How to get listed in E-Catalogue 1. Visit the website http://www.ingineering-brands.com 2. Along with many useful information about the E-Catalogues, you will get the names of the industry, for which currently the E-Catalogue registration is open, a. Pumps & Valves, b. Medical Devices, c. Electrical Machineries, Equipment & Components d. Textile Machinery & Accessories 3. Click on the link for the desired E-Catalogue.
be part of the E-Catalogue along with product certification information. Please note, certification is mandatory, if you do not have product certificate, then you will not be able to list your products in the E-Catalogue. c. You will also be able to upload maximum five product images in a predefined format and size mentioned in the E-Catalogue interface. d. The third step is the optional questionnaire. After responding to the questions, companies are requested to accept the Terms & Conditions and submit their entry.
4. The corresponding E-Catalogue home page is displayed. It describes about the industry and some important statistics.
8. Once all the data entry validations are successfully passed, your registration will be submitted.
5. On the top banner, there is a button named “Get Listed”.
9. After submission, the E-Catalogue Admin will verify your entry for accuracy or any missing information and your application will be either accepted or rejected. If your entry is approved, your company and products gets listed in the E-Catalogue.
6. Click on that button, which will take you to the Manufacturer Registration page for the corresponding catalogue. 7. Manufacturer Registration is a 3 step process. a. In the first step, you need to mention details about your company. b. In the second step, enlist all the products that you want, to 20
Reference : http://www.eepcindia.org/eepc-download/ 96-Users-Guide.pdf
Mar.-Apr. 2017
Table of
Contents Vol. 25
No. 2
Mar. - Apr. 2017
24 Cover Story
• ASEAN Medical Devices & Plastics Sectors : Immense Market Potential Medical manufacturing is one of the key growth areas in countries belonging to the Association of Southeast Asian Nations (ASEAN). A rapidly expanding middle class is largely responsible for a projected near doubling of the medical device market in these countries.
26 Manufacturing • Developing Drug / Device Combination Products: Concept to Commissioning Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi A Drug Device combination products are emerging as innovative medical products due to their contribution in advancing medical care and are thus expected to have an impact in coming years. Development of Drug / Device combination entails the following steps….. • Packaging Testing for Medical Devices Mr. Bunty Kundnani, Business Manager, Life And Health Science, UL India Pvt. Ltd., Mumbai. Historically devices have been tested for degradation by accelerated aging and other various material characteristics. Testing a new packaging design before full scale manufacturing can save time and money.
34 Product Gallery • Dilators and Introducer Sheaths
30 Global Trends • Global Medical Disposables Market to Reach US$193.9 Bn by 2018 • Medical Polymers Market to exceed $24bn by 2024 • Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to 2027
32 Industry News • Med Devices Import up 16.8%, Export By 25.7% During 2012-16 • DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B medical devices • 10% price hike cap on most medical devices • CDSCO to go online for all services in six months
22 Did You Know? • About Drug / Device Combination Products & ASEAN Markets
42 Events Calendar • • • • Mar.-Apr. 2017
T-Plas, 2017: Sept. 20 – 23, 2017, Thailand, with “MEDICAL & HEALTHCARE PLASTIC PAVILION” Medicall 2017, 17th Edition: July 28 - 30, 2017, Chennai Medicall 2017, 18th Edition: Oct. 6 – 8, 2017, Mumbai MEDICAL FAIR INDIA 2017 Event Report
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Flashback Sept.-Oct. 2004 From Editor’s Desk Dear Reader’s, Importance of “Plastics” in medical grows more and more with growth of medical technology. This is because of excellent forming qualities, low weight and favourable economics. ......As per Prof. Jurgen Fleischer, the chair of the Institute For Production Technology at the University of Karlsruhe, “Increasing miniaturization combined with simultaneous integration of functions is a key theme of global product development in the most diverse application fields”. In particular, this applies to medical technology, which receives major inspiration from ComPaMED. On one hand, the focus is on materials that are prerequisites for permanent system reduction and, on the other hand, these innovative materials require that their manufacturing and forming processes are co-developed. As per Mr. Horst Giesen, Project Director for MEDICA and ComPaMED, “there can be no doubt: small and tiny components, functional surfaces and innovative materials will play an important role at ComPaMED 2004”. ........CBI, The Centre For The Promotion Of Imports From Developing Countries, Under their export development programme for medical devices which covered high-tech products as well as less sophisticated ones, supported 26 companies including about 10 companies from India. In the report by CBI Consultant Leendart Santema, “The second and third time participants saw an overwhelming increase of turnover”....... CONTENTS • Cover Story : Plastics Gain New Importance In Medicine. • Materials : Present Trends and Future Prospects of Plastics in Medical Applications. • Global Trends : CBI’s Export Development Programme For Medical Devices • Industry News : - Indian Healthcare Federation (IHFC) To Launch Country’s First Accreditation System For Healthcare Institutions - Asia’s Largest Healthcare City Soon In West Bengal (India) - Medical Insurance Set To Grow By 30 % - Medical Tourism in India: Attracting 15 million
22
Did You Know ?
?
About Drug / Device Combination Products & ASEAN Markets Many of today’s most innovative medical devices are actually drug/device combination products that generally include a medical device part and a drug part. The growth of global drug device combination products market is attributed to the growing incidence of chronic diseases such as prostate cancer, cardiovascular diseases, colorectal cancer, diabetic neuropathy; increasing concerns related to obesity and diabetes; and growing geriatric population. As per a recent BCC Research Study , the overall global market for Drug-Device Combinations is growing at a compound annual growth rate (CAGR) of 7.1% from 2014 to 2019, and thus sales are projected to reach $31 billion in 2019. Western- type diseases have become increasingly prevalent in Asia. Increased lifespans and growing incomes have led many to adopt Western habits—such as overeating, consuming fast food, smoking, and engaging in little exercise—putting Asians at an increasingly higher risk for lifestyle diseases. In particular, the growth rates of diabetes, orthopedic problems, cardiovascular disease, and cancer are rising quickly. Western device manufacturers already make products to diagnose and treat these diseases. Hence, the ASEAN nations are attractive markets for Western device firms. Although ASEAN countries have traditionally been known for low-end medical device product manufacturing, such as simple catheters and drainage bags, this is no longer the case. Some manufacturers in ASEAN countries are now able to produce more sophisticated Class II and, in some cases, Class III medical devices. Besides selling their device products in ASEAN countries, an increasing number of Western medical device companies are also manufacturing or sourcing their products there. They are doing so for a variety of reasons, including Asia’s low overhead costs, low labor costs, and improving technical capabilities. While labor costs have increased significantly in China, they remain low in some of the ASEAN countries, including Vietnam.
