TOC(Total Organic Carbon)
Cleaning validation measures the organic carbon content of a sample to determine whether the cleaning procedure is assessed to have completely removed residues, including microorganisms and their metabolites. The purpose of cleaning validation is to demonstrate that the equipment consistently meets the acceptance requirements for product, cleaning agent and microbiological residues in order to prevent possible contamination and cross-contamination, which is extremely important for safeguarding the quality and safety of products in industries such as pharmaceuticals, etc. The first step in TOC cleaning validation is the collection of samples, and the selection of a guaranteed sample collection tool and the correct collection method is extremely important.
TOC cleaning validation assesses the effectiveness of the cleaning procedure by measuring the organic carbon content. As a surface sampling tool, cotton swabs have the advantages of high accuracy, simplicity and speed, high efficiency, strong adsorption and wiping ability, high security, easy to transport, etc., and they are an effective tool in the cleaning validation process.
Cleaning verification swabs are a kind of testing tools specially used in the process of cleaning verification.
Cleaning verification is an important part of the pharmaceutical, food, cosmetics and other industries to ensure that the production equipment, containers and environmental cleanliness in line with the standard.
Cleaning verification swabs usually have the following characteristics: I. Material and design
- Fine material: – Generally made of special polyester fibre or similar material, which has good adsorptive properties and can effectively adsorb contaminants such as active ingredients, detergents, micro-organisms and other contaminants left on the surface of the equipment. – The head of the swab is usually carefully designed in a variety of shapes, such as round, pointed, etc., to fit different shapes of equipment surfaces and hard-to-reach corners to ensure that it can fully reach and collect as much residue as possible.
- Low residue: – The material of the cleaning verification swab itself does not release substances that could interfere with the test results during use, ensuring accurate testing. – After special treatment, the swabs will not leave excessive fibre residue after wiping the surface of the equipment, avoiding the impact on subsequent testing and analysis.
II. Application Scenarios**
- Pharmaceutical industry: – In the process of drug production, strict cleaning of equipment is required between different batches of drug production to prevent cross-contamination. Cleaning verification swabs can be used to detect drug residues on the surface of production equipment such as reactors, filling machines, pipelines, etc. to ensure that the cleaned equipment meets the quality requirements of drug production. – For the production of highly active, highly toxic drugs, cleaning verification is particularly important, cleaning verification swabs can accurately detect very low levels of residues, to protect the safety of drugs.
- Food industry: – In the cleaning validation of food processing equipment, cleaning validation swabs can detect food residues, cleaning agent residues and microbiological contamination. For example, in the dairy processing equipment, beverage filling equipment and other cleaning verification, to ensure that the surface of the equipment is free of residual protein, sugar and other substances, to prevent cross contamination between different batches of food, to ensure the quality and safety of food.
- Cosmetic industry: – Cosmetic production equipment also need to carry out strict cleaning verification, in order to prevent cross-contamination of ingredients between different products as well as microbial contamination. Cleaning verification swabs can be used to detect residues of active ingredients, fragrances, colours, etc. on the surface of cosmetic production equipment to ensure the quality and safety of cosmetics.
III. Detection and Analysis
- Sample collection: – Wiping samples on the surface of the equipment using a clean validation swab is simple and convenient. According to different equipment surfaces and cleaning requirements, a reasonable wiping programme can be developed to ensure that representative samples are collected. – For some hard to reach parts, you can use special shaped cleaning verification swabs for sampling, to improve the comprehensiveness of the test.
- Laboratory analysis: – Collected samples can be tested by various analytical methods, such as high performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), etc., to determine the type and content of residues. – Microbiological tests, such as culture and rapid test methods, can also be performed to assess the microbiological contamination of equipment surfaces. In conclusion, cleaning verification swabs play a vital role in the cleaning verification process in various industries, which can provide companies with accurate and reliable cleaning test data to ensure the quality and safety of the production process.