TOC Cleaning Validation Swab

Huachenyang TOC Cleaning Validation Swab Kit were designed to simplify sampling as part of a

cleaning validation protocol. The swabs and vials are further cleaned using a proprietary process to

make these kits excellent for use in total organic carbon (TOC) analysis. Lot coded for traceability and

quality control.

TOC Cleanliness Verification Swabs are a kind of tool used for detecting Total Organic Carbon (TOC) during the cleanliness verification process. The following is an introduction to them:

Principle

• The detection principle of TOC cleanliness verification swabs is based on the conversion of organic carbon in the sample into carbon dioxide after wiping and sampling with the swabs. Then, through specific detection techniques, such as non-dispersive infrared absorption method and conductivity method, the generated carbon dioxide is quantitatively analyzed to obtain the TOC content in the sample. In this way, it can be evaluated whether the cleaning effect meets the specified standards.

Characteristics

• High Sensitivity: They are capable of detecting extremely low concentrations of organic carbon, accurately detecting tiny contamination residues, ensuring the accuracy and reliability of cleanliness verification, and meeting the high cleaning requirements of industries such as pharmaceuticals and food.
• Good Adsorption Capacity: The swab materials have special surface structures and chemical properties, enabling them to efficiently adsorb organic pollutants on the wiped surfaces, ensuring the representativeness and integrity of sampling and making the detection results more truly reflect the actual cleaning status.
• Low Background Interference: They undergo strict processing during the production process, and their own organic carbon content is extremely low and negligible, avoiding interference with sample detection and improving the accuracy of detection.
• Strong Compatibility: They can be used in conjunction with a variety of TOC detection instruments and are suitable for different brands and models of detection equipment, facilitating different laboratories and enterprises to conduct cleanliness verification tests according to their existing instruments.
• Convenience: They are reasonably designed, simple to operate and easy to use. Staff can quickly master the sampling methods, improving work efficiency. They are also convenient to carry and store, and are suitable for on-site sampling and laboratory testing.

Application Fields

• Pharmaceutical Industry: In the process of drug production, they are used to detect the cleanliness of the surfaces of production equipment, containers and other items, ensuring that the drug production environment complies with the requirements of Good Manufacturing Practice (GMP), preventing drugs from being contaminated by organic pollutants, and guaranteeing drug quality and safety.
• Food and Beverage Industry: They are used for cleanliness verification of the surfaces of food processing equipment and packaging materials to detect whether there are food residues or other organic pollutants, ensuring the hygienic safety of food and complying with relevant food safety standards.
• Electronics and Semiconductor Industry: In the processes of chip manufacturing and electronic component production, they are used to detect organic pollutants on the surfaces of production equipment and clean rooms, avoiding the impact of pollutants on the performance of electronic components and ensuring product quality and the cleanliness of the production environment.
• Medical Device Industry: They are used for cleanliness verification of medical device production equipment and surgical instruments to detect the residue of organic pollutants on the surfaces, ensuring the cleanliness and sterility of medical devices and preventing patients from being infected during use.

Precautions for Use

• Pre-sampling Preparation: Ensure that the swab packaging is intact, without damage, contamination or other issues, and use it within the validity period. Select appropriate types and sizes of swabs according to the detection requirements and the material and shape of the surface to be wiped. Meanwhile, calibrate and debug the detection instrument to ensure its normal operation.
• Sampling Operation: Strictly follow the standard operating procedures for sampling, control parameters such as the wiped area, force and number of times to ensure the consistency and accuracy of sampling. During the sampling process, avoid contact between the swabs and other non-detection surfaces to prevent cross-contamination.
• Sample Preservation and Transportation: After sampling, put the swabs into specific preservation containers as soon as possible and preserve and transport them according to the required preservation conditions to prevent changes in the organic carbon components in the samples and affect the detection results.
• Detection Process: During the detection process, strictly follow the operation manual of the detection instrument to ensure the consistency and accuracy of the detection conditions. Meanwhile, regularly maintain and calibrate the detection instrument to ensure its stable performance.
• Result Judgment and Recording: Judge the detection results according to relevant standards and specifications to determine whether the cleaning is qualified. And record in detail various parameters and results during the detection process, including sampling time, location, swab model, detection value, etc., for traceability and query.