Theraxel-Point Forty Five
Chemical and Microbiological Contamination Control in the Life Science industry
Theraxel-Point Forty Five is a meeting between two professionals: a chemical engineer and a microbiological pharmacist .
We work on the entire life cycle of a drug or a health care product to secure the chemical and microbiological contamination control at all stages of the production chain.
From the manufacture of experimental drugs, from toxicological studies conducted on animals and pharmacological studies carried out on patients, to finished product manufacturing processes, our mission is to help you master your operational activities.
We bring you practical expertise related to the regulations in force, as close as possible to the field.
We offer customized training on-site, public courses in cooperation with our accredited training organizations partners, audits and technical assistance.
Our know-how covers the following topics :
- Biocleaning: zones with controlled atmosphere, cleanrooms, operating theatres, animals facilities …
- Validation of production equipment cleaning
- Risk analyzes to control cross-contamination
- Risk analyzes to control viable and non-viable particulate contamination
- Good Aseptic Practices
- Regulations: European GMP Annex 1 and Annex 15
- Investigations in the form of a tailor-made audit to diagnose the origin of contaminations in your production batches
- Qualification and validation of equipment: scrubbers, autoclaves, airborne disinfection…
- Develop and / or improve quality documents
- Writing protocols and procedures in accordance with the quality standards
