Pharmaceutical Microbiological Testing | Sterility Bioburden Endotoxin | NABL | Auriga Research
Auriga Research operates an NABL-accredited pharmaceutical microbiology laboratory covering the full pharmacopoeial scope required for drug-product release and regulatory submission — sterility, bioburden, microbial limits, environmental monitoring, bacterial endotoxin testing (BET), and antimicrobial effectiveness testing (PET). The microbiology suite is anchored at Manesar (Plot 136, Sector 5, IMT Manesar) and Bangalore — both USFDA Inspected facilities, with companion capability at Delhi HQ (Arbro Analytical Division). Testing is conducted in cleanroom-grade aseptic suites with validated growth media preparation, qualified incubators, and continuous environmental controls.
Sterility testing per USP 71 and EP 2.6.1 is the critical release test for injectables, ophthalmic preparations, and inhalation products. Both membrane filtration and direct inoculation are offered, selected based on product volume and antimicrobial properties. Every batch undergoes validated bacteriostasis and fungistasis suitability testing, positive and negative controls run with every session, and media batches are growth-promotion tested before use — ensuring every result is scientifically defensible and audit-ready.
Alongside sterility, the laboratory delivers bioburden and microbial limit testing per USP 61 and 62 (TAMC, TYMC, specified organisms), environmental monitoring against ISO 14644 cleanroom classification and EU GMP Annex 1 / WHO TRS 961 alert and action limits, water-for-pharmaceutical-use microbiology per USP 1231, and microbial identification by MALDI-TOF and 16S/18S rRNA sequencing for OOS investigation. Bacterial endotoxin testing (LAL and rFC) is delivered from the dedicated BET subpage.
Six Pharmaceutical Microbiology Services
Each card maps the service to the governing pharmacopoeial reference, the analytical method, and the lab where it is performed.
Sterility Testing
Membrane filtration and direct inoculation per USP 71 and EP 2.6.1 for batch release of injectables, ophthalmic, and inhalation products. Method suitability (bacteriostasis / fungistasis) verified every session.
Bioburden Testing
Bioburden enumeration per USP 61 and 62 — TAMC, TYMC, and specified-organism screening (E. coli, Salmonella, S. aureus, P. aeruginosa, Clostridia). Also ISO 11737-1 for medical devices.
Microbial Limits Testing
Microbial limit testing per IP and USP for non-sterile dosage forms — oral solids, liquids, topicals, and herbal/AYUSH products. Quantitative enumeration with route-of-administration acceptance criteria.
Environmental Monitoring
Cleanroom monitoring — settle plates, active air sampling, surface contact plates, personnel monitoring — per ISO 14644 and EU GMP Annex 1 / WHO TRS 961. Sampling map, alert/action limits, trend reports.
Bacterial Endotoxin Test (LAL & rFC)
LAL gel-clot, KTA, KCA, and rFC per USP 85, EP 2.6.14, IP 2.2.3, and USP 1085.1 — delivered from the dedicated BET page. Method suitability and validation at Manesar (USFDA Inspected).
Antimicrobial Effectiveness Testing
Preservative challenge per USP 51 and EP 5.1.3 for multi-dose and non-sterile pharmaceutical products. 28 to 35 day protocol with bacteria + yeast + mould challenge organisms.
Project Timelines
Indicative TAT from sample receipt. Sterility and PET turnaround is incubation-driven and cannot be shortened. Confirm exact timeline with your SPOC at quote stage.
| Service Type | Turnaround Time |
|---|---|
| Sterility Testing (USP 71 — 14-day incubation) | 17 to 21 business days |
| Bioburden / Microbial Limit Testing (USP 61 / 62) | 5 to 7 business days |
| Bacterial Endotoxin Test (USP 85, LAL or rFC) | 2 to 3 business days |
| Environmental Monitoring Report | 7 to 10 business days |
| Microbial Identification (MALDI-TOF / 16S rRNA) | 5 to 10 business days |
| Antimicrobial Effectiveness Testing (USP 51) | 28 to 35 days |
How It Works
Get a Quote
Share your product type, regulatory authority, and specific microbiological test required. Your SPOC confirms the method (USP, IP, or EP), sample volume, and TAT.
Collect and Send Your Sample
Prepare sample per SPOC instructions at quote stage. Each sample is bar coded and registered in YLIMS on receipt.
Testing and QA Review
Your sample is tested under NABL-accredited conditions. Results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.
Receive Your NABL Report
Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.
Who Needs Pharmaceutical Microbiological Testing
- Manufacturers of sterile injectables and parenterals requiring USP 71 sterility release testing.
- Pharma companies conducting cleanroom environmental monitoring per ISO 14644 and EU GMP Annex 1.
- CDMO clients requiring microbiological testing as part of batch release and stability programmes.
- Medical device manufacturers requiring bioburden per ISO 11737-1 and device-extract endotoxin per ISO 10993-12.
- Generic companies requiring microbial limits data for CDSCO and USFDA dossier submission.
- Pharmaceutical water system operators (WFI, purified water) requiring routine USP 1231 microbiological monitoring.
- Non-sterile dosage form manufacturers (oral solids, liquids, topicals) needing USP 61 and 62 bioburden release testing.
- QA and OOS investigation teams requiring microbial identification by MALDI-TOF or 16S/18S rRNA sequencing.
Why Auriga for Pharmaceutical Microbiology
Dedicated Microbiology Suite with ISO-Classified Cleanroom
Cleanroom-grade aseptic suite with validated media preparation, qualified incubators, and continuous EM controls. Method suitability run with every session for audit-ready validity.
Full Scope in One Lab
Sterility, bioburden, microbial limits, environmental monitoring, BET, and PET — all under one accredited NABL scope. No need to split work across different microbiology vendors.
USFDA Inspected at Manesar and Bangalore
Microbiology data from Manesar and Bangalore is generated at the USFDA Inspected facilities — accepted in USFDA dossier submissions without re-testing.
NABL Reports Accepted by CDSCO, USFDA, EMA, WHO
NABL accredited (ISO/IEC 17025:2017) microbiological reports accepted by CDSCO regulatory submissions, USFDA dossier inclusion, EMA filings, WHO PQ, and PMDA.
BET — LAL and rFC Both In-House
Bacterial endotoxin testing covers traditional LAL (gel-clot, KTA, KCA) and animal-free rFC per USP 1085.1 — delivered from the dedicated /testing/pharmaceutical-testing/bacterial-endotoxin-testing/ subpage.
MALDI-TOF + 16S/18S rRNA Identification
Microbial identification by MALDI-TOF mass spectrometry and 16S/18S rRNA gene sequencing for OOS investigations, root-cause analysis, and contamination event response.
5+
NABL Accredited Labs
5 Cities
Delhi · Manesar · Bahadurgarh · Baddi · Bangalore
12,000+
Clients Served
1985
Arbro Group · Auriga Research
Regulatory References
- • USP <71> / EP 2.6.1 — Sterility testing.
- • USP <61> / <62> — Microbial enumeration tests and tests for specified microorganisms.
- • USP <51> / EP 5.1.3 — Antimicrobial effectiveness testing (PET).
- • USP <85> / EP 2.6.14 / IP 2.2.3 — Bacterial endotoxin test (delivered from dedicated BET page).
- • USP <1231> — Water for pharmaceutical purposes microbiology.
- • ISO 14644 + EU GMP Annex 1 / WHO TRS 961 — Cleanroom classification and EM limits.
- • ISO 11737-1 — Bioburden testing for medical devices.
- • IP General — Indian Pharmacopoeia microbiology references.