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Cleanliness Knowledge of GMP Manual
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Cleanliness Knowledge of GMP Manual

  • 分类:知识中心
  • 作者:Marya
  • 来源:original
  • 发布时间:2021-05-25 15:36
  • 访问量:

【概要描述】

Cleanliness Knowledge of GMP Manual

【概要描述】

  • 分类:知识中心
  • 作者:Marya
  • 来源:original
  • 发布时间:2021-05-25 15:36
  • 访问量:
详情

 Questions and answers ————————————————————————————-———————————————————

 

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1.What are the requirements of GMP for pharmaceutical production environment and region?
A: Drug production companies must have a clean production environment, and have a certain amount of green area. Ground of the plant are area all must be hardened, pavement and transportation should not pollute the production of drugs; The overall layout of production, administration, living and auxiliary areas should be reasonable, separated from each other, and must not interfere with each other.
 

2.What requirements should clean area surface meet?
A: Cleanroom’s inner surface should be smooth, with no crack, tight interface, no particles fall off, and can withstand cleaning and disinfection, the junction between the wall and the plant surface should be curved or other measures should be taken to reduce accumulation and facilitate cleaning.
 

3.How much lux should the illuminance of the clean area be?
A:The illuminance of the main work room should not be less than 300 lux, the production parts with special requirements for illuminance can be equipped with local lighting.
 

4.What levels are the air cleanliness for clean room of drug production divided into?
A: Air cleanliness for clean room of drug production divided into four levels, 100、10000、100000、300000. The air comes into clean room must be purified, and separate air cleanliness level according to production technological requirements.
 

5.What is the pressure difference between a clean room and a non-clean room, and adjacent rooms of different cleanliness levels?
A: Static pressure difference between adjacent rooms with different air cleanliness level should greater than 5 Pa, static pressure difference between clean room and outdoor atmosphere should greater than 10 Pa, and there should be a device to indicate the pressure difference. (differential gauge)
 

6.How the air purify when air come into clean room?
A: The air which comes into clean room is filtered by three-stage filters of primary, medium and high efficiency, making the air reach the required cleanliness level. Because HEPA filter can filter<1μm dust particles, the penetration rate of bacteria is 10-6, so the air passing through the HEPA filter can be regarded as sterile.
 

7.What is the temperature and relative humidity of the clean room?
A: The temperature and relative humidity of the clean room should match the drug production technology. With no special requirements, the temperature should be control in 18~26℃, and the relative humidity should be controlled in 45~65%.
 

8.What requirements should clean room(area) management meet?
A: Clean room(area) management meets the following requirements: 
     (1)The personnel entering clean room(area) must change shoes and clothes, wash and disinfect their hands as required, then they can enter the clean room(area). The number of personnel in the clean room (area) should be strictly controlled. Its staff (including maintenance and auxiliary personnel) should be regularly trained and assessed on hygiene and microbiological basic knowledge, clean operations, etc. The temporary foreigners who have been approved to enter the clean room (area) shall be guided and supervised, and registered for future reference.
    (2)There must be a buffer facilities between clean room(area) and non-clean room(area), the trend of people and materials is reasonable. 
    (3)Clean work cloth in areas above 100000 should be washed, dried, arranged in a clean room (area), and sterilized as required if necessary. 
    (4)Equipment insulating layer surface in clean room(area) should be smooth, bright and clean, no particulate matters fall off. 
    (5)Clean room should use clean and hygiene tools that free of falling objects, easy to wash and disinfect, hygiene tools should be put in special sanitary tool room. 
    (6) The number of dust particle and settled bacteria detected in the clean room (area) under static conditions must meet the requirements, should inspect the cleanliness state in dynamic condition at regular intervals.
    (7) The clean air in clean room(area) is recyclable, and adds fresh air properly. For processes with a large amount of dust, the return air should be discharged outside to avoid pollution and cross-contamination.
    (8)Air purified system should be cleaned, repaired, maintained and recorded as required. Indoor disinfection and floor drain cleaning all should be recorded. 
    (9)Production tools, containers, equipment, finished products, and intermediate products are all set and stored with state marks.
    (10)Personal hygiene is strictly implemented in accordance with (Article 66) production personnel hygiene requirements.
 

 

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