05/09/2025
🚨 When Your Lab Says PASS but Another Lab Says FAIL.
It’s every microbiologist’s “uh-oh” moment.
Your lab: ✅ “All good, batch passes!”
Another lab: ❌ “Fail detected, contamination found!”
Now the batch is like a student who cleared the school exam but failed in tuition class. 😅 What do you do? Panic? Nope. Investigate smartly.
🔬 Step-by-Step Actions (with Examples)
1️⃣ Immediate Risk Assessment
➡️ Put the batch on hold — no further dispatch.
Example: Like hitting the pause button in Netflix when two friends argue about the plot. Nobody continues until it’s clarified. 🎬
2️⃣ Review Your Internal Records
➡️ Check raw data, instrument calibration, media/reagent CoAs, analyst training, and SOP adherence.
➡️ Don’t forget environmental monitoring (EM) and sterility controls.
Example: Sometimes your incubator is fine, sometimes it’s “feverish” at 33.5°C instead of 32.5°C. 🌡️
3️⃣ Cross-Check Testing Protocols
➡️ Compare methods, pharmacopeial references (USP/EP/IP), neutralizers, incubation, sample handling.
➡️ Even one dilution difference can flip results.
Example: One chef adds a pinch of salt, the other adds a spoon — same soup, very different taste. 🍲
4️⃣ Communicate with the Other Lab
➡️ Request their raw data, photos of growth plates, deviations, media lot history.
➡️ Sometimes, contamination is real; sometimes it’s a handling error.
Example: Maybe Bacillus subtilis sneaked into their incubator with a fake moustache. 🎭
5️⃣ Independent (Third-Party) Testing
➡️ If unresolved, send your retained sample to an independent lab.
➡️ This is the Supreme Court of Microbiology — final verdict, no appeals. ⚖️
6️⃣ Document & Escalate
➡️ Prepare an Investigation Report (background → findings → CAPA).
➡️ Escalate to QA/Regulatory if required.
Example: In pharma, even subtilis needs a full biography before closing the case. 📑
7️⃣ Final Decision
➡️ If Fail confirmed → Quarantine/Recall + OOS + CAPA.
➡️ If Pass confirmed → Release with QA justification but monitor future batches.
📖 Real-Life Style Example
This actually happened with one of our purified water batches. Our in-house lab showed