aseptic processing areas facility classification qualification and routine monitoring n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring PowerPoint Presentation
Download Presentation
Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring

Loading in 2 Seconds...

play fullscreen
1 / 6

Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring - PowerPoint PPT Presentation


  • 105 Views
  • Uploaded on

Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring. West Coast Chapter PDA November 30,2006 Kirsten Vadheim, PhD, RAC klvadheim@hotmail.com 651.260.6560. Initial Qualification. As-built, static assessment Define HVAC systems’ capability

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring' - gypsy


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
aseptic processing areas facility classification qualification and routine monitoring

Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring

West Coast Chapter PDA

November 30,2006

Kirsten Vadheim, PhD, RAC

klvadheim@hotmail.com 651.260.6560

initial qualification
Initial Qualification
  • As-built, static assessment
    • Define HVAC systems’ capability
    • Many sampling points
    • No production activity, limited personnel in place
  • Dynamic assessment
    • Essential for room classification
    • Establishes baseline for production activities

KLVadheim 651.260.6560

dynamic monitoring
Dynamic Monitoring
  • All systems in place
    • Personnel
      • Normal number of personnel
      • Performing normal production activities
    • Equipment in place and operational
    • Operations ongoing
  • For initial definition of classification
  • For continuing assessment under normal operating conditions

KLVadheim 651.260.6560

active v passive monitoring
Active v. Passive Monitoring
  • Active monitoring
    • Air - Centrifugal air samplers, e.g.
    • Surface – contact plates, e.g.
  • Passive monitoring
    • Settling plates –
      • Positioning, timing critical

KLVadheim 651.260.6560

alert and action limits
Alert and Action limits
  • Established at initial classification
  • Data continually trended
  • Limits adjusted as necessary
  • “In the absence of any adverse trend, a single result above an action level should trigger an evaluation and a determination about whether remedial measure may be appropriate.”

-X.A.1, p. 33, Sterile Drug Products Produced by Aseptic Processing – cGMP. CBER, CDER, ORA Sept. 2004

KLVadheim 651.260.6560

dynamic monitoring1
Dynamic Monitoring
  • Critical for clean rooms as well as supporting areas
  • Classes 100, 10,000 and 100,000 (ISO 5, 7, 8)

KLVadheim 651.260.6560