environmental qualification of new production areas on a former site

Ensuring the environmental qualification of new production areas on a former site

Use cases Pharma & Biotech Qualification / Validation

Key challenges of our client

Our client is a Belgian supplier of buffer solutions for biosciences. They have old and new production areas. The old production areas were experiencing difficulties in managing their environment.

They therefore wanted to:

  • control and ensure the compliance of the environments in order to qualify the zones previously faulty during the initial qualifications;
  • follow a zone construction process: from the production of the plans to the commissioning of the zone

Our approach consisted in:

  1. the drafting of a qualification protocol for a new zone and for an old zone
  2. the drafting of a procedure based on the good practices of environmental sampling

How we proceeded on the former site

  • Gemba in the production area and brainstorming with the production teams
  • Mapping to trace the path of contamination in the area and implementing new procedures
  • Weekly monitoring and communication to the teams on environmental trends
  • Launching qualifications after the realization of good trends.

Our approach on the new site

  • Drafting of the risk analysis of the area
  • Organization of the cleaning and disinfection of the area
  • Environmental qualification at rest and in operation
  • Processing of results and writing of reports

Results at the client

The client moves from intensive monitoring of unclassified areas to routine monitoring which halves the frequency of environmental monitoring.
As a result, there are fewer environmental samples to be taken per month, less analysis and therefore less cost.

Therefore, the customer can use the new production areas once the initial qualification of a new area is validated.

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