The PharmaTwin Blog

Insights on GMP zoning, HVAC engineering, and cleanroom facility design.

Contamination Control Strategy (CCS): Annex 1 Guide
·8 min read

Contamination Control Strategy (CCS): Annex 1 Guide

What a contamination control strategy is, the 16 elements EU GMP Annex 1 asks it to cover, who owns it, and how most of it is decided at facility design stage.

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Cleanroom HVAC Design for Pharmaceutical Facilities
·7 min read

Cleanroom HVAC Design for Pharmaceutical Facilities

How to size cleanroom HVAC for EU GMP Annex 1 and ISO 14644: air change rates, pressure cascades, HEPA filtration, and recovery time explained.

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GMP Cleanroom Classification: Grades A–D and Zoning
·7 min read

GMP Cleanroom Classification: Grades A–D and Zoning

How EU GMP grades A, B, C and D map to ISO 14644 classes, what "at rest" and "in operation" mean, and how pressure cascades and airlocks make a zoning plan work.

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