Contents Table of Vol. 25
No. 3
22 Cover Story
May. - June. 2017
• Medical Polymers Processing – Selecting Right Materials & Manufacturing Systems Materials selected for use in new medical devices can have major ramifications throughout the product lifecycle, from design through testing…
23 Materials
• Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets - Ms. Elena Draganoiu, Global Technology Manager, Lubrizol LifeSciences, USA. The purpose of this study was to evaluate in vitro compatibility of IV sets of thermoplastic polyurethanes with an array of drugs with different properties.
26 Manufacturing
• Designing and Manufacturing of Molds for Medical Components - Mr. Ketan Panchal, Production Manager, IndoGerman Tool Room, Ahmedabad. The better output need more attention in the area of product applications, standards, plastic material selection, product design considerations, injection molding machine to be use etc.
30 Technology
• Syringe Plungers Can Contribute to Patient Safety Silicone contains only a small number of additives, reducing the likelihood that harmful substances will be released. The material can, therefore….
35 Global Trends
• Healthcare Plastics Recycling Project: A Success • Trends Pushing Solid Growth in Global Market for Medical Plastics
36 Industry News
• Tekni-Plex Announces $15 Million Investment in New China Manufacturing Facility (Page 22) • AMTZ Partners With GMDN Agency For Identification Of Medical Devices • Gujarat FDCA To Tie Up With NIPER Ahmedabad To Train Inspectors For Detecting SAE Of Medical Devices • HLL Takes Over Tech For Production Of 3 Medical Devices • NIPER To Team Up With Cos Furthering Make In India
38 Product Gallery
• ‘Male And Female Connectors And Caps, Low Dose Syringes, Spikes, Adapters And Y Connectors’ • New Tuohyborst Adapters
20 Did You Know?
• Why “PEEK” Offers Success For The Manufacture Of Medical Parts
46 Events
May-June 2017
• • • • • • •
Motivation Behind “Medicall”, Now With 16 Successful Edition Medicall 2017, 17th Edition: July 28 - 30, 2017, Chennai T-Plas, 2017: Sept. 20 – 23, 2017, Thailand. Medicall 2017, 18th Edition: Oct. 6 – 8, 2017, Mumbai Plastivision Arabia 2017: Dec. 11-14, 2017, UAE PLASTINDIA 2018: Feb. 7-12, 2018, Ahmedabad Medical Fair India 2018: March. 16-18, 2018, Mumbai
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Flashback Nov.-Dec. 2004
From Editor’s Desk Dear Reader’s
The total healthcare market in India is expected to grow significantly and its contribution to the country’s GDP will increase from 5.2% at present to 8.5% over the next ten years. The expenditure on healthcare will more than double by the year 2012 and the healthcare spending is expected to increase from Rs 86,000 crore at present to Rs 2,00,000 crore in the next decade, reveals a CII-McKinsey study on healthcare. According to the study, private healthcare will continue to be the largest component of healthcare spending and is expected to double from 60,000 crore to Rs 156,000 crore by 2012. Moreover, if health insurance cover becomes operative, the private spending will further go by an additional Rs 39,000 crore. Some other important features of Indian Healthcare Industry are : • Growing Exponentially: An Innovation - led growth • The economy is passing through a vibrant phase, with an exceptionally high rate (17.9%) of entrepreneurial activity, second only to Thailand (18.9%), among 37 Entrepreneurship Monitor (GEM) Report. • Suitability For contract research as well as clinical trials • The IT skill of Indian manpower offer services in bioinformatics and data mining.
These and many such enlightening facts, figures and data have been highlighted in this issue of “MEDICAL PLASTICS DATA SERVICE” as well the two web sites, www.medisourceasia.com and www.medicalplasticsindia.com from time to time.
For the benefit of readers, some of the important developments covered in last 2-3 years in the magazine are reproduced in this issue which gives an overview of this important “Growing And Innovating High-Tech Area : Indian Healthcare Industry”. Contents : • Coverstory : Indian Healthcare Industry : Growing and Innovating High-Tech Area. • Materials : Present Trends and Future Prospects of Plastics in Medical Applications. • Global Trends : European Disposable Surgical Drapes and Gowns Markets. • Events: CompaMED 2004 - A report, HOSPIMedica INDIA 2005
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Did You Know ? Why “PEEK” offers success for the manufacture of medical parts Medical devices that are intended for long-term contact with body tissues must meet particularly high quality requirements for registration in Europe or in the US. The manufacturers have to demonstrate on the one hand, that the raw materials are suitable for the respective area of application, and on the other hand demonstrate how they ensure consistent quality.
Today more and more manufacturers of medical products are using PEEK (polyetheretherketone) for bone surgery, but also in areas of traumatology and orthopaedics. Why PEEK? Because this material is biocompatible, inert to body fluids and can be processed relatively easy with high precision micro moulding for individual implants or surgical instruments. PEEK provides a great benefit: It saves weight, allows more design freedom and a greater functional integration, it also scores with X-ray transparency and elasticity which corresponds approximately to bone. At the same time it is a lower cost alternative to Titan the classic implant material, especially when using medical instruments or endoscopes, where the good electrical insulation properties of PEEK come into play. The complete detachment of ligaments, tendons or other soft tissues from their associated bones within the body is relatively commonplace injuries, particularly among athletes. Such injuries are generally the result of excessive stresses being placed on these tissues. For example, tissue detachment may occur as the result of an accident such as a fall, over-exertion during a work-related activity, during the course of an athletic event, or activities. For a complete detachment, however, surgery may be needed to re-attach the soft tissue to its associated bone or bones. Numerous devices made out of PEEK material are currently available to re-attach soft tissue to bone. Examples of such currently-available devices include screws, staples, suture anchors and tacks. ( Ref : http://www.medicalplasticsnews.com/news/close-to-the-bone-whymanufacturers-are-using-peek-products/ )
In a Nutshell....
