (SIA) set up for the purpose. The initiative is expected to help reduce the cost of production significantly at medical device parks and would be beneficial to new zones planned in Andhra Pradesh, Telangana, Tamil Nadu, Maharashtra and Gujarat.

Of late, the government has been adopting strategies to promote localisation in the medical devices industry and the aid plan is the latest step in that direction. The new Medical Devices Rules, which came into effect in January, were introduced to remove regulatory bottlenecks in the government’s Make in India initiative and facilitate ease of doing business. The rules classify medical devices into Class A, B, C and D based on associated risks.

The Department of Pharmaceuticals (DoP), which proposed the scheme, allocated Rs.100 crore for the initiative for the next two years. The maximum limit for the grant would be Rs.25 crore per medical device park common facility centre (CFC) or 70 per cent of its project cost, whichever is less. The grant will be cleared by a Scheme Steering Committee (SSC) headed by the DoP secretary after screening the proposal. The CFC should go on stream within two years from the date of final

A tripartite agreement should be entered into among the Central government, the state government concerned and the SIA for CFC projects. The SIA should be a legal entity set up by the state government for implementing the park project and responsible for its day-to-day management.

According to official data, the sector is valued at $5.2 billion and contributes 4-5 per cent to the health care industry. Currently, there are about 750–800 medical device manufacturers in the country, with an average investment of Rs.170–200 million and an average turnover of Rs.450–500 million. (http://www.pharmabiz.com/ NewsDetails.aspx?aid=109834&sid=1 - July 5, 2018 )

Indian Pharmacopoeia Commission ( PC ) issues first 'Standards for Medical Devices - To provide information on quality Parameters Nearly eight months after the implementation of the Medical Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has brought out the first reference document for medical devices manufactured and sold in the country. Framed mainly on the basis of MD Rules, the 241-page draft rule book is expected to provide manufacturers, licence holders, regulators and healthcare professionals with requisite information on regulatory and technical requirements under one umbrella. In addition to the new MD Rules, the document is based on the standards adopted in Indian Pharmacopoeia 2018, British Pharmacopoeia, Japanese Pharmacopoeia, European Pharmacopoeia and the Bureau of Indian Standards. Currently, India’s medical device sector is dominated by multinational companies, which is evident from the fact that about 80 per cent of the sales are generated by imported devices. Though many multinationals have set up operations in India over the years, a majority of them focus on distribution of imported devices and support functions. The MD Rules 2017 were framed around the guidelines of the Global Harmonisation Task Force to ensure that the Indian norms are on par with those in vogue globally. Medical devices, both indigenously produced and imported, now have to conform to the best international practices of manufacturing. Against this backdrop, the new reference document will come in handy since the industry is growing at a rapid pace and there is need for an easy-to-access guidebook on regulations and export-import guidelines. The draft document is likely to be modified as the IPC has requested industry experts and other stakeholders to submit their comments and suggestions on it. Comments can be submitted July-August 2018

till September 1, 2018. The document, reviewed by Pharmabiz, has elaborate sections on classification, registration process, grouping and labelling. More than 20 pages are dedicated for classification of devices and quality parameters. The reference manual is the latest step from the Union health ministry to ensure the reliability of medical devices available in the domestic market. Plans are afoot to bring all implantable medical devices and other critical medical equipment under the purview of the Drugs and Cosmetics (D&C) Act 1940 and the Central Drugs Standard Control Organisation has notified the list of devices to be regulated under the Act. Apart from all medical implantables, the list includes defibrillators, bone marrow cell separator, dialysis and X-ray machines as well as PET, CT scan and MRI equipment. While welcoming these positive moves, the domestic industry representatives continue to make a pitch for creating a separate act to regulate medical devices. A draft medical devices regulatory bill has been lying with the health ministry since 2016. “The law to regulate medical devices needs to be passed and stakeholder consultation for the draft created by the health ministry needs to be expedited as clearly medical electronics are not drugs and a misfit in current legislation of D&C Act,” says Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry. (http://www.pharmabiz.com/ NewsDetails.aspx?aid=110485&sid=1&utm_source=Mailer&utm_ medium=ET_batch&utm_campaign=ethealth_news_2018-0810 - , August 10, 2018 )

