APAS Pharma

APAS Pharma is an expansion of Clever Culture Systems’ innovative image analysis technology, delivering intelligent automation solutions for pharmaceutical microbial quality control deployed on the APAS Independence. APAS Pharma uses artificial intelligent algorithms to automatically detect microbial growth for environmental monitoring applications.

Status: Coming soon

Challenges for Pharmaceutical Manufacturers

Microbial quality control (QC) is an essential activity for monitoring the sterility of critical production environments for drug manufacture. Each year over 350 million microbial QC tests are performed to ensure the safety of drugs. Current environmental monitoring techniques rely on the manual review of settle plates, a labour-intensive process. The reliability of test results is limited by the abilities of the human observer (subjectivity of counting colonies) and data recorder (subject to transcription errors).

The errors and challenges associated with microbial quality control may be considered, by a health authority investigator, to be an indication of data integrity issues.¹ This has become a major area of focus for regulators with more than 200 FDA warning letters per year with data integrity findings since 2015.

Consequently, there is an increased need for automated microbial detection systems in pharmaceutical microbiology to reduce sources of human error, accelerate return of results and improve traceability for this critical activity.

Challenges for Microbial Quality Control

Variability and inconsistency of microbial counts due to human variation

High volume of samples with no microbial growth (up to 90%)¹

Operational inefficiency - Critical time spent performing repetitive labour-intensive tasks

Increased regulatory burden and requirements for second analyst verification

¹ A 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 Pharma – Never miss a colony

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 Pharma has proven performance with 100% growth detection across the plate. Linearity studies have shown a high accuracy for bacterial enumeration (R2 value of >0.9)²

² APAS Pharma Proof of Concept Study – February 2022

APAS Pharma Features and Benefits

Automatic reporting of plates showing no microbial growth

Reduces need for contemporaneous/second analyst verification

Improved data integrity through automation and direct image capture

Greater standardisation of results - removes reader variability, subjectivity and transcription errors

Audit and data reports available

Rapid high-throughput laboratory instrument able to read 200 plates/hour

Automated integration with laboratory information system to remove transcription errors

Digital record of results - plate images available for review