CTSA interview about our inspection table

[Customer testimonial]

Published on 31/03/2021

Interview conducted by Lucile YZERMAN, Marketing & Communications Manager at STERIGENE, on 30 March 2021

Who are you? Tell us a little about your organisation.

I am Anne-Christine, Chief Pharmacist and Deputy Director at the Armed Forces Blood Transfusion Centre (Centre de transfusion sanguine des armées (CTSA)).

The CTSA is an organisation of around one hundred staff, located in Clamart (92), near the Percy Military Hospital.

The CTSA's primary mission is to provide transfusion support with labile blood products for military personnel on overseas operations, as well as transfusion support for the various Military Teaching Hospitals located in the Paris region and the PACA region. The CTSA has all the technical facilities required across the transfusion chain, from donation to distribution and delivery, including preparation, haemovigilance and the biological qualification of blood products.

It also has a cell and tissue therapy unit and an innovative therapy medicinal product manufacturing unit. Lyophilised plasma (PLYO) is one of the CTSA's flagship products.

How did you first come across STERIGENE?

It's a long story! I first met its founder, Dominique Weill, during a presentation on sterilisation at Paris V University, while I was completing my industrial pharmacy internship. His presentation was so clear and passionate that it left a lasting impression on me. What I found innovative, I think, was that he explained the sterilisation equipment and the underlying principles in a comprehensive and holistic way — everything was crystal clear. I subsequently worked alongside STERIGENE at Roche Laboratories, the Central Military Pharmacy and then at the CTSA, on various projects: commissioning an injectable product manufacturing line, retrofitting an oven, upgrading controlled atmosphere zones and bio-decontaminating cleanrooms.

What were your visual inspection requirements?

Our lyophilised plasma production line had an inspection table that had been designed in-house at the CTSA, but which did not fully comply with the requirements of the European Pharmacopoeia. It was more of a visual inspection setup than a proper inspection table in the European Pharmacopoeia (EP) sense. Given our small batch sizes, I was looking for a manual inspection table that was compliant with regulatory requirements, compatible in terms of footprint with our premises, and suited to our batch size (150 units).

Why did you choose the STERIGENE inspection table?

In 2017, at the A3P international congress, the inspection table was on display at the STERIGENE stand. After a convincing presentation by Dominique LAGARTO, Head of the Furniture division at STERIGENE, I felt this was the equipment perfectly suited to our needs: ergonomic, straightforward, EP-compliant and aesthetically pleasing — which is also an advantage. I reviewed the documentation provided and put together a file with a supporting case to obtain the equipment. Funding for this project was made possible through a sponsorship from the association "Les Gueules Cassées". The association was won over both by the PLYO we produce, by the inspection table — which contributes to enhancing the quality of this labile blood product — and by the story of STERIGENE. The table was quickly acquired and commissioned.​ table de mirage​

How did STERIGENE meet your expectations, and what are the main product advantages for you?

My expectations were met in two words: relevance and responsiveness. STERIGENE first addressed my questions back in 2017: Dominique LAGARTO had a thorough knowledge of his product, but also of its limitations — the professional and honest approach made the message both credible and impactful. All subsequent requests were then fulfilled within very short timeframes.

The advantages of this product are: its ease of use, its ergonomics, its cleanability and its adaptability. The operators in charge of visual inspection also appreciated working with it. We also put in place a physical and photographic defect library. During our inspection by the health authorities in 2019, the inspectors took a keen interest in both the inspection table and the defect library — and everything went smoothly!

Are you familiar with STERIGENE's other products and services?

We are familiar with the bio-decontamination consumables and products that we use, as well as the cleanroom furniture for controlled atmosphere zones. We have also called upon STERIGENE, through tender processes, for the retrofit of our depyrogenation oven and the retrofit of our autoclave.​consommables de bionettoyage​/mobilier-salle-propre​ four de dépyrogénation​autoclave​

Many thanks to Anne-Christine for this exchange and for the trust she has placed in STERIGENE.​

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