A multi-national vaccine manufacturer approached Bioquell in order to perform a Biodecontamination within its FDA approved facility. The facility itself, some 5,500 cubic meters, was treated as a single Biodecontamination enclosure with the entire process completed within 30 hours. After a successful deployment of the project,the customer contacted Bioquell wishing to establish an industry leading best practice protocol of repeating the Biodecontamination process after batch; some 10 deployments per annum!
It was clear that minimizing production downtime was key for this to be a viable option and, as such, Bioquell has worked closely with the client to develop a bespoke deployment model to integrate into the customer’s production schedule as efficiently as possible.
To minimize downtime, the facility is now treated as two discrete areas – the production and packaging zones. Once activities are completed within the production areas of the facility, the RBDS equipment is rapidly installed and the Biodecontamination cycle performed whilst the purification and packaging phases continue in the adjacent areas.
As soon as the Biodecontamination process is completed, the RBDS equipment is retrieved and the 4,000 cubic meters production area goes immediately back into production less than 15 hours after shutdown. The Bioquell team then returns three days later to biodecontaminate the 1,500 cubic meters packaging zone, again returning the area to operation within 15 hours of the initial shutdown.
Chris Langley, RBDS life sciences specialist said, “Fully integrating the Biodecontamination process into the customers’ production schedule makes hydrogen peroxide vapor, or HP Vapor, a viable option to replace routine ‘inter-batch’ cleaning procedures. Validated Biodecontamination cycle parameters have also been developed so the customer has the peace of mind of a 6-log bioburden reduction without having to wait for biological indicator results.”