Validations

validations_comecer
Nous contacter pour plus d'informations

Avertissement ! Le contenu de cette page est disponible uniquement dans les langues suivantes: Anglais - Russe

Validations are a “GMP” requirement of good manufacturing practice that each manufacturer identifies what validation work is necessary to prove control of the critical aspects of their particular operation.

Comecer supplies FAT (Factory Acceptance Test) protocol validation for every Hot Cell/Dispensing system/Isolator.
Comecer performs SAT (Site Acceptance Test) and supply if request IQ & OQ protocols (Installation Qualification & Operational Qualification)

The validation protocols comply to the following standards:

  • ISO 14644 (Cleanrooms and associated controlled Environments)
  • ISO 10648 (Containment enclosures)
  • EEC-GMP (Good Manufacturing Practice – Annex 1 Manufacture of sterile Medicinal Products)
  • PDA – TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products)

Sign up for your Comecer Account

If you already have a Comecer Account, log in for faster access. Members get access to our on demand and live webinars, guides, product data sheets, catalogues, exclusive videos, and more.
 
 
 
 
 
 
I have read and understood the information sheet pursuant to Art. 13 GDPR.
I express my consent also for the processing of my personal data for profiling purposes and for the analysis of the preferences, interests and habits, as indicated in the section “Data processed and Purposes of processing” of the Privacy Policy published on the website.
 
 
I express my consent to process my personal data for marketing purposes and the sending of promotional and informative material, including newsletters and commercial communications concerning Comecer products/services, as indicated in the section “Data processed and Purposes of processing” of the Privacy Policy published on the website.
 
 
 
Cancel

Technical

Chiudi

Cancel

Statistical

Chiudi

Cancel

Targeting

Chiudi