Medical Device Microbiology Testing Services - Wickham Laboratories
“Conducting testing for over 30 years, our Microbiology department at Wickham Laboratories is experienced in experimental design and we have assisted many companies to explore antimicrobial activity in a variety of medical devices.”
Wickham Laboratories have a large microbiology facility separated into different laboratory areas. With staff in excess of 30 people we are able to cope with both large and small projects in a timely manner.
Our microbiology staff have experience of a wide range of medical device types and the different methods used to test them.
Our approach is to listen and understand your outsourcing requirements. We will translate this into an effective plan to deliver your testing requirements.
Medical Device Microbiology Testing conducted on contact Lenses, surgical instruments, hip replacement joints, breast implants, wheelchair covers, catheters, inhalation devices, syringes, surgical gloves and plastic ware are just a few of the products tested by our staff at Wickham Laboratories.
We are able to undertake development work to confirm proof of concept, as well as the routine requirements of bioburden and sterilisation testing.
Microbiology Medical Device Testing Legislation
Our services meet the stringent requirements of the regulators with our reports supporting claims for CE marking at various notified bodies.
We are conversant with the microbiological requirements of:-
- BS EN ISO 11135-1:2007
Sterilisation of health care products - Ethylene oxide - Part 1:Requirements for the development, validation and routine control of a sterilisation process for medical devices. - BS EN ISO 11737-1:2006
Sterilisation of medical devices - microbiological methods - Determination of a population of microorganisms on products. - BS EN ISO 11737-2:2000
Sterilisation of medical devices - microbiological methods - Tests of Sterility performed in the validation of a sterilisation process. - BS EN ISO 11137:1997
Sterilisation of healthcare products - Requirements for validation and routine control - Radiation Sterilisation
Medical Device Testing Services
Bioburden determination.
BS EN ISO 11737/1
Sterilisation of medical devices - microbiological methods or
BS EN ISO 11737-2
Dedicated facilities with two flexible film isolators.
Sterility testing for regulatory compliance using Ph Eur, USP, or
BS EN ISO 11737-2.
Microbiology Sterility Testing – Monitoring of Clean Rooms
We are able to offer a consultancy service to help with the setting up and microbiological monitoring of clean rooms to comply with ISO 14644 and the orange guide.
- Risk assessment
- Commissioning
- Routine monitoring
Using Settle plates, Contact plates and active air samples were appropriate.
Microbiology Sterility Testing
Dedicated facilities with two flexible film isolators.
Sterility testing for regulatory compliance using Ph Eur, USP, FDA or BS EN ISO 11737-2.
Validation of the test system to ensure recovery of low levels of micro-organisms.
Sterility testing by direct inoculation method.
Sterility testing of fluid pathway.
Cytotoxicity Testing of Medical Devices - ISO 10993 part 5
We offer two methods of Microbiology Testing depending upon the Medical Device;
Cytotoxicity Testing by extraction
This method is suitable for most Medical Devices which may be tested as a composite (part piece) or individual components.
Cytotoxicity Testing by agar overlay
Suitable for testing transparent materials such as contact lenses or flat clear plastic parts.
Detection of Bacterial Endotoxin (LAL testing)
We offer all three Microbiology Testing methods for the detection of Bacterial Endotoxin.
- Classic gel clot method.
- Kinetic chromogenic method.
- Turbidimetric method.