Workshops for Biodecontamination Process Development and Validation

A sterile and reproducible aseptic filling process inside isolators must be developed and validated.

Valicare experts offers workshops to lead you through this process step by step

A biodecontamination process development and validation has to be planned thoroughly to meet regulatory and customer specific requirements for the aseptic production process.

To meet these requirements we offer workshops with customers responsible parties (e.g. process owners, qualification personnel, QA). Basis for the workshop is the draft version of a biodecontamination process development plan.

In the workshop following subjects are explained and clarified:

• prerequisites for the biodecontamination process development
• necessary materials and equipment
• specific details of test procedures
• sequence of process development tests to determine possible worst case positions within the isolator (fill and compounding isolators)
• verification of the developed process parameters
• verification of the aeration time
• prerequisites, test procedures and documentation for process validation
• contents and details of test documentation.

The workshops can either take place at the customers sites at the Valicare sites in Crailsheim or Frankfurt or as online conferences.