Comprehensive Overview

Medical devices, surgical sutures, injectable formulations, ophthalmic solutions, and packaged drinking water must undergo rigorous sterility testing (14-day membrane filtration or direct inoculation method) to confirm zero viable microbial contamination. We also determine pre-sterilization bioburden counts for medical device manufacturers.

Applicable Regulatory Standards & Testing Protocols

✓ Indian Pharmacopoeia (IP 2.2.11 Sterility) ✓ ISO 11737-1 (Sterilization of Health Care Products - Bioburden) ✓ USP <71> Sterility Tests

Analyzed Parameters & Test Methods

Sterility Test in Fluid Thioglycollate Medium (FTM at 30-35°C for 14 Days)

Sterility Test in Soyabean Casein Digest Medium (SCDM at 20-25°C for 14 Days)

Pre-Sterilization Bioburden Count (CFU per Device / Unit)

Bacterial Endotoxin Test (LAL Gel-Clot Test EU/ml)

Bacteriostasis and Fungistasis Validation

Sample Intake & Turnaround Protocol

20 Units Sealed Medical Device / Bottled Product | Turnaround Time: 14 Days (Mandatory Incubation Period)

Key Scope & Execution Deliverables

Sterile isolator / Laminar Flow Cleanroom testing to prevent false positives

Validation against antimicrobial product interference (B/F Testing)

IP/USP compliant Certificate of Sterility

Bioburden recovery efficiency calculations for gamma and EO sterilization

Key Business & Regulatory Benefits

Ensures 100% sterile medical devices for hospital surgical use

Fulfills Central Drugs Standard Control Organisation (CDSCO) mandatory licensing rules

Required Document Checklist

Batch Number & Sterilization Method (EO Gas / Gamma Irradiation / Autoclave)
Drug License Certificate