APAS PharmaQC

Reliable environmental monitoring plate reading powered by A.I.

APAS PharmaQC provides automated imaging, analysis and interpretation of microbiology culture plates used in environmental monitoring. The cutting-edge technology utilises advanced imaging and sophisticated artificial intelligence algorithms to identify and count microbial growth on culture media delivering a greater level of traceability and data integrity to your environmental monitoring workflow.

Status: Available

Challenges in Environmental Monitoring

Microbial quality control is an essential activity for monitoring critical production environments where sterility is required to ensure the safety of drugs. Contamination control processes generate a large volume of environmental monitoring data that must be reviewed and interpreted by skilled microbiologists.

  • Data Integrity – Manual counting and recording processes subject to human error
  • Operational Inefficiency – Critical time spent performing repetitive labour-intensive tasks
  • Variable Results – Interpretation inconsistencies between microbiologists
  • Time Consuming – High volume of samples with no microbial growth (up to 90%)1
  • High Regulatory Requirements – Contamination control strategy and Annex 1 requirements
  • Validation Burden – Hurdles to implement new technologies and processes within controlled environments

1A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems, Sven Deutschmann, Bill Carpenter, Caroline Duignan, et al., PDA Journal of Pharmaceutical Science and Technology 2022

APAS PharmaQC Workflow

APAS Pharma saves time and enhances Microbial QC practices through automated imaging and interpretation of settle plates used in environmental monitoring. APAS Pharma integrates with existing work practices and is able to be validated across a range of standard 90mm Tryptone Soy Agar culture media.

APAS-PharmaQC-Workflow

APAS Pharma QC – Demonstrated Performance

Studies assessing the performance of APAS PharmaQC have demonstrated outstanding performance for growth detection across the plate and accuracy for microbial enumeration.

  • Proof of Concept – Linearity of count3:
    • Bacterial enumeration: R2 >0.98
    • Fungal enumeration: R2 > 0.95
  • Pilot Secondary Validation Study2:
    • Sensitivity for growth detection: 100%
    • False positive rate: 7.3%

For more scientific information on the performance of the APAS technology visit our scientific library.

2Pilot secondary validation study data, July 23
3Data Integrity Challenges in the Pharmaceutical Microbiology Laboratory, Considerations for Current State and the Application of Technology to Mitigate Risk, Miriam Guest, Dr Steven Giglio, White Paper, Aug 23

APAS PharmaQC linearity of count for Staphyloccus aureus

APAS Pharma Features and Benefits

  • Greater standardisation of results – removes microbiologist variability and subjectivity of results
  • Compliant automation – Full data integrity and audit trail to meet your contamination control strategy, Annex 1 and CFR 21 Part 11 requirements
  • Rapid high-throughput system – minimal user interaction for to read 200 plates/hour
  • Integrated automation – reports directly to laboratory information system to remove transcription errors
  • No proprietary media – compatible with all major media suppliers
  • Mould workflow – Growth of moulds identified by the system and triaged for priority review
  • Flexible system – No need for separate systems for 90mm and contact plates (in development)
  • Cost effective – efficiently removes no growth plates from the workflow
  • Increased traceability – Digital record of results and images available for review
  • QC proportion in-built – Configurable percentage of plates selected randomly for review
  • Simple validation – aligns with existing processes for environmental monitoring (no change to media used, incubation, etc…)

Example APAS PharmaQC web report for TSA settle plate