Production

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.

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.

Scalability

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.

Standardisation

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.