THERAXEL carries out tailor-made risk analyses for you using the tools described in ICHQ9 or related models.
In order to perform these risk analyses, depending on the context, we use, among others, the following regulatory texts:
THERAXEL is here to provide you with the necessary support for all risk analyses, i.e. including defining continuous improvement actions and assisting in their implementation.
THERAXEL has a proven track record in the cleaning and disinfection sector and wishes to continue to offer its customers the benefit of its experience gained in this field in a number of industrial and service sectors.
THERAXEL is here to support you for the overall management of all the cleaning and disinfection processes of your premises (Bio-cleaning processes) and of your equipment (process qualification and cleaning validation).
To carry out these advisory projects, audits and technical assistance, we rely on our historical know-how (expertise in the products used, consumables and associated processes) and on the skills of our team of confirmed experts.
THERAXEL carries out operational projects for you relating to the implementation and monitoring of environmental controls in your Controlled Atmosphere Zones and is responsible for any investigations in the event of chemical and microbiological contamination for the processes in place.
In order to perform these mission, we use the following regulatory texts :
THERAXEL makes its entire team of experts available to you to find a solution to the contamination of your batches as quickly as possible and allow you to decide what to do with the products affected.
THERAXEL assists you in the development of new premises, in the implementation of manufacturing processes and participates in the Quality management throughout the creation of new production premises or Revamping actions.
To carry out these technical assistance projects, we rely on the skills of our team of experts who are confirmed experts in their respective fields of activity (process control, Quality Control laboratory activities, Biotechnologies, laboratory animal houses, contamination control, etc.) and on our reference partners.
THERAXEL is committed to working alongside you in the field to make your new industrial projects an operational and quality success within the deadlines set.
THERAXEL assists you in controlling the contamination of your cleanrooms via a qualification programme implemented in accordance with current standards and by drafting IQ, OQ and PQ protocols/reports.
For checking controlled atmosphere areas, we use the current standards in force: ISO 14 644-1 (particle counting) and 14644-3 (physical measurements, Emery test, air flow study…) ISO 14 698-1 and 2 (microbiology of air and surfaces), GMP (pharmaceutical sector), NFS 90-351 (hospital sector) or a protocol subject to a client-supplier agreement.