Govt amends Medical Devices Rules to remove regulatory hurdle, all NABL-accredited labs can issue performance report on IVDs The approval process for in-vitro diagnostic (IVD) devices will soon enter the fast track as the Central government has done away with a regulatory bottleneck and allows all NABL-accredited laboratories and institutes specified by respective state licensing authorities to issue performance evaluation report (PER) on such products. According to top officials at the Central Drugs Standard Control Organisation (CDSCO), the health ministry has amended relevant provisions in the Fourth Schedule of the Medical Devices (MD) Rules to this effect after weighing up suggestions from various industry stakeholders. The proposal was backed by the Drugs Technical Advisory Board (DTAB), the country’s highest drug advisory body on technical matters, in May. IVDs include all blood testing techniques and test kits that can detect major diseases or infections including Human Immunodeficiency Virus (HIV) and viral hepatitis. “The amendment will facilitate ease of doing business as a manufacturer can now obtain the PER from any accredited laboratory in the country,” Dr Ravi Kanth Sharma, Assistant Drug Controller, CDSCO, told Pharmabiz. As per the MD Rules 2017, it is mandatory for an applicant to submit a PER to obtain approval for a product. In June, almost six months after notifying the rules, the government named five laboratories in the public sector to evaluate medical devices and the Noida-based National Institute of Biologicals (NIB) was designated as the apex institution to test IVD devices for HIV, Hepatitis B surface antigen, Hepatitis C virus, blood grouping sera, glucose test strip and analyser-based glucose reagent. However, there was no designated laboratory for many other IVDs, including those for malaria, dengue, chikungunya, syphilis, typhoid, tuberculosis or cancer markers. With the new amendment, a manufacturer can approach any NABL-approved lab or healthcare

facility approved by National Accreditation Board for Hospitals and Health care Providers and obtain a PER. Industry representatives have cheered the move as a step in the right direction. “This will help manufacturers get products tested nearer to their facility and is a welcome move for ease of doing business. Earlier they had to get products tested at NIB and if there was any dispute it was difficult to resolve as the tests were done by the highest decision maker in hierarchy of regulations for IVD testing. Now these accredited labs will be the safe middle ground and disputes can be referred to the higher hierarchy of NIB for retest of batch and settlement. Industry is hopeful that this initiative will greatly reduce the time taken for issuing the manufacturing licenses as currently it’s taking 6-9 months against 3-4 months earlier, and we were hopeful that, with an online application system, the process will hasten the process than earlier and not make it lengthier," Forum Coordinator of Association of Indian Medical Device Industry Rajiv Nath said. Of late, the government has been adopting various measures to ensure the quality of medical devices sold in the country. Recently, an extensive set of safety and performance guidelines was formulated by the ministry. These norms are applicable to all medical devices including IVDs. In the coming days, the government may also remove the clinical trial clause for IVDs which have been marketed for a minimum of two years in countries such as the UK, the US and Canada to increase their availability in the domestic market. The DTAB has already agreed to this proposal, the minutes of its meeting show. Currently, India imports around 80 per cent of its medical devices’ requirement and a fourth of that comes from the US. The overall medical devices market in the country is estimated to be Rs. 640 billion. ( Pharmabiz - August 3, 2018, )

Use Auto-Disable Syringes to Prevent Infection: Medical devices industry official The official said Punjab has the highest incidence of hepatitis B and C spreading from drug addicts to other patients in the already-challenged healthcare infrastructure. Rather than banning the sale of syringes without a doctor’s prescription to prevent drug abuse, it will be better if the government hastens the switch over to auto-disable syringes, said a senior medical devices industry official. He was referring to the recent ban on sale of syringes without doctor’s prescription in some districts in Punjab as a measure to fight drugs. “While the law exists in the US of syringe sale limited to prescription, this is not the case in India, and the intent of solving a problem may be noble but the management tool being used is questionable,” Rajiv Nath, forum coordinator at Association of Indian Medical Device Industry (AIMED) said. He is also the joint

managing director of Hindustan Syringe and Medical Devices Limited. He said Punjab has the highest incidence of hepatitis B and C spreading from drug addicts to other patients in the alreadychallenged healthcare infrastructure. According to Nath, the ban on sale of syringes without prescription will amplify the problem of reuse by drug addicts and accelerate the spread of hepatitis C in Punjab. “It would be more prudent to accelerate a switch to auto-disable syringes in private sector in Punjab and have a state policy as was done by government of Andhra Pradesh to prevent reuse with the help of state drug controller to address this magnifying problem in Punjab,” Nath said. https://www.hindustantimes.com/punjab/use-auto-disablesyringes-to-prevent-infection-medical-devices-industry-official/ story-jfn01LngFoFYRFNo6q7YNM.html - July 7, 2018. July-August 2018

Industry News Mitsubishi expanding Indian footprint with PVC business acquisition Japan’s Mitsubishi Chemical Corp. (MCC) is acquiring the PVC compound business of WelsetPlast Extrusions Pvt. Ltd, a Mumbai, India-based plastics specialist.

