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.

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Risk-based decision tree for selecting moist heat sterilization cycles in pharmaceutical manufacturing.

Risk-based Decision Tree for Heat Moist Sterilization in Pharma

A GMP-aligned, risk-based decision tree for moist heat sterilization in pharma, covering cycle selection, validation strategy, F₀ use, and routine...
GMP cleanroom operators performing controlled pharmaceutical manufacturing activities.

Pharmaceutical Cleanrooms: Design, Classes, and Control in GMP Manufacturing

Cleanrooms explained: what they control, ISO 14644 classes vs EU GMP Grades, where they’re used, and how monitoring, trending, and...
Moist heat sterilization using an autoclave for pharmaceutical and GMP applications.

What Is Moist Heat Sterilization?

What moist heat sterilization really means in GMP: mechanisms, cycle types, limitations, and regulatory expectations beyond 121 °C for 15...
Featured graphic comparing terminal sterilization and aseptic processing in GMP manufacturing, with laboratory autoclave and sterile bottles.

Terminal Sterilization vs Aseptic Processing: Key Differences

Terminal sterilization vs aseptic processing explained. Compare sterility assurance levels, risks, validation expectations, and GMP regulatory guidance....
ISO 5 cleanroom requirements infographic showing airflow design, monitoring strategies, and validation elements according to ISO 14644-1.

ISO Class 5 Cleanroom Requirements According to ISO 14644-1

Overview of ISO 5 cleanroom standards, airflow control, monitoring requirements, and qualification steps under ISO 14644-1...
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....

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