Our purpose-built Pharmaceutical Testing Facility is fully equipped to examine Raw Materials, Finished Products and Medical Devices in accordance with Pharmacopoeia methodology.

Routine testing is covered by the scope of our UKAS schedule and we work to both Pharmacopoeia and Clients own methods.

We are GMP compliant, MCA and FDA inspected.

Our facilities included a Class 100, Grade B MCA sterility suite, 3 walk-in incubators with full temperature mapping and a clean room specifically for bacterial endotoxin testing.

Current testing capabilities are:

• Sterility Testing
• Antibiotics Assay
• Preservative Efficacy Testing (PET)
• Bacterial Endotoxin Testing (LAL & Kinetic Turbidimetric Assays)
• Microbial Contamination / Bioburden testing
• Irradiation Dose Setting determination studies to ISO 11137
• Purified Water and Water for Injection
• Method Development and Validation
• Regulatory Assistance

This services covers the testing requirements for the registration of Pharmaceutical products in conjunction with preparing regulatory submissions, including:

Advice on data requirements

• Consultation with regulatory authorities for advice on studies
• Co-ordination of searches for published safety & efficacy data and it’s scientific evaluation
• Advice on applications for Marketing Authorisation