Qualification of a new controlled atmosphere area for a pharmaceutical industry customer in Wallonia

During the extension of one of its pharmaceutical production buildings located in Wallonia, the company Delphi Genetics launched a asked for bids for the qualification of a new cleanrooms. Mecotec won this bid and invites you to discover the stages of this project below.

Role of Mecotec during the qualifications of cleanrooms

Opérateurs de l'industrie pharmaceutique travaillant dans une ZAC

Founded in November 2001, Delphi Genetics is a company that develops original genetic solutions and services for businesses. Delphi Genetics in particular has significant expertise in the field of genetic constructs and DNA production for gene therapy.

Mecotec’s mission during a controlled atmosphere clean rooms qualification is to check each of the operating parameters that the customer has specified according to their needs and to compare them with the current standards according to the classification of the room which is also defined by our client.

These missions involve the following tests:

  • Air flow measurements with the anemometer or balometer
  • Filter integrity and HEPA filter leak testing
  • Pressure measurements
  • Smoke study (air flow pattern)
  • Non-viable particulate tests including
    • GMP classification by particle counts
    • Measurement of clean room recovery time
  • Microbiological tests including
    • GMP classification by microbiological air survey
    • GMP classification by microbiological survey of surfaces
  • Pressure cascades and direction of flow testy
  • Pass-box test

The objective of these tests is in fact to demonstrate the installation complies with GMP and the equipment and premise specifications. We also make sure to prove that the entire installation complies with the operational requirements specified by the customer, namely Delphi Genetics.

However, the challenge was huge, because all this had to be done in a very short time frame. To achieve their goals efficiently and precisely, our teams worked in partnership with the internal players in charge of quality to define together the most suitable locations for viable and non-viable particle counts.

Solutions provided by Mecotec teams to complete the objectives

To meet customer requirements, Mecotec teams have made every effort to complete the assignment with precision and speed:

  • Intervention on time so as not to impact production
  • Reactivity during AS found” non-conformities in partnership with the installers for possible filter replacement. Added to this is the investigation of leaks, cleaning of areas and re-testing As Left” in stride
  • Flexibility for schedules so as not to impact the deadline, while working in complete safety following the VCA certification, in particular by carrying out an ARDM (Last minute analysis).

What’s more, all of this was done in compliance with the standards GMP, BPF, ISO 14644-1, ISO 14644-3, EUROVENT 4/8, NORME NF S90-351BPF 2015/12Bis, NORME NF EN 16211.

Results obtained following the intervention of Mecotec for the qualification of the new Clean Rooms qualification

At the end of our tests, we were able to give our client’s quality managers the data and allow them to complete their protocol on time, so that they could then begin their performance test (PQ).

Thanks to a joint effort of our technicians, the installer and the customer, we kept the fixed schedule without deviating and within the initially established budget.

Testimony of Delphi Genetics’ QA Director on Mecotec’s intervention

Below, discover the testimony of Delphi Genetics’ QA Director, Mr Fabrice Sonville, following the intervention of Mecotec experts for the qualification of a new Clean Rooms qualification:

“We knew from the start that the timing constraints and requirements were going to be a big challenge and that enormous flexibility was required from our service provider. We immediately encountered listening to our needs/ constraints and high level of flexibility on the part of Mecotec to support us in meeting this challenge. Their expertise and great autonomy in carrying out qualification activities, in sometimes difficult conditions and with major unforeseen events, nevertheless, enabled us to complete the qualification work on time. All of the work as well as the detailed documentation allowed us to successfully present the file during the FAMHP approval inspection of our extension at the end of January 2020.”

Are you interested in our Cleanrooms qualification services?

Do you need controlled atmosphere area qualification services no matter your industry? Don’t hesitate to contact us via the online form or by phone and we will make sure to give you the same attention as our customer Delphi Genetics.

A team ready to listen

Tailor-made advice

Field experts

Over 20 years of experience

A unique experience

We are committed to offering you secure and customizable browsing. We use cookies for this purpose to provide you with offers tailored to your areas of interest, anonymously collect statistical data and make your visit as pleasant as possible.