Non-clinical testing for global regulatory submissions
ANNOUNCEMENT:
UL Expands South Bend, Indiana Laboratory to Add Non-Clinical Testing Capabilities
SOUTH BEND, INDIANA, February 12, 2013 - UL (Underwriters Laboratories), a world leader in advancing safety, announced today the expansion of the South Bend, Indiana analytical laboratory to offer non-clinical testing services for the medical device industry. Click here to read the full press release.
UL offers the health sciences industries a way to complete another required submission through one provider. UL's non-clinical test services meet the requirements of the specifications generally accepted by the three major global medical device markets: ISO 10993, USP, or MHLW. Working with UL for non-clinical testing provides the benefit of test plan consolidation, which can be faster than managing multiple test labs.
Biocompatibility
Biocompatibility is defined as "compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection." For medical devices, which come into contact with the human body for the purpose of treatment, diagnosis, or physical aid, making sure that every point of contact will not cause irritation, changes in blood composition, or toxic response is especially critical. Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, shipping, packaging, and sterilization may have adverse affects on the material's composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals.
The three global major medical device markets prescribe different test protocols to assess biocompatibility in medical devices. The U.S. FDA and European Union commonly accept the ISO 10993 standards for biocompatibility. USP (U.S. Pharmacopoeia) standards are accepted by the U.S. FDA, are generally regarded as more stringent, and may be used by manufacturers as a marketing tool or for specific uses. Finally, Japan's MHLW has test criteria different from both the ISO 10993 and USP protocols. UL offers our customers a comprehensive test package to satisfy requirements for global regulatory approvals, and use the "worst case" criteria to minimize testing, samples required, and time.
Basic Microbiological Tests
Medical devices must be designed and manufactured in such a way as to eliminate or reduce the risk of microbial and/or chemical contamination as far as possible. Consequently, clean room facilities and manufactured devices must be subjected to regular bioburden determinations and must be sterilized in validated procedures. UL can provide:
- Bioburden determinations
- Sterility tests
- Endotoxin determination
- Validation of sterilization procedures
Virological Testing
According to EN ISO 22442-1 to -3, medical devices manufacturers must prove virological safety of their devices containing materials of animal origin. Therefore, the final product and/or the respective manufacturing processes must be subjected to virological validation studies. "mdt" has a long history in virological testing and in the validation of such manufacturing processes. UL can support selection of appropriate virus species and test procedures.
Cleaning, Reprocessing, Sterilization
Numerous medical devices are subjected to a first-time cleaning process at the end of the manufacturing process. Reusable devices are subjected to a defined cleaning and disinfection process and are typically sterilized afterwards. UL can perform any of these process validations pursuant to EN ISO 17664 and can help select suitable "worst case" devices for testing.
Physico-Chemical Analyses
Physico-chemical analyses and mechanical test procedures are used to characterize medical devices pursuant to EN ISO 10993-18 and -19. Also, potential surface contaminants as well as volatile and leachable chemical substances can be identified and evaluated toxicologically. Therefore, UL uses numerous modern analytical test procedures like GC/MS, HPLC, FTIR, ICP, XPS and SEM/EDX.
Shelf Life of Devices & Packages
According to EN ISO 11607-1, the specific properties of medical devices and their packaging systems must remain stable during their shelf life. Consequently, medical device manufacturers must perform appropriate validation studies in order to justify shelf life and transport stability of their devices. However, before these validations can take place, a validation of the forming and sealing process must be performed pursuant to EN ISO 11607-2.
In the course of a combined stability and packaging validation study, test devices are subjected to a thermal and regular ageing and to a transport simulation. Afterwards, the packages are subjected to the following test systems: dye test for seal integrity, peel test, burst and creep test, air permeability test and test for microbiological tightness. Furthermore, the stressed medical devices are subjected to specific performance tests.
Testing of Ophthalmic Devices
We provide complete testing services for ophthalmic devices like contact lenses and lens care products, intraocular lenses and viscosurgical devices, which are highly regulated in numerous specific product standards
The UL advantage
- Custom project planning -- Our staff will work with you to prepare a project plan to meet your current and future product launch needs. This includes meeting with senior-level scientists with years of experience in preparing test protocols to meet regulatory submission requirements.
- Experience -- Through UL, you gain access to over 50 years of experience in analytical chemistry, biocompatibility, toxicology, bioanalytical, microbiological, pharmacology testing, and specialty services.
- Global accreditation services -- UL is a leader at getting our customers access to existing and emerging markets so you only need to work with one test, regulatory and certification provider to meet your global sales and distribution needs.
Additional resources
Training:
On demand (pre-recorded webinar) "Key strategies needed for biocompatibility for global market access" Click here for a full course description and to register.
Links to webpages:
