Summary

Wickham Laboratories Limited is a contract analytical laboratory specialising in microbiology testing for quality control, research and product development.

Profile

Wickham Laboratory facilities are GMP and GLP compliant and inspected by MHRA, FDA and other overseas regulatory authorities. Harmonised methods compliant to Ph. Eur, USP, JP.

• Dedicated clean room 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 demonstrate recovery of low levels of micro organisms.
• Sterility testing by fluid pathway or direct inoculation method.

Other services offered include environmental monitoring services for cleanrooms, bioburden, cytotoxicity and bacterial endotoxin testing.

Wickham Laboratories is currently relocating and expanding into a purpose built facility. Sterility testing will become a flagship department providing a 50% increase on existing testing capacity.

Facilities

In May 2011, Wickham Laboratories announced the expansion of the company with the purchase of a new facility. This complex, now known as Hoeford Point, is a former GMP-compliant small-scale pharmaceutical manufacturing facility and has seen extensive refurbishment since purchase in Spring 2011. Hoeford Point represents a 50% increase in floor space over our existing location.
Together with a general refurbishment of existing laboratories, we have created a new media preparation department and purchased additional equipment to complement the facilities including new laminar flow cabinets, incubators and isolators.

Sterility Testing

Sterility testing is seen as our flagship microbiology department with a clean room complex finished to the highest standards that is especially well equipped for Sterility and Cytotoxicity testing. The facility was originally designed for aseptic packing and boasts accommodation suitable for a number of isolator units and comes complete with ballasted pass-through autoclaves.

Additional isolator units have been sourced to supplement our existing flexible film isolators, allowing increased testing capacity for an ever increasingly busy department.

Microbiology Expertise & Services:

• Pharmaceutical Microbiology
• Pharmacopoeial, client and bespoke methodology
• Method development and validation
• On-site consultancy and environmental monitoring
• Sterility testing and LAL
• Preservative efficacy, bioburden and TAMC testing
• Medical Device testing
• Pharmaceutical testing

Toxicology Expertise and services:

• Quality control of existing products
• Registration of new formulations
• Research into new medicines and medical devices for the human and veterinary pharmaceutical and medical device industries.