无尘车间物料管理（Dust-free workshop material management）

1、无尘车间物料管理（Dust-free workshop material management）1.1, the deployment of work by more than elongated cadres in accordance with the needs of the job to determine the location of personnel, any person affected by the post can not be picky about the behavior of the work(except in exceptional cases, but c

2、onfirmed by the officer at the competent level)1.2. The operator must complete the work in accordance with the operation instruction or the instruction manual of the machine. The operation method change or special technical operation must be done by the competent personThe clerk will confirm the exe

3、cution.1.3, operators must be self check (including raw materials inspection and component inspection) assembly line operation station, other operators need to carry out the last station inspection,And requires all operators must be familiar with their previous station and next station job content1.

4、4, operators must be completed according to the provisions of production, in order to ensure efficiency.1.5, when the operation is found abnormal, must promptly report to elongated above cadres request processing.1.6, when the workers found their homework is not enough materials 1 hours in advance t

5、o report material or material handler or elongated issue, not allowed to materialPick up the material on the rack.2. clean room material management regulations2.1, all materials must be clearly marked (including raw materials, combinations, finished products)2.2. All materials must be put in order a

6、ccording to regulations.2.3, material handler must periodically repaying the bad material (1 times, each batch according to the order confirmation)2.4, every time when the material material handler when Queliao must report to the main person in charge of production or elongated.2.5, or elongated mat

7、erial handler must be responsible for material import and make the account details.3. clean workshop production discipline3.1, all personnel must be 5 minutes ahead of time to work3.2, all personnel must be required to wear clean clothes, hats, shoes, you can enter the dust-free workshop, and not in

8、 the dust-free workshop finishing dust-free clothing.3.3, the relevant personnel must be required to wear gloves, before entering dust-free workshop operation.3.4, the work time can not have chat phenomenon, still more dont allow quarrel phenomenon.3.5, dust-free workshop is not allowed to bring per

9、sonal things unrelated to work.3.6, all personnel, half an hour before work and half an hours work is not allowed to go to the bathroom.3.7, to Restroom personnel must use to change the label off card to leave, to Restroom time shall not exceed 10 minutes.3.8, all personnel to and from work must be

10、placed in accordance with the provisions of their clothes and static clothing.3.9. All personnel must clean their jobs according to the regulations before and after work.3.10, all personnel to and from work must be lined up according to the provisions of the dust-free workshop.4. dust-free workshop

11、operating environment regulations4.1, dust test, every three months outside the commission test, and attached to test results to the management of the Department archives.4.2, dust-free workshop standard temperature: 21 degrees -25 degrees, humidity: 50%-70%, every day to have thermometer records.4.

12、3, the operator will be 10 minutes before and after the work of their own station environment for cleaning (including overtime), by the competent staff review and confirm irregularly.1. purposeThis procedure aims to provide a standardized procedure for the protection of aseptic operations and asepsi

13、s room.2. scope of applicationBioassay Laboratory3. responsible personQC supervisor, student tester4. definitionsnothing5. safety precautionsStrict aseptic operation to prevent microbial contamination; operators should turn off the UV light when they enter asepsis room.6. rules6.1.Asepsis room shoul

14、d be equipped with aseptic operating room and buffer room, the cleanliness of aseptic operation should reach 10000 levels, the indoor temperature is kept at 20-24 degrees, and the humidity is maintained at 45-60%. Ultra clean table should reach 100 level.6.2. asepsis room should be kept clean, no st

15、acking of debris, in case of pollution.6.3. to prevent all sterilization equipment and medium pollution, polluters should stop using.6.4. asepsis room should be provided with a concentration of disinfectant, such as 5% cresol solution, 70% alcohol, 0.1% new benzalkonium solution, and so on.6.5. asep

16、sis room should be regularly disinfected with appropriate disinfectant cleaning, so as to ensure the cleanliness of asepsis room meets the requirements.All instruments, instruments, dishes, etc. used by the 6.6. to be used in the asepsis room should be tightly bandaged and should be sterilized by su

17、itable methods.The 6.7. staff before entering asepsis room, must use soap or disinfectant wash disinfection, and then in the buffer room for replacing work clothes, shoes, hats, masks and gloves (or with 70% alcohol wipe hands, again) before entering asepsis room operation.6.8. asepsis room must be

18、opened before the asepsis room UV lamp irradiation sterilization for more than 30 minutes, and open the super clean table for blowing. After the operation, the asepsis room should be cleaned in time, and then sterilized with ultraviolet light for 20 minutes.6.9. samples should be kept intact before

19、inspection and must not be opened to prevent contamination. Before examination, disinfect the outer surface with 70% alcohol cotton balls.6.10. should be negative control during each operation to check the reliability of aseptic operation.When 6.11. absorbs the liquid, it must be sucked by the ear b

20、ulb. Do not touch the straw directly.6.12. inoculation needles must be sterilized by flame before and after each use, and can be inoculated until they are cooled.6.13. straws, test tubes, culture dishes and other containers containing bacteria liquid should be soaked in sterilized tanks filled with

21、5% to Suhl solution, and removed after 24 hours.6.14. if the liquid is sprinkled on the table or on the ground, it should be promptly treated with 5% stone carbonate solution or 3% to Suhl for more than 30 minutes at the contaminated area. Work, clothing and other contaminated by bacteria, should be

22、 immediately removed, high-pressure steam sterilization after washing.6.15. any products containing live bacteria must be sterilized before they can be washed under the tap. No pollution drains are allowed.6.16. asepsis room should examine the number of colonies every month. Open in the clean bench

23、under the condition of asepsis 90mm diameter Petri dish of aseptic operation were injected into nutrient agar, melted and cooled to about 45 DEG 15ml to the culture basis, after solidification in 30 35 degrees, inverted incubatortraining 48 hours after taking 3 tablet proved sterile, 5 from left to

24、right, etc. are respectively arranged working position, open the cover after 30 min of exposure to 30 to 35 DEG C inverted incubator for 48 hours, check out. The average number of miscellaneous bacteria in the 100 clean zones should not exceed 1 colonies, and the average number of colonies in the 10

25、000 clean rooms should not exceed 3 colonies. In case of exceeding the limit, the asepsis room should be thoroughly disinfected until repeated inspection is required.7. referencesMethods for examination of drug hygieneChapter of the operation standard of Chinese drug inspection standard (asepsis exa

26、mination)Peoples Republic of China pharmaceutical industry standard YY/T0188.6-1995 operation rules for drug inspection8. Distribution DepartmentQuality control departmentClean room management rulesScope of application: all into the clean room personnel (including personnel, the companys vendors and

27、 visitors etc.) and goods and materials accepted the rules governing constraint specification.Two objective: to ensure the environmental quality of cleanroom and reduce the management cost, ensure the quality of products and improve the efficiency of operation.Three contents: (a) staff and clean roo

28、m shall comply with the management, 1 items: before entering the clean room of the 1.1 company personnel entering the clean room in the area will be more shoes outdoor shoes placed in the shoe cabinet, personal items (handbags, books, etc.) shall be retained shall be placed in the outdoor, indoor du

29、st, and then walk to the locker area wearing a mask and in accordance with the personal identification number for clean and clean shoes and clothes to wear latex gloves,Wearing special dust-free clothes shall not expose personal clothing and hair, but only the part of the eyes and face. 1.2 if the manufacturers or guests to enter the clean job execu