We are engaged throughout the life cycle of a drug or health product to ensure that chemical and microbiological contamination is managed at all stages of the manufacturing chain.
From the manufacture of experimental medicinal products, through toxicological studies performed on animals and pharmacological studies performed on patients, to the manufacturing processes of finished products, our work is to help you manage your operational activities.
We will be working closely with you in the field to provide you with practical expertise and knowledge of the current regulations in force.
We can provide tailor-made in-house training courses, inter-company training with our partners, accredited training organisations, audits and technical assistance.
Our know-how relates to the following areas:
As a chemical engineer, I have been working for more than ten years in close collaboration with the healthcare industries. My career path is specialised in industrial hygiene and follows the life cycle of a drug from its creation to its application. I have worked with research and development teams in hospitals, animal husbandry and the pharmaceutical industry; production sites for hygiene products, medicines and cosmetics; as well as medical centres.
This is more than a job, it’s my passion. So in 2013 I created Theraxel, a company wholly dedicated to hygiene in these areas of activity.
At the beginning, Theraxel mainly worked in the veterinary field, to support producers of biocide products when designing ranges adapted to areas subject to little control: laboratory animal houses and zoos. Theraxel has also supported many users of these ranges through audits, training and technical assistance.
Over the years, the activity has gradually extended to other adjacent sectors and has expanded to include contamination management in the broadest sense, particularly in the pharmaceutical industry.
In terms of regulations and associated quality requirements, I have worked on a daily basis with GLP, COFRAC and AAALAC certified establishments.
During my experience working with pharmaceutical establishments, I have acquired a solid knowledge of European GMPs, known as Good Manufacturing Practices. In 2017, I strengthened my knowledge of this standard by working alongside Pierre Devaux, via UPS Consultants, on technical assistance projects for production equipment cleaning validation pursuant to Annex 15 “Qualification and Validation” of this standard.
With both of us being experts in contamination management in different sectors and also in many similar sectors, we wanted to combine our skills to meet your needs in contamination management: a pharmacist microbiologist and a chemical engineer.
We have a shared vision with different and coherent approaches.
Our association works for you and has only one goal: to manufacture health care products that meet their chemical and microbiological specifications in order to market quality products that ensure the comfort, well-being and quality of life of users and patients, all of us!
Elodie PASTRE
As a tribute to Gerard Terrom (THER) and my son, Axel
I have a PhD in Pharmacy with a thesis in microbiology, a Master’s II in Quality Management and a Master’s degree from the IPIL-Institut de Pharmacie Industrielle de Lyon. This education has allowed me to gain a lot of knowledge about the pharmaceutical industry, namely by working on two production sites in the Lyon region: the FAMAR site in Saint Genis Laval and the Sanofi Pasteur site in Marcy l’Etoile.
In October 2007, I was recruited by Thierry Depauw at the Excelvision-Fareva site in Annonay, a site manufacturing sterile liquids mainly for ophthalmic use. My first job was to optimise the batch records for three conventional aseptic filling lines after receiving a comment from the ANSM, AFFSAPS at the time. Since I didn’t know anything about pharmaceutical production, I spent six months fully immersed with the site’s different operational business areas in order to be able to work on redesigning the batch record so that it would be practical for those involved in the “field” and meet the requirements of Good Manufacturing Practices.
As this first job went well, I was able to apply for the position of head of the microbiology laboratory. I was lucky that the site managers trusted me. This position was been a stepping stone for my career, it had two sides to it: the control laboratory side and the management of the production environments side, i.e. the ZACs (accreditation for design, environmental monitoring, MFT, investigation for microbiological contamination problems).
Alongside my activities on the site, I followed a training programme to become an auditor for the Fareva holding company. This enabled me to perform audits of the holding company’s suppliers and service providers.
In September 2011, Thierry and his team once again placed their trust in me by making me responsible for the chemistry laboratory in addition to my microbiology activities. And so for 3 years, I managed a team of about 45 people.
We were inspected by the ANSM and the FDA and also by our many customers on a very regular basis.
In 2013, I was offered a new challenge: to join Eric and Martine Petat’s Teranga group and become Pharmacist Quality Manager of ACM Pharma and, at the same time, to take over the activities of Laban Consultant on behalf of the group’s consulting company, UPS Consultants. We were inspected for the first time by the FDA at the ACM Pharma laboratory in 2014 and, as part of my duties in the laboratory, I had to manage contamination issues, including a major public health problem. I shouldered my responsibilities as Head Pharmacist, but as the months went by, it became difficult to manage both roles.
Naturally, I devoted myself to consulting. And, for this role, Frédéric Laban imparted his teaching and know-how to me. Fred passed on his knowledge and know-how to me and introduced me to many manufacturers. He likes to call me his “padawan”. From the middle of 2014, the pace for my work over the weeks was set by site visits for training, audits, consulting projects, in a wide range of business sectors: sterile and non-sterile pharmaceutical industry, cosmetics industry, manufacturer of pharmaceutical and cosmetic raw materials, manufacturer of culture media, glass ampoules, advanced therapy drugs, biotechnology sites, veterinary industry, manufacturer of ZAC consumables, primary packaging items for injectable products… In short, I acquired solid foundations in the operational activities and management of contamination in close contact with many manufacturers in very different sectors, which has provided me with a broad outlook on the issues of interest to manufacturers.
In 2015, the A3P association, through A3P Services, offered me the job of doing their inter-company training. This was an enriching experience on both a human and professional level. In 2016, the association offered me responsibility of the working group (GIC) dedicated to Annex 15 and the validation of cleaning. We published a practical guide on the subject in the spring of 2018.
As a speaker for the A3P Association, for the ISPE and for the Biomérieux group’s “Symposium” events, and having also worked on projects with sites in many foreign countries (Algeria, Morocco, Tunisia, Denmark, Belgium, Switzerland, Germany, USA, Israel, Russia, Slovenia, Spain, Canada), I was keen to pass on my knowledge.
In 2017, I contacted Elodie Pastre again, Elodie with whom I had worked at Excelvision through her position as a service provider. We had had the opportunity to work together on a case and I had been impressed by her knowledge of the risks of contamination and by her ability to support us in the “field”. As I knew that she had created her own structure, I was interested. I suggested to Elodie that she work with UPS Consultants on consulting projects, particularly relating to bio-cleaning and cleaning validation. Our complementarity, with her being a chemist and myself a microbiologist, was a plus for the clients. So over the months, we thought about the idea of joining forces within our own structure. This idea is now a reality, with the purchase of Frédéric Laban’s company Point Forty Five and my entry as co-manager of Theraxel. We are therefore in keeping with our roles and consistent with our ideas and pathways.
Pierre DEVAUX
