We help you ensure the microbiological quality of your pharmaceutical, medical device and healthcare products, demonstrate that you are meeting regulatory requirements and prove that you have good hygienic production procedures.
You can rely on our MHRA-inspected microbiology laboratory to test your product’s microbiological quality and safety and provide method development and validation services. We also partner with you in instances where microbiological consultancy and troubleshooting are required, for continuous improvement of your processes and procedures or in response to a specific incident.
We perform microbial limits testing for specific pathogens, bacteria, yeast and moulds at all stages of the production cycle, from raw materials, finished products and medical devices.
In addition to this, we also offer preservative efficacy testing, kinetic turbidimetric LAL (Limulus Amebocyte Lysate) endotoxin analysis, analysis of water, challenge testing,and environmental monitoring to fully support in ensuring the microbiological quality and of your products.
Microbiological services include:-
- Microbial limits to EP, USP and JP
- Quantitative endotoxin analysis
- Preservative efficacy testing
- Environmental monitoring
- The European Suspension Test (eg EN1276, EN13697)
- Water testing
- Method development and validation
Typical product types tested:-
- Medical devices
- Raw materials