“Just because you are CEO, don’t think you have landed. You must continuously increase your learning, the way you think and the way you approach the organization” - Indra Nooyi, Chairperson & CEO of PepsiCo
May-June 2017
EDITOR
D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR Mr. Rutul Bhavsar
B.Tech (Biomedical & Instrumentation Eng.)
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, 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
Editor’s Desk
From the
For selecting the right material for a Medical Device, it is important to have understanding of polymers, additives and their properties including basic understanding of polymer morphology. Thoroughly defined application requirements are needed to select appropriate material. One such application is Intravenous Infusion. An excellent analysis showing “Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets” is covered in the article by Ms Elena Draganoiu, Global Technology Manager, Lubrizol Lifesciences, USA . Process for manufacturing injection moulds for medical components has become more complex as the Medical Device Industry places higher demands on Polymeric products.Industry expects moulders to provide parts that meet all their requirements of dimensional stability, low cost, fast turn around and particulate free (clean). An article by Mr. Ketan Panchal, Production Manager, Indo German Tool Room, very effectively explains how to take care of all the requirements in “Designing and Manufacturing of Molds for Medical Components”. One more interesting case for using right material is regarding Syringe Plungers made of silicone to facilitate precise dosing of the drug being administered as detailed in the “Technology” column in this issue. The “Did You Know “column explained “ Why “PEEK” offers success for the manufacture of Medical Parts, particularly in the areas of Traumatology and Orthopaedics . We hope, the coming GST regime creates beneficial impact on all the stakeholders of the Indian Medical Devices Sector, and not increase the healthcare cost. As Per “AiMED”, there will be little or no impact. However, it is important for the Government to see that Patients benefit by lowering of MRP and “GST” boost s “Make in India” in Medical Device Sector.
This issue also highlights very important positive trends favoring the Growth of Indian Medical Device Industry. Shining examples of building up of right ecosystem are “AMTZ”, “NIPER, Ahmedabad”, FDCA, Gujarat and many more. While already covered in one of our issues earlier, an interesting highlight is the report on a collaborative multi-hospital recycling project between Healthcare Plastics Recycling Council ( HPRC ) and the Plastics Industry Association aimed to introduce a viable recycling model for healthcare plastics. The focus being on non-infectious plastic packaging and products from clinical areas of the hospitals. It is high time, Indian Industry understands the importance and takes such initiative.
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.
May-June 2017
21
MEDICAL POLYMERS PROCESSING – SELECTING RIGHT MATERIALS & MANUFACTURING SYSTEMS
Applications in the healthcare industry and medical devices in particular, have some demanding requirements for polymeric materials. While polymers have been used in the healthcare industry for decades, it has only been in the recent past the designers have started to explore the benefits of using special materials in the medical applications. Materials selected for use in new medical devices can have major ramifications throughout the product lifecycle, from design through testing, during regulatory approvals and production, and in the build up to market adoption and even disposal. There are many considerations to keep in mind while choosing a polymer for Medical Device viz Environment during transportation and product use, Chemical Resistance, Durability, Biocompatibility, Appearance, Feel, Sterilization, Molding, Price, Weight, Recyclability etc. Discussions analyzing two important aspects follows. The first is related to selecting a polymer in direct contact with the flow of drugs through a device. It is required to look at the effect the material has on drugs. Chemical resistance is also important, as the drugs should not promote the materials degradation. Also the potency of the drug should not be affected by the polymeric material it is in contact with either via extraction of additives and monomers, or via the chemical reactivity between the drug and the polymer. One more important aspect is regarding molding. It is possible to make extremely precise design tolerances. Complex, intricate features can be effortlessly included with the help of rightly designed moulds.
Tekni-Plex Announces $15 Million Investment in New China Manufacturing Facility
New facility supports Tekni-Plex’s continued commitment to global supply network
Wayne, Pa. (June 8, 2017) —Tekni-Plex, Inc. is announcing a $15 million investment in a new state-of-the-art manufacturing facility in Suzhou, China, near Shanghai. It represents the single largest recent investment by Tekni-Plex and reflects the growing needs of the AsiaPacific pharmaceutical and medical device market. Production for some product lines has already begun.
The facility also will produce Natvar’s recently-announced silicone extrusion tubing for catheters, feeding tubes, drug delivery and peristaltic pump applications, as well as micro extrusion tubing that targets a wide variety of demanding neurovascular interventional therapies and surgical applications. The facility will also manufacture Colorite custom compounds for medical device applications, and Action Technology’s dip tubes used in a wide variety of food/beverage, pharmaceutical, personal care, industrial and household pump applications. “Tekni-Plex’s investment in our new China facility is another step in our continuing commitment to support our customers with robust global supply. Pharmaceutical, medical device and other manufacturers want access to exactly the same components and materials regardless of where in the world their manufacturing facility is located. It is our goal to meet those objectives,” said Paul Young, chief executive officer. Tekni-Plex is in the process of phasing out production at its existing facility in Suzhou that it has operated since 2005.
Initially, the more than 140,000-square-foot (13,000-square-meter) facility will manufacture products for Tekni-Plex’s Natvar, Colorite and Action Technology business units. The facility will feature three Class 100K cleanrooms to accommodate medical-grade tubing and components production plusone Class 10K cleanroom that will produce Natvar’s pharma-grade tubing.
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About Tekni-Plex, Inc. Celebrating its 50th anniversary in 2017, Tekni-Plex is a globallyintegrated company focused on developing and manufacturing innovative packaging materials, medical compounds and precisioncrafted medical tubing solutions for some of the most well-known names in the medical, pharmaceutical, personal care, household and industrial, and food and beverage industries. Tekni-Plex is headquartered in Wayne, Pennsylvania, and operates 30 manufacturing sites across eight countries worldwide to meet the needs of its global customers. For more information visit www.tekniplex.com.
May-June 2017
Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets Ms. Elena Draganoiu, Global Technology Manager, Lubrizol LifeSiences, USA.
