ISCC'24 Symposium




Andrew D. Watson


cleanroom construction, clean build protocols (CBP)


A clean build protocol (CBP) is an essential component of a cleanroom
construction project. This paper provides guidance on how to develop and implement a
CBP in order to deliver a cleanroom that can successfully achieve its designated ISO



A Clean Build Protocol (CBP) is a fundamental part of the construction quality documentation of any cleanroom build. It should be proportional in response to the specific cleanroom project and encompass all aspects that will influence the handover
quality of the internal cleanroom surfaces. Stricter controls are often necessary if work is occurring in close proximity to an operational facility or if the finished cleanroom will be a sterile environment.
Construction is fundamentally a messy business. Contamination is inevitable and ultimately necessary if we want to deliver a cost-effective project. Ultimately, we want a series of protections and controls that will deliver a sufficiently clean facility that can be
commissioned and classified in a predictable and timely manner.
The purpose of this document is not to envisage every scenario, but provide a broad approach that should help to facilitate an individual response to any cleanroom project.

Clean-At-The-End Vs Clean-As-You-Go

There are three main sources of contamination during construction:
  • Construction related activities
  • Material that enters the site from the outside environment
  • Material that proliferates due to inadequate cleaning practices and waste removal
It is feasible that the main cleaning activity occurs at the end of the project just before commissioning. It is well acknowledged that the implementation of a CBP will add cost and time to a project (Whyte, [2010]), however the overall cost and time for a facility that
fails the first round of testing due to residual contamination could end up being more expensive. For sterile facilities, colonies of micro-organisms can form that make an aseptic space very difficult to achieve. Also, irreparable damage to flooring, seals and
even sensitive production equipment can occur.
Control of contamination during construction in accordance with specific procedures will reduce the risk to budget and program, particularly in the final stages of project completion.


References in ISO Standards

There is limited reference to clean build (construction) protocols in the ISO 14644 suite of cleanroom standards:
ISO 14644-4:2001 Design, construction and start up There is a reference in the Further, in Annex E, Construction and Materials Section E.3.3 a CBP is outlined
in four short paragraphs.
ISO 14644-4 is currently being revised. More detail on CBPs have been proposed.
ISO 14644-5:2004 Operations In Annex F, Cleanroom Cleaning, there is a section on a Construction-related cleaning program (F.9). In this section a
cleaning program, based on 10 separate project stages, is provided. It should be noted that this is quite a strict protocol, possibly best suited for construction that is
occurring in close proximity to an operational area.

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