REMOTE ACTIVE COUNT UNITS FOR INTEGRATION INTO MONITORING SYSTEMS

RAC series – ISO 14698-1 Annex B compliant remote ActiveCount air sampling heads for monitoring the microbiological air quality in cleanrooms

Engineered by Sistema-MK in Germany and distributed by Lighthouse Worldwide Solutions, the Remote Active Count Microbial Air Samplers provide precise, reliable microbial air monitoring for the pharmaceutical industry. Designed for cleanrooms, isolators, and other critical manufacturing spaces, these stainless-steel samplers integrate seamlessly with continuous monitoring systems, offering remote operation and real-time environmental data without manual intervention.

Built to meet international regulatory standards, including ISO, EU GMP Annex 1, and FDA requirements, the samplers combine durable, easy-to-clean construction with high-precision performance. They enhance sterility assurance by detecting contamination early, improve operational efficiency through automated sampling, and support global pharmaceutical operations with Lighthouse’s worldwide service network.

Ideal for sterile manufacturing cleanrooms, isolators, RABS, aseptic filling lines, vaccine and biologics production, and pharmaceutical research labs, these samplers provide a future-proof solution for next-generation environmental monitoring. The collaboration of Sistema-MK’s engineering excellence with Lighthouse’s global expertise ensures a reliable, compliant, and precise tool for safeguarding product integrity and patient safety.

Remote Active Count Microbial Air Samplers (RAC series) – A Next-Generation Solution for Continuous Cleanroom Monitoring

Pharmaceutical and biopharmaceutical manufacturers operate under strict global regulations to ensure the sterility of aseptic processes. With the introduction of ISO EN 17141 and the updated EU GMP Annex 1:2022, continuous microbial air monitoring in Grade A/B cleanrooms has become a regulatory expectation. Traditional manual sampling methods no longer meet the demands for efficiency, compliance, and real-time oversight.

The Remote Active Count Microbial Air Sampler series, engineered by Sistema in Germany provides a validated, compliant, and future-proof solution. Designed from 316L stainless steel and fully sterilizable, the system integrates seamlessly into cleanroom monitoring networks, enabling real-time microbial air sampling with automated operation and robust data integrity.

The Need for Continuous Microbial Air Monitoring

Cleanrooms exist to protect patients by preventing microbial and particulate contamination of sterile medicines, vaccines, and biologics. While airborne particle monitoring (per ISO 14644-1) is long established, microbial monitoring presents additional challenges:

• Patient safety risks: Microorganisms can compromise sterility assurance and product integrity.
• Regulatory requirements: Annex 1:2022 requires Grade A zones to be continuously monitored, including during aseptic filling.
• Operational limitations: Manual sampling methods can disrupt workflows, delay detection, and increase operator error.

Integrating the right microbial air sampling head into a real time monitoring system is therefore not just a compliance tool but a critical part of a pharmaceutical company’s contamination control strategy.

Technology Overview: Sistema Remote Active Count Series (RAC)

The Remote Active Count series employs the impaction principle, whereby airborne particles carrying viable microorganisms are drawn onto agar plates or Petri dishes containing nutrient media. This classical and proven method supports cultivation and enumeration, making results both scientifically robust and regulatorily accepted.

Key Design Features of Sistema’s Remote Active Count Series (RAC)

• 316L stainless steel housing: Resistant to corrosion, easy to clean, fully sterilizable and autoclavable.
• Seamless integration: Designed for remote connection to cleanroom monitoring systems, including Lighthouse’s environmental monitoring software platforms.
• Automated operation: Enables continuous microbial sampling without operator presence, minimizing human intervention risks.
• High precision & reliability: German-engineered for accuracy, repeatability, and long service life.
• Compliant with global standards: ISO EN 17141, EU GMP Annex 1:2022, and FDA expectations.

Strategic Benefits for Pharmaceutical Operations

• Enhanced Sterility Assurance
• Provides continuous microbial monitoring during aseptic operations, meeting Annex 1 requirements.
• Detects contamination events early, enabling faster corrective action.
• Generates standardized, traceable data suitable for inspections and audits.
• Durability and Cleanroom Compatibility
• Autoclavable stainless steel ensures resistance to repeated sterilization cycles.
• Designed for use in critical cleanroom environments, including Grade A/B zones.
• Integration with Lighthouse’s global service and monitoring platforms ensures scalability and aligns with international standards (ISO, FDA, EMA) for global deployment.
• Supports aseptic filling lines, vaccine and biologics production, isolators, RABS, and advanced pharmaceutical research facilities.

Conclusion

As regulatory expectations evolve, pharmaceutical manufacturers must demonstrate not only compliance but also a proactive approach to contamination control. Sistema’s Remote Active Count Microbial Air Sampling Heads of the RAC series represents a decisive step forward, combining proven impaction sampling with automation, sterilizable design, and seamless integration into continuous monitoring systems.

By pairing Sistema-MK’s engineering precision with Lighthouse Worldwide Solutions’ global reach and expertise, these samplers provide a reliable, audit-ready foundation for cleanroom monitoring in aseptic production. They help manufacturers meet the stringent requirements of ISO EN 17141, EU GMP Annex 1:2022, and FDA guidance, while also enhancing operational efficiency and sterility assurance.

References

ISO EN 17141:2020 – Microbiological Air Samplers

EU GMP Annex 1:2022 – Manufacture of Sterile Medicinal Products