Yolanda Zhu1, Clark Yan1, Wei-bo Qiu1, Hong Zhang2, Elena Draganoiu3 1 Lubrizol LifeSciences, Lubrizol Specialty Chemicals Co., Ltd., Shanghai, China, 2Institute of Chemistry Research, China National Science Academy, Beijing, China, 3 Lubrizol LifeSciences, Lubrizol Advanced Materials, Inc., Cleveland, OH, USA Introduction Thermoplastic polyurethanes(TPU) are formed by step-growth polymerization between di-isocyanates and diols. Polymeric diol and isocyanate groups aggregate to form a two phase domain structure consisting of : - Soft segments (low Tg) - contribute to the elasticity / flexibility - Hard segments (urethane) form crystalline domains and physical crosslinks due to hydrogen bonding; they confers mechanical strength TPU schematic structure
TPUs have a long history of proven biocompatibility and in vivo stability in biomedical applications, including cardiovascular (central venous catheters, heart pacemaker connectors, cardiac assist pump bladders, tubing, housing, coatings, lead insulators, vascular grafts, patches, percutaneous shunts), urology (catheters, hemodialysis tubing, membranes), orthopedics (orthopedic splints, bone adhesives), wound care, etc.
Pellethane ® TPUs produced by Lubrizol LifeSciencesare aromatic polyether and polyester TPUs available in natural color and in a wide range ofdurometers. Specially developed extrusion and molding grades allow ease of use with existing equipment and minimal modifications. Pellethane® TPUs are widely used for a variety of medical applications including tubing, catheters and implants due to theirattributes: • Excellent biostability and biocompatibility • Outstanding hydrolysis resistance and non-hemolytic properties
May-June 2017
• Plasticizer free • Good compression strength, excellent kink resistance, flexibility and softness • Superior clarity • Greater strength with good flexibility compared to PVC, allowing thinner wall tubes ab fluid storage bags with enhanced burst resistance • Easily incinerated, no corrosive or dangerous chemical emissions • Manufactured on world class ISO 9001:2008 facilities The use of thermoplastic polyurethanes for intravascular (IV) sets has seen a recent increase, however comprehensive testing to evaluate their compatibility with drugs has not been conducted prior to this study.
Compatibility between medications and intravascular administration sets (containers, tubing, and delivery) is important for administration of prescribed medications to assure predictable delivery of the drug dose, safety and efficacy. Potential interactions between drugs and IV sets include: Sorption • Adsorption of the active pharmaceutical ingredient (API) to the inner surface (without further penetration) results in initial reduction in drug concentration delivered to the patient and as the surface become saturated, concentration restores • Absorption of the API into the material. The drug concentration in the infusate is initially low and slowly recovers as the material becomes saturated • Permeation - drug migrates through the material and out onto the outer surface of the IV set. Substantial drug loss that continues throughout the duration of administration • Leaching - components of IV sets (plastics) migrate to drug • Polymer modification – drug modifies properties of the IV set (polymer)
The purpose of this study was to evaluate in vitro compatibility of IV sets of thermoplastic polyurethanes with an array of drugs with different properties.
Methodology Three types of infusions sets (manufactured by Jiangsu Suyun Medical Materials Co., Ltd., China)were tested : • Thermoplastic polyurethane set made from Pellethane® TPU • Styrene butadiene thermoplastic elastomer set (TPE) • Polyvinyl chloride(PVC) set (standard PVC with diethylhexyl phthalate) All sets had similar tube design: OD 4 mm,ID 2.4mm, length 1.6 m (Fig. 1-3).
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designed to simulate clinical administration (Table 1).
The concentration of drug in the solution circulated through the IV sets was quantified atdifferent time intervals by highperformance liquid chromatography with UV detection, using reference standards. The impurity level, pH of the solution and particulates were measuredbefore and after circulation in the IV sets. IV sets based on TPE and PVC were alsoevaluated for comparison.
Fig. 1. TPU IV set Fig. 2. TPE IV set Fig. 3. PVC IV set The study included seven common IV drugs, to cover different properties (aqueoussolubility and log P) and therapeutic classes as shown in also tested. The study parameters (drug dose, volume, concentration, flow rate, administrationtime) were
Table 1.Drug properties and study parameters
Drug Class log P
Levofloxacin hydrochloride
Moxifloxacin hydrochloride
2.10
2.90
Antibacterial Fluoroquinolone
Solubility in water (USP/NF)
Sparingly soluble
Volume (ml)
80
Daily dose (mg) Concentration (mg/ml)
400 5
Metronidazole
Docetaxel
Antibacterial Fluoroquinolone
Antibactrial Nitroimidazole
Antibacterial Loop diuretic Antimicrotubular
H2 antagonist
Sparingly soluble
Sparingly soluble
Practically insoluble
Practically insoluble
Very soluble
Freely soluble
250
500
134
400
140
100
2.86
404
160
0.25
0.73
400 1.6
-0.02
1000 2
2.40
120 0.9
Furosemide
2.03
Ranitidine hydrochloride
Pantoprazole sodium
0.27
0.50
Proton pump inhibitor
220
Administration time (h)
1.0
1.5
1.0
1.0
1.67
2.0
0.25
80
167
500
134
84
200
880
Recirculation time (h)
24
24
24
6
24
24
4
Administration rate (ml/h)
Results Lubrizol’s Pellethane® TPU IV sets did not affect the pH, impurity and particulates of the drug products tested. For all drugs tested, independent of their aqueous solubility and logP, Pellethane ®TPU sets showed verylow drug sorption during infusion ofthe recommended administration time, delivering more than90% of the dose. Further recirculation of the solution in the sets beyond the recommended administration time did not result in an increased drug absorption (for up to 4 – 24 hours) - Fig. 4. Pellethane® TPU based IV sets performed similar or better than TPE or PVC – Fig 5, 6. In the case of pantoprazole sodium,Pellethane ® TPU IV sets performed slightly better, having lower initialsorption compared to TPE and PVC – Fig. 7.
