Author: James B. Tarter Jr., Commissioning & Validation Department Manager

August 5, 2015

I was “shadowing” the facility walk-through inspection as best I could; staying close enough to the group to hear their comments, but also doing my best to stay out of the way.  That’s when the auditor asked the question we all knew was coming, “How is it that I hear jack-hammers working on that side of the door and I see pharmaceutical production on this side of the door?”  The project “Construction Segregation Plan” just became the most important and heavily scrutinized document of the audit.

Conducting construction operations in an active cGMP facility is indeed possible, however, it requires planning, engineering, and most importantly, oversite in the form of documented verification.  A Construction Segregation Plan (CSP) is the tool that brings these elements together in a useable format that can withstand an auditor’s review.

The specific purpose of a CSP is to describe the tasks and the verification testing necessary for construction to take place within, or adjacent to, a cGMP compliant area with the objective of preventing contamination of the clean areas by construction dust and debris.  The essential steps of Construction Segregation Planning include:

  • Defining boundaries between construction zones and clean areas, and then locating construction segregation barriers so they segregate dirty areas from clean areas with as little impact to operations as possible.
  • Verifying that construction segregation barriers are built to correct specifications and they adequately protect cGMP production areas from construction dust, debris, and microbial contamination.
  • Verifying that the construction zone air pressurization scheme is negative with respect to all adjacencies as measured at designated construction zone ingress / egress points.
  • Verifying that the air pressurization scheme / differential pressure in adjacent cGMP production areas is not adversely affected by construction segregation barriers or the resultant changes to HVAC systems.
  • Verifying that existing, alarmed differential pressure set points located within the construction zone or in adjacent cGMP production areas are either adhered to or taken out of service via formal change control.
  • Verifying that any qualified utility sample points (e.g. purified water drops, compressed air use points, etc.) within the designated construction zone are taken out of service via formal change control prior to construction activities commencing.
  • Verifying the ongoing integrity of the construction segregation barriers through documented monitoring of barrier integrity, construction zone pressurization, transition zone housekeeping, and compliance to plant wide environmental monitoring procedures.
  • Providing guidance and direction for construction personnel passing through or working in cGMP production or packaging areas.
  • Verifying that the renovated facility is “construction clean” and that the facility fits and finishes are cGMP compliant prior to the construction segregation barrier being removed.

This degree of Construction Segregation Planning is obviously not done in a vacuum; it requires coordination and input from various stakeholders and subject matter experts including:

  • Operations – “My input to the CSP includes determining flow paths and showing you what areas I must have access to.”
  • Facility Engineering – “My input to the CSP includes determining how we will render the construction zone negative and what impact the construction segregation barriers have on qualified environmental conditions.”
  • QC/Microbiology – “My input to the CSP includes a plan for monitoring the perimeter of the construction area for particulates and for microbial contamination.”
  • Quality / Validation representative – “I have overall approval of the CSP and ultimate responsibility for its successful execution.”
  • Contractor – “I have to build the construction segregation barriers to precise specifications, maintain the barriers for the duration of the project, and provide housekeeping in the transition areas.”