The placement of the filter should be convenient for its installation, disassembly, testing, and other operations, and should not affect its functional use. The connection between the filter and the supporting equipment, floor, wall, etc. should be firm and reliable. The components of the filter should be tightly connected, well sealed, able to withstand production operating pressure, and have no leakage or deformation. Before installing filters and filter membranes, their specifications, models, and appearance should be confirmed to meet the requirements. During the assembly process, pollution should be avoided as much as possible. The installation should be carried out according to the instructions for using the filter. If there are multiple specifications of filters on site, a second person should review and confirm the filter information, and the review should be recorded.
In order to reduce the impact of particles and other foreign objects generated by the filter on the product, necessary pre flushing can be carried out on the installed sterilization filtration system. The flushing should be carried out in conjunction with the methods provided by the supplier. The flushing method should be validated. During normal operation, the flushing volume should not be lower than the minimum verified flushing volume. After rinsing, appropriate methods should be used to remove the rinsing solution.
The sterilization filtration system should undergo risk assessment and try to confirm its airtightness as much as possible. The airtightness of the upstream system of the filter can be confirmed through pressure maintenance and online integrity testing. The downstream sealing of the filter can be confirmed by pressure maintenance, and the relevant parameters should be validated.
Sterilization filtration should be carried out within the specified process control parameter range. To ensure the effectiveness of sterilization filtration, key parameters that affect the sterilization filtration effect should be controlled and recorded. The control items should include sterilization filtration temperature, time, pressure, upstream and downstream pressure difference, etc; Sterilization parameters of the system and sterile receiving containers; And the results of filter integrity testing, etc.
In addition to process parameters, key information of the filter should also be recorded (such as item number, batch number, serial number, or other unique identification number) for traceability purposes.
A training plan should be developed for the enterprise, and relevant training on sterilization filters should be included in the training plan. The training content includes theoretical knowledge and operational skills. Theoretical knowledge training includes usage instructions, working principles, relevant parameters, and validation requirements for filter cartridges and filtration systems provided by filter manufacturers; Operational skills training includes standard operating procedures for the use of relevant filter elements, such as integrity testing training, cleaning and sterilization, drying, storage and other operational training, product sterilization and filtration process training, system tightness testing training, etc. Personnel should undergo theoretical and practical assessments, and only those who pass the assessment can take up their positions. When there are changes in the system or parameters and the relevant standard operating procedures are revised, personnel should be retrained.
When there is a deviation in the sterilization and filtration process, a thorough investigation should be conducted to identify the root cause and take corrective measures. Risk assessment should be conducted for products that have deviations.