Fig. 4. Drug recovery following circulation through TPU IV sets
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Fig. 5. Drug recovery following circulation through TPE IV sets
May-June 2017
Fig. 6. Drug recovery following circulation through PVC IV sets Conclusion Lubrizol’s Pellethane® TPU based IV sets performed similar or better than TPE or PVC, showing very low sorption for drug of different properties: • Levofloxacin hydrochloride • Moxifloxacin hydrochloride • Metronidazole • Docetaxel • Furosemide • Ranitidine hydrochloride • Pantoprazole sodium
May-June 2017
Fig. 7. Pantoprazole recovery following circulation through TPU, TPE and PVC IV sets In the case of pantoprazole,Pellethane® TPU IV sets performed slightly better, having lower sorption compared to TPE (initial stage) and PVC (entire duration). Lubrizol’s Pellethane® TPU properties and their compatibility with drugs, make them suitable for use in intravascular administration sets. Reference: *The United States Pharmacopeia and The National Formulary (USP–NF) USP 39–NF 34, United States Pharmacopeial Convention, Rockville, Maryland, 2016.
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Designing and Manufacturing of Molds for Medical Components Mr. Ketan Panchal, Production Manager, Indo German Tool Room, Ahmedabad. The best output is based on optimum inputs. Normally we believe that the mold makers has main role to produce the best components. The mold maker’s selection is based on low cost and minimum delivery time. Sometime we also choose mold maker based on only quality of product. In fact in all the case our output is samples to produce molds. Some time we also demand merging of different features of different samples and make one product design. Sometime we provide samples of existing mold and ask for modification. Now all the mold makers are used to with this situation and do the work.
2) Parts with uniform and non uniform wall thickness The uniform wall thickness will give warpage free component due to even cooling of wall thickness. Some time non uniform wall thickness is the requirement of product need better cooling to avoid warpage. More cooling is required in thick wall area and less cooling is requiring in thin wall area. This can be judge with mold flow analysis.
Stated requirements are dimensions, tolerances, weight, surface finish, fitments, applications and mold life. These are the most important requirement which is always stated in the drawing. We should study all the points and try to make very informative product design.
Part with non uniform wall
The better output need more attention in the area of product applications, standards, plastic material selection, product design considerations, injection molding machine to be use etc,. There are stated requirement, non stated requirement and hidden requirement.
Non stated requirements are flash free, sink mark free, warpage free etc. These are not stated but it should be taken care as stated requirement by the mold maker.
Hidden requirements are assembly of parts in automatic machine, automatic packaging, adhesive use in assembly, use of temperature in post process, sterilization, ultrasonic welding etc. These requirements should be clear in the beginning in product design. This will clear product design requirements in the beginning. The above requirements are input which give better output in mold making.
Product design features 1) Parts with thick wall thickness and thin wall thickness The plastics material is having range of minimum and maximum wall thickness. During product design the range of plastic material thickness should be taken care to produce defect free component.
Part with thick wall
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Part with thin wall
Part with uniform wall
3) Sharp corners and corners with radius. The sharp corners are not advisable in plastic products. Some radius must be providing in the product design which make deformation free product.
Part with sharp corners
Part with rounded corners
4) Parts with draft angles. The draft angles are must in plastics products. The draft angle to be provided in the direction of ejection. The draft angles can be half degree to one and half degree according to product design requirement and plastic material to be use.
Part without draft angle
Part with draft angle
May-June 2017
5) Parts with ribs. The ribs can help to reduce wall thickness and confirm application as it is. The ribs will eliminate warpage, sink mark etc. The ribs design is also important to control weight of the component.
Part with thick wall
Part with ribs to avoid thick wall
Part with incorrect ribs
Part with correct rib direction
Ribs design
6) Part design with boss Sometime boss is required for clamping of two components with screw or pin. The boss cannot be eliminating form the product design but the boss design has different design possibility.
Part with isolated boss
Boss withgussets
May-June 2017
Boss with ribs option no. 1
Boss in corner
Ribbed boss in corner
SELECTION OF STEEL MATERIAL FOR MEDICAL COMPONENTS
Selection of steel is very much important in medical plastics because the product should be produce in corrosion free with highly polished mold surface. The some of the recommendation of steel selection is as under. 1) Plastic materials like PET, Polyimide, PC, ABS, PEEK, PU, PMMA • 1.2344,SKD61, H13 for better hardness and toughness • 1.2083, AISI420 having 13% chromium for good polishing • 718M high nickel alloy for corrosion resistance • D53 (D2 supreme) for PC and PEEK material 2) Plastic materials like PP,PE,PS,PBT • 8407 supreme for excellent toughness, high purity and fine structure • S136, 1.2083 pre hardened steel for corrosion resistance • 618,P20,1.2738,1.2711 for good wear resistance 3) Plastic materials like PVC,PA • 718M nickel alloy ( 17-21% chromium, 50-55% nickel, 32-40 HRC) • 1.2316 ( 15-17% chromium, 40-46 HRC)
SURFACE TREATEMENT OF MOLD SURFACES
1) Hard chrome plating can be used for PP,PE,PS and ABS. We can get 72HRC surface hardness. 2) Electroless nickel plating can be used for PVC,PC,PMMA and Polyamide. We can get 50HRC hardness. 3) Titanium nitride plating can be used for glass filled material and PVC. We can get hardness up to 90 HRC. It has good abrasive resistance, corrosion resistance and excellent wear resistance.
METHODS OF PRODUCT DEVELOPMENTS
The product development technology improved a lot in last 10 years of period. The product developed in past days with concept design sketch, then detail drawing. With detail drawing model makers were making model from wood, plaster of paris and acrylic sheets. This kind of proto type was time consuming and without perfection. The modification in proto type was also difficult as especially in intricate parts. Then the product development was improved with 3D model in concept design. The proto type was made with hand molds, jigs, fixture or cnc machining. This was again time consuming and difficult in machining of intricate parts. This was costly and disturbing production activity of tool room. Now days it is very easy to develop product proto type without limitations. The 3D model of concept design is required. Then additive manufacturing processes like SLS, SLA, FDM, 3D printing can be use for proto type model. This has only one disadvantage of higher cost but development is possible in minimum time with accuracy. The proto type can also use in application and confirm the function. The plastic material of proto type is nylon, ABS, PC, epoxy resin and other rubber based materials. The proto type machines can be use for various applications and also for marketing of product.
