Development of an effective contamination control system is essential in aseptic, terminally sterilised and non-sterile medical device manufacture also many re-useable devices requiring reprocess before continued use constituting a critical factor in qualification and subsequent control of product to ensure safety, quality and performance.
QFI has extensive experience in laboratory testing, residual testing, disinfection studies, biological safety and cleaning, disinfection and sterilisation. The Microbiology Advisory Program (MAP) provides all the benefits you would expect from Europe’s leading consultancy, ensuring that you can demonstrate that your microbiological contamination level is documented, trended and appropriately controlled and fulfils the appropriate regulatory requirements.
QFI’s specialists can help in the following key areas:
- determining microbiological requirements for placement of medical devices on the market
- advice, organisation and co-ordination of sterilisation validation and routine cycles
- specialist protocol and report preparation and review
- defining controls for product release
- developing practical, cost-effective testing
- defining controls for hygiene and environmental control
- preparation of procedures
- regulatory support, including conformity and microbiological risk assessment
- on-site attendance and support during customer, Notified Body, MDSAP, MHRA and FDA audits and inspections
- vendor and sub-contractor audits
Additionally, QFI advises on clean room cleaning practices, selection and qualification of cleaning agents and methods, investigation of episodes of contamination and related hygiene matters.
QFI can assist in development of cleaning, disinfection and sterilisation methods, evaluation of materials and techniques, investigates excursions also design validations. Our specialists have lengthy, successful practical experience in producing sterilisation protocols, assessing compliance of sterilisation cycles and operations and much more.
QFI is one of only few consulting specialists able to perform detailed microbiological risk analysis on medical devices and operations. We can also help devise Formal systems.