Microbiology

Microbiologists play an essential role in monitoring for microbial contamination that may be present throughout the manufacture of pharmaceutical drug products.
lab assistant holding a petrie dish
Contamination control
It’s vital to exercise good contamination control practices through the monitoring of processes, production environments and finish product testing to meet safety and quality requirements.

Challenges for microbiology labs

Resource constraints
Retaining skilled microbiologists, high turnover and keeping everyone cross-functionally trained remain challenges for most microbiology labs1.
Manual workflows
“Four eyes” protocols can lead to significant microbiologist time spent manually reading and verifying large volumes of agar plates that show zero microbial growth (up to 98%)2.
Competing priorities
Laboratories need to balance operational priorities as well as evolving regulatory demands, whilst ensuring results are released accurately and efficiently.
Human factors
Manual review of microbiology culture plates can lead to subjectivity and variability in colony counts for environmental monitoring results.

APAS Independence

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A solution designed by microbiologists for microbiologists

APAS Independence automates the reading and reporting of culture plates after incubation, delivering efficiencies to pharmaceutical microbiology workflows.

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Automation to benefit microbiologists

Clever Culture Systems designed the APAS Independence to automate the most important part of the workflow while minimising change and disruption to your processes.

APAS Independence workflow diagram
Key features of APAS Independence
No-growth plates can be auto-validated in LIMS with no need for microbiologist review (>90% of plates)
Bacteria and mould colony counts automatically provided by the APAS system
Digital microbiology workflow allows for enhanced review of plates improving consistency of results
Plates identified with mould or spreading colonies are automatically separated and flagged for review
Minimal change to workflow – APAS Independence supports existing culture media and incubation processes

Benefits of APAS Independence for microbiology

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Rapid & high-throughput

Scalable automation solution. APAS instrument reads 200 plates per hour – 24/7

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Minimal user interaction

Intuitive user interface and easy operation. Simply load culture plates and walk away

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Flexible operation

Works with both 90mm and contact culture plate. No proprietary media required – supports major media brands

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Improved analyst satisfaction

Frees microbiologist from time spent confirming zero growth counts to focus on complex tasks for product release

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Automated digital workflow

APAS Web User Interface provides high-quality plate images for review with digital tools to support final reporting

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Improved traceability

Increased compliance and traceability concerning the detection, confirmation and reporting of microbial growth

1Cundell T, ‘Top Five Challenges Facing Pharmaceutical Microbiologists’, American Pharmaceutical Review, June 2006.
2Andrew Gravett.Automated Reading of Agar Plates using AI, PharmaLab Congress 2023.