The manufacture of pharmaceuticals is a highly controlled and regulated process to ensure the safety and quality of drugs for patients, and even more so when they must be manufactured under sterile conditions.
clever culture systems APAS Independence
Microbial quality control
Monitoring for the presence of airborne and surface microbes is a requirement of the cGMPs.

Challenges of microbial environmental monitoring

The results from microbial environmental monitoring form a critical part of a facility’s overall contamination control strategy. They are also vital to the release of product to market.

Subjective manual processes
Production decisions and product batch release rely on subjective results from manual microbial environmental monitoring practices.
Human error
Even when adopting best practice — dual analyst verification (the ‘4 eyes’ principle)1 — there remains the potential for human error.
Lengthy investigations
Microbial environmental monitoring that does not meet acceptance criteria results in lengthy and costly investigations.
Data integrity problems
A review of inspections and warning letters from 2007-2018 demonstrated a high degree of focus on data integrity for compliance2.

The solution — APAS Independence

Digital automation to enhance batch release records

APAS Independence provides best-in-class automation for microbial environmental monitoring culture plate reading. The automated system minimises concerns around data integrity and traceability of results.

APAS Independence workflow diagram

Benefits of the APAS Independence

Efficiency gains
Automated release of microbial environmental monitoring results can streamline the overall product release cycle. This allows manufacturing to accelerate production schedules and market delivery​.
Automation of culture plate reads ensures microbial environmental monitoring processes can be scaled alongside the demands of increased manufacturing.
Increased data integrity
Human errors are reduced, while data traceability is enhanced by providing an audit trail and digital records of all results. Images of culture plates are available to support quality investigations.
APAS removes the subjectivity of results and provides digitally integrated workflows to support microbial environmental monitoring workflows.

Why consider APAS Independence for your pharmaceutical lab


It delivers high efficiency automation for your laboratory


It is designed for simple integration with your processes


It provides for digital integration that improves workflows


It strengthens data integrity and traceability


It’s a best-in-class, scientifically validated solution

1USP <1117> Microbiological best practices.
2Rogers, C.A., Ahearn, J.D. andBartlett, M.G., 2020. Data integrity in the pharmaceutical industry: analysis of inspections and warning letters issued by the bioresearch monitoring program between fiscal years 2007–2018. Therapeutic innovation & regulatory science, 54, pp.1123-1133.

Learn more about APAS Independence for pharmaceutical labs