The company has indicated that it is also expanding its TPE business for automotive applications in India, focussing mainly on airbag covers.

Welset currently has two masterbatch and PVC compounds businesses and MCC expects the acquisition of the PVC business to be completed by the fourth quarter of this year.

With the acquisition, MCC expects to find a foothold in the medical PVC compound business, while improving its existing PVC and thermoplastic elastomers businesses in India and ASEAN markets.

According to Tokyo-based MCC, Welset’s PVC compound business has a “leading” market share in India’s medical segment, and a solid presence in the ASEAN markets in general. The Japanese supplier is already active in the Indian market, manufacturing and supplying thermoplastic elastomers in India.

The acquired business has a production plant in Silvassa, west India, and manufactures medical devices, electrical wires and cables. As of 1 June, the plant has 100 employees. (http://www.plasticsnewseurope.com, 26 June 2018)

Covestro Strengthens its Global Film Production Covestro intends to expand its global production capacities for special films, to meet the growing demand in all regions. The company plans capacity expansions at its site at Map Ta Phut, Thailand, Guangzhou, China, South Deerfield, USA, and Dormagen, Germany. More so, Covestro will invest more than •100 million to expand any associated infrastructure and logistics. Current plans are anticipated to create over 100 jobs across the world for the operation of the new plants. Speaking about the plans, Dr Markus Steilemann, CEO of Covestro, said: “With this capacity expansion, we are investing in promising technologies and applications. The innovative hightech materials offer solutions for future challenges and deliver their contribution to making the world a brighter place."

"We want to expand our global film production as quickly as possible to meet the growing demand in the regions," explains Michael Friede, global head of the Coatings, Adhesives and Specialties segment. "With modern and efficient production facilities, we want to offer our customers growth opportunities and strengthen them in their competitive environment. " At the Guangzhou site in China, Covestro’s focus will initially be on converting the existing coextrusion line. New capacities are expected to be available by the middle of 2019 with a second phase already planning to be scheduled. Dr Thorsten Dreier, global head of the Specialty Films business, said: “With these expansions we create the conditions to meet customer requirements more flexibly and quickly. Our tailor-made products enable versatile applications in various industries.” (https://www.medicalplasticsnews.com, 20 July 2018 )

AMTZ sets up Centre for Bio-Materials Testing A scientific facility - Centre for Biomaterial Testing - has been developed in country’s first medical technology manufacturing park- Andhra Pradesh Med Tech Zone (AMTZ) to help manufacturers test their products and assist them to overcome deficiencies in their products, thereby enhancing product value in the market.

medical device industry for physio-chemical evaluation as well as biological evaluation of samples can also serve industries like chemical, polymer and pharmaceuticals to evaluate the characteristics of materials using spectroscopic and imaging modalities like scanning electron microscopy (SEM) and transmission electron microscopy (TEM).

The facility will help serve the purpose of sterility evaluation, histopathology evaluation, physio-chemical evaluation, accelerated aging and package validation in accordance with international standards like ISO and ASTM to to address unmet clinical needs.

AMTZ has also inked formal agreements to set up scientific facilities like Centre for Electro-Magnetic Interference/ ElectroMagnetic Compatibility (EMI/EMC) and Electrical Safety Testing (EST), Centre for X-ray and CT Scan Tube Manufacturing, Centre for 3D Designing, Printing, Rapid Prototyping & Centre for Gamma Irradiation.

Accelerated aging is an artificial procedure for establishing the lifespan or shelf life of a product in an expedited manner. Data obtained from the study is based on conditions that simulate the effects of aging on the materials. The state-of-the-art laboratory which is primarily intended for

AMTZ with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent. (http://pharmabiz.com , July 30, 2018 )

India, US move a step closer : Trade Issues including Medical Devices. India and the United States have moved a step closer in resolving trade disputes, with India agreeing to accept some of the US' demands on medical devices and electronics (IT), Hindustan Timesreports. The two countries have discussed concessions on medical devices, dairy and IT products, sources told the paper. It is still unclear if there has been breakthrough on US tariffs on steel and aluminium, and India's retaliatory tariffs, the report said. The update on the trade issue is likely to be announced before the 2+2 talks between India and the US, which will be held in July-August 2018

