Latest Guidance Note of PHSS for GMP

The latest Guidance Note of PHSS for GMP refers to the appropriate use of protective covers in the aseptic processing. Key details related to Tyvek® include:

  • Removal of Tyvek® covers inside the Isolator and before VHP/vH2O2 cycle
  • Covering equipment and parts which constitute container closure contact surfaces properly for moist heat sterilization
  • Additional gowning: mask and eye covering (or full face covering) and sterile Tyvek® long sleeves to slip-on over grade C gowning to reduce risk of bioburden contamination

To learn more, review the full Guidance Note of PHSS for GMP.