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Cleanroom rules and practices
- 1. Cleanroom Rules andPractices (Cleanroom Behavior) - Chittaranjan Das
- 2. All cleanroom employees shouldbe neat and clean. The general condition of health for cleanroom personnel must be satisfactory. Cleanroom Rules and Practices
- 3. The skills andaptitudes that a cleanroom employee should possess include the following: • a minimum of 2 years of high school education, • above-average intelligence, • good manual dexterity, • good work habits, and • an understanding of the operation being performed. Cleanroom Rules and Practices
- 4. Cleanroom Rules andPractices Before entering any clean environment, personnel should understand the responsibilities of their position and know aseptic techniques. Clean room Project
- 5. Only authorized personnel whoare trained properly and are qualified for cleanroom activities through gowning and media fill simulation study. Cleanroom Rules and Practices
- 6. Wash hands* properlyand disinfect before entering any cleanroom. Proper gowning is the main prerequisite for entering into a cleanroom. *https://www.slideshare.net/Chittara njanDas3/hand-wash-175652101?qid Cleanroom Rules and Practices
- 7. People is themain source of contamination in the cleanroom. Approximately 80% of the contamination found in a cleanroom is generated by people.
- 8. The greater the activityof the people, the larger the number of particles emitted. Cleanroom Rules and Practices
- 9. Limit the numberof personnel working in the cleanroom. Cleanroom Rules and Practices
- 10. Always be alertin the cleanroom. Cleanroom Rules and Practices
- 11. Move Slowly: Movement inthe cleanroom must be slow. Cleanroom Rules and Practices
- 12. Personnel movement increased thedegree of friction between the clothing and skin, thereby increasing the number of particles emitted from the skin surface. Up to 10 mg of skin particles may be deposited in a person’s clothing during a 2-hr period. Cleanroom Rules and Practices
- 13. Horseplay is strictlyforbidden in the cleanroom. CLEANROOM RULES AND PRACTICES
- 14. Personnel should not walkaround the room unnecessarily. Cleanroom Rules and Practices
- 15. Personnel must be awareof the direction of the airflow and must not interrupt it by placing any part of their body between the source of the airflow and the work area. Cleanroom Rules and Practices
- 16. Personnel shall position themselves correctlywith respect to the product, so that contamination does not land on it. Cleanroom Rules and Practices
- 17. Handle products and/or container- closurewithout any direct touch of hands and in such a way so that hands do not reach over those. Cleanroom Rules and Practices
- 18. Personnel should not reachover or lean over open vials on the line. Personnel should keep their hands and body away from vial openings. Cleanroom Rules and Practices
- 19. Trays containing vials shouldbe handled from the bottom and such a way so that the body and hands do not reach over the vials. Cleanroom Rules and Practices
- 20. Product containers should notbe exposed unnecessarily to the cleanroom environment. Trays containing product containers should be opened only under a laminar airflow device. Cleanroom Rules and Practices
- 21. Avoid direct touchwith the product containing trays if possible. All vials, bottles, and ampoules must be handled in covered trays where appropriate. Cleanroom Rules and Practices
- 22. Disinfect hands frequently inside cleanroom. Disinfecthands before and after touching any objects. Change hand gloves at a certain time interval, e.g. 1 hour. Cleanroom Rules and Practices
- 23. Loud, unnecessary talk throughthe mask should be avoided. Laughing, whistling, singing and shouting increase the number of bacteria emitted from the mouth. Cleanroom Rules and Practices
- 24. Nervous relief-type mannerisms suchas head scratching or rubbing hands, facial or parts of the body must be consciously avoided. Cleanroom Rules and Practices
- 25. Do not congregatein the vicinity of the work area. The air lock is not to be occupied by personnel. Cleanroom Rules and Practices
- 26. No eating offood, chewing of gum or tobacco, or smoking is permitted in the clean area. No drinking is also permitted. Even no medicine is permitted. Cleanroom Rules and Practices
- 27. Do not smoke immediatelybefore entering cleanroom. Non smokers are preferable for cleanroom. Cleanroom Rules and Practices
- 28. Personal items suchas: keys, coins, cigarettes, matches, handkerchiefs, watches, tissues, combs etc. must not be carried into the cleanroom. Cleanroom Rules and Practices
- 29. Cosmetics are notbe worn or applied in the cleanroom. This includes : rouge, lipstick, facial powder, eye shadow and eyebrow, mascara, eyeliner, false eyelashes, fingernail polish, hair spray, and the heavy use of an aerosol deodorant. No jewelry (i.e., rings, necklaces, earrings, lockets, watches, bracelets) is to be worn in the cleanroom. Cleanroom Rules and Practices
- 30. No pencils orerasers can be used in the cleanroom. Paper* in any form is not allowed in the clean facility. *(except that meeting Class 100 conditions as specified in Federal Standard 209D) Cleanroom Rules and Practices
- 31. Only approved garments,gloves and goggles shall be worn inside the cleanroom. Protect clean room No particle shed Lint free ESD Withstand multiple sterilization Comfortable Cleanroom Rules and Practices
- 32. Cover all hairinside the cleanroom all time. No skin is to be exposed inside cleanroom. Cleanroom Rules and Practices
- 33. No skin isto be exposed between the gloved hand and coveralls. Do not cross hands inside cleanroom. Cleanroom Rules and Practices
- 34. Coveralls are notto be unzipped in the cleanroom. Personnel should avoid reaching under the hood or other parts of the garment with gloved hands. Cleanroom Rules and Practices
- 35. Do not exposeyour nose or face in the cleanroom. Cleanroom Rules and Practices
- 36. Any one whois physically ill, especially with a stomach or respiratory disorder, must not enter the cleanroom. Must report to the supervisor. Cleanroom Rules and Practices
- 37. Personnel must report any irregularitiesor adverse changes in environmental conditions to the supervisor. Cleanroom Rules and Practices
- 38. Once inside the cleanroom,personnel should remain until the break or lunch period. Cleanroom Rules and Practices
- 39. Paper, pens, keys,and so on, must not be passed from the non- clean to the clean area, or vice versa. The air lock is not to be occupied by clean and nonclean equipment simultaneously. Cleanroom Rules and Practices
- 40. All verbal communication with peopleoutside the clean area should be accomplished through the use of an intercom or telephone. Cleanroom Rules and Practices
- 41. ALL equipment, materials and containers introducedinto a sterile facility must be subjected to stringent sterilization prior to entrance. Cleanroom Rules and Practices
- 42. Components that have fallenonto the floor must not be picked up and used. Cleanroom Rules and Practices
- 43. Only cleanroom approved wipersare allowed to be used. The wipers must be approved for the Class of cleanroom being cleaned. Use of paper or fabric towels is prohibited. Cleanroom Rules and Practices
- 44. Personnel should be trainedthe proper procedures to follow for power failures-how to protect the product and exit the clean area. Emergency lights and generators should be provided. Cleanroom Rules and Practices
- 45. Emergency fire existsshould be provided if the normal exists are inadequate or are likely to be inaccessible. Fire extinguishers should be provided and all personnel should be trained in their use. Emergency fire drills should be held regularly. Cleanroom Rules and Practices
- 46. Emergency teams, such asfirst aid, should be trained and readily available during all working hours. Cleanroom Rules and Practices
- 47. 1. https://www.europeanpharma ceuticalreview.com/article 2. CleanRoom Handbook Rev. 2.1.3 : https://www.eng.yale.edu/clea nroom/clean%20room%20han dbook%202_1_3.pdf 3. https://www.researchgate.net/ publication 4. https://www.cleanroomtechno logy.com/ 5. https://www.iso.org/ 6. https://www.pharmaceuticalo nline.com/ 7. https://www.academia.edu/ 8. https://www.microntraining.co m/ 9. Google Images References
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