September. Commerce minister Suresh Prabhu spoke to US Trade Representative Robert Lighthizer last week, the report said. Moneycontrol could not independently verify the news. For medical devices, India will probably cap the prices for some US products, instead of imposing direct price controls, the report added. India is likely to postpone the retaliatory tariffs, which are due to start on August 4. https://www.moneycontrol.com

Product Gallery Qosina Adds New Closed Male Luer Lock Valves to Its Line

Ronkonkoma, NY, USA, July 9, 2018— Qosina has added four new closed male luer lock valve connectors to its existing line of luer-activated valves. These normally closed male valves connect directly to a female luer lock or luer-activated valve, and disconnect simply by twisting counterclockwise. These valves are DEHP-free and completely close upon disconnection, eliminating the need for clamping or capping. They are ideal for flushing and drainage applications; prevent dripping and leakage; restrict the free flow of fluids; and are suitable for gamma and EtO sterilization. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time-to-market by providing thousands of stock com-

ponents. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 9001, ISO 13485 and ISO 14001 registered, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products. visit www.qosina.com or call +1 (631) 242-3000. Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

Qosina Unveils a New Line of Tyvek® Sterilization Supplies

Ronkonkoma, NY, USA, August 1, 2018— Qosina has rolled out a new line of Tyvek® sterilization supplies for biopharmaceutical equipment and medical device components. With 54 options from which to choose, the company’s off-the-shelf Tyvek® sterilization supplies include a large assortment of pouches, sheets and tubes, and are available in many sizes and styles. Qosina’s new Tyvek® line provides optimum contact clarity for visibility; is offered with and without sterilization indicators; and is compatible with autoclave, steam and EtO sterilization methods. Lightweight and durable, Tyvek® is the trusted material of choice as it provides a superior microbial barrier to ensure devices stay sterile; excellent tear strength and puncture resistance; heat sealing and self-sealing options; peelable and non-peelable fusion seal options; and maximum breathability during sterilization. Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical in-

dustries. Qosina’s philosophy is to address its customers’ need to reduce time-to-market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 9001, ISO 13485 and ISO 14001 regis tered, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Contact : Qosina Corporation, Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com

July-August 2018

ISO : 13485 : 2012

We are a leading Consulting organization providing an integrated services with focus on project technology :

Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.

JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &

CERTIFIED COMPANY

Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc.

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA

F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com

July-August 2018

Tele : +91-79-25835567, +91-79-25834850

E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com 47

Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

Manufacturer And Exporter Of a wide range Of Medical Devices Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc... The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing. – Supply of Components for Medical Devices.

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

GMP ISO - 9001-2008 Certified Company

S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980

IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

I. V. SETS AND MEDICAL DISPOSABLES MANUFACTURING UNIT FOR SALE

Unit in Good Running Condition • Holding Gujarat State FDA Mfg. Licence • Located in Industrial Area in Ahmedabad • Built up Area More Than 390 Square Meter • Machinery / Equipments in Good Working Condition • Includes : Assembly Furniture, Clean Room Systems, E.T.O. Sterilizer, Laboratory Equipments, Urine Bag Mfg. Machines, Packaging Equipments, Utilities Etc. • Promoters Interested to sell because of other business commitments. • No Short Term / Long Term Liability

Contact : E-mail mpdsadvt1@gmail.com, medicalplastics@gmail.com July-August 2018

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

ISO 9001:2008 CERTIFIED COMPANY

•

I.V. Infusion Sets

•

Blood Administration Sets

•

Scalp Vein Set

•

Urine Collection Bags

•

Ryles / Feeding Tubes

•

Catheters and Tubes

•

Surgical Gloves.

Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

Address :

Apex Medical Devices Plot No. 10/B, Shyam Ujjawal Indurstrial Estate, Opp. SBI Bank, Phase 1, G.I.D.C, Vatva, Ahmedabad-382445. Gujarat, India. Phone No. : +91-79 - 29701333 E-mail : apexmedical@live.in Website : www.apexmedicaldevice.com July-August 2018

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 49

ISO 9001-2015 ISO 13485-2012 CE WHO GMP

Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter

• • • • • • • • • • •

Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter

Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901

July-August 2018

Medical Plastics Data Service Magazine July - August 2018

Articles inside

AiMeD & REGULATORY UPDATES

INDUSTRY NEWS

Simplifying Setting-up Of Plastic Processing Clean Room By : Medline Department, The Conair Group, USA Depending on the products being manufactured, medical plastic processors have adopted several different configurations for clean environments. Each requires a different level of cleanliness

Global Market Insights : Snapshots