Effective Cleaning is key to Product Quality Assurance
Cleaning procedures, whether automated or manual need validating.
Cleaning Validation can be defined as,
'A
Method of confirming the reproducibility and efficiency of a cleaning procedure in reducing the potential for cross contamination
by a wide range of factors'
We have a wide range of expertise in the following
areas:
Cleaning Method Qualification
Operator Sampling Qualification
Establishment of Acceptance
Limits
Clean In Place (CIP) Design
Sprayball Coverage
Direct and Indirect Surface Sampling
Preparation of Cleaning Validation Protocols & Reports
Consideration of 'Dirty' & 'Clean' Hold Times
Ongoing Monitoring, Change Control & Revalidation
Wider Reading
Guide to Inspections of Validation of Cleaning Processes, FDA, July 1993
Monograph No. 10, Cleaning Validation, Pharmaceutical Quality Group, 1999
Points to Consider for Cleaning Validation, Technical Report No. 29, PDA, August, 1998
Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations, Pharmaceutical
Technology International, June 1993