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RAPID TOOLING
Rapid tooling is one the benefit of rapid proto typing. We can manufacture core and cavity with metal rapid proto typing with H11, SS316 material and reduce mold making time. IGTR has produced plastic injection molds and die casting dies with metal proto typing machine. The core and cavity can be hardened with 50 HRC and any surface treatment is possible on core and cavity surface. The other advantage is conformal cooling. The conformal cooling will reduce 30% cooling time and produce components in less cycle time. This will give more productivity. The example of conformal cooling is in below pictures. Some of the examples of product development with additive manufacturing.
Conformal cooling can be provide very close to cavity surface which give uniform cooling. Medical device housing developed with proto type
Core and cavity of mold made with metal proto typing. Medical device housing assembly view.
3D SCANNING WITH BLUE LIGHT SCANNER
Dental teeth development in plastic proto typing as well as metal proto typing die
Scan data of body inplants.
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The scanning will reduce manual errors of measurement. This is the fast process of capturing data and make 3D model for the product reverse engineering.
Inplant made with metal proto typing after scanning the object and made 3D model.
May-June 2017
MOLD MAKING WITH USE OF CAD
The input is product design in 3D model. The product design confirmed with proto type and its application and function. The mold design can be done with use of CAD software. The steps are….. • Use database of CAD software for standard parts • Use of libraries for frequent use of components • User interface for machine suitability • Mold ability assessment of product design • Nos. of cavity to be done with layout • Mold base selection from library • Feed system design • Shrinkage calculation according to use of plastic material • Parting line design • Cooling design • Venting design • Detail mold design After the completion of mold design mold flow analysis will confirm the mold functions and product design defects solving. The mold flow analysis can give clear idea about mold filling, cooling and warpage. The animation of mold function is also possible to give idea to mold manufacturing section as specially assembly and processors.
PREVENTIVE MOLD MAINTENANCE
• Parting surface to be clean with mild clean solvent with soft tissue papers • All water lines should be drained and blown free of all residual water • Do not use hard tools on any molding surface, parting surface or shut or surface • Use soft or treated water in cooling • Avoid excessive clamp pressure, high injection pressure and over packing • Use rust preventive like WD40 on molding surface before unloading mold from machine • Lubricate the appropriate mold components • Bag the last shot as an example of the typical quality of this run and store this part with mold.
INSPECTION OF MOLD
• Inspection is to note small problems and scheduled for repairs • This inspection to be done by experience operator after about 20,000 cycles. • Preventive to be done every day and every time the mold unload from the machine • It is recommended maintenance after 1,00,000 cycles • It is also recommended major maintenance like replacement of wear parts, bearings, ejector pins, springs, resurfacing or re plating etc., after 2,50,000 cycles. The use of above technology will improve product quality and reduce time of correcting mold after first trial.
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 May-June 2017
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Syringe Plungers Can Contribute to Patient Safety
Syringe plungers made of silicone allow for precise dosing of the drug being administered. Other advantages of this material include its physical/mechanical properties and the high-chemical purity of its formulation. Finally, silicone allows for customized product configurations and designs. Enhance safety aspects Silicone contains only a small number of additives, reducing the likelihood that harmful substances will be released. The material can, therefore, contribute to protecting the patient, while also increasing product safety for the medical and pharmaceutical manufacturer.
Polymer specialist Raumedic produces custom-tailored silicone components, including high-grade syringe plungers produced by injection moulding. But that’s not all: Thanks to its staff of scientifically-trained professionals, the company’s Regulatory Affairs department can also provide support in preparing productspecific extractables studies. In Raumedic’s own laboratory or in external labs, potentially critical extractables from the material’s interaction with the pharmaceutical formulation can be quantified and evaluated for their toxicological properties.
A focus on customization Silicone is known for its immense versatility in terms of form and design. At Raumedic, medical engineering and pharmaceutical manufacturers can decide for themselves what their syringe plungers should look like. There are virtually no limits on a manufacturer’s design ideas or size and shape requirements. As a development partner for the medical and pharmaceutical industry, Raumedic’s focus is on custom-tailored product solutions, not mass-produced items.
assistance with product approval.”
For instance, the special material formulation for Raumedic silicone plungers is officially registered in a “master file” at the U.S. Food and Drug Administration (FDA). So, medical engineering and pharmaceutical manufacturers that are active on the international market can get their new products approved more quickly and easily not only in the United States but also all around the world.
(Ref: http://www.medicalplasticsnews.com/ How%20syringe%20plungers%20can%20contribute%20to%20patient%20safety/)
AVAILABLE
PRE USED SYRINGE MANUFACTURING EQUIPMENT
One clear sign that the silicone plunger is truly custom-tailored involves access to tools: Raumedic provides its customers with an individualised tool from which the geometry of the respective component is manufactured exclusively for them. Geometry modifications and optimizations can also be carried out during the development phase. Ensure competitive advantages “We’re able to offer real competitive advantages,” says Jörg Prescher, Head of the Technical Center of Excellence for silicone moulding at the Bavarian company. “Personalised consulting is our top priority. From the initial idea to product development, and right through to industrial manufacturing, we’re there for our customers at every step in the process. We even provide
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Contact : 7895648113 May-June 2017
Healthcare Plastics Recycling Project: A Success
A collaborative multi-hospital recycling project between the Healthcare Plastics Recycling Council (HPRC) and the Plastics Industry Association (PLASTICS) has been completed in the Chicago market.