In a Nutshell.... “ The illiterate of the future will not be the person who cannot read, it be the person who does not know how to learn” -Alvin Toffler
Mar.-Apr. 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 DESIGNED AND PRINTED BY :
Editor’s Desk
From the
Focused “Medical & Healthcare Plastics Pavilion “ @ T-Plas 2017, Thailand – A Unique Opportunity For Medical Plastics Industry Suppliers to reach Asean Markets . For the first time ever in the Industry, “Medical Plastics Data Service” conceptualized and successfully created a focused Pavilion during the Plastivision India 2017 event in Mumbai in Jan.2017 as a mission with multiple objectives : - A knowledge Platform complete with Posters, Audio-Visuals, Models and Samples. - To help Medical Plastic Industry Suppliers To Reach Out To Medical Devices, Pharmaceuticals & Diagnostic Industry. - To help Non-Medical Plastics Industry To branch Out Into Medical Products. - Enhance the value of “Brand Plastic”. The experiment was extremely successful and very well received not only by the existing Industry but also new entrepreneurs as well as those looking for expansions and diversifications. Extending same objective , “MPDS” has conceptualized similar Pavilion in association with “T-Plas 2017” at Bangkok during Sept. 20 – 23, 2017, providing global platform with an ASEAN perspective. Medical manufacturing is one of the key growth areas in the ten member Asean countries led by Malaysia, Indonesia, Thailand and Singapore. Unlike the past, these rapidly expanding countries are not only projected to double the medical device industry markets, they are fast moving from low-end medical device products to more critical and sophisticated products manufacturing. Dedicated Pavilion in “T-Plas” show is a very good opportunity for Medical Plastics Industry Suppliers to reach Asean Markets. This issue covers two excellent and well researched articles by Dr Atul Sardana and Mr Bunty Kundanani covering very important Medical Device manufacturing issues. We are extremely grateful to them, particularly Dr Atul Sardana , for being generous enough to share his valuable experience in developing Drug / Device Combination products from concept to commissioning for the benefit of Indian Industry. Under Brand India Engineering campaign by Govt. of India, EEPC India has developed Brand India Engineering E-Catalogue with an objective to bring out 360 degree change in perception of Indian products from a supplier of low value added products to high value, technologically advanced and price competitive supplier. “Medical Devices “ is one of the focus sectors as part of e-catalogue. We appeal the Indian Medical Device Industry manufacturers to take benefit of this golden opportunity by getting listed in this world class catalogue at the link : http://ingineering-brands.com
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.
Mar.-Apr. 2017
23
Cover Story ASEAN Medical Devices & Plastics Sectors : Immense Market Potential ASEAN (Association of Southeast Asian Nation). Economy The ten member states making up ASEAN include Indonesia, Malaysia, Philippines, Singapore, Thailand, Brunei, Vietnam, Laos, Myanmar and Cambodia. ASEAN’s fertile consumer base with a combined population of over 600 million and a combined GDP of US$ 2.6 trillion, as well as presence in the global market, enables the region to tap the right opportunities, hinging on the region’s rising middle class sector and substantial consumer base. One of ASEAN’s top export sectors by value is plastics and plastic products earning US$ 39.3 billion in export revenues in 2013, the International Trade Statistics reported. The sector’s production rates have witnessed a steady average growth over the recent years, especially in the ASEAN-6: Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam, which account for more than 95 % of regional GDP, according to McKinsey & Company. Countries like Cambodia and Myanmar are growing strongly, with increased economic liberalisation and development, but will still contribute only a
small percentage of manufacturing foreign direct investment (FDI) in the coming years. ASEAN’s Plastics Industry ASEAN’s plastics industry is anticipated to expand in the coming years . In the ASEAN Business Outlook Survey , by the American Chamber of Commerce Singapore and US Chamber of Commerce, it was revealed that 19 % of ASEAN businesses themselves plan to shift investment or business from China into their own region. Respondents also identified Indonesia as the most attractive country for new business expansion, followed by Vietnam, Thailand, and Myanmar. The availability of low-cost labour in countries such as Cambodia, Indonesia, Laos, Myanmar, and Vietnam could be a competitive advantage. With the growth of ASEAN countries’ consumer bases, broadening of plastic import and export markets, and expanding foreign trading powers, ASEAN’s plastics industry offers significant opportunities.
24
ASEAN Medical Devices Industry : Immense Market Potential Medical manufacturing is one of the key growth areas in countries belonging to the Association of Southeast Asian Nations (ASEAN). A rapidly expanding middle class is largely responsible for a projected near doubling of the medical device market in these countries, from $4.6 billion in 2013 to $9 billion by 2019. Three ASEAN countries—Malaysia, Indonesia, and Thailand— account for approximately 65% of the current medical device market among the 10 member countries, according to Matthew Zito, Benedict Lynn, and Emily Liu of business intelligence firm Dezan Shira & Associates. The other seven are Singapore, the Phillipines, Brunei, Vietnam, Laos, Myanmar, and Cambodia. Medical device markets within the region have been charting double digit growth rates in recent years, and will likely continue to do so. “With the increased demand for better healthcare, encouraged by governmental focus on healthcare as a priority sector for trade and service liberalization . . . the upside market potential for medical devices in the region is immense,”.
