QC/QA microorganisms are vital components of quality assurance programs in food, pharmaceutical, and cosmetic testing laboratories. The use of designated QC/QA microorganism challenges leads to quality assurance documentation of satisfactory procedure, product, and personnel performance. The following highlights the use of these lyophilized microorganisms in microbiology QC/QA programs.
Process controls are measurements that provide quality assurance documentation to ensure that all elements contributing to the proper performance of a test are in "control." EZ-FPC™ microorganisms are assayed stock culture preparations derived from American Type Culture Collection (ATCC) reference cultures. These lyophilized and assayed microorganisms are used to validate or challenge the performance of microbiological testing procedures. Qualitative (presence/absence) and quantitative (enumeration) microorganism preparations are available to challenge the sensitivity and detection limits of microbiological testing methods on a routine basis. The same preparations can be used as validation, calibration, prequalification, and requalification challenges.
Automated and semiautomated equipment requires calibration for target microorganism populations in specific test sample matrices. Prior to equipment use, and at regular intervals, use QC/QA microorganism preparations to verify that calibration remains within anticipated ranges of tolerance.
An important aspect of maintaining a quality laboratory environment is the ability and proficiency of the analyst. Use QC/QA microorganisms as challenges to document specified test methods, such as sequential dilution, pipetting, and aseptic techniques.
LYFO-DISK® and KWIK-STIK™ microorganisms are reference stock cultures derived from ATCC reference cultures. Individual lyophilized microorganism preparations are used to prepare quality control cultures to challenge the performance of specific products and devices used in microbiological testing. They are also used to isolate identification schemes.
EZ-FPC™, EZ-APC™, LYFO-DISK, and KWIK-STIK microorganisms are of a known and defensible quality. All microorganism preparations include a Certificate of Assay or Certificate of Analysis. These certificates are quality assurance records documenting recovery and purity; traceability to reference culture status; microorganism authenticity determinations; and assayed values for quantitative preparations. These features support USP, food safety and quality, fragrance, and water testing services.
Disclaimer: Cole-Parmer products are not approved or intended for, and should not be used for medical, clinical, surgical or other patient-oriented applications.
