A useful QC plan does more than record that a control passed; it explains what the control protects and what happens when it fails. This guide uses the manufacturer IFU for catalogue 24100 as its technical anchor and translates it into practical review questions for professional laboratories.
Start with the product’s documented role
ALKALINE PEPTONE WATER is recommended by WHO and APHA as transport and enrichment medium for vibrio cholera. Enrichmentin liquid medium is necessary for Vibrio isolation from feces (after the first 48 hours of disease), for control of the carriers and for theexamination of beverages, foods or slurry.
Review Liofilchem Alkaline Peptone Water (Liquid medium) Culture Media 24100 at Kormay Biomedicals
Design the workflow before opening the pack
Define the sample type, inoculum or preparation step, incubation conditions, control organisms, reading window, confirmation pathway, and acceptance criteria in the SOP. Record the catalogue number, lot, expiry, analyst, equipment, and any deviation that could change interpretation.
Procedure points worth controlling
Take the sample with a loop, inoculate the medium, incubate at 36 ± 1°C for 5-6 hours or at 18-20°C for 18-20 hours. After incubationperform subcultures on isolation media. Common used media are: MONSUR AGAR (ref. 10016), TCBS AGAR (ref. 621010) e SPSAGAR (ref. 610148). READING AND
Read and document the result
After incubation evaluate the
Quality control as a decision tool
1.Control of general characteristics, label and print2.Sterility control7 days at 22 ± 1°C, in aerobiosis7 days at 36 ± 1°C, in aerobiosis3.Microbiological controlInoculum for productivity: 10-100 UFC/mlIncubation Conditions: 24 h ours at 36 ± 1°CMicroorganismGrowthVibrio choleraeATCC 11218GoodEscherichia coliATCC 25922InhibitedStaphylococcus aureusATCC 25923InhibitedTABLE OF SYMBOLS Batchcode In vitro DiagnosticMedical Device Manufacturer Use by Fragile, handlewith care Cataloguenumber Temperaturelimitation Contains sufficientfor <n> tests Caution, consultinstructions for use Do not reuse
Storage and handling
10-25°C away from light, until the expiry date on the label or until signs of deterioration or contamination are evident.WARNING AND
Safety and professional-use reminder
The product does not contain hazardous substances in concentrations exceeding the limits set by current legislation and therefore is notclassified as dangerous. It is nevertheless recommended to consult the safety data sheet for its correct use. The product is designed forIn vitro diagnostic use and must be used only by properly trained operators.
A practical pre-release checklist
- Current IFU revision and catalogue code verified
- Receipt, storage, lot, and expiry documented
- Controls and acceptance criteria defined before testing
- Reading time and observations recorded without forcing an ambiguous endpoint
- Confirmation and deviation actions linked to the laboratory SOP
Final perspective
Useful technical content should help a laboratory make a better-controlled decision, not replace the IFU or validated method. Confirm the current manufacturer documentation and local regulatory requirements before implementation.