Aseptic Processing Areas: Facility Classification, Qualification and Routine Monitoring

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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