Cleaning Validation
Cleaning validation is a documented process that provides evidence that equipment is cleaned consistently and effectively to prevent contamination.
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Product Description
Cleaning validation is a documented process that provides evidence that equipment is cleaned consistently and effectively to prevent contamination.
Technical specifications
| Technique | Features |
|---|---|
| Total Organic Carbon (TOC) Analysis |
|
| High Performance Liquid Chromatography (HPLC) |
|
1. Rinse Sampling - TOC Measuring Method
Water-insoluble residues cannot be sampled, but this method is suitable for evaluating large areas, narrow areas that are out of reach, and thin tubes.
2. Swab Sampling - Extraction - TOC Measuring Method
The object is wiped with a swab material, and the deposit is extracted with water for analysis with a TOC analyzer.
3. Swab Sampling - Direct Combustion Carbon Measuring Method
The residue is wiped and the swab material is inserted directly into the heating section. There is no need for solvent extraction, so the water-insoluble residue can be measured reliably. Although total carbon (TC) is measured by this method, it can be considered equivalent to TOC measurement in the sense that it is judged to be below the acceptable limit.
Procedure for Swab Sampling - Direct Combustion Carbon Measuring Method
Swab Material: "Easy wiper-S"
The "Easy wiper-S" is available for swab sampling. It has the following features.
- Fibrous, soft and easy to wipe
- Efficiently samples hard-to-get swab debris from the wiping surface
- Easy to hold and put in the sample boat