Validations

Media Shelf Life Validation Protocol | USP & Compliant. PHARMA MICRO HUB VALIDATION PROTOCOL TITLE: SHELF LIFE DETERMINATION OF PREPARED MICROBIOLOGICAL MEDIA Protocol No: PMH/VP/001-00 Effective Date: April 2026 1.0 OBJECTIVE To define the detailed procedure for determining the shelf life of prepared microbiological media by evaluating pH stability, physical integrity, and growth promotion capability over a 14-day study period. 2.0 SCOPE This protocol is applicable to all dehydrated media lots prepared, sterilized, and stored at 22.5 ± 2.5°C within the Microbiology Laboratory of Pharma Micro Hub. 3.0 RESPONSIBILITY Designation Responsibility Microbiologist Execution of media preparation, sterilization, pH measurement, physical checks, and GPT. Head – Microbiology Technical review of raw data, calculation of recovery percentages, and report verification. Head – QA Final approval of the protocol and authorization of the established shelf life. 4.0 PRE-REQUISITES 5.0 PROCEDURE 5.1 Media Preparation: Reconstitute dehydrated media powder in purified water and mix properly. Sterilize at 121°C for 15 minutes at validated autoclave as per SOP. Cool to 45-50°C and pour 20-25ml into sterile plates aseptically under LAF. 5.2 Physical Check: Visually inspect the plates for colour change, excessive moisture, cracks or microbial contamination. 5.3 pH Procedure: Calibrate the pH meter using standard buffers then Measure pH of solidified agar and broth media at 25°C. Acceptable limit is ±0.2 or as per manufacture recomenadtions. 5.4 GPT Performance: Inoculate test organisms in media with 10-100 CFU of challenge organisms. Incubate per USP <61>/<62> and confirm recovery is 50-200% compared to fresh control media. 6.0 ANNEXURES Annexure I: Media Preparation & GPT Log.Annexure II: Physical & pH Observation Sheet. 7.0 REFERENCES 8.0 ABBREVIATIONS GPT: Growth Promotion Test LAF: Laminar Air Flow USP: United States Pharmacopeia CFU: Colony Forming Unit. PHARMA MICRO HUB VALIDATION SUMMARY REPORT Report No: PMH/VR/001-00 REF PROTOCOL NO: PMH/VP/001-00 Date: April 2026 1.0 OBJECTIVE To summarize and evaluate the analytical data obtained during the 14-day hold-time study to establish the final shelf life for prepared media. 2.0 SCOPE This report covers the stability evaluation of media batches stored under controlled laboratory conditions (22.5 ± 2.5°C). 3.0 RESPONSIBILITY Designation Responsibility Microbiology Team Compiling results from Day 0, Day 7, and Day 14 into the summary report. QA Department Reviewing summary against protocol and authorizing the final shelf life. 4.0 REQUISITES USED Qualified ATCC organisms, validated dehydrated media lots, and calibrated pH analysis systems. 5.0 PROCEDURE FOLLOWED The study was executed per Protocol PMH/VP/001-00. Testing for GPT, pH, and physical appearance was performed at Day 0, Day 7, and Day 14 intervals. 6.0 RESULTS SUMMARY Media Name Parameter Day 0 Day 7 Day 14 SCDA / SCDM pH & Appearance Pass Pass Pass SDA GPT Recovery Pass Pass Pass 7.0 CONCLUSION All prepared media batches met the acceptance criteria for pH stability, physical integrity, and growth promotion capability (50-200% recovery) throughout the 14-day study duration. 8.0 RECOMMENDATIONS The validated shelf life for prepared microbiological media is established as 10 days from sterilization date at 22.5 ± 2.5°c. ANNEXURES Annexure I: GPT Recovery Log Template Organism Control (CFU) Test (CFU) % Recovery         Annexure II: pH & Physical Appearance Log Interval pH Observed Physical Appearance Day 0 / 7 / 14       Get ready to download editable validation in word document.