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)
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.
Products and Services
Benefits of Using a Contract Research Organisation for Medical Devices
Contract research organisations (CROs) are typically perceived as supporting medical device companies only with product testing and validation as part of their cGxP regulatory requirements. In reality they can do much more.
Join Smithers Rapra experts Tim Hulme and Michael Creese for our specialist training course.Read more
Join leading expert Dr Andrew Feilden at a live webinar, Introduction to Extractables and Leachables, on 21 February.Read more
Smithers Rapra has released a new, free to download, white paper entitled 'Benefits of Using a Contract Research Organisation for Medical Devices'.Read more
Smithers Rapra, the leading specialist in polymer and composite consultancy, analysis and testing, is pleased to announce that its Shawbury, UK, operation is now a full member of the UK GLP (Good Laboratory Practice) compliance monitoring programme. The Smithers Rapra test facility hasRead more
Smithers Rapra, the leading specialist in polymer and composite consultancy, analysis and testing, is glad to announce the appointment of Dr Andrew Feilden to the position of principal consultant within the consultancy centre at the European headquarters site near Shrewsbury, West Midlands, UK.Read more
New Book Reviews Techniques Used to Perform a Controlled Extraction Study for Extractables and Leachables
iSmithers Rapra Publishing has announced the release of 'Update on Undertaking Extractable and Leachable Testing'. The assessment of all materials - and especially elastomeric and plastic components - for the presence of leachable and extractable components, forms an important paRead more
Smithers Rapra Releases New White Paper: ‘Extractables and Leachables Testing of Polymer Device Components’
Smithers Rapra, a leading supplier of design, testing, analytical and consultancy support to major companies in the medical device industry, has released a new, free-to-download white paper. The white paper, entitled 'Extractables and Leachables Testing of Polymer Device Components', diRead more
Sukhy Toot has joined Smithers Rapra as product manager for medical and pharma services. In her new role, Ms Toot will concentrate on growing the segment of Smithers Rapra's business that combines an expertise in polymers with knowledge of pharmaceutical products and medical applications. SpecifiRead more
Smithers Rapra, the leading specialist in polymer and composite consultancy, analysis and testing, is pleased to announce that senior consultant Michael Creese will present at the Medical Device Technology Show in Cologne, Germany, on 8-10 February, as part of the HuLST Expo. The titleRead more
The Smithers Group has announced the formation of the global brand Smithers Rapra, pulling together what had been Smithers Rapra Technology, UK, and Smithers Scientific Services, US, into one integrated business unit. As these companies have grown, it has become clear that clients will benefit frRead more
The Smithers Group has announced the acquisition of Pira International, a leading provider of independent, knowledge-based information and testing services to clients in the packaging, paper and print industry and their supply chains. Headquartered in Leatherhead, UK, Pira InternationaRead more
Smithers Rapra, the leading polymer and composite consultancy, analysis and testing specialist, is pleased to announce that principal consultant Dr Martin Forrest will be presenting a paper at the 3rd International Conference on Extractables and Leachables Products 2010 in London on the 14 and 15Read more
Extractables & Leachables for Pharmaceutical Products Conference to Drive Safe Use of Polymers in Medical Applications
iSmithers, formerly the information group within Smithers Rapra Technology, a subsidiary of US-based independent testing, research and consulting organisation, The Smithers Group, will host its third international conference on Extractables & Leachables for Pharmaceutical Products, 14-15 SeptRead more