Innovative Styrenics Solution for IV System & Drug Delivery

Styrenics are marvelous polymers. Its copolymerization capability generates added quality and value, such as high impact strength, outstanding transparency, excellent chemical resistance, low density, balanced performance and good process ability etc. INEOS Styrolution offers broad medical styrenics portfolio with regulatory compliance & special service packages, which has been widely appreciated by global medical device OEMs.

With its long years commitment & experience in medical industry, INEOS Styrolution introduces innovative styrenics solutions for medical applications, like IV System and Drug Delivery System. INEOS Styrolution medical portfolio: Zylar® & Clearblend® (MBS), Styrolux® & K-Resin® (SBC), Novodur® HD (ABS), Terlux® HD (MABS), Luran® HD (SAN), NAS® (SMMA), Styroflex® (S-TPE)

Formulating life & Enhancing solution: Global advance products for local medical device Industry

Individual medical care with increased life expectancy and complex diseases, is a challenge today. Let us make durable medical devices to support the billions with high safety standards.

Covestro High Performance Polycarbonate is a proven choice with 50 years of Makrolon in the global medical market. We enhance design freedom by weight reduction, heat resistance, toughness & transparency.

Voluntary Certification Scheme for Indian Medical Devices Manufacturers

The Quality Council of India (QCI), in collaboration with the Association of Indian Medical Device Industry (AIMED), launched a voluntary quality certification scheme for medical devices, the "Indian Certification for Medical Devices (ICMED) Scheme" on 15 March 2016 at New Delhi.

The scheme is intended to bridge the regulatory vacuum in medical devices in the country, enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. Approval from the scheme will support in eliminating trading of substandard products or devices of doubtful origins. It also aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits.

Significance Of Intellectual Property Rights (Mainly Design And Patent) In Drug Device Combination Products

Drug device combination products involve process technology, unique product features and also design and shape. All these are crucial intellectual property. It's important to protect this under IPR framework of India and other countries. Equally important is not to infringe on others IPR.

Requirement of Regulatory Testing for Drug / Device Combination Products

• Medical Device Testing requirements are globally harmonized by the standards of ISO, which have been accepted by many regulatory agencies of the world.

• To comply above, India has revised its Medical Device Rule in the year 2017, which came into force from 1st January, 2018.

• Further, when any drug is coated or combined as a part of Medical Device product, it makes it use better on one hand and risky on another hand. Such devices are categorized under Class III (class D) devices

• Safety is big concern for all such Biomedical Devices for its product registration

• In this session, various Physico-chemical, Microbiological, Biocompatibility, Extractable / Leachable and Packaging testing requirement for such kind of Drug / Device combination products will be discussed in line with ISO, EMA, CDSCO and USFDA guidelines.

Physical Testing Of Prefilled Syringes

Prefilled syringes (PFS) are required to be tested for the quality for various TESTS for Physical Properties. The Test required tests depends on the assurance of the quality of the various components used to complete the PFS. The Tests to be performed and the required minimum maximum value of parameters are broadly decided by user (customer) and manufacturer of PFS or various components. There are many testes which can be performed using a single Instrument and that is what we will cover in this presentation. The tests performed can be,

For PFS

• Break Out Force
• Gliding Force
• Syringe Un-filling Force (for filled)
• Tip cap removal Force
• Needle separation from Hub
• Flange Break
• Needle Break
• Syringe Breakage Force (For Barrel)
• Tip Breakage Force
• Needle Penetrations
• Needle Shield Removal Force
• Leak Test

For Cartridges

• Cartridge Multistep Breakout – Gliding Force
• Cartridge Un-filling Force Syringe Un-filling Force (for filled)