Microbiological
🦠

Microbiological Analysis

Sterility testing, bioburden, microbial limits, endotoxin, and environmental monitoring per USP & IP guidelines.

SterilityBioburdenEndotoxinMLT
Overview

About This Service

AnalytiLab's microbiology laboratory provides comprehensive microbiological testing services for pharmaceutical products, medical devices, and environmental samples. Our ISO-classified cleanrooms and experienced microbiologists ensure accurate, reliable results for sterility testing, bioburden determination, endotoxin testing, and environmental monitoring programs.

USP <71>USP <61>USP <62>USP <85>IPEP 2.6

Key Information

Cleanroom ClassISO Class 5 (Grade A/B)
Turnaround Time14–21 days (sterility)
StandardsUSP, IP, EP, ISO
Regulatory AcceptanceUSFDA, EU, India CDSCO

Accredited by

NABLISO 17025USFDA
Scope of Work

What's Included

Sterility testing (USP <71>, EP 2.6.1)
Bioburden determination
Microbial limit testing (USP <61>/<62>)
Bacterial endotoxin test (LAL) (USP <85>)
Environmental monitoring (air, surface, water)
Antimicrobial effectiveness testing (USP <51>)
Preservative efficacy testing
Identification of microorganisms
Cleanroom qualification support
Water for injection (WFI) testing
Equipment

Instruments Used

LAL Reader (Kinetic Turbidimetric)

Bacterial endotoxin testing

Laminar Air Flow / Biosafety Cabinet

Sterility and aseptic testing

Membrane Filtration System

Sterility testing and bioburden

Incubators (Aerobic/Anaerobic)

Microbial culture and growth

Compliance

Regulatory Standards

USP <71>
USP <61>
USP <62>
USP <85>
IP
EP 2.6
Our Process

How We Work

01

Sample Receipt in Cleanroom

Samples received and logged in ISO-classified area; integrity checked.

02

Media Preparation & Sterility Check

Growth media prepared and sterility verified before use.

03

Testing & Incubation

Tests performed per pharmacopoeial methods; incubated for required duration.

04

Observation & Report

Results observed at intervals; final report with compliance statement issued.

Get Started

Ready to Start Your Microbiological Analysis?

Our scientific team is ready to assist. Submit your sample or request a quote today.