Environmental monitoring is critical in the pharmaceutical quality control (QC) microbiology lab. The sample workload can be tenfold the total of all the other microbiology tests combined. The high throughput and very repetitive tasks make this area of microbiology prone to user errors, which can result in costly contamination events.
In this informative study we explore the following validation requirements:
- IOQ: proof of 21CFR11 compliance, incubator performance and vision accuracy to detect all colony types.
- PQ: proof that the presence of the membrane on the media does not affect Growth Promotion.
- PQ-TTR: Selection of reduced incubation time for final assay
- Method Suitability: proof that the membrane format does not affect, disinfectant inactivation or microbial capture from surfaces or active air streams.
- Equivalence: Proof that the new method results in the same detection capability as the standard method with no change in Action limits
Validation of and Corporate Value from Automation of Environmental Monitoring Test Methods proves that the use of rapid microbial methods helps facilities achieve greater efficiencies…and greater ROI.
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