The individual medical device markets across ASEAN’s 10 member countries are in various stages of development. Those with the greatest presence in the medtech market can be broken down as follows: • Malaysia and Indonesia, which are rich in rubber, lead global production in latex products such as surgical gloves and syringes. Malaysian exports in diagnostic imaging have expanded in recent years, according to research by Espicom, which estimates the country is likely to see compound annual growth of 16.1% to 2018, with growth for consumables as high as 24.8%. • Singapore, the region’s medical and technological hub, has a thriving biomedical research and development industry, and a competitive advantage in advanced manufacturing. It is home to the manufacturing operations of more than 30 medical technology firms. • Thailand also has a relatively robust medical device market, worth approximately $1 billion and growing 15% annually, Mar.-Apr. 2017
Cover Story according to Ames Gross, President of Pacific Bridge Medical (Bethesda, MD). On the regulatory front, ASEAN member countries have made significant strides toward developing a mature regulatory framework for medical devices, both individually and regionally. ASEAN countries currently remain reliant on imports to satisfy demand for medical devices: for example, as much as 97% of devices consumed in Indonesia in 2013 were imported, mainly from the United States, Japan, and Europe. Nevertheless, momentum is building for local manufacturing to transition toward more advanced products, as foreign companies move into the region to take advantage of lower costs and rising demand. South East Asian Pharma Industry The South East Asian pharma industry has been growing at an average of 6-10 percent in the past 10 years. The governments across the ASEAN region are introducing universal healthcare programmes, with the consequential rising demand for all categories of medicines, especially generic drugs. Comprising almost 40 per cent of the SEA economic output, Indonesia is now the largest pharma market in the Southeast Asia/Asia Pacific region (SEA/AP), experiencing an impressive 85 per cent growth in between 2007-2013. The country has the biggest and fastest growing economy in the SEA region and a pharma economy consisting of approximately 200 pharmaceutical companies. There are already 25-30 generic domestic companies with access to the international market and equally, there are approximately 35 multinational companies, such as Sanofi, ACG and Novo Nordisk, established in the area. Most significantly however, are the remaining domestic manufacturers, who are increasingly targeting international sales in neighbouring countries.
conceptualized by “T-PLAS 2017 “ in association with “MEDICAL PLASTICS DATA SERVICE” which will be participated by Exporters and Manufacturers of Materials , Machinery and Products to the Medical Plastics, Medical Devices and Pharmaceuticals Industries.
The Pavilion will showcase latest developments by regional and international exporters And manufacturers Of Medical Plastics Processing Machinery, Pharmaceuticals / Medical Products Packaging Machinery, Medical Polymers, Components / Tubings / Adhessives, Packaging Films / Pouches etc. Driven by the nation’s various burgeoning sectors such as Medical, Pharmaceuticals, Packaging as well as Lifestyle, Thailand is well positioned to become Southeast Asia’s very own hub for its plastics and rubber industries. These areas of interests have seen significant growth in recent years, and are projected to expand to new heights in years to come.
Special Visitor Campaign for Medical Device and Pharmaceutical Industries Calling all Exhibitors specialising in :
Sept. 20 – 23 , 2017 T-PLAS 2017 - A Global Platform with an ASEAN Perspective on the Buoyant Opportunities in the region. Bringing together industry leaders from the best local and international brand names from the plastic and rubber sectors, T-PLAS 2017 to be held in Bangkok offers a full spectrum of specialised equipment, high-precision machinery, semifinished products, raw materials, applications and solutions serving the plastic and rubber value chain. Gain special insights on growing markets such as manufacturing of plastics for the medical, packaging, and automotive sectors.
Clean Room Products Medical Plastic - Components, Sub-assemblies Medical Plastic Tubings and Extruded Products Medical Plastic Resins, Chemicals & Additives Medical Plastic Processing Machinery Medical Plastic Devices Medical Packaging Films and Pouches Medical & Pharmaceutical Packaging Supplies & Machinery
Concept & Contents By :
A synergistic platform with Focused Medical & Healthcare Plastic Pavilion - Global Innovations , Strategic Presence A dedicated “Medical & Healthcare Plastic Pavilion” is Mar.-Apr. 2017
25
Manufacturing
Developing Drug / Device Combination Products : Concept to Commissioning
Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi. Definition of Drug/ Device Combination • A Drug Device combination is a product comprising of active pharmaceutical ingredient(s) and a medical device that are physically or chemically combined to produce a single product. • Such combination products are emerging as innovative medical products due to their contribution in advancing medical care and are thus expected have an impact in the coming years. • These offer several advantages including reduced adverse/side effects, improved patient compliance, controlled release of drugs and targeted drug delivery, overall reduction in healthcare expenses and augmented performance.
Classification of Drug/ Device Combination • “Single Entity” or “Integral” product comprises of two or more different regulated components (drug/device) that are physically, chemically, or otherwise combined or mixed. • “Co-packaged” or “Kitted” unit in a single package comprising of drug(s) and device(s). • “Cross-Labelled” comprise of drug(s) or device(s) packaged separately that according to its investigational plan or proposed labelling is intended for use only with another individually and where both are required to achieve the intended use, indication, or effect.
