Monday, 16 March 2020

Good Hygienic Design Principles for Pharmaceutical Manufacturing

An important objective of hygienic design relating to the pharmaceutical and healthcare sectors is with the avoidance of product contamination by microorganisms, particles and chemicals. Each of these contaminants is considered, although the focus is on microbial contamination. This concerns the application of good hygiene design techniques that allow for all assets to be cleaned effectively and efficiently in order to minimize the risk posed by these different hazards.

As well as addressing contamination, a hygienically designed pharmaceutical manufacturing facility is also cost effective and sustainable for other reasons. First, the well-designed facility may reduce labor costs as less time and effort are required to clean and disinfect and secondly, such a facility may allow for cost savings in terms of the consumption of water, cleaning agents/disinfectants, as well as the energy required to heat the cleaning and disinfection solutions. This becomes doubly complex when adopting continuous manufacturing, which requires additional flexibility in adapting internal facility resources to accommodate a wide variety of process formats and scales.

In relation to this, Tim Sandle has written an article:

The article is concerned with good hygiene design for pharmaceutical facilities. This, in itself, is a large subject and so the examples selected are intended to be illustrative. The article is divided into six subject areas:

Hygienic design – what is it?
Materials of choice

Equipment selection; valves, pumps, vessels
Pipework and system design
Processing conditions
Maintaining hygienic security

With each area presented as a case study, applying quality risk management.

For details, contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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