Lucideon Supports Environmental Monitoring Qualification of GMP Laboratories
The manufacturing and testing of pharmaceuticals, biopharmaceuticals, and medical devices requires a strictly controlled environment with a high degree of cleanliness. When companies within these industries move sites, the cleanliness of the new facilities must be assessed to ensure they comply with the relevant regulations.
The challenge
In 2023, Lucideon moved facilities as part of the ongoing growth and development of the business. As a result of the site move, the new GMP microbiology laboratories required an in-depth assessment of the level of microbial contamination within the new facility prior to the commencement of any testing. An environmental monitoring programme was subsequently introduced, thus ensuring compliance with the MHRA and Annex 1 requirements for the testing of sterile and non-sterile pharmaceutical products.
The delivery
Lucideon utilised in-house expertise and capabilities to design and carry out an environmental monitoring qualification of the new facilities. Lucideon’s microbiologists determined a protocol comprising a review of the facility and the most appropriate locations in each laboratory and frequency for analysis. Following the design of the protocol, monitoring of the facility was performed. An intensive 7-day monitoring session was initially performed which involved an in-depth review of each area at multiple locations. The microbiological methods comprised the evaluation of the environment using settle plates, active air, and contact plates. Non-viable particle testing was also measured to determine the general cleanliness of the laboratories. Following the intensive 7-day period of monitoring, and using the same methodology, more data was obtained over several months. A detailed review of the data was then performed which highlighted high risk areas and enabled determination of locations requiring routine environmental monitoring and alert limits where necessary.
The Lucideon Advantage
Utilising extensive knowledge of environmental monitoring qualification, the environmental background of the new laboratories was ascertained and Lucideon gained MHRA accreditation to enable pharmaceutical product testing to be performed at the new facility. Organised and efficient work from the Lucideon team enabled a successful facility move and the setup of a brand new GMP microbiology laboratory. Quick work meant that Lucideon’s service offerings experienced minimal disturbance during the facility change.