1. Clean plant main structure of the inspection and maintenance
1.1 monthly clean plant periphery, including windows and doors, auxiliary rooms in the lamps and lanterns, air curtains, fly lamps, rodent repellents, and other facilities for inspection, found that the problem, and timely repair and make a record.
1.2 monthly clean plant technology mezzanine, color steel plate structure, sealing doors, windows and transfer windows, pools, ground epoxy layer, etc., found that the leakage degumming, doors and windows of the wind leakage, ground damage and other timely repair and make a record. For the facilities that can not stop using, arrange for maintenance during the shutdown overhaul.
1.3 Weekly clean plant lighting, emergency lighting, ultra-clean table, air shower room, sterilizer and other equipment for inspection, found that the problem of timely repair and make records.
1.4 clean plant fire and monitoring system, monthly routine inspection, found that the problem of timely repair and make records (without the approval of the quality control department, shall not open the security door).
1.5 clean plant maintenance shall not use open flame. Maintenance process shall not cause pollution to the plant and drugs.
2. Clean plant purification air conditioning system maintenance and maintenance
2.1 clean area air conditioning system should be operated by a person licensed to operate, every two hours on the clean air conditioning system temperature, humidity, wind pressure, unit water temperature, high and low pressure, etc. to check and make records.
2.2 air-conditioning unit and fan maintenance, maintenance must be strictly in accordance with the "air-conditioning unit maintenance procedures.
2.3 Purification of air-conditioning system used at all levels of filters must be purified according to the requirements of the selected manufacturers from the factory and need to have the factory to provide proof of qualification and in the transportation, installation process shall not be contaminated and damaged.
2.4 Reusable filters should be cleaned and inspected in a timely manner after replacement and kept by the person in charge for reuse, and the replacement cycle is as follows:
Weekly replacement of fresh air filter cloth (filter cloth can be cleaned and reused once);
Monthly replacement of return air filter cloth (filter cloth can be cleaned and reused once);
Every half a year Replace the center teach filter bag once (filter bag can be cleaned once).
According to the purification test results and the final resistance shown by the differential pressure meter, replace the high-efficiency filter every 4-6 years.
2.5 The cleaning and replacement of the filter unit must be carried out in strict accordance with the mounting and dismounting procedures and under the premise of meeting the GMP requirements, so as to avoid contamination and make a good record of filter replacement.
3. Requirements for personnel entering the clean plant
Personnel entering the clean plant must be regular physical examination, often to protect personal cleanliness, no skin disease and trauma, by the relevant departments of the post after passing the training, strictly in accordance with the "personnel to enter the clean plant procedures" implementation.
4. Clean plant testing
Clean zone purification and air conditioning system, daily testing in accordance with the "clean plant monitoring procedures. Every year, according to the "clean room construction acceptance specification" (JGJ71-90) < Note: This site: the current standard is "clean room construction acceptance specification GB50591-2010"> comprehensive re-validation. If the monitoring or verification problems should be found by the quality control department in a timely manner to repair the Ministry of repair and testing by the Ministry of Science and Technology qualified. Before production.
5. Clean plant cleaning and disinfection
Clean plant can be used to clean the new cleaner and chlorhexidine acetate cleaning, disinfection, respectively, with propylene glycol and formaldehyde alternating to prevent drug resistance, the specific operation of the "clean plant cleaning and sterilization management procedures," the implementation.
The above by the Anhui people and purification for you to answer.