Frequently Asked Questions for the Bioquell Qlear™ System

Yes. The Bioquell Qlear™ integrated bio-decontamination system is designed to support GMP requirements by providing controlled, repeatable, and validated 6-log sporicidal kill on exposed surfaces. Bio-Decontamination systems are commonly installed in aseptic processing areas (including RABS), material airlocks, and cleanroom suites to support contamination control strategies.

The Bioquell Qlear™ integrated system is well suited for aseptic and sterile manufacturing environments because it delivers consistent, room-specific bio-decontamination without reliance on portable equipment which can be prone to human error if set up incorrectly. Integrating bio-decontamination equipment within the fabric of the cleanroom helps maintain cleanroom integrity and supports contamination control in critical environments.

By providing automated, documented, and repeatable bio-decontamination cycles, the Bioquell Qlear integrated system forms a key part of a facility’s contamination control strategy, particularly to address the need for a routine sporicidal disinfection. It supports routine, event-driven, and campaign-based bio-decontamination while reducing variability associated with manual disinfection processes.

Validation typically includes installation qualification (IQ), operational qualification (OQ) to ensure that the system is operating as designed. This is followed by gassing cycle development to establish which parameters are required to achieve a repeatable 6-log sporicidal kill, followed by performance qualification (PQ) to confirm that the developed cycle is robust. The system is then validated for routine use. Integrated bio-decontamination systems support validation by eliminating manual equipment setup and consistent vapor distribution, simplifying ongoing requalification.