THE SCENARIO
Assured Micro worked with a pharmaceutical company involved in sterile manufacturing to create a new cleanroom where they had no previous onsite microbiology capabilities. The pharma company needed cytotoxic, non-cytotoxic and component prep areas to be qualified, a team of operators to be trained and gown qualified, and an MHRA inspection to approve the cleanrooms.
THE CHALLENGES
Our client had no existing data for rooms or sample plans in place and had no cleaning experience. They needed the work completed with a quick turnaround to be ready for an MHRA inspection. MHRA requirements for stringent monitoring prior to a licence being granted meant the race was on. Our client also required 8 operators to be gown qualified – a total of 24 gowning sessions.
THE ACTIONS
We paid our client a site visit to establish an account of material and people flow and we followed this up with a number of risk assessments and determined key locations for sampling. We set up cleaning procedures for our client in partnership with Cleanroom Zone Ltd to allow for the most efficient and quickest cleaning turnaround possible. We also implemented a sampling plan for gown monitoring based on key areas where there is a risk of contamination.
THE RESULTS
A detailed initial sampling plan was developed to cover key areas which would demonstrate effectiveness of cleaning along with the functionality of the room itself. A further 44 gown monitoring sessions were performed as the client expanded their staff resource and required them to enter cleanroom areas. Following on from initial monitoring the sampling was ramped up to provide meticulous detail of all areas. Consisting of 63 air samples, 282 contact sample locations and 194 settle plate locations using 2 different media types.
After MHRA inspection Client was awarded their manufacturing licence.