Profile
As a GMP & GLP compliant laboratory with over 60 years of experience, Wickham Micro Ltd is a trusted name in the pharmaceutical and medical device industries, maintaining only the highest standard of quality at all stages while providing rapid turnaround for both routine testing and bespoke one-off projects. Whether assisting a start-up company demonstrating proof of concept, or working with a global medical device manufacturer, our expert technicians recognise the importance of delivering an exceptional service by taking the time with every client to fully understand their individual requirements.
At Wickham Micro, we operate a secure site. We are also equipped with a team of in-house qualified service engineers, enabling a self-sufficient facility without major service disruptions.
ANNEX 1
Wickham Micro is committed to staying up-to-date with the latest regulations and guidelines in the medical device industry, including the recent update to Annex 1 of the EU Medical Devices Regulation (MDR). We understand the importance of compliance with these regulations and guidelines to ensure the safety and effectiveness of medical devices. Our team of experts is well-versed in the requirements outlined in Annex 1 and are able to provide the necessary testing and documentation to accommodate these requirements for our clients.
We work closely with our clients to understand their specific needs and tailor our services to meet those needs, ensuring that their products are in compliance with the latest regulations and guidelines. Whether it's routine testing or bespoke projects, Wickham Micro is equipped to handle any requirements related to the Annex 1 update of the EU MDR, and are committed to providing exceptional service and support to our clients.
The Cormica Group
Wickham Micro along with Medical Engineering Technologies Ltd is apart of Cormica, a leading provider of testing services for medical device and pharmaceutical manufacturers, drawing on the expertise and heritage of its world renowned laboratories. With a commitment to quality, reliability, and customer service, we help our clients launch and release their life-saving products quicker, safer, and to more markets around the world.
Cormica is a one-stop-shop for all your testing needs, drawing from the expertise and heritage of our group laboratories.
Our heritage is a source of pride for us, and we believe it shows in the quality of our testing services. We’re GMP, GLP, ISO17025, and our customers tell us we offer high-quality, reliable testing with excellent customer service.
We’re based in the UK, but service customers across the globe. Whether you need analytical chemistry, microbiology, physical, packaging testing, or consultancy, we’re here to help you every step of the way.
Our services include:
Microbiology Testing
We regularly perform microbiological testing for pharmaceutical and medical device manufactures, conducting routine quality control analysis of a wide variety of pharmaceutical products for batch release into European and International markets. As one of the largest UK Microbiology laboratory, we are well know for our high quality Medical Device Testing and Pharmaceutical testing, our 60 years of history speak for itself.
Our microbiology services include:
- Antimicrobial / preservative efficacy testing
- Bioburden testing
- Biological indicator testing
- Environmental monitoring
- Microbial identification, both rapid identification via MALDI-ToF (Matrix Assisted Laser desorption Ionisation – Time of Flight)
- Microbial ingress testing
- Microbial limits testing including total aerobic microbial counts (TAMC) / total yeast and mould counts (TYMC) and absence of specified pathogens
- Sterility testing
In Vitro Testing
Wickham Micro understands the importance of using alternative testing methods in our research and development. We have a dedicated division that specialises in developing new test systems that can replace traditional methods.
We work closely with our clients to understand their specific needs and tailor our services to meet those needs. Our goal is to always provide exceptional service and support to our clients, while also being at the forefront of new and innovative testing methods.
Our in vitro testing services include:
- Monocyte activation test (MAT)
- Bacterial endotoxin (LAL)
- Cytotoxicity testing
- ELISA (enzyme-linked immunosorbent assay)
- BCA (bicinchoninic acid assay)
- Western blot
Consultancy Services
In addition to laboratory and testing services, Wickham Micro offers global support and consultancy services relevant to a wide range of medical device and pharmaceutical development and manufacturing concerns. Our experienced microbiologists can assist clients with cleanroom qualification, validation of water systems and other general microbiological issues encountered in manufacturing environments, including appropriate cleaning practices and identifying contamination sources.
Our consultancy services include:
- Biocompatibility assessments
- Cleanroom qualification
- Process validation / identification of contamination sources
- Regulatory applications support
- Training on appropriate cleaning practices
- Validation of water systems
Customer Service
We are a distinctive company, with customer relationship skills that set us apart. Whether we are assisting a start-up company demonstrating proof of concept, or working with a global medical device manufacturer, we recognise the importance of understanding individual client requirements. We provide rapid turnaround for both routine testing and projects, while maintaining our high standard of quality at all stages.
Wickham Micro is a GMP/GLP compliant laboratory with over 60 years of experience in the pharmaceutical and medical device industries.
Medical Engineering Technologies is a leading provider of physical and mechanical testing services along with chemistry analysis for the medical device and combination device industry.
If you would like to discuss your testing requirements in more detail, call us directly on +44 (0)1329 226600, or email us info@wickhammiro.co.uk. / wickhammicro.co.uk
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