S-03 · Microbiological testing
Compendial screening, on the record.
Bioburden, sterility, endotoxin, and specified-organism screening per USP compendial methods. Reports formatted to match the compliance framework your buyer expects.
Standard TAT
5–14 d
Detection
1 CFU/g
Sample req.
Product-specific
Deliverable
USP-format report
Method reference
MA-S03-USP-01
Instrument-calibrated● ValidatedSigned releaseRaw data retained
Method sheetHK · Kwun Tong
§ 01 — Assay scope
What is measured.
Every attribute is quoted, run, and reported against the same reference method. Add-ons run from the same submission.
A-01USP <61>
Total aerobic count
Total aerobic microbial count (TAMC) and total yeast/mould (TYMC) per USP <61>.
A-02USP <62>
Specified organisms
E. coli, Salmonella, S. aureus, P. aeruginosa, C. albicans, bile-tolerant Gram-neg.
A-03USP <85>
Bacterial endotoxin
LAL kinetic-chromogenic assay to USP <85>. Suitable for injectables.
A-04USP <71>
Sterility
Membrane filtration or direct-inoculation sterility per USP <71>.
§ 02 — Method sheet
MA-S03-USP-01
Abbreviated method sheet. Full validated method (linearity, robustness, system suitability) available under NDA.
Method code
MA-S03-USP-01
Environment
ISO Class 5 laminar-flow, ISO Class 7 background
Media QC
Growth-promotion tested per batch, USP <62> panel
Incubation
Bacteria: 30–35 °C · Fungi: 20–25 °C
Neutralisation
Suitability verified per product matrix
Reference
USP <61> <62> <71> <85> · Ph. Eur. 2.6.12/13/14
Reporting
CFU/g or CFU/mL · EU/mL for endotoxin
§ 03 — Deliverable
A certificate you can hand to a regulator.
- USP-format report with method, media lot, and incubation record
- Positive/negative controls included on every run
- Suitability testing (product interference) documented per matrix
- Deviations logged and reviewed by QA before release
- Raw plate images retained 5 years, available on request