Category: Microbiology

The Microbiology category addresses microbial control in pharmaceutical manufacturing, where aseptic processing, product quality, and contamination prevention are central to GMP compliance. It focuses on how companies apply structured monitoring, testing, and facility design to reduce risks and meet regulatory expectations.

Topics include environmental monitoring, aseptic techniques, microbial risk assessment, cleanroom operation, and method validation, aligned with EU GMP Annex 1, Ph. Eur., USP, and ISO standards.

If you don’t find what you are looking for, try using a different term or contact us.

Mold contamination in cleanrooms featured image showing mold growth on an agar plate under laboratory light.

Mold Contamination in Cleanrooms: An Invisible but Critical Threat

Even modern cleanrooms face mold risks from HVAC systems, materials, and humidity. Understand how maintenance and monitoring programs can prevent...
Pre Use Post Sterilisation Integrity Testing (PUPSIT) According to Annex 1 - Featured Image

Pre-Use Post Sterilisation Integrity Testing (PUPSIT) in Annex 1

Explore Annex 1 PUPSIT requirements, causes of filter damage, and how proactive integrity testing strengthens sterility assurance in aseptic processing....
Bioburden testing in the pharmaceutical industry - featured image

Bioburden Testing in the Pharmaceutical Industry

Bioburden testing in pharmaceuticals: methods, validation, and regulatory expectations for microbial control and sterilization assurance....

Cleanroom Classification According to ISO 14644-1

ISO 14644-1 cleanroom classification explained: particle limits, GMP grade mapping, and key compliance insights for sterile pharma manufacturing....
Media Fills In Sterile Manufacturing: Aseptic Process Simulation - Featured Image of Article

Media Fill Tests: Aseptic Process Simulation (APS) in Sterile Manufacturing

Media fill tests verify aseptic process integrity by simulating sterile drug manufacturing under worst-case conditions to ensure contamination control....
environmental monitoring in pharmaceutical industry - featured image

Environmental Monitoring in the Pharmaceutical Industry

Essential strategies for environmental monitoring in pharma to ensure GMP compliance, prevent contamination, and maintain cleanroom control....
Growth promotion testing (GPT) in pharmaceutical microbiology

Growth Promotion Testing (GPT) in Pharmaceutical Microbiology

Growth Promotion Testing (GPT) verifies culture media performance to support microbial growth in pharmaceutical microbiology applications....
GMP Cleanroom

GMP Cleanroom Classifications: Grade A, B, C and D

Explore GMP cleanroom classifications A to D, ISO equivalents, particle & microbial limits, and key qualification steps for contamination control....
rabs-vs-isolators-fi

RABS vs Isolators: Which Barrier System Meets Annex 1 Expectations?

RABS vs Isolators: Key differences, Annex 1 expectations, and how to choose the right barrier system for your aseptic manufacturing...
How to Select and Justify the Right Biological Safety Cabinet for the Laboratory

How to Select the Right Biological Safety Cabinet (BSC) for the Lab?

Learn how to choose the right Biological Safety Cabinet (BSC) for your lab. Explore BSC types, features, biosafety levels, and...

BECOME A GMP INSIDER

Stay in touch and be the first to get the latest GMP News!