Microbiological Considerations In Cleanroom Validation

Wickham Laboratories Ltd is delighted to announce our most recent technical article on, “Microbiological Considerations in Cleanroom Validation”, which has been featured in European Pharmaceutical Review’s December 2018 issue.

Microbiological contamination is a major safety concern within the manufacturing and development of all pharmaceutical & medical devices. This article discusses how and why a cleanroom environment plays an important role during these processes.

An excerpt of this article as follows:
CLEANROOMS and other controlled environments play a vital role in manufacturing and testing processes through the control of airborne and surface contamination as the levels of particles allowed within these environments are strictly regulated.

Cleanroom grading systems are governed by a number of regulatory bodies and standard-setting organisations, with classification assessing the level of cleanliness of the environment against a specified range. These grades take into consideration the measured or specified concentration of macroparticles per cubic metre of air, the airflow within the room and the condition of the room.
If you are interested in reading further you can find the full version of this application note available on the EPR website, or contact us today to request the full version.

Company Overview
As a GMP/GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of our laboratory technicians and managers enables us to be fully conversant with global regulatory expectations.

We are committed to providing a quality testing service, combining high levels of client satisfaction together with the maintenance of appropriate accreditation. This and the continual pursuit of delivering excellence remain central to our business.

We are routinely inspected by the MHRA, FDA and Home Office, and offer the opportunity for clients to conduct audits on a regular basis.