The highest volume of material collected was sterilisation wrap and as such, the material was evaluated as a viable substitute or supplement for virgin resins in product manufacturing. Other packaging materials such as film plastics, as well as rigid plastic packaging were also collected.
The team were also successful in testing the potential to demonstrate value through energy conversion and chemical recycling, showing that value can still be realised through other recovery processes.
The project aimed to address the issues surrounding the use and recycling of plastics used in the healthcare industry. HPRC and Plastics aimed to introduce a viable recycling model for healthcare plastics, the focus being on non-infectious plastic packaging and products collected from clinical areas of the hospitals.
Plastic materials in hospitals are currently difficult to recycle in an economically viable way due to the material failing to represent enough value to attract the attention of recyclers. The project brought together multiple hospitals in an attempt to overcome this issue.
Plastics primarily from main operating rooms and ambulatory surgery centers were collected and then transported by waste haulers to material recovery facilities (MRFs) for processing, or transferred to specialised plastics recyclers. The project was a success in many areas, such as defining the relative quantities of material types and understanding the complexity of sorting the materials once collectively amassed.
Chris Rogers, HPRC project manager said: “This project provided valuable insights into the realities of implementing plastics recycling programs in clinical healthcare settings. What we learned is that collection of plastics must be made simple for clinical staff in order to be effective. Detailed sorting at the point of generation is too complex and a distant priority from clinician’s primary focus of ensuring positive patient outcomes. It’s also important to remember that behavioural change around recycling can be a slow process, one that takes constant reinforcement over time.” Kim Holmes senior director of recycling and diversion at PLASTICS said: “In addition to testing the recovery and mechanical recycling of healthcare plastics, we were also able to explore alternative pathways of chemical recycling and conversion to fuel products with our technology partners. Proving the value of these hospital plastics in the conversion process was an exciting dimension of this project and underscores the importance of adding non-mechanical recovery technologies to our resource management tool kit.”
Participating hospitals included Advocate Illinois Masonic Medical Centre, and NorthShore University HealthSystem’s Evanston, Skokie and Glenbrook Hospitals.
(Ref : http://www.medicalplasticsnews.com/news/healthcareplastics-recycling-project-is-a-success/)
Trends Pushing Solid Growth in Global Market for Medical Plastics
New proprietary research by BCC Research reveals that long– term trends in the global healthcare industry are boosting the medical plastics market. Among its key drivers, aging populations and the increasing use of minimally invasive surgical techniques are pushing the global medical plastics market to reach about 17.2 billion pounds in 2021, up from 12.7 billion pounds in 2016.
Plastics usage in medical devices has been growing faster than the gross domestic product (GDP) of the U.S. and other major markets. The aging U.S. population, ongoing cost-reduction pressures in the healthcare field, advances in polymer performance, and environmental issues surrounding disposable and non-disposable medical devices are key factors in the market’s 6.2% CAGR. Research Highlights • The demand for lighter materials is rising as healthcare activities move to locations outside clinical and hospital settings. • The shift toward using disposable medical products, especially single–use versions packaged and placed in kits, continues to expand. • Other market drivers include advances in polymer performance
May-June 2017
and the introduction of new and lifesaving devices.
“Commodity thermoplastics dominate the global market with around 60% of total volume”. requirements, pricing, environmental and regulatory issues.” Emerging Healthcare Trends Shaping the Plastics Market Long–term trends in the global healthcare industry are favorable to the continued growth of the medical plastics market, particularly aging populations in most major markets, which drive increased healthcare spending. “One key trend that should benefit the market is healthcare provision in settings such as the home or outpatient clinics,” Fitzgerald says. “The movement of healthcare activities to less costly locations have increased the need for lighter materials, especially for housings. Thus, home healthcare and other outof-hospital treatment and service systems require prepackaged diagnostic and therapeutic kits that can be used on site and discarded. Most of these kits are plastic, as are the package contents.”
( Ref : https://globenewswire.com/news-release/2017/06/13/ 1018090/0/en/Trends-Pushing-Solid-Growth-in-Global-Marketfor-Medical-Plastics.html )
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AMTZ Partners With GMDN Agency For Identification Of Medical Devices
Shardul Nautiyal, MumbaiSaturday, June 03, 2017, 08:00 Hrs [IST]
Attracting attention of medical device fraternity across the world, the Andhra Pradesh MedTech Zone (AMTZ) recently joined the Global Medical Device Nomenclature (GMDN) Agency as partners. The GMDN Agency is responsible for the Global Medical Device Nomenclature used for identification of medical devices. Formed in 1991, medical device experts from around the world (regulators, healthcare providers and manufacturers) have compiled the GMDN to facilitate taxonomy on medical devices.
GMDN is a list of generic names used to identify all medical device products including those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
A standardized and unambiguous system for naming and coding medical devices is critical in an environment increasingly dependent on electronic data records for sharing and storing patient information. GMDN is recommended by the International Medical Device Regulators Forum (IMDRF) and is now used by over 70 nationalmedical device regulators to support their activity. With AMTZ as a Consulting Organisation to GMDN, it will be a great value-addition to all the manufacturers at AMTZ. GMDN association with AMTZ will come as an enabler of export and global market expansion potential.
In order to facilitate regulation of medical device with classification system as stipulated in medical device rules, 2017 among other aspects like sale and distribution, import and labeling of medical devices, Union Health Ministry has permitted AMTZ to host a dedicated help desk for understanding and smooth implementation of Medical Device Rules, 2017.
The help desk would also facilitate information on following changes of medical devices rules to manufacturers like licensing authorities and functions of notified body, manufacture of medical devices for sale and distribution, import and labeling of medical devices, clinical investigation of medical device and clinical performance evaluation of IVD’s, import or manufacture medical device which does not have predicative device, duties of medical device officer, medical device testing officer and notified body, registration of laboratory for carrying out test for evaluation. Taking forward its mandate of Make in India, Government of Andhra Pradesh last year established country’s first medical technology manufacturing park, AMTZ in Vishakhapatnam. N Chandrababu Naidu, chief minister of Andhra Pradesh laid the foundation stone of AMTZ.
