Texwipe Absorbond® Polyester Nonwoven TX716 Large Cleaning Validation Swab is a high-performance cleaning swab designed for use in pharmaceutical and cleanroom environments, particularly for cleaning validation processes. These swabs are essential for verifying the effectiveness of cleaning procedures, particularly in compliance with FDA regulations and industry standards. Here’s a detailed breakdown of the TX716 and related products:
Texwipe TX716 – Absorbond® Polyester Nonwoven Cleaning Validation Swab
Key Features:
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Material Composition:
The TX716 features a nonwoven polyester head that effectively traps contaminants within the swab structure, preventing them from adhering to the swab head. This ensures high recovery rates, making it ideal for sampling contaminants that may be present on cleanroom surfaces or equipment. -
Handle Design:
The swab features a grooved, detachable polypropylene handle, which is 100% rigid, providing durability and excellent chemical resistance. -
Applications:
Specifically designed for HPLC (High-Performance Liquid Chromatography) analysis, this swab is effective in collecting organic residues, contaminants, and particulate matter that could affect pharmaceutical production or research processes. -
Performance:
The TX716 swab provides outstanding recovery of contaminants due to the polyester nonwoven fabric, which captures pollutants within the swab without releasing them back into the sample. This makes it ideal for use in cleanrooms where contamination control is critical. -
Batch Control & Traceability:
Each swab comes with a batch code, ensuring easy traceability and quality control.
Other Texwipe Cleaning Validation Swabs:
- Alpha® Polyester Knitted Series – TX714K and TX761K:
- Suitable for TOC Analysis (Total Organic Carbon):
These swabs are ideal for TOC analysis, which is essential for measuring organic residue levels on surfaces after cleaning. The swabs are certified to have low TOC levels (<50 μg/L, <50 ppb), ensuring that the swab itself does not contribute to the organic carbon levels in the samples, providing consistent and reliable results.
- Suitable for TOC Analysis (Total Organic Carbon):
- Alpha® Polyester Knitted Series – TX715:
- Suitable for HPLC Analysis with UV Detection:
The TX715 features additional UV treatment to reduce background interference, particularly in the 230 nm wavelength range. This unique cleaning process minimizes UV background interference, improving the sensitivity of HPLC analysis and enabling more accurate detection of contaminants.
- Suitable for HPLC Analysis with UV Detection:
Benefits of Texwipe Cleaning Validation Swabs:
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No Adhesives Used:
Precision-manufactured without the use of adhesives, ensuring that no residue is left behind on the surface being sampled. This is critical for achieving accurate and reliable results during the cleaning validation process. -
Chemical Resistance:
Made from materials that offer excellent chemical resistance, ensuring that they can withstand exposure to cleaning solvents and reagents commonly used in the pharmaceutical industry. -
High Recovery Rates:
The nonwoven polyester head used in TX716 has superior performance in capturing contaminants while ensuring that they can be efficiently recovered in solvents for analysis. -
Certifications:
Texwipe’s cleaning validation swabs, such as the TX714K, TX715, and TX716, are manufactured to meet strict industry standards, providing high consistency and traceability for regulatory compliance. -
Tailored to Specific Analysis Needs:
Each product in the Texwipe cleaning validation swab range is designed for specific analytical techniques such as HPLC, UV-vis, and TOC, ensuring that the swab is optimized for the intended application.
Applications in Pharma Industry:
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HPLC/UV-Vis Total Organic Carbon (TOC) Analysis:
Extensively used for cleaning validation in pharmaceutical manufacturing and research. The swabs collect contaminants, which are then analyzed to ensure that cleaning procedures are effective and that no residual product remains on equipment surfaces. -
Cleaning Equipment Surfaces:
used to verify that pharmaceutical manufacturing equipment, including mixing tanks, filling lines, and contact surfaces, are free of residues that could lead to cross-contamination in subsequent production runs. -
Microbial Testing:
In addition to chemical contaminants, for microbial testing to verify the absence of bacteria, fungi, or other microorganisms in critical areas of production.
Texwipe’s Absorbond® TX716 and related cleaning validation swabs are ideal tools for the pharmaceutical industry’s cleaning validation needs. By offering high recovery rates, chemical resistance, and traceability, these swabs help ensure that cleaning procedures meet FDA guidelines and are effective in preventing contamination during manufacturing processes. With precision-engineered designs and a range of swabs tailored for specific analytical methods (such as HPLC, UV, and TOC), Texwipe provides reliable, consistent products for maintaining the integrity of pharmaceutical production environments.
