Moving to Continuous Microbial Air Monitoring with ActiveCount

The new requirements introduced with the 2022 update of EU GMP Annex 1 call for uninterrupted monitoring of viable microorganisms in Grade A and B areas in aseptic manufacturing. Classic “sequential” sampling is no longer considered sufficient; a continuous control mechanism based on real-time data is now expected. This transformation calls for both equipment modernization and process redesign, but it also offers a significant opportunity to improve product safety and reduce contamination risk.

The Critical Role of Microbial Air Samplers

By determining the microbial load in sterile manufacturing areas, viable air samplers:

• Detect contamination early,
• Report deviations instantly through a continuous data stream,
• Demonstrate that cleanroom validation remains in place,
• Document regulatory compliance during inspections.

This makes risk-based management and proactive contamination control possible.

Portable vs. Remote Air Sampling

Portable samplers are ideal for spot checks, whereas remote air samplers work as fixed installations that can be programmed and monitored online. This delivers long-term, trend-focused data without the need for operator intervention. To meet Annex 1’s expectation of “continuous monitoring,” remote solutions are now the preferred choice.

The ActiveCount Series: Continuous, Compliant, Flexible

The ActiveCount family from Lighthouse Worldwide Solutions was designed to meet exactly these requirements.

• Continuous or periodic operation: real-time or scheduled sampling options
• Local or remote control: start/stop with the button on the instrument, or integrate through the software interface
• 316L stainless steel side- or bottom-mounted impactor: adapts to different process areas
• 10 L/min low-flow sampling head: maintains biological and physical collection efficiency, including the d50 value
• “Plug & Play” compact design: fast integration with the LMS Pharma and LMS Express real-time monitoring software
• cGMP compliance: reliable measurement inside a cleanroom, biosafety cabinet or laminar flow bench.

Seamless Integration with the Real-Time Monitoring System

ActiveCount runs on the same infrastructure as Lighthouse’s Real-Time Monitoring System. LMS Pharma software takes data security to the highest level with automatic alarms, notifications, reporting and audit trails. Its redundant data collection architecture and user-friendly interface simplify validation and produce transparent records to present to auditors.

Benefits for Manufacturers

• Regulatory compliance: meets the “continuous monitoring” requirements of Annex 1, ISO 14698 and EN 17141.
• Risk reduction: real-time alarms and trend analysis enable a rapid response to the source of contamination.
• Operational efficiency: automation minimizes operator error and personnel exposure.
• Quality assurance: adds an extra layer of safety to validation and media fill studies.

The strict requirements of GMP Annex 1 aim to make aseptic manufacturing safer and more traceable. ActiveCount speeds up this transition with its high biological collection efficiency, flexible installation options and ability to work integrated with the Real-Time Monitoring System. If you are aiming for a data-driven, compliant production line that manages contamination risk proactively, now is the time to get to know the ActiveCount series.