Examples of Drug/ Device Combinations “Single Entity” or “Integral” • Prefilled Drug Delivery Systems - Prefilled syringes - Prefilled autoinjectors - Prefilled pen injectors - Prefilled on-body delivery systems - Dry-powder inhalers - Metered dose inhalers - Prefilled nasal sprayers - Transdermal patches - Oral Vaccine Delivery Devices
• Medicated Devices - Drug-coated stents - Drug-coated catheters - Drug-coated pacemaker leads - Antimicrobial surgical scrubs - Antimicrobial wound dressings - Antimicrobial Sutures - Drug impregnated surgical mesh - Antibiotic bone cements - Spermicidal condoms
The Development of Drug/ Device Combination entails the following steps : 1.Unmet Need Identification • A Device may require a drug to • Improve its Safety especially over long term implantation or when being placed in pathological conditions or challenging environments within the body. • To augment the function of the device by providing synergy • To enhance the efficacy of the device by suitably modifying the local or systemic conditions To reduce device associated co-morbidities and complications. • A Drug may need a Device in order to : • Ensure or regulate proper dosing • To provide a constant rate of drug elution and sustained release • To monitor drug release and concentration levels as in a loop feedback • Improve patient compliance • To ease administration and make self administration possible. • To enhance the shelf life of the drug • To reduce filling and administration losses and drug contamination • To improve drug safety
26
Examples of Drug/ Device Combination “Co-packaged” or “Kitted” • Convenience kits - Surgical trays with anaesthetic and/or surgical scrub - Vial and syringe packs - Injector pen with user-loaded prefilled cartridge - Liquid medication with dosedispenser
• Other - Collagen sponge with bone morphogenic protein “Cross-Labelled” • Companion diagnostics • Photodynamic therapy (laser activated drug) • Contrast agent and diagnostic imaging • Iontophoretic delivery systems
• To provide targeted drug delivery 2.Design Development Design development of a drug device combination needs in depth understanding and critical analysis of the following : • Understanding the drug device Interphase with the body • Understanding the interactions between the drug and the device throughout the product life cycle Raw Material Selection for the device is based on the following criterion that need to be evaluated in all phases of the product development and use. • Leachable interaction with the body and the drug • Extractable interaction with the body and the drug • Additives and Coatings to be used on the device and their interactions with the drug. • Barrier Properties of the Material and effects of oxygen, moisture and other gases on the drug. • Stability Testing of Drugs in the drug device combination • The effect on drug(s) on Polymer(s) properties and function • DMPK (Drug Metabolism and Phamacokinetics) Study • Shelf life study and accelerated ageing of the drug device combination • Method of sterilization to be used for the combination with Mar.-Apr. 2017
Manufacturing respect to drug stability. • Prototyping challenges for drug device combination usually preclude 3D printing as the combination needs to be tested with actual polymer proposed. Though it may be used for mechanical and dimensional validation. • A thorough understanding by the devices manufacturer is required with regards to the drug filling lines and due consideration should be given to the environmental challenges of the aseptic conditions to be maintained. The Current Challenges faced During the Development and Marketing of Drug / Device Combination can be summarized as below : 1.During Manufacturing of the Drug Device combination the following challenges may be encountered • Large Scale Manufacturing • Device Filling in Aseptic Lines with Drugs • Replication of the Drug Impregnation / Coating process on commercial scale • Combipack Development
Mar.-Apr. 2017
• • • • •
Integration of Automation From Production to Filling/ Coating Validation Protocols to be used Clinical Trials requirements for Novel Devices P a c k a g i n g R e q u i r e m e n ts (Intermediate and Final) • Filling Lines • Sterility of Ready to Fill Systems in Aseptic Lines • Labeling for Regulators and Users • Choice of Sterilization Methods • Standardization of Exchange of Data amongst Device and Drug Manufacturers 2. Affixing Responsibility • Post Market Clinical Feedback • Post Market Surveillance • Vigilance and Incident Reporting • Complaints • Corrective and Preventive Actions 3. Classification of Drug/Device combinations in the currently prevailing law in India. 4. Regulatory Approvals 5. Legal and Intellectual Property Right Issues amongst the parties involved in collaborative development (drug manufacturer and device manufacturer)
27
Manufacturing
Packaging Testing for Medical Devices
Mr. Bunty Kundnani, Business Manager Life and Health Science, UL India Pvt. Ltd. Mumbai. Introduction Medical Device Packaging is highly regulated and must meet the standard requirement. Historically devices have been tested for degradation by accelerated aging and other various material characteristics. Packaging testing is measuring the characteristics and property of packing material. Most precarious factor is the sterility which should be maintained through the distribution and storage. Packaging must comply with ISO 11607 and EN 868-1, in order to satisfy European regulations and obtain a CE Mark. Testing a new packaging design before full scale manufacturing can save time and money. Many manufacture conduct packaging testing in-house or through third party lab (ISO/IEC 17025 accredited) which is accredited and certified (ISTA certified, ISO 17025). The testing is vital to ensure integrity of the package's seal. The general factors that influence the product stability are physical, chemical, microbiological and toxicological.Most of the
manufacturer conducts the testing at different phases of product life cycle like product design stage, product launch, and new package design, resolve package damage issue and sometimes based on client requirement. Regulations and Standards for Packaging Testing Packaging testing guidelines are listed in ISO 11607 describing the available ASTM packaging tests. The key aspects of packaging validation are material qualification, seal validation process and whole package seal integrity. Physical tests like burst, peal, creep and leak tests are performed as per ASTM standards. ISO 11607 require both accelerated and real time aging to be performed simultaneously. The key areas to be focused in the packaging are stability, performance, package integrity and strength testing(Figure 1).
Figure 1 : Package validation testing with Standard Reference
Regulations and Standards Package Validation Testing Package Integrity Testing
Distribution Simulation Testing
Stability Testing
Test Procedures : • Seal Intefrity - Visual inspection (ASTM F1929) • Seal Strength - Peel Test (ASTM F18) - Burst Test (ASTM F 1140) - Bubble Test (ASTM F 2066) • Microblel Challenge - ASTM F1603
Test Procedures : • Atmosphere Conditioning (ASTM D4332) • Drop Test (ASTM D5276) • Vibration Test (ASTM D4728) • Compression Test (ASTM D642) • Low Pressure (ASTM D6653)
Test Procedures : • Accelerated Aging (ASTM F 1980)
Package Integrity Test Depending on package design, a variety of packageintegrity testing methods may be employed. Thisis to ensure the integrity of package seal and system.Visual inspection, peel strength, burst strength, creeps and bubble emission test are some of the package integrity test. During the study conduct deformities break or crack, blister can be observed(Figure 2).
Figure 2 : Deformities from visual inspection
Seal strength test is conducted through a simple burst and / or creep test where packages are pressurized and evaluated for the rupture pressure points and time of failure. It is conducted to measure the ability of package seal to resist separation. Burst and creep testing entails pressurizing theinside of the package and measuring the pressurerequired to either cause seals to separate or packaging materials to rupture. Some packages use porous materials,allowing the contents to be gas sterilized throughthe porous package walls after the package has beensealed; burst testing of these packages can require higher inflow capability in order to achieve sufficientpressure to challenge the package.
