Peracto Validation Solutions

Cleaning Validation
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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'

Let Us Help You

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