Since then, AMTZ has received good response in terms of commencing of booking of plots and its active participation at Indian Medical Device Conference – 2017, one of the largest events for the Indian pharmaceutical market. (Ref : http://www.pharmabiz.com/ NewsDetails.aspx?aid=102330&sid=1)
SANIDHYA ENTERPRISE
Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •
Urine Container Adaptors (PP) Regulators / Cord Clamp All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures PP Mucas Container And many other Surgical Medical Components
Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 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 36
May-June 2017
Gujarat FDCA To Tie Up With NIPER Ahmedabad To Train Inspectors For Detecting SAE Of Medical Devices
Gujarat FDCA is planning to collaborate with National Institute for Pharmaceutical Education and Research (NIPER) Ahmedabad to equip officers on detection of serious adverse events (SAE) caused by the use of medical devices to ensure patient safety. This will be a major boost to the government’s materiovigilance programme of India launched two years ago. Materiovigilance Programme of India was launched by the Union Health Ministry on July 6, 2015 at Indian Pharmacopoeia Commission (IPC), Ghaziabad. Ministry has already sanctioned an amount of Rs. 15 crore towards setting up a dedicated medical device testing lab at Vadodara some time back. Recommended and promoted by the Union commerce ministry, the country’s flagship project will be developed in partnership with Union health ministry with technical support from Healthcare Technology Division of National Health Systems Resource Centre (NHSRC), a technical support institution under the Union health ministry. Setting up of a dedicated medical device testing lab in the country
would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety as the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care. Till date, products are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Though the government plans to set up two medical device testing labs in the country at Vadodara in Gujarat and another at Noida subject to getting approvals, medical device testing lab in Gujarat would be the first and the only dedicated biomaterials and implants testing lab in the country. The lab at Noida will be set up primarily to test electrical and electronic medical devices in the country. Gujarat FDCA pursued the matter of setting up the medical device testing lab based on an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad one and a half years ago which raised the demand for setting up a dedicated medical device testing lab to ensure quality assurance of medical devices manufactured in the country. (Ref : http://www.pharmabiz.com/ NewsDetails.aspx?aid=102360&sid=1)
Public sector HLL Lifecare Limited (HLL) will take over industrial production of three medical devices, technology for which has been developed by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTMST) here. Union Minister of Health and Family Welfare J P Nadda officially transferred the know-how to HLL CMD R P Khandelwal during the 2nd Technology and Industrial Meet organised by Sree Chithra Institute here recently. The three technologies transferred to HLL are Blood/IV Fluid Warning System, a Thermo Regulated Infant Warming Bassinet and Thermo Regulated Infant Warming Wrapper, a company release said here today. “The two infant warmers will mark a first for HLL in paediatric medical devices. By warming fluids with accuracy and speed, the Blood/IV Fluid Warming System can help providers deliver higher-quality care to more patients,” HLL CMD RP Khandelwal said. The infant warmer bassinet and wrapper are both transportable, light weight, battery-operated devices that can be used to keep
babies in thermo neutral condition and come with temperature controls, displays, alarms and safety features, he said. The blood and IV fluid warming system enables quick warming of refrigerated material (from 4 degrees Celsius to 37 degrees Celsius in just a few minutes) for transfusion. It consists of a blood bag warming chamber and IV tube warming cartridge lined with infra-red LEDs for the heating, and adjustments that allow for both slow and rapid transfusion. The Instant Warming Bassinet has a retractable top cover fitted with a warming pad and a bed with a warming pad under it. The pads have infra red-emitting LEDs for warming and sensor to control temperature levels. “As with all products and services of HLL, our goal with these new devices will be to ensure quality care and affordability to general public,” Khandelwal said. (Ref : http://www.business-standard.com/article/pti-stories/hlltake s-o v er-t ech-for-produ ctio n-o f-3-med ic al-dev ic es 117051701186_1.html)
The National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad is planning to collaborate with two Ahmedabad-based biotech companies for research and development with an integrated approach to equip students to take up job roles for the development of medical device industry and further the Make in India campaign.
updates on technology advancements in the country.
HLL Takes Over Tech For Production Of 3 Medical Devices
NIPER To Team Up With Cos Furthering Make In India
This is a significant milestone as India’s import dependency on high-end medical devices is over 80 per cent and 60 per cent to 70 per cent for other devices.
This comes close on the heels of its tie-up recently with Johnson & Johnson and Sahajanand Laser Technologies for development of industry-oriented skilled manpower in the medical device sector. This would also be a value addition to the post-graduate studies in medical devices run exclusively at the NIPER Ahmedabad campus towards equipping students with the latest
May-June 2017
Development of domestic industry has gained further impetus as government of India is planning to expand NIPERs across the country to nurture manpower and hence boost domestic manufacturing of medical devices in the country. More than 70 per cent of medical devices are imported as of today which has impacted the development of the domestic industry.
As a step towards setting up a National Centre for Medical Devices (NCMD), National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad has sent a fresh proposal to the Department of Pharmaceutical (DoP) to sanction an amount of around Rs. 150 crore for setting up a Centre of Excellence (CoE) for strengthening academic research and development of skilled manpower for medical device Sector. (Ref : Chronicle Pharmabiz, June 8, 2017 & June 1, 2017)
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Qosina Expands Its ENFit™ Product Line
Ronkonkoma, NY, May 2, 2017—Qosinahas addeda number ofcomponents to its extensiveENFit™ product line, including male and female connectors and caps, low dose syringes, spikes, adapters and Y connectors. ENFit™ is a brand of enteral feeding connectors that meet the ISO 80369-3 standard, which was developed to improve patient safety and reduce the risk of smallbore misconnections used in liquid and gas healthcare applications. Thesenew partsare available in various sizes and materials and complement Qosina’s already-vast selection of ENFit™ products. Qosina continues to grow its ENFit™line to meet clients’ enteral project needsandcan modify any existing component or build new tooling to suit exact requirements. Visitqosina.com/enfit to view all ENFit™ products, as well as request samples and place orders.