Figure 3 : Burst test (ASTM F1140) Dye penetration test is conductedto detect the presence of any leakage in the seal, (Figure 4). This test method is limited to porus material which can retain the dye penetrant solution and prevent
28
Mar.-Apr. 2017
Manufacturing it from discoloring the seal for 5 seconds. The study can be conducted through different methods like injection, edge dip and eye dropper.
Figure 4 : Dye penetration
Drop test study is used to determine the package ruggedness nature and interior cushioning effectiveness when the products/ packages systems are exposed to bumpy situation during material handling operations. Vibration study as per ASTM D999 & ASTM D4728is used to determine the package withstand to the stresses, shock and vibration that will be encountered during the transit and package's ability to function and protect in real world conditions. Compression study as per ASTM D642 is to determine the maximum resistance of compression and lock term stacking strength of the packages (Figure 7). For example, foam is compressed to determine how well it maintains its cushioning properties.
Figure 7 : Study results
Bubble test as per ASTM F2096 standard is conducted by visually inspecting for bubble streams caused due to affect in the packaging while it is submerged in water.This destructive testing provides a practical way to examine packages for gross leaks, which may render the product non-sterile. This test may apply to very large or long packages, which do not fit into any other package integrity test method apparatus.
Figure 5 : Bubble Test Peel Testing is performed in accordance with ASTM F88 and EN 868-5Standard Method for Seal Strength of Flexible Barrier Materials.The test results are not only related to package integrity, but also to measuring the packaging processes' ability to produce consistent seals. Given that seal strength is a necessary requirement for packaging, Peel Tests are ubiquitous for all types of packaging. Transport Simulation The medical packages encounter many variables during the transit from the manufacturing site to the sterilization facility, distribution center, health care facility, etc. Distribution Simulation is large and quintessential component that complies with the standard and are of three types (Figure 4);Drop test, Vibration test and Compression test. It is necessary to expose the packages and products to atmospheric conditioning in order to simulate particular field conditions that a packaged product or component may encounter during its expected life cycle.
Figure 6 : Transport Simulation
Compression Mar.-Apr. 2017
Vibration
Drop
Drop Test
Shock Test
Compact Test
Stability Testing/ Shelf Life Testing Accelerated Aging is a testing method used to estimate the product lifespan when actual data is unavailable or have not gone through the entire product lifespan cycle. A product can be released to market based upon successful Accelerated Aging of the package/product that simulates the period claimed for product expiration (1 year, 2 years, etc). Accelerated Aging data is recognized by regulatory bodies as an acceptable means to generate data quickly, but is only accepted until those tests can be repeated on "real time" samples. Accelerated Aging test is carried out by subjecting the product to unusually high levels of stress (rapid, but controlled, changes in temperature, humidity, pressure, strain, etc.) designed to mimic the effects of normal use. Real-Time Aging provides the actual data to determine shelf life and the effects of aging on materials. Conclusion In packaging medical products that impact lives andhealth, the costs of poor quality control can be enormous.In today’s fastmoving global markets, thestakes are higher than ever. As competition and timepressures have grown, the industry and its regulatorshave come to recognize that traditional testing methodscan be slow and potentially risky. Package integritytesting has been acknowledged to be an importanttool for ensuring the safety of package systems and the products they protect. UL testing and validation services are based on ISO 11607-1:2006 and ASTM standards are designed to assure compliance with FDA, ISO, EN and CE Mark requirements. UL can support the non active medical device manufacturers with Biocompatibility testing as per ISO 10993, Materials Characterization, Microbiological testing, Virological testing, Physico-Chemical analysis, Shelf Life of devices and packages, Transport safety and Testing of Ophthalmic devices. References 1. ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices; Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems 2. ASTM D999 – 08, Standard Test Methods for Vibration Testing of Shipping Containers
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Global Trends Global Medical Disposables Market to Reach US$193.9 Bn by 2018 As per a recent study by Transparency Market Research, the global medical disposables market was worth US$144.6 Bn and is anticipated to be worth US$193.9 Bn by the end of 2018, growing significantly at a 4.30% CAGR between 2012 and 2018. Rising demand for healthcare due to the rising global aging population, rising prevalence of chronic conditions that need long-time therapies, and expanding volume of inpatient days and hospital admissions are some of the major factors boosting the demand for medical disposables in the coming years. On the other hand, rigid FDA and GMP approval norms and reduction in the prevalence of healthcare-associated infections are the factors that are expected to curb the growth of this market in the forecast period. The market has been classified on the basis of end use into home healthcare facilities, outpatient facilities, emergency care, hospitals, and physician offices. Among these, the hospitals segment is at the forefront of the U.S. medical disposables market. The demand for medical disposables is anticipated to rise in hospitals, thanks to the rising number of patient
admissions, surgical procedures, and emergency visits. It has been further segmented on the basis of geography into North America, Asia Pacific, Europe, and Rest of the World. Among all these regions, North America exhibited strong demand for all product segments of the market in the recent years. The U.S. medical disposables market held around 70% of the North America medical disposables market. In 2011, and was accounted for the largest share of 35% in the global medical disposables market. On the other hand, Asia Pacific is expected to witness rapid growth owing to rising awareness for healthcare. Some of the other factors that are expected to boost the demand for medical disposables in the Asia Pacific market are the huge aging population, increasing disposable income, and rising expenditure by governments on healthcare. The substantial rise of developing nations such as China and India is anticipated to propel the Asia Pacific medical disposables market. (Ref.: http://www.transparencymarketresearch.com/ pressrelease/medical-disposables-market.htm)
Medical Polymers Market to exceed $24bn by 2024 Medical Polymers Market size is slated to cross USD 24 billion by 2024; as per a new research report by Global Market Insights, Inc. rapidly enhancing pharmaceutical devices demand owing to the prevalence of heart diseases, infections, or general illness and technological advancements in the treatment process will steer the global medical polymers market growth in upcoming years. Increasing health awareness among developed nations will also support the industry throughout the forecast spell.
healthcare industry generated more than USD 200 billion and it will grow by CAGR over 8% up to 2024.
