The following are the usage methods and precautions of cleaning validation swabs:

Usage Methods

1. Preparation Work
   • Select the Appropriate Swab: According to the object and requirements of the cleaning validation, choose the cleaning validation swab with the appropriate material, size, and specification. For example, a common nylon swab can be selected for smooth surfaces, and a swab with a special shape may be required for surfaces with gaps or irregularities.
   • Prepare Auxiliary Tools: Prepare auxiliary tools such as sterile gloves, tweezers, sampling bags, and marking pens to ensure the sterility and standardization of the operation process.
   • Clean Hands: The operator should thoroughly wash their hands with soap and running water, or disinfect their hands with a hand sanitizer to prevent the hands from contaminating the swab and the sampling site.
2. Sampling Operation
   • Open the Packaging: Open the packaging of the cleaning validation swab in a sterile environment. Be careful not to touch the sampling end of the swab to avoid contamination.
   • Sampling Method: Use the sampling end of the swab to wipe and sample the surface that needs to be verified for cleaning. Generally, it is carried out in a certain order and direction, such as from left to right and from top to bottom, to ensure that the entire area to be sampled is covered and missed sampling is avoided. For a large surface, sampling can be carried out in partitions. Apply appropriate pressure when wiping to ensure that the swab is in full contact with the surface to ensure that an adequate sample is collected.
   • Sample Quantity: Determine the appropriate sampling quantity according to the detection method and requirements. Usually, it is necessary to ensure that the swab collects enough pollutants or residual substances so that the subsequent detection can accurately reflect the cleaning effect.
   • Post-sampling Treatment: After sampling is completed, immediately put the swab into the sampling bag, seal it well, and use a marking pen to indicate information such as the sampling time, location, and sampling object on the sampling bag.
3. Detection and Analysis
   • Send for Inspection: Send the swab with the collected sample to the laboratory for detection and analysis as soon as possible. During the process of sending for inspection, pay attention to maintaining the stability and integrity of the sampling swab to avoid interference and contamination from external factors.
   • Detection Method: The laboratory usually uses corresponding detection methods, such as Total Organic Carbon (TOC) analysis, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), etc., to qualitatively and quantitatively analyze the residual substances in the swab sample to determine whether the cleaning meets the validation standard.

Precautions

1. Swab Storage and Shelf Life
   • Storage Conditions: The cleaning validation swab should be stored according to the conditions required in the product instruction manual. Generally, it needs to be stored in a dry, cool, and sterile environment, avoiding direct sunlight and high temperature and humidity.
   • Check the Shelf Life: Before use, carefully check the shelf life of the swab. An expired swab may affect the sampling effect and the accuracy of the detection results and should not be used.
2. Aseptic Operation
   • Environmental Requirements: The sampling process should be carried out in an aseptic environment as much as possible, such as a clean room or an aseptic operation room. If sampling is carried out in a common environment, appropriate protective measures should be taken to reduce the contamination of the sampling by the external environment.
   • Operation Specification: The operator must strictly comply with the aseptic operation specification, wear protective supplies such as sterile gloves and masks, and avoid directly touching the sampling end of the swab and the cleaned sampling surface with their hands.
3. Representativeness of Sampling
   • Select Sampling Points: According to the characteristics and usage conditions of the equipment or surface, reasonably select the sampling points to ensure that the sampling points can represent the cleaning status of the entire cleaning area. For example, for the sampling of equipment, the parts where pollutants are likely to remain, such as pipeline interfaces, valves, and corners, should be selected.
   • Sampling Quantity: Determine the appropriate sampling quantity according to the scope and requirements of the cleaning validation. Generally speaking, the more the sampling quantity, the more accurately it can reflect the cleaning effect, but the feasibility and cost of the actual operation should also be considered.
4. Recording and Identification
   • Detailed Recording: During the process of using the cleaning validation swab, record the relevant information of the sampling in detail, including the sampling time, location, sampling personnel, sampling object, detection results, etc., for subsequent data statistics and analysis.
   • Clear Identification: Ensure that the identification on the sampling bag and relevant records is clear, accurate, and complete to avoid sample confusion or incorrect detection results due to unclear identification.