Cleaning Validation Services

The cleaning process and methods used for testing cleaning effectiveness must be validated. The validation must show s that the cleaning process is effective in reducing contaminants to safe levels and the cycles are reproducible. MQA provides services to achieve compliance with FDA or European cleaning validation requirements. Our services include sampling personnel, sampling materials, and testing services.


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CLEANING VALIDATION SERVICES

Assay Description
Service Code
Sample volume

USP Water Bioburden - membrane filtration method

mHPC medium

WT01
> 200 mL

Standard Method Water Bioburden membrane filtration method

R2A medium

WT02
> 200 mL

Endotoxin test - LAL KQCL method

ET11
> 10mL

Endotoxin test - LAL gel clot

ET01
> 10mL

Endotoxin test - LAL Kinetic Turbidimetric method

ET06
> 10mL

USP TOC analysis

WT10
> 40mL

USP conductivity analysis

WT11
>100mL

Cleaning validation method validation

CV01
NA

Protocol generation

EM04
NA

Validation project management

EM06
NA

Sampling labor (does not include materials or equipment

EM05
NA

Data analysis and trend reports

EM07
NA

Materials - see materials section

NA
NA


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