Daily management and maintenance of gmp clean room
Daily management and maintenance of gmp clean room
For a gmp clean room, in terms of importance, design, construction, installation and maintenance management each account for 1/3. In general, the purpose of clean room maintenance and management is to control indoor dust and bacteria production under the design requirements; make the system and equipment operate normally, and effectively realize the design...
Text label: gmp clean room maintenance, clean room personnel management
Daily management and maintenance of gmp clean room
For a gmp clean room, in terms of importance, design, construction, installation and maintenance management each account for 1/3. In general, the purpose of clean room maintenance and management is to control the indoor dust-producing bacteria under the design requirements; make the system and equipment operate normally, and effectively prevent the entry of dust and bacteria by design; the generated dust and bacteria should be removed immediately , so as not to accumulate into a sudden clean load and prevent the occurrence of extraordinary events.
gmp clean room personnel management: key personnel should be full-time personnel of the enterprise, at least including the person in charge of the enterprise, the person in charge of production management, the person in charge of quality management and the quality authorized person; the person in charge of quality management and the person in charge of production management shall not communicate with each other concurrently; and product production
. All personnel related to quality should be trained. In addition to the theoretical and practical training of this code, they should also have skills training. The training should have regular and effective assessments; personnel entering the clean production area are not allowed to wear makeup or wear. Accessories; production personnel who have direct contact with products shall undergo a health check before taking up their jobs, and shall have a health check at least once a year thereafter.
The number of people in the clean area should be strictly controlled, generally based on the density of people (person/m2). Workers, including cleaners and equipment maintenance workers, should be regularly trained; those engaged in animal tissue processing or those engaged in microbial culture unrelated to current production are usually not allowed to enter the sterile product production area, and when unavoidable, they should be strictly Implement relevant personnel decontamination procedures. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of clean workshops and gmp workshops and other supporting services.
Education for gmp clean room staff, especially relevant technical personnel, and the contents they should master generally include: cleanliness required by products; dust sources and control in gmp clean rooms; hazards of dust and bacteria to products; Knowledge of cleanliness measuring instruments, measuring methods and evaluation methods for clean rooms, products and work clothes; operating procedures and troubleshooting methods for purification equipment and systems; process operations and their impact on cleanliness; safety measures; hygiene measures; this gmp construction and performance.
The content of training for gmp pharma clean room staff generally includes:
(1) Practice taking off personal clothing and keeping it in the prescribed method.
(2) Practice wearing clean work clothes according to the prescribed method.
(3) Practice hand washing, drying, and use of special paper towels for gