Process skids
In order to meet your production constraints, SOFAST offers custom-made solutions capable of integrating all of its manufacturing experience and know-how for the preparation of pharmaceutical products.
Sterile and contained process skids
These complete packages are entirely custom-made according to the needs of the process.
- From Sterile Bioprocessing Skids to filling machine/ freeze-dryer/
- From Sterile Bioprocessing Skids to freeze dryer
- From Contained Bioprocessing Skids under glove box
- Packages manufactured and tested in our workshops
- FAT/SAT protocols
- IQ/OQ qualifications performed on site as per protocol validated by the final Customer
One process, one solution
Complete modules integrating:
- Process equipment
- Storage tanks and sharing of bulk raw materials
- Preparation tanks
- Storage tanks and sharing of finished products until distribution
- Glove boxes (for contained bioprocessing skids)
- Tank for the temperature maintenance of raw materials
- Distribution lines to
- Filling machine
- Small tank
- Freeze dryer
- Process piping
- Support and access platforms
Are also integrated:
- Fluid distribution loops
- WFI
- sterile air
- nitrogen
- pure steam
- Bridging table
- CIP
- Sterilizing filtration online with CIP/SIP
- Programming of the line according to the functional analysis
- Supervision device compliant with the recommendations of the 21 CFR part 11 standard integrating a traceability software allowing:
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- Configuration of the application
- Management of recipes
- Archiving of manufacturing and CIP/SIP cycles
- Editing reports and curves
Example of Bioprocessing Skid
Preparation line, storage, transfer to filling machine of a solute at a temperature of 5°C maintained by the circulation of ice water.
Equipped with a CIP and SIP device for the 3 tanks with computer traceability and monitoring on animated synoptic.
