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Aravindsai (www.pharmacygraduates.org
Cleaning Validation
Protocol
For formulation and filling
Supervised and controlled by QA
2010
WRITTEN: REVIEWED:
Signature:
Position: Validation manager Laboratory Manager Microbiology Manager
Date: 22/05/2010 23/05/2010 24/05/2010
APPROVED
Signature:
Position: QA Manager Engineering Manager Production Manager
Date: 24/05/2010 24/05/2010 24/05/2010
Table of Contents
1. OBJECTIVE
2. SCOPE
4. REFERENCED DOCUMENTS
6.1 Evaluation of the Product Mix to select the worst-case product or marker product
6.2 Operator training
6.3 Cleaning limits selection criteria based on MAC approach
7. VALIDATION PLAN
8. SAMPLING LOCATIONS
The objective of this protocol is to define approach to the validation of cleaning procedures for
formulation and filling
2. SCOPE
This document covers the protocols of cleaning validation for formulation and filling equpments
Preparing Performin
validation g cleaning
report
4. REFERENCED DOCUMENTS
5.1 Equipment’s
Mixing vessels
Transfer pipes
Vial Filling and closing machine
6.1 Evaluation of the Product Mix to select the worst-case product or marker product
Batch
Product Strength Solubility Toxicity Decision**
Size
Maximum allowed concentration from previous batch x minimum batch size of next product
7. VALIDATION PLAN
Products having high toxicity and low solubility should be considered as marker because if they
can be cleaned without any toxic residue all the others can be cleaned
Medium toxicity and Low solubility =FCP 250mg C&C Oily Liquid
For detecting the chemical residues HPLC is used and for detecting microbial contamination
Analyte Method
Protein HPLC
Method for detecting Cell culture and count Selective growth on Immunological
plaque forming units agar and count colony staining and count
forming units fluorescent cysts
Sugar spheres 100 Should not be Should not be Should Should not
present present not be be present
present
Swab
Swab Location (100 square cm area)
Number
S1 Under mixing tank lid
S2 Right side wall surface
S3 Under the mixing blade
S4 Valves
S5 Pipes
Flush
1000 mL of final flush purified water
Number
F1 Drain line from Bulk Tank
Swab in the mixing vessel with one side in horizontal direction and other side in the
vertical direction, back and forth to cover the entire area (in the locations mentioned
above)