Comparison of Candidates for Automated Colony Counting Systems Using Mandatory Core Requirements
| Characteristic | Required Attribute | Traditional Human Reading | HD-Camera and Illumination Only | HD-Camera and Illumination in Conjunction with Intrinsic Autofluorescence |
|---|---|---|---|---|
| Data Integrity | Improves data integrity | No ability to control / no validated method to preserve original data | Full audit trail via barcodes | Full audit trail via barcodes |
| Subjective | Instrument with validated software performs plate handling, incubation, and read, with user roles restricted to avoid loss or undocumented change to data | Instrument with validated software performs plate handling, incubation, and read, with user roles restricted to avoid loss or undocumented change to data | ||
| Validated data migration available | Validated data migration available | |||
| Opportunity to save original image data if warranted | Opportunity to save original image data if warranted | |||
| Fully objective | Fully objective | |||
| LIMS Connectivity | Proven, may require some ITS and vendor interaction and customization | None; manual transcription | Bi-directional interfacing between the proprietary software and LIMS. LIMS-specific drivers will be required to enable connectivity | Bi-directional interfacing between the proprietary software and LIMS |
| Established in Biopharma / Extent of Use in the Industry | Clear path for implementation established | Well established, to the point of deficiencies being “accepted” or addressed with counts verified by a second analyst (contemporaneous verification) | System uses an HD camera to detect growth with colonies being detected before they are visible to the human eye | System uses an HD camera to detect growth (using intrinsic autofluorescence) with colonies being detected before they are visible to the human eye |
| Proof of concept of intrinsic autofluorescence is widely accepted | ||||
| Several biopharmaceutical companies have evaluated the system as part of the development cycle prior to commercial launch | Several biopharmaceutical companies have qualified instrument (IOPQ) and validated the method | |||
| First approvals for product samples (IPC as well as release samples) obtained | ||||
| Several companies use the instrument for testing of water samples as well as environmental samples. This application has been inspected by various Health Authorities around the globe and no concerns were expressed about the use of the instrument for these types of samples | ||||
| Technology Platform / Maturity of the Technology | Proven technology. Minimal development work for end user (i.e., plug-and-play) | Dependent on observer | 2nd generation system | 2nd generation system |
| System has been available since 2017 for Food laboratories; hardware, software, and algorithm have been improved for use in Pharma—available from 2021 | Several biopharmaceutical companies have successfully implemented the technology | |||
| Level of Automation | Automation | None | Fully automated | Fully automated |
Abbreviations: HD, high definition; LIMS, laboratory information management system; ITS, IT services, IOPQ, installation, operation, performance qualification; IPC, in-process control.