Swab limit for cleaning validation
473Q. How do you calculate the swab limit for cleaning validation, once it has been extracted in solution? A. Swab limits are an expression of an acceptance criteria converted to an amount of ...
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huachenyang offers the following cleaning validation swabs:
iclean®Polyester Knit Series -CY-714K, CY-761K – suitable for use in TOC analysis
iclean®Polyester Knit Series – CY-715 – suitable for HPLC analysis using a UV detector analytical method
ICLEAN® Polyester Non-Woven Large Swab -CY-716 – suitable for HPLC analysis
huachenyang offers the following cleaning validation swabs:
iclean®Polyester Knit Series -CY-714K, CY-761K – suitable for use in TOC analysis
iclean®Polyester Knit Series – CY-715 – suitable for HPLC analysis using a UV detector analytical method
ICLEAN® Polyester Non-Woven Large Swab -CY-716 – suitable for HPLC analysis
cleaning validation cleanroom swabs are used to determine the effectiveness of cleaning protocols as specified by the US FDA. HPLC/ UV-Vis Total Organic Carbon (TOC) analysis are different methods used to validate these cleaning processes.
Benefits
All Cleaning Validation swabs are precision-manufactured and constructed to exacting and consistent tolerances without the use of adhesives for superior performance
Notched, rigid 100% polypropylene, break-away handle allows the head to be placed into the vial with minimal handling and contamination and provides excellent chemical resistance
Lot coded for traceability and quality control
CY-714K, CY-761K: Certified Low TOC level (<50 μg/L, <50 ppb) ensures consistency in swab background contribution
Double layered, double knit polyester head entraps contaminants in the knit structure during sampling, allowing maximum contaminant collection and release into the diluent to provide for excellent recovery rates
CY-715: This swab is additionally processed to reduce the UV background. Proprietary cleaning process reduces interference in the 230 nm range, resulting in an improved limit of detection
Part No. | Head Width | Head Thickness | Head Length | Handle Width | Handle Thickness | Handle Length | Total Swab Length |
---|---|---|---|---|---|---|---|
CY-714K | 12.7mm (0.500″) | 4.2mm (0.165″) | 25.7mm (1.012″) | 5.2mm (0.205″) | 3mm (0.118″) | 101.8mm (4.008″) | 127.5mm (5.020″) |
Part Number: CY-714K
Inner Bags: 20 swabs/bagOuter Bags: 50 bags/casePackaging: 1,000 swabs total/case
MADE IN CHINA
Q. How do you calculate the swab limit for cleaning validation, once it has been extracted in solution? A. Swab limits are an expression of an acceptance criteria converted to an amount of ...
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