Gmp Cleanroom For Medical Devices System Maintenance Requirements
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Gmp Cleanroom For Medical Devices system maintenance, the company shall send the maintenance team (every time should not less than 3 people) is responsible for the scene, on a regular basis for related equipment, facilities for routine inspection and maintenance, equipment running status and important operation parameters, a month before 5 will check table, equipment maintenance, repair, maintenance table, registration form to hand in logistics of hospital equipment failure.
1. According to the specification requirements, conduct a comprehensive self-inspection on the clean area maintained every six months and provide a written test report. The monitoring data include: dust concentration in the air; Bacterial concentration in air; Send air volume; The new air volume; Positive and negative pressure; Temperature; Humidity; The intensity of illumination.
2. The maintenance company shall employ a third-party qualified testing company to conduct an annual inspection of the air quality in the operating room and the NICU purification area according to the standard, and issue the inspection report approved by the relevant national authority. If the test is qualified, the cost will be borne by the hospital.
3 Gmp Cleanroom For Medical Devices purification unit equipment inspection, cleaning, disinfection and replacement (including filter cleaning and disinfection of the replacement) : (1) is responsible for regularly to purify air condition unit and fresh air system with filters and the high, high, medium and coarse effectively filter for replacement (efficient every year for a replacement, high efficiency filter generally change for 2 to 3 years, or in accordance with the relevant test results determine replacement cycle). (2) clean the air supply, return, exhaust, fresh air intake, y-type filter and primary filter of air conditioning circulating unit and fresh air unit every (week) month. If dust collection is found to be serious during daily inspection, the cleaning or replacement period should be shortened. (3) indoor efficient air supply outlet air supply hood is cleaned quarterly.
4. The maintenance quality of hospital cleaning system meets the following requirements: (ii) hospital air purification management code WS/ t368-2012; (iii) technical specifications for the building of the clean surgery department of the hospital gb5033-2013; (4) YYT0187 general technical conditions for oxygen supply system of hospital center; (v) WS 435 -- 2013 hospital medical gas system operation management; (6) GB 50751 -- 2012 technical specification for medical gas engineering; (7) ws435-2013 hospital medical gas system operation management; (8) guidelines for the planning, construction and operation management of medical gas system; (9) maintenance manual of the equipment manufacturer.