Smithers Rapra - Plastics and Rubber Experts for the Medical Device Industry

Smithers Rapra's understanding of the requirements of the pharmaceutical and medical device industries has enabled the development of an extensive range of services to support the use of plastics and rubbers within these industries.

Recognised as one of the world's foremost technology providers, we supply design, testing, analytical and consultancy support to many major companies on a global basis. We partner with our customers to support them from device concept to regulatory submission and into production. Operating to cGMP and GLP, our services are regarded as essential by our customers.

Materials, healthcare products, medical devices and packaging

Smithers Rapra is able to validate and qualify medical devices and packaging for shipment and supply to demonstrate the product's fitness for purpose. This type of testing is critical in the prevention of premature failure.

Product and materials testing carried out includes:

• Failure diagnosis
• Product validation
• Packaging integrity and shelf life assessment
• Real time and accelerated ageing
• Glove testing
• Permeability testing
• Materials conformance testing

Transport testing for healthcare products, devices and packaging

Delivering your product to your customers is an important part of the supply chain process. Accidents and knocks during distribution are commonplace, not to mention large temperature fluctuations, so drug products and medical devices must be carefully packaged. If packaging breaks, a considerable loss of investment can occur. This will have an effect on your reputation and timelines will be affected as you will have to reship new product.

Consequently, it is of the utmost importance that full distribution testing (including external packaging, decorative packing and immediate packaging) is performed before product launch. Typical distribution tests performed by The Smithers Group include:

• Vibration representing road, rail, and air transport, including global shipments
• Horizontal impacts associated with mechanical pallet handling, automated conveyors and vehicle transport
• Verticle impacts representing mechanical and manual handling events throughout the supply chain, including order picking
• Compression recreating warehouse and vehicle stacking
• Thermal / climatic (elevated temperature, elevated humidity, frozen and chilled chain distribution and climatic cycling - cabinets and walk-in pallet scale chambers available)

Materials technology

Plastics and rubbers are widely used in medical and drug delivery devices and their packaging; Smithers Rapra offers a wide range of consultancy services to support their use in these applications. Our consultants will work with you and offer guidance and support as an integral part of the product design and regulatory submission process. We have unrivalled understanding of how polymer materials perform in service, not just early in their lifecycle but after many years of use.

Extractables and leachables testing

The examination of extractables and leachables from materials in contact with drug product or the patient is growing in importance due to increased regulatory scrutiny from FDA and EMEA; our data has been used in many such submissions. We work with various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI), implantable medical devices, stoppers, syringes and pharmaceutical process equipment. Extractables and leachables assessment of all materials forms an integral part of the submission for approval of a new drug system or medical device.

Analytical method development and validation

The analysis of rubber, plastic and other polymer materials is a highly specialised activity and our in-depth knowledge can save you time and money. Smithers Rapra's extensive laboratories are equipped with state-of-the-art analytical equipment and, most importantly, a team of consultants that have the experience to develop methodologies, collect and interpret data and report our findings to assist you in achieving your goals.

Instrumental techniques used in these methods include gas chromatography-mass spectroscopy (GC-MS), liquid chromatography-mass spectroscopy (LC-MS), infrared spectroscopy and ICP-OES.

Biological evaluation - characterisation and equivalence studies

Smithers Rapra offers biological evaluation services by characterisation and equivalence studies:

• ISO 10993 Part 13: identification and qualification of degradation products from polymeric medical devices
• ISO 10993 Part 18: chemical characterisation of materials

Pharmacopeia testing services

Smithers Rapra offers EU, US and Japanese pharmacopeia testing services. Services include:

• Containers and materials for containers
• USP <661>
• USP <381>
• USP <671>
• Ph Eur 3.1 to 3.1.15
• Various other monographs

Stability storage for drug products

Smithers Rapra provides storage in accordance with the International Conference on Harmonisation (ICH) guidelines for the four defined 'world climatic conditions' for the short term, intermediate and long-term storage of drug product for the purposes of stability and leachable testing:

• 25°C ± 2°C / 60% ± 5% RH
• 30°C ± 2°C / 60% ± 5% RH
• 40°C ± 2°C / 75% ± 5% RH
• Refrigerated -2°C to 8°C

Other storage conditions are available, including photo stability testing. Smithers Rapra has an adaptable approach to meet client-specific and bespoke non-standard conditions.