Pharmaceutical device industry generated over USD 300 billion in 2015, of which U.S. had a major share of around 45%. U.S. recorded over 6,500 pharmaceutical device manufacturers by 2015 and the growing demand in the country as well as export demand in the emerging economies will escalate the market growth in coming years. Growing application of polymers including polysulfone, polyphenylsulfone, polyether-etherketone or PEEK, and polyetherimide in pharmaceutical devices will propel the overall medical polymers industry growth.
Developments and preferences of bio-based polymers for environmental sustainability will characterize the growth of biodegradable medical plastics and are likely to register a CAGR over 15% in the overall medical polymers market. Medical packaging applications will be a fast-growing segment owing to mandatory sterilization and medical disposable regulations.
Increasing global geriatric population will also be a significant medical polymers market driver. Population over the age of 65 years increased from 7.6% of global population in 2010 to around 8.3% in 2015 and will increase owing to pharmaceutical developments and increasing geriatric care units. The American Geriatrics Society has predicted the U.S. geriatric population to reach 20% of total population by 2030. Ubiquity of chronic disorders such as cardiac diseases, calcium deficiencies, arthritis, etc. will likely have a positive influence on global. Medical polymers market will also be driven by the growing home-based private healthcare demand due to its ease and affordability along with factors including commotions in public facilities, chronic or contagious diseases, and elderly patients will enhance the home-based healthcare industry in the upcoming years. In 2015, the global home-based private
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Medical fibers & Resins will be a noteworthy product segment which generated more than USD 8 billion in 2015. Polypropylene based fibers & resins will likely grow at a significant rate owing to its chemical inertness, light weight, and favorable mechanical properties. Overall medical fibers & resins will flourish at more than 8% CAGR up to 2024.
Regional medical polymers market growth will be focused around the emerging economies in Asia Pacific, Latin America, and Middle East & Africa, owing to rapidly increasing medical awareness and government initiatives. Asia Pacific will register more than 10% CAGR in the forecast time span. Raw material price volatility will hinder the medical polymers market growth. As, Petrochemical based raw materials prices are dependent on the global crude oil prices, which is highly fluctuating in nature. Strict norms about volatile organic compound (VOC) content in the polymers may also restrain the medical polymers market. End products are based on superior biocompatibility with various product blends, and the expensive manufacturing technologies will restrain the entry of new market participants. (Ref.: https://www.gminsights.com/pressrelease/medicalpolymers-market)
Mar.-Apr. 2017
Global Trends Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to 2027 Availability of reprocessed medical devices at low prices, coupled with assurance of qualitative production, has also prompted the market’s growth to a considerable extent. According to recent report by ‘Future Market Insights’ on the reprocessed medical devices market in Asia-Pacific region projects that in 2017 and beyond, Japan, China and Southeast Asia will collectively account for more than 60% share of overall market revenues. It estimates that reprocessed medical devices market in Asia-Pacific is presently valued at US$ 236.9 Mn. In a ten-year forecast period, the market is being projected to expand at 15.7% CAGR and bring in a little over US$ 1 Bn by the end of 2027. Rising focus of government authorities towards dumping of medical waste or biowaste is slated to promote the reprocessing of medical devices. Manufacturers of medical devices are continuously striving to control their product costs for recording greater sales. Reprocessed medical devices, thus, become the most feasible option for both, manufacturers and end-users. Availability of reprocessed medical devices at low prices, coupled with assurance of qualitative production, has also prompted the market’s growth to a considerable extent. The report reveals that in 2016, more than US$ 100 Mn worth of reprocessed medical devices turned out to be used in the field of cardiology. Demand for reprocessed cardiology devices is expected to continue surging in the years to come, registering the highest revenue CAGR of 18.4%. Reprocessing will also gain traction among laparoscopic tools & devices, revenues from which are predicted to reach US$ 111 Mn by
2027-end. Meanwhile, orthopedic or arthroscopic devices, gastroenterology devices, ENT devices and other such medical devices will be showcasing a comparatively steady growth in terms of revenues. By the end of 2027, one of every two reprocessed medical devices sold in Asia-Pacific will be classified under semicritical medical devices. This indicates that demand for reprocessing is higher for semi-critical medical devices, as opposed to critical or non-critical medical devices. The most prominent method of reprocessing medical devices, observed across Asia-Pacific, is likely to be third-party reprocessing. Third parties assisting drug makers in reprocessing businesses is serving as a consolidator for Asia-Pacific’s reprocessed medical devices market. The hospitals are identified as the largest end-user of reprocessed medical devices in Asia-Pacific. Similarly, diagnostic centers and ASC’s will also contribute significantly, by exhibiting revenues growth at more than 11% CAGR. Furthermore, the leading reprocessed medical device manufacturers partaking in the Asia-Pacific region are companies such as Stryker Sustainability, Medline ReNewal, Hygia Health Services, Inc., CLEANPART HEALTHCARE, ReNu Medical, Inc., SureTek Medical, and NEScientific. (Ref.: http://www.crossroadstoday.com/story/35077832/ asiapacific-reprocessed-medical-devices-market-will-hit-at-acagr-of-157-by-2017-to-2027)
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
Mar.-Apr. 2017
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Industry News Med Devices Import up 16.8%, Export By 25.7% During 2012-16 Between FY12 to FY16, the import of medical devices into India has increased by 16.8 per cent, whereas export increased by 25.7 per cent, as per the key findings of a government led study in collaboration with Andhra Pradesh MedTech Zone (AMTZ) and World Health Organisation (WHO). India is one of the top 20 global medical device markets and the 4th largest medical device market in Asia. The import of medical devices has grown from USD 2.46 billion ( Rs.15,990 crore) in FY12 to USD 2.87 billion ( Rs.18,655 crore) in FY16. The export of medical devices has grown from USD 0.78 billion ( Rs.5,070 crore) in FY12 to USD 0.98 billion (Rs.6,370 crore) in FY16. Diagnostic imaging (e.g. CT scan, X-Ray, MRI, USG, X ray-tubes etc.), IV Diagnostic (lab equipment and reagents, etc.) and Other Medical Device (ECG, opthal equipment, heart lung machine, etc.) form 70% of total import in India in FY16. However it is estimated that import trade will fall with increasing number of international and Indian manufacturers setting up medical device manufacturing in India. Diagnostic imaging, consumables and