Qosina offers low minimums and short lead times. Log on to qosina.com to see pricing, obtain our latest catalog, request complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product additions. Our product development team can work to
customize a part to your specifications. Call our customer service specialists to discuss your project in detail via phone +1(631) 242-3000 or email info@qosina.com.
Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, ISO 13485 and ISO 14001registered.Qosina also is a member of the Global Enteral Device Suppliers Association (GEDSA). For Immediate Release Contact : Qosina, Rachelle Morrow, 2002-Q Orville Drive North, Ronkonkoma, NY 11779 Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 Email: rmorrow@qosina.com
Qosina Adds 2 Tuohy Borst Adapters to Their Line
Ronkonkoma, NY – June 7, 2017 – Qosina is pleased to announce 2 new tuohyborst adapters. One adapter features a female luer lock side port connector (#80460), while the other has a 6 inch DEHP-Free PVC side port tube to a female luer lock connector (#80461). Both tuohyborst adapters are available to fit 0 – 9 French guidewires and have a proprietary tri-cut silicone valve technology which provides a leak proof seal. Made of a polycarbonate body and cap, it takes less than 3 rotations to seal the valve, providing rapid engagement of the seal and prevents hand fatigue. The wide cap design is preferred for its ease of use and also has a stop mechanism which prevents it from separating from the body when fully opened. These adapters feature aCOPEswivel male luer lockwhich minimizes tubing kinks and have a lower profile than a typical valve. Qosina offers a variety of caps, syringes, tuohyborst adapters, hemostasis valves and guide wire accessories for you to complete your project. Call or log on to Qosina.com to request samples or place an order. Qosina offers low minimums and short lead times. Log on to qosina.com to see pricing, obtain our latest catalog, request
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complimentary samples and place orders. Be sure to sign up for our monthly e-newsletter to stay current with our newest product additions. Our product development team can work with you to customize a part to your specifications. Call our customer service specialists to discuss your project in detail via phone +1(631) 2423000 or email info@qosina.com.
Founded in 1980, Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohyborst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina is based in Ronkonkoma, NY in a 95,000 square-foot facility with an ISO Class 8 Clean Room and is ISO 9001, 13485 and 14001 registered. For Immediate Release Contact : Qosina Corporation, Maria Stazzone, 2002-Q Orville Drive North, Ronkonkoma, NY 11779 Phone: +1 (631) 242-3000, Fax: +1 (631) 242-3230 Email: mstazzone@qosina.com
May-June 2017
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.
May-June 2017
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®
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
• In house Imported Injection Molding Machines • Latest ET.O. Sterilization Facilities
• Own certified laboratory to perform Physico Chemical, Sterility & Micro Biological Tests.
NEW PRODUCTS
• Easy Morning Walker • Adult Diapers • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Personal Weigh Scales • Nebulizers
• 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
ISO 13485 : 2003
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
May-June 2017
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
May-June 2017
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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.
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
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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
Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com May-June 2017
May-June 2017
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Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
Manufacturer And Exporter Of a wide range Of Medical Devices
ISO 9001-2000
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
R E GI S TER E D 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
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PACK-EQUIP
(Mfg. Packaging Machinery)
Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. May-June 2017
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
Incentive Spirometer
ET Holder with Bite Block
Expandable Catheter Mount
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
I.V. Infusion Sets
•
Scalp Vein Set
• • • •
Airovent T-Humidifier
Anaesthesia Circuits
• •
Breathing Filters
Blood Administration Sets Urine Collection Bags
Ryles / Feeding Tubes Catheters and Tubes Surgical Gloves.
Contact :
Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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 May-June 2017
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Motivation Behind “Medicall”, Now With 16 Successful Editions
Medicall, is India’s largest B2B Medical Equipment Exhibition is organized by Medexpert Business Consultants Pvt Ltd, promoted by Dr. Manivannan S, Joint Managing Director of Kauvery hospital a1000 bedded Hospital group in South India. Early in his career, he identified that nursing homes, small hospitals and clinics in tier 2 and 3 cities faced a distinct disadvantage in the market while procuring hospital equipment or service. They neither had the choice nor the price advantage enjoyed by the biggies. While talking about the motivation behind starting this expo, Dr Manivannan S says, “Small and medium sized hospital owners from tier II and III cities cannot afford to have qualified purchase managers. Equipment companies also do not have adequate
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
MED IC A RE D E VICE S
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
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sale force to meet all these hospital owners. Since I have undergone the difficulty for my hospital, I thought Medicall will bring in all equipment manufacturers under one roof.” Medicall serves as a marketing platform wherein the equipment companies showcase their products and services to Hospital owners and decision makers. Thus Medicall was born. Medicall shows are held at Chennai, Mumbai, Delhi, Ahmedabad, Kolkata, Hyderabad and Colombo since 2006. Medicall has completed 16 successful editions. Medicall Chennai 2016 had more than 750 exhibitors, 15000 professional visitors and over 5000 products. www.medicall.in
Events Calender
• Medicall 2017 : India’s Largest Hospital Equipment Expo, 17th Edition Date: July 28 - 30, 2017. Venue: Chennai.
• T-Plas 2017 : A Synergistic Platform With Focused Medical & Healthcare Plastics Pavilion Date: Sept. 20 – 23, 2017. Venue: Bangkok, Thailand.
• Medicall 2017 : India’s Largest Hospital Equipment Expo, 18th Edition Date: Oct. 6 – 8, 2017. Venue: Mumbai.
• 4th PLASTIVISION Arabia 2017 : International Plastics, Printing & Packaging Exhibition Date: Dec. 11-14, 2017. Venue: Sharjah, UAE.
• PLASTINDIA 2018 : 10th International Plastics
Exhibition, Conference & Convention Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India.
• Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018. Venue: Goregaon (East), Mumbai.
May-June 2017
