HEPA-Filtered Cleanroom

Cleanroom Microbiological Testing & Sterility Assurance

Microbiological quality assurance protects consumers from pathogenic contamination. Our microbiology department includes laminar air flow bio-safety workstations, calibrated incubators, autoclaves, and dedicated media preparation suites engineered to eliminate cross-contamination and provide reliable bioburden metrics.

Standard Turnaround
5 - 7 calendar days (incubation periods determined by pharmacopoeia)
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Cleanroom Microbiology (MLT)

Satvam Research operates an environmentally controlled, HEPA-filtered cleanroom microbiology vertical dedicated to Microbial Limit Testing (MLT), Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), and designated pathogen verification conforming to IP, BP, USP <61>/<62>, and ISO guidelines. We serve pharmaceutical, cosmetic, food, water, and herbal industries.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Total Aerobic Microbial Count (TAMC) and Total Combined Yeasts and Molds Count (TYMC)
Absence testing for Escherichia coli, Salmonella species, Pseudomonas aeruginosa, Staphylococcus aureus
Bile-tolerant gram-negative bacteria enumeration and testing
Microbial suitability and method validation testing as per USP <61>/<62>
Cleanroom environmental monitoring: settle plates, air sampling, surface swab counts
Preservative efficacy testing (Antimicrobial Effectiveness Testing - USP <51>)
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

Cleanroom Microbiology Infrastructure - HEPA-Filtered Laminar Flow & Multi-Temp Incubators
SRPL Cleanroom Engineered
Model: HEPA-Filtered Laminar Flow & Multi-Temp Incubators

Cleanroom Microbiology Infrastructure

Aseptic inoculation, colony enumeration, and pathogen incubation.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
USP <62> Microbiological Examination: Tests for Specified Microorganisms
Ph. Eur. 2.6.12 & 2.6.13 Microbiological Examination
IP Microbiological Limit Tests
ISO 17025 Microbiology Standards
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
30 - 50 g of solid/semi-solid or 50 - 100 mL of liquid product in unopened sterile containers.
Container Type
Sterile screw-capped containers or original sealed commercial packs.
Storage Condition
Ambient or 2-8°C; never freeze samples intended for microbiological testing.
Standard TAT
5 - 7 calendar days (incubation periods determined by pharmacopoeia)
Special Instruction: Clearly note if sample contains active antimicrobial preservatives.
Frequently Asked Questions

Technical & Regulatory Inquiries

Why cannot microbiological testing be expedited in 24 hours?

Pharmacopoeial incubation periods are biologically fixed: TAMC requires 3 to 5 days of incubation at 30-35°C, and TYMC requires 5 to 7 days at 20-25°C to allow viable organisms to form visible, countable colonies.

Initiate Your Cleanroom Microbiology (MLT) Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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