other medical devices form 86 per cent of total export trade in India in FY1613. Amongst the exporters’ portfolio, USA was the chief destination for export and contributes close to 15 per cent of the export trade. Singapore, Germany and China were the other leading export destinations with shares of 7.0 per cent, 6.7 per cent and 6.4 per cent respectively. The European Union (including Germany) cumulatively constitutes of 21.7 per cent of the total export trade13. USA, Germany, China, Japan, and Singapore constitute the five largest exporters of high technology medical equipment to India. In FY 2015 imports alone from these five countries accounted for approximately 65 per cent of total import of high technology medical equipment while USA, remained the largest exporter accounting for 28.1 per cent. Diagnostic imaging medical device import trade has grown by 19% from USD 636 million ( Rs.4,134 crore) in FY12 to USD 757 million ( Rs.4,921 crore) in FY 16. IV Diagnostic medical device import trade has grown by 43.2% from USD 225 million ( Rs.1,463 crore) in FY12 to USD 322 mil-
lion ( Rs.2,093 crore) in FY 16. Other Medical Device (e.g. ECG, opthal equipment, heart lung machine, etc.) has grown by 9.6% from USD 878 million ( Rs.5,707 crore) in FY12 to USD 964 million (Rs.6,266 crore) in FY 16. Diagnostic imaging medical device export trade has grown by 27.2 per cent from USD 210 million ( Rs.1,365 crore) in FY12 to USD 267 million ( Rs.1,736 crore) in FY16. Medical Consumables export trade has grown by 26.1 per cent from USD 228 million ( Rs.1,482 crore) in FY12 to USD 288 million ( Rs.1,872 crore) in FY16. IV Diagnostic devices export trade has grown by 58.7 per cent from USD 24 million ( Rs.156 crore) in FY12 to USD 39 million ( Rs.254 crore) in FY16. While technological advancement and expertise that the global market leaders offered has proved to be an advantage, India’s medical device sector is dominated by multi-national companies, which is evident from the fact that about 78% of the sales are generated by imported medical devices. http://www.pharmabiz.com/ ArticleDetails.aspx?aid=100896&sid=1
DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B medical devices The Drugs Controller General of India (DCGI) has started the process of registration of notified bodies to carry out audit of manufacturing sites of Class A & Class B medical devices as laid down in the Medical Device Rules 2017 which will come into effect in the country from January 1, 2018. The Medical Device Rules 2017 have already been published vide G.S.R. 78 (E) dated 31.01.2017 under Drugs and Cos-
metic Act, 1940 to regulate the clinical investigation, manufacture, import, sale and distribution of the medical devices. The Chapter III (Rule 13) of Medical Device Rule 2017 provides for the registration of notified bodies with the DCGI office (CDSCO). Subsequently, with effect from July 1, 2017, the notified bodies have to file their application to the Central Licensing Authority (DCGI) for registration in Form MD-1
through online portal to carry out the audit of manufacturing sites of Class A & Class B medical devices to verify conformity with the Quality Management System and other applicable standards. In this regard, CDSCO has put in place an online portal for the registration of notified bodies. http://www.pharmabiz.com/ ArticleDetails.aspx?aid=101382&sid=1
10% price hike cap on most medical devices The prices of all medical devices except for stents, condoms and intrauterine devices can only be raised by up to 10% in a year, the National Pharmaceutical Pricing Authority (NPPA) said in a new office order on Friday. The drug price regulator also clarified that all medical devices notified as drugs under the Drugs and Cosmetics Act, including stents, orthopaedic implants, catheters and intra-ocular lenses, will have to mandatorily carry their maximum retail price (MRP) on their packs.
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While the government has notified 22 medical devices as drugs under the Act, the prices of stents, condoms and intrauterine devices are capped by the NPPA directly, and companies manufacturing or selling these products have to take permission from the regulator before implementing any hike. However, for other 'non-scheduled' products, the regulator has allowed an annual increase of 10% in prices. For any hike beyond the limit, companies will have to seek permission from the regulator. Cautioning companies against overcharg-
ing consumers, the regulator said it was closely monitoring prices of not only scheduled but also non-scheduled products, and any violation wo*uld attract severe action and penalty under the Essential Commodities Act. Several leading hospitals have already come under the NPPA's scanner for allegedly overcharging
Mar.-Apr. 2017
Industry News CDSCO to go online for all services in six months The Central Drugs Standard Control Organisation (CDSCO) is set to become paperless within six months with completely shifting its services to online portal Sugam. The agency digitized 60-70 per cent of its services through Sugam portal so far. In another six months we are planning to go completely electronic for all our services by doing away with requirement of any physical documents, said a senior CDSCO official. With the launch of Sugam on November 14, 2015, firms can apply online for grant of registration certificates for import of drugs or import license of drugs in Form 10, under D&C Rules. They can also file online applications with respect to import registration and license of medical devices. Online submission has also been started for grant of approval to conduct bioequivalence studies for export purposes. The main aim of this e-governance drive is to bring in transparency, accountability and competency in CDSCO which allows creating a real time platform and improve the safety and security programmes taken up by it. http://www.pharmabiz.com/ PrintArticle.aspx?aid=100721&sid=1
Mar.-Apr. 2017
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Product Gallery Dilators and Introducer Sheaths
Ronkonkoma, NY, Qosinacarries a dilatorsavailable with introducer sheaths in materials and colors.
March 15, 2017— large selection of and without tear-away various lengths, sizes,
Tear-away introducer sheaths with dilatorshave a zero clearance dilator-to-sheath transition and are equipped with a unique locking mechanismon the hub. The sheaths areconstructed of Teflon® for a smoother tear-away, or pre-scored polyethylene, which ensures consistent peel-away performance. Tear-away introducer sheaths and dilators with griplock hubsalso have a zero clearance, a locking mechanism on the hub and an ergonomically designed handle for easy removal. Valved tear-away introducer sheaths with dilatorsincludetabs for more comfortable handling after device insertion, and the valve maintains a tight seal to help prevent air or fluid leakage.The Teflon® sheath allows for a smoother peel. Qosina also carries introducer needlesin a wide range of gauge sizes, hub configurations, needle lengths and tips to complete your project needs.
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. 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
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 34
Mar.-Apr. 2017
Events
MEDICAL FAIR INDIA 2017 closes with a huge boom in visitors New programme highlights were well received With a huge boom in visitors, the MEDICAL FAIR INDIA has definitely marked out its position as the leading medical trade fair for the Indian market and built on the growth of the previous years. 13,480 decision makers from all sectors of the healthcare industry came to MEDICAL FAIR INDIA 2017 at the Pragati Exhibition Center in New Delhi from 6 to 8 April. They visited 519 exhibitors to learn about the latest trends and innovations for medical healthcare. “Visitor numbers increased by 15% in comparison with the 2016 event in Mumbai. The floor space booked by the exhibitors also expanded by 16%. As expected with great results like these, the atmosphere in the trade halls was buzzing”, summed up Thomas Schlitt, Managing Director of Messe Düsseldorf India. The MEDICAL FAIR INDIA takes place in New Delhi and Mumbai, alternating between these locations each year.
International Tradefair for the Plastic and Rubber Industries
Opportunity For Exporters And Manufacturers Of Medical Plastics Processing Machinery, Pharmaceuticals /Medical Products Packaging Machinery, Medical Polymers, Components / Tubings / Adhessives, Packaging Films / Pouches etc. EXHIBIT IN THE ”Medical & Healthcare Plastics Pavilion” @ T – PLAS BITEC, Bangkok, Thailand. September 20 – 23, 2017 Organized By : Messe Dusseldorf Asia A dedicated “Medical & Healthcare Plastic Pavilion” is conceptualized by “T-PLAS 2017 “ in association with “MEDICAL PLASTICS DATA SERVICE” which will be participated by Exporters and Manufacturers of: Clean Room Products, Medical Plastics-Components, Sub-assemblies, Medical Plastic Tubing’s and Extruded Products, Medical Resins, Chemical & Additives, Medical Plastics Processing Machinery, Medical Plastics Devices, Medical Packaging Films and Pouches, Medical & Pharmaceutical Packaging Supplies & Machinery.
“The MEDICAL FAIR INDIA is the top event for the healthcare industry. We saw that it was even better than our expectations” said Raghvendra Bansal, Managing Director of RR Instruments, recapping the successful trade fair on behalf of many very satisfied exhibitors. The synopsis of Prashant Narula, Marketing Director of Narula Udyog was also positive: “Not only the numbers but also the quality of the visitors was well above our expectations. We are very happy with the outcome.”
T – PLAS 2017 (www.tplas.com), organized by “Messe Dusseldorf Asia, provides a global platform with an ASEAN perspective on the buoyant opportunities in the region by bringing together local and international industry leaders from these dynamic growth sectors.
New highlights also contributed to the success of MEDICAL FAIR INDIA. They enriched the supporting programme for the event and aroused much interest from visitors on all three of the trade fair days. A novel digital health platform was created in the FTR4H Lab & Lounge (Future for Healthcare powered by MEDICA). The Lab & Lounge centred around information, start-ups presenting their product ideas, expert dialogues and networking on all the fascinating topics concerning the digital transformation of the healthcare industry (i.e. mobile health, the internet of things and targeted and secure data handling).
A SPECIAL VISITOR COMPAIGN FOR MEDICAL PLASTICS, MEDICAL DEVICE AND PHARMACEUTICALS INDUSTRIES IS BEING CARRIED OUT
The Indian market for health IT offers particularly good opportunities, with an estimated volume of 2.5 billion USD (Deloitte). High-tech infrastructures for state-of-the-art clinics in big cities as well as remote medical applications that ensure medical care in remote countryside regions are included in this, among others. The CLIN LAB INDIA also celebrated its premier as an integral part of the programme of MEDICAL FAIR INDIA this year. The conference and its accompanying exhibition were designed by Scherago International and organized in cooperation with the Messe Düsseldorf Group. The focal point of the talks was on trend topics that are particularly relevant to the practice of laboratory medicine, such as point-of-care testing, molecular diagnostics and clinical chemistry. The CLIN LAB INDIA exhibition area (in Hall 9) had booked out 330 square metres, with companies such as Mindray, Randox and SMC Pneumatics along with others, taking up this space. Mar.-Apr. 2017
The top 6 country visitors for this show are from Indonesia, Malaysia, Singapore, Thailand and Vietnam on and above India.
Capitalize on the leading trade show and connect with the world today! Driven by the nation’s various burgeoning sectors such as Medical, Pharmaceuticals, Packaging as well as Lifestyle, Thailand is well positioned to become Southeast Asia’s very own hub for its plastics and rubber industries. These areas of interests have seen significant growth in recent years, and are projected to expand to new heights in years to come. For more details, please write to: Medical Plastics Data Service, mpds00@vsnl.com
In terms of content, the MEDICAL FAIR INDIA 2017 included the following areas and many more: Medical products and medical technology, laboratory technology and diagnostics, equipment and furniture for clinics and health centres, products for physiotherapy and rehabilitation as well as health IT and mobile health solutions. All the details on MEDICAL FAIR INDIA are available online at: http://www.medicalfair-india.com. The next MEDICAL FAIR INDIA will take place from 16 - 18 March in Mumbai.
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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 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 36
Mar.-Apr. 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
Mar.-Apr. 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.
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
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Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Mar.-Apr. 2017
Mar.-Apr. 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
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
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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. Mar.-Apr. 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
Breathing Filters
Airovent T-Humidifier
Anaesthesia Circuits
Incentive Spirometer
ET Holder with Bite Block
Expandable Catheter Mount
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
•
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
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 Mar.-Apr. 2017
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Events 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.
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
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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 GMP. & ISO 9001 – 2000 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 / URINE BAGS / MEASURE VOLUME SETS ETC.
Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India Mar.-Apr. 2017