Results of the Survey "Implementation of the new Annex 1 requirements for Capping"

The requirements of the EU-GMP Guidance Annex 1 "Manufacture of Sterile Medicinal Products", published in 2008, came into force in 2010. In terms of Vial Capping (Chapter "Finishing of sterile products"), there was a need for interpretation. The PIC/S provided the first interpretations with their document PI 032-2 entitled "GMP Annex 1 Revision 2008, Interpretation of most important changes for the manufacture of sterile medicinal products" - see our GMP News from 13. January 2010.

However, other interpretations are possible. A survey about industrial practice for the implementation of those requirements was launched during autumn 2010. Around 230 persons participated. 

How do you perform capping?

  • 44 % undertake capping as an aseptic process with sterilized caps inside the aseptic core. 
  • 56 % undertake it as a "clean process" outside the aseptic core.

What is your clean room background for your capping station?

  • 17% said Grade B
  • 39 % - Grade C
  • 37 % - Grade D
  • 7 % answered "miscellaneous" (Grade E/F or another one).

How do you implement "restricted access" to your the capping process?

  • 23% answered a RABS (Restricted Access Barrier Systems - with gloves)
  • 7% said an isolator.
  • 54% have a safety cabinet.
  • 16% answered "miscellaneous".

The complete results of this survey will be presented at the Pharma Congress 2011 which will take place on the 22/23 March 2011 in Düsseldorf.

Author:
Dr. Andreas Mangel
CONCEPT HEIDELBERG (a  service provider entrusted by the ECA Foundation)

Literature:
EU-GMP Guidelines Annex 1
PIC/S PI 032-2

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