1. Objective: To establish a standard operating procedure for the replacement of primary, medium and HEPA air filtration treatments so that the air conditioning system is in compliance with the medical device production quality management regulations.
2. Scope: Applicable to the air outlet system coarse filter (bump network), primary filter, medium filter, HEPA air filter cleaning and replacement.
3. Responsibility: The air conditioning operator is responsible for the implementation of this procedure.
4. Content:
4.1 The primary filter, medium filter, and HEPA filter must be replaced in accordance with the production process conditions to meet the basic requirements of the production of air conditioning systems, while achieving the necessary production conditions.
4.2 Air outlet louver filter (wind filter coarse filter).
4.2.1 The coarse filter screen of the air intake must be replaced (cleaned) once every 30 working days, and the coarse filter screen of the lower air outlet should be replaced for cleaning (tap water flushing, no brush, high pressure water gun), and the coarse filter of the air inlet should be fully inspected for damage ( If it is damaged, it should not be used again. When the coarse filter of the air intake is cleaned, it should be placed in a relatively sealed room. After the filter is dry, the staff will check the coarse filter of the air intake one by one. It can be installed and used. If the coarse filter of the air outlet is damaged, it will be replaced in time.
4.2.2 The coarse filter screen of the air intake is replaced according to the damage, but the maximum service life shall not exceed 2 years.
4.2.3 In the spring and autumn, the dusty season will increase the number of cleaning of the coarse filter screen.
4.2.4 When the air supply is insufficient, clean the air outlet to clean the dust on the net.
4.2.5The coarse filter screen for disassembling the air outlet can be carried out without stopping the group, but the new filter outlet coarse filter should be installed in time.
4.2.6 Each time you clean and replace the air filter, you must fill in the “Air Cleaning Filter Cleaning and Replacement Record Form”.
4.3 Primary filter:
4.3.1 It is required to open the chassis check every quarter to check whether the initial filter frames are damaged or not, and clean the primary filter once.
4.3.2 Each time the primary filter is cleaned, the primary filter must be removed (no direct cleaning on the frame), placed in a special cleaning room, washed repeatedly with clean water (tap water), and the filter is inspected for damage. Damaged Replacement in time (Do not use high temperature water or high pressure water during cleaning). When the filter is cleaned, it should be placed in a relatively sealed room. After the filter is dry, the staff will check the filter one by one for damage. Can be installed and used, such as the initial filter is damaged and replaced in time.
4.3.3 When the primary filter is removed and cleaned, the staff should simultaneously clean the inside of the air-conditioner cabinet with clean water. The removable and washable parts should be removed and cleaned, the surface of the equipment should be cleaned, and finally the dry cloth (cloth can not be shed) Wipe it again until the cabinet body meets the dust-free requirements before installing the primary filter.
4.3.4 The initial filter replacement time is changed according to the damage, but the maximum service life shall not exceed 2 years.
4.3.5 Each time you replace or clean the primary filter and the chassis, you should fill in the “First-Purpose Filter Cleaning and Replacement Record Form” in time and prepare for review.
4.4 Medium filter
4.4.1 The medium filter requires that the chassis must be fully inspected every quarter, the fixing and sealing of the medium frame, and the intermediate effect check should be carried out once to see if the medium bag body is damaged or not, and the dust is fully vacuumed once.
4.4.2 Every time the intermediate vacuum is removed, the medium-effect over-the-counter bag must be disassembled and vacuumed with a special vacuum cleaner. In the vacuuming operation, the staff should pay attention to the vacuum cleaner pipette not to break the medium-effect bag, and check the color of each bag one by one. Normal, whether the bag body has open lines or leaks, etc. If the bag body is damaged, the dust should be replaced in time.
4.4.3 When vacuuming under medium-effect disassembly, the staff should clean the frame and scrub it in time to meet the dust-free requirements before installing the medium filter.
4.4.4 To install the medium filter, the bag body should be flattened to the frame and fixed to prevent gaps.
4.4.5 The replacement time of the medium filter is replaced according to the damage and dust holding condition of the bag, but the maximum service life shall not exceed two years.
4.4.6 Fill in the Medium Filter Cleaning and Replacement Record Form each time you clean and replace the medium efficiency filter.
4.5 Replacement of HEPA filter
4.5.1 For HEPA filters, when the resistance value of the filter is greater than 450Pa; or when the airflow velocity of the wind surface is minimized, the airflow speed cannot be increased even after replacing the coarse and medium filter; or when the HEPA filter if there is an unrepairable leak on the surface, a new HEPA filter must be replaced. If the above conditions are not available, it can be replaced once every 1-2 years depending on the environmental conditions.
4.5.2 The replacement of the HEPA filter is replaced by the technician of the equipment manufacturer. The air-conditioning operator of the company cooperates and fills in the “HEPA filter replacement record”.
4.6 Exhaust fan filter box cleaning and filter replacement measures:
4.6.1 Each exhaust fan filter box requires that the chassis check be opened every six months to check whether the medium effect net frame is damaged or not, and wipe the medium effect and the box cleaning once. The medium efficiency net cleaning work standard is the same as (4.4). The effect is replaced according to the damage, but the maximum service life shall not exceed 2 years.
4.7 Every time the inspection is completed, it can be put into operation after meeting the requirements.
4.8 The spare medium and primary storage should be packed in a plastic bag and sealed. It should be stored at a special point for drying. It should not be stacked or mixed with other items to prevent heavy pressure deformation. The person is responsible for daily storage and has a cargo account.
4.9 The model parameters of the coarse filter screen (concave net), the primary filter, the medium filter and the HEPA filter of each unit’s air intake are subject to the record form.
4.10 The medium filter and HEPA filter used by each unit must be selected from regular manufacturers, with corresponding qualifications, and the products have corresponding test reports.
4.11 After each cleaning and replacement, the quality inspector shall inspect the clean workshop according to the “Clean Workshop Environmental Monitoring and Management Regulations” and meet the requirements before use.
Post time: May-08-2014