ISPE

1
ISPE

• SIG HVAC

2
SIG HVAC

• Active since 2001
• Group meets two to three times a year
• on average 5 companies attending the meetings
• meetings last typically from 10.00 to 13.00 hours

3
SIG HVAC

• Fixed dates for meetings in 2004
• March / September / November
• Easier to plan and to attend

4
SIG HVAC

• Recent subjects covered
• Modular programming of PLCs (October 2003)
• ISO standard 14644 (November 2003)
• Energy management in cleanroom environments
  (March 2004)
• Planned
• Visit of technical installations GSK (September
  2004)

5
SIG HVAC

• Planned subjects
• Risk analyses on HVAC installations
• Issues with respect to ER/ES
• Disinfection of cleanrooms, e.g. H2O2
• testing methods on fume hoods EN-14175-2 versus
  ASHRAE norm 110

6
SIG HVAC

• Planned sub-subjects
• compromises between GxPs and safety
• HEPA filtration benchmarking of suppliers
• Maintenance strategies with respect to HVAC
  installations
• Positive pressure control in cleanrooms

7
SIG HVAC - comments

• guest speakers - working well
• presence of consultants / engineering companies -
  positive

8
SIG HVAC - conclusions

• objectives set at the beginning of the SIG group
  are being met
• platform for exchange between pharmaceutical
  companies
• enhances networking
• present meeting frequency is doable
• enough subjects for future meetings