- Methods
- Microbiological Testing
Microbiological Testing
USP-aligned microbiological testing supporting contamination detection, microbial quality, and controlled manufacturing environments.
Overview
About Microbiological Testing
PLS Analytical delivers microbiological testing capabilities designed to support contamination control, environmental monitoring, microbial quality assessment, and regulatory compliance across pharmaceutical and healthcare manufacturing environments. Our laboratories support routine microbiological testing, endotoxin analysis, organism identification, environmental monitoring, and investigation-driven studies through scientifically controlled and cGMP-aligned processes.
Using validated methods aligned with USP, FDA, and global regulatory expectations, we help manufacturers maintain product quality, support controlled operations, manage contamination risks, and ensure reliable microbiological performance throughout development and commercial manufacturing.
Why it matters
Microbiological testing is a critical part of pharmaceutical quality control, helping detect microbial contamination before it impacts product safety, stability, or performance. By identifying microorganisms, endotoxins, and bioburden at early stages, microbiological testing helps maintain product integrity, and support safe, reliable, and market-ready products throughout the manufacturing lifecycle.
Testing Types
Scientific testing services designed to support reliable and compliant products
Endotoxin Testing
Designed to detect bacterial endotoxins that may impact product safety in injectable products and medical devices.
Method Suitability
Verifies that product formulations do not interfere with microbial recovery or testing performance, supporting accurate and reliable results.
USP <60>, <61>, <62>, <2021>, <2022> Testing
Supports evaluation of microbial quality, specified microorganisms, and microbiological limits in non-sterile pharmaceutical products.
Antimicrobial Assay (USP <81>)
Helps assess the potency and effectiveness of antimicrobial and antibiotic products using microbiological assay methods.
Kill Rate Study
Designed to evaluate the effectiveness of disinfectants, sanitizers, and antimicrobial products against targeted microorganisms over time.
TOC Analysis
Helps monitor organic contamination levels in pharmaceutical water systems to support water quality and process control.
Antimicrobial Preservative Effectiveness Test (AET) USP <51>
Assesses the ability of preservative systems to inhibit microbial growth and maintain product protection throughout the lifecycle.
Organism Identification by VITEK
Supports rapid identification of bacteria and fungi recovered during testing, monitoring, or contamination investigations.
Key Advantages
Testing is performed in a cGMP-compliant environment using controlled laboratory systems to detect contamination risks across raw materials, water systems, manufacturing areas, and finished products.
Regulatory-aligned testing
Testing performed in accordance with USP chapters, FDA expectations, and globally accepted microbiological quality standards.
Reliable detection & recovery
Validated methods and suitability studies help minimize interference and improve the accuracy of microbial recovery and detection.
Faster investigation support
Rapid organism identification and contamination assessment support quicker root-cause investigations and corrective actions.
Resources
Explore our insights and successes
Contact Us
Let’s explore the right support for your product
Connect with our team for reliable scientific and regulatory-focused testing support.
Address
40E Cotters Lane, Suite A, East Brunswick, NJ-08816
Telephone
+1 (732) 698-5050Our Methods
Robust testing services for transformative outcomes
