New Microbial Monitor Enables Continuous Cleanroom Testing
The device allows pharmaceutical manufacturers to maintain compliance with EU GMP Annex 1 without production interruptions.
Updated on Oct. 21, 2026 in Life Sciences
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Particle Measuring Systems has launched the BioCapt Single-Use STS, a microbial monitor designed to perform active air sampling within high-containment manufacturing environments. The system is designed to allow for continuous sampling without requiring traditional decontamination cycles.
Why it matters
This technology aims to streamline pharmaceutical manufacturing compliance, specifically addressing the stringent requirements of EU GMP Annex 1. By eliminating the need for routine sterilization of monitoring equipment, it reduces contamination risks during production.
The monitor provides active air sampling for up to four hours at a constant flow rate of 25 LPM. This performance replaces standard reusable impactors that require repeated decontamination cycles.
The players
Particle Measuring Systems
A manufacturer specializing in contamination monitoring equipment and environmental test systems for the pharmaceutical industry.
Getinge
A medical technology firm that develops sterile transfer systems, including the DPTE-BetaBag technology utilized in this monitor.
The details
The system combines the BioCapt Single-Use microbial impactor platform with Getinge DPTE-BetaBag transfer technology. It operates via Rapid Transfer Ports, which are specialized sealed interfaces that allow for the transfer of sterile components into clean environments. This design enables the introduction of monitoring consumables into isolators—controlled environments that separate the process from the external room—without additional cleaning or sterilization steps.
Timeline
October 21, 2026: Particle Measuring Systems launched the BioCapt Single-Use STS.
The Tech Race
The launch marks an industry-wide shift toward single-use systems to meet the strict sterility standards required by EU GMP Annex 1. This development directly competes with legacy reusable hardware that requires manual sterilization between every monitoring cycle.
Pharmaceutical manufacturing plant operators can now integrate active microbial sampling directly into existing isolators without pausing production for decontamination. The system is designed to simplify workflow logistics by removing the cleaning requirement for monitoring hardware.
The takeaway
Manufacturers should monitor the adoption rate of these single-use technologies as firms attempt to satisfy Annex 1 requirements without slowing line speeds. Watch for future integration data comparing these single-use units against traditional reusable systems in high-throughput sterile facilities.
Further reading
For broader trends in cleanroom technology, see our coverage of Life Sciences.
Source note: This article includes information reported by AZoM.
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