【摘要】 对一次使用性医疗用品生产环境调查表明,不同生产条件车间的污染程度有所不同,且八月份的污染较二、五、十一月份为高。人工通风净化车间与自然通风自动生产线上的灭菌前产品污染轻微,未超过100cfu/件,但自然通风车间手工生产的棉垫类污染超标甚多,应加强消毒与管理措施。更多还原

【Abstract】 In order to find out the sanitary conditions in production of disposable medical products in Beijing and to improve GMP control, investigation was carried out in three different workshops, namely, a completely closed clean workshop of clean grade 100 000 with artificial ventilation (for production of infusion sets and scalp needles), a workshop of automatic production line with natural ventilation (for production of swabs and non-adhesive dressings) and a manual operation workshop with natural ventilation in residential building (for production of various medical pads and operating coats). The result indicated that both the surfaces of benches and the hands of operators in all three types of workshop were contaminated by bacteria. The contamination was lightest in the artificially ventilated clean workshop and heaviest in the naturally ventilated workshop of automatic production line. The degree of contamination of workshop was related to the building, equipment and production form, as well as strictness of administration. The contamination of products before sterilization in both artificially ventilated clean workshop and naturally ventilated automatic production line workshop did not exceed the requirement (<100 cfu/sample). Since the pads produced by manual operation were heavily contaminated, this is the focal point for intensive control and sterilization.更多还原