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PHSS Clarity of GMP Guidance - Assurance of Sterility Dec 2018

16 December 2018  
Posted by: Tamsin Marshall
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PHSS Clarity of GMP - Guidance Note 1

 

PHSS are pleased to announce the newly available PHSS Clarity on GMP Guidance note on Assurance of Sterility of in-direct product contact surfaces. This guidance document is now distributed to the MHRA and US FDA.

 

The feedback on this practical guidance that connects VHP science and role in assurance of Sterility for in-direct product contact parts has been very positive from the industry, regulators and collaborative associations.

 

Please note the planned Aseptic processing workshops in the UK April 2019 these will all be good practical and hands-on sessions that apply at all levels. We are building the details of the workshops so more info to follow in the new year.

 

We expect a full house (80) with 40 booked already. These workshops will be an annual event.

 

Ensuring sterility of indirect product contacting surfaces

 

This article is the fist in a series of PHSS guidance notes prepared by industry subject matter experts and sterile product manufacturing specialists to facilitate understanding and interpretation of aspects of GMP guidelines for aseptic manufacturing of sterile medicinal products. The initial focus of this guidance is on the assurance of sterility of surfaces that contact product contacting parts e.g. product container closures/ stoppers, associated vibratory feeder bowls, hoppers and chute/ trackway surfaces.

 

  • Assurance of sterility in Aseptic manufacturing of surfaces that contact product contact parts
  • Localised uni-directional airflow :L-UDAF
  • Barrier Leak rates and leak Integrity
  • Continuous particle monitoring
  • Airflow visualisation
  • Avoiding Wet loads in Moist heat sterilisation
  • Glove management strategy for Barrier system gloves -sleeves
  • VHP/VH202 surface Bio-decontamination of loads
  • Definitions of 'Open and Closed' applied to Aseptic processing

 

 

Please click here for download of guidance. 

 

 


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