Lab-service - Micronisation, Grinding, Sieving, PSD analysis
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Facilites and Utilities


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- Eight totally independent production rooms dedicated to API.

Each production room is equipped with a personnel airlock, raw materials input airlock, finished product airlock and a cleaning room.
- A room dedicated to the micronisation of steroids
- A separate building dedicated to the micronisation of ß-lactamines, with 2 production rooms
- Dedicated rooms and approved equipment

- Three independent flows: raw materials - finished products - personnel
- A VMP defines qualifications and validation on the site
- Different equipment with specific size and shape adapted to nature and volume of each batch
- Each production room has its own approved HVAC and compressed air system
- Regular microbiological monitoring is carried out on the equipment, production room, compressed air
systems and demineralised water, in compliance with European Pharmacopeia standards
- A regular particle count is carried out on the compressed air system and the HVAC
-Training and Qualification of each new employee

Qualified Equipment


micronisationAll our equipment has been approved in accordance with GMP guidelines (production equipment, laboratory equipment, etc).
Qualification requirements are implemented and checked regularly both internally and by outside companies.
Qualification reports are established for each piece of equipment.
The different qualifications and validations to be implemented at our plant are defined annually in the VMP (Validation Master Plan), which is supervised by our Quality Assurance department.

Cleaning Validation


broyageAfter each production run, the equipment is dismantled and the room and equipment are thoroughly cleaned.
These operations ensure the total elimination of the product and avoid risks of cross contamination.
The phases of dismantling and cleaning are detailed in internal procedures.
In order to check the compliance of the cleaning operation, a worst-case cleaning validation procedure has been set up at our site.
Authorized production operators are in charge of carrying out cleaning operations.
The Laboratory is in charge of validating worst-case cleaning operations.
The Quality Assurance department ensures the follow-up of the validation results.

Practical Information
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