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1. Purpose
Establish a management procedure for monitoring, use and maintenance of clean rooms to ensure that the environment of clean rooms meets production requirements.
2. Scope
100,000-level clean area in the workshop.
3. Responsibilities
Director of the production and manufacturing department, director of the equipment and power department, and QC personnel.
4. Contents
4.1 Use of clean rooms
4.1.1 Before the newly built or renovated Clean Room is put into operation, the company's production and manufacturing department, equipment and power department, quality department and construction unit must jointly verify the purification and air conditioning system, and it can only be put into use after the relevant indicators are tested and qualified.
4.1.2 All personnel entering the clean room must wear the clean work clothes of this area in accordance with the process hygiene management regulations and enter the clean room according to its purification procedures.
4.1.3 Operators in different positions in the clean area shall not visit each other during work.
4.1.4 Approval procedures must be followed to enter the clean room, approved by the production and manufacturing department, and temporary personnel entering the clean room should be guided and supervised.
4.1.5 All materials, instruments, process water, and cleaning and sanitation water used in the clean area must be purified before entering.
4.1.6 The purification air conditioning system should maintain a relative positive pressure. During normal production, the air conditioner starts to supply air normally half an hour before production to ensure that the cleanliness of the room meets the requirements before production.
4.1.7 Air disinfection is performed for 60 minutes with an ozone generator every week.
4.2 Clean room monitoring
4.2.1 In order to ensure the purification environment and cleanliness of the clean room, the clean room needs to be monitored, and the monitoring items and frequency are tested under static conditions as required.
4.2.2 If the overhaul or shutdown lasts for more than 10 days, the clean room should be processed according to the cleaning procedures before production, and all indicators should be tested before it can be put into use.
4.2.3 After 3 months of continuous production, the number of dust particles and Wind speed and volume in the clean area should be tested statically, and the number of colonies should be tested and recorded every week.
4.2.4 The monitoring work is organized by the Quality Department, and QA, QC personnel and workshop negative meters monitor and keep monitoring records. When the test results deviate, they should be handled in time according to the management procedures for clean room deviations.
- 4.2.4.1 When the Wind speed, dust particle number, and pressure difference deviate, the primary, medium, and high efficiency filters should be replaced.
- 4.2.4.2 When the number of microorganisms deviates, the workshop should carry out process sanitation disinfection according to the relevant cleaning procedures.
- 4.2.4.3 When the Air volume of the high efficiency Air Filter is 70% of the original air volume, or when the air flow speed drops to the minimum, the high efficiency filter should be replaced.
4.3 Clean room maintenance
4.3.1 Establish management procedures for materials and personnel entering the clean area.
4.3.2 The clean room is cleaned by the user, that is, the operator at the post, to maintain the cleanliness of the clean room, and keep records in the post record.
4.3.3 According to the monitoring results, clean the primary and medium efficiency air filters in time according to the cleaning procedures of the primary and medium efficiency air filters and the replacement operating procedures of the high efficiency filters.
4.3.4 Regularly inspect and maintain the air conditioning system and purification Equipment of the clean room.
