Facility bioquelling (annual-shutdowns)
Good practice. A term not only limited to GMP environments, it is something that most of us follow on a daily basis. In many ways it can be used to guide our routines which make us more efficient, or faster, perhaps even safer. Most importantly, Good Practice is a holistic approach to being able to design, develop and produce products, safely and effectively which in the healthcare environment benefits patients and suppliers alike.
Good Manufacturing Practice for sterile products in the pharmaceutical and biotechnology fields is a wide-ranging exercise and the control of bioburden is a small but nevertheless very important part of this strategy. Whether the background environmental bioburden needs to be maintained or brought down to acceptable levels in the first place, Bioquell HPV technology is the most efficient and effective method.
The choices of a fully managed service approach to bio-burden control via a Bioquell response team (RBDS), or having your own equipment on-site and ready to use, coupled with a trusted range of consumables, will lead to reduced or zero colony counts in your environmental monitoring. Add to that the Bioquell validation services and carefully honed documentation which will satisfy stringent regulations, then Bioquell support for your contamination control strategy is compelling to say the least. Applied annually as part of a shutdown period, facility bioquelling can improve uptime and therefore productivity – something that cannot be ignored in manufacturing today.