Microbial environmental monitoring is a key element of a pharmaceutical company’s contamination control strategy required by industry regulators for drug products manufacturing around the world.
people working in a lab

Quality challenges for pharmaceutical labs

Increasing scrutiny

Data from the monitoring of production environments is attracting tougher regulatory scrutiny.

79% of FDA warning letters cite 'Data Integrity', increasing by over four times between 2015 & 20181.

Risk assessment

There is an increasing demand for a risk assessment to govern how culture plate reads are performed — and when second analyst verification will be used.

Data integrity

Manual counting and recording processes are subject to human errors and fatigue.

There is often no long-term record of culture plates that are destroyed after reading, creating traceability challenges.

Subjectivity of results

There can be interpretation inconsistencies between analysts.

There is potential to not visually detect microbial growth that presents a risk to critical production areas.

APAS Independence for pharmaceutical microbiology

The APAS Independence is a scientifically validated instrument that provides improved data capture and resulting of environmental monitoring culture plates.

Key features of APAS Independence
Full integration with laboratory information management systems (LIMS)
Provides contemporaneous data capture as plates are read
Enduring records of results captured through digital plate images
Faster identification of results that do not meet acceptance criteria
clever culture systems APAS Independence