Chief pharmacist and Deputy Director at the Army Blood Transfusion Center (Centre Transfusion Sanguine des Armées CTSA), Anne-Christine MENDES has agreed to answer our questions regarding the choice of our inspection table for her lyophilized plasma production line.
Chief pharmacist and Deputy Director
INTERVIEW done on March 30, 2021
/ Who are you ? Tell us a bit about your company.
I am the Chief Pharmacist, Anne Christine, Deputy Director at the Armed Forces Blood Transfusion Center (CTSA).
The CTSA is an establishment of around one hundred people located in Clamart (92) near the Percy hospital, in France.
The main mission of the CTSA is the transfusion support in labile blood products of soldiers in external operations and the transfusion support of the various Army training hospitals located in the Paris region and in the PACA region (South of France). The CTSA has all the technical platforms of the transfusion chain, from collection to distribution-delivery, including preparation, hemovigilance, biological qualification of blood products.
It also has a cell and tissue therapy unit and an advanced therapy drug manufacturing unit. Lyophilized plasma (PLYO) is one of the flagship productions of the CTSA.
/ How did you hear about STERIGENE ?
It’s a long story ! I first got to know its founder Dominique Weill, during a conference on sterilization at the University of Paris V during my internship in industrial pharmacy. His presentation was so clear and so passionate that it left an impression on me. What was innovative I think was that he comprehensively explained both the sterilization equipment and its principles : everything was crystal clear. I then worked with the STERIGENE company within the Roche laboratories, at the Central Pharmacy of the Armed Forces and then at the CTSA during various projects: a manufacturing line for injectables, retrofit of an oven, modernization of areas with controlled atmosphere and decontamination of clean rooms.
/ What was your need in terms of inspection ?
Our lyophilized plasma production line had an inspection table designed by the CTSA but which did not exactly meet the requirements of the European pharmacopoeia. It was more about classical visual inspection than visual inspection in the European Pharmacopoeia (EP) sense. Our batch size being small, I was looking for a manual inspection table, compliant with regulatory requirements, compatible in terms of space requirements with our premises and adapted 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 shown at the STERIGENE stand. After a convincing presentation made by Dominique LAGARTO, Head of the furniture unit of STERIGENE, I thought that it was the equipment perfectly suited to our needs: ergonomic, simple, compliant with the European Pharmacopeia and aesthetic which is also an asset. I looked at the documentation provided and put together a file with a sales pitch in order to obtain this equipment. The funding for this project was made possible thanks to a sponsorship from the association “les gueules cassées”. The latter has been won over both by the PLYO that we produce, by the inspection table which reinforces the quality of this labile blood product and by the history of the STERIGENE company. The table was quickly acquired and put into service.
/ How did STERIGENE meet your expectations and what are the main product advantages for you ?
The answer to my expectations can be summed up in two words: relevance and responsiveness. STERIGENE first answered my questions in 2017: Dominique LAGARTO knew his product well, but also its limits, the professional discourse was therefore true and powerful. Then the various requests were met very quickly.
The advantages of this product are : its ease of use, its ergonomics, its cleanability, its adaptability. The operators in charge of inspection also appreciated its use. We have also set up a physical and photo defect library. During our inspection by the health authorities in 2019, the inspectors were interested in both the inspection table and the defect check and everything went well !
/ Do you know about other STERIGENE products and services ?
We know the decontamination products and consumables which we already use, as well as the furniture for controlled atmosphere areas. We also called on STERIGENE following calls for tenders, for the retrofit of our depyrogenation furnace and the retrofit of our sterilization machine.
We are grateful to Anne-Christine for this exchange and for the trust placed in STERIGENE.