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Workshops for
Workshops for Biodecontamination Process

Developing and validating an aseptic filling process in isolators

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 must be planned thoroughly to meet regulatory and customer-specific requirements for the aseptic production process.

To meet these requirements, Valicare isolator experts offer workshops with your responsible parties (e.g. process owners, qualification personnel, QA). The workshop is based on the draft version of a biodecontamination process development plan.

The following subjects are explained and clarified in the workshop:

  • 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 (filling 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 your sites, the Valicare sites in Crailsheim or Frankfurt, or as virtual conferences.

Free first consultation now!

Free first consultation now!

 

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.