Professional Documents
Culture Documents
Eun-Sook Gi
April 12, 2004
㈜ 삼양제넥스 생명공학
연구소
Regulatory and Requirements
FDA, July 1993
Guide to inspection for validation of cleaning
process
Application
regulation and requirements:
21CFR 211.65, 21CFR 211.67
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상부 P01
Product/Cleaning Agent
Relationship
Molecular structure (Bio product or small
molecule)
Prod related compound
Solubility: in water or in org. solvent?
Reactivity
Contaminant: Fluid or Solid?
Cleaning agent selection
Coupon Study
Coupon: Equipment Same surface type SUS or
Glass (5 x 5 cm, 10 x10 cm)
Swab: polyester
Characterization of residue
Worst case of cleaning condition
Selection of cleaner visually clean
Cleaning condition Set : temp. range, cleaning
agent conc., pressure(agitation, shaking), rinse
volume visual inspection
Swab Test / Swab Recovery
Swab method: sample, control and blank test
P 01
Equipment System Design
Consideration of CIP system for effective
cleaning
Piping size And structure (slope)
Potential dead leg
Turbulence of CIP solution
Nozzle design: locate seal near vessel wall
Branch piping
Instrument Tees
Instrument Tee for CIP: L/D <1.5
L D
Vertical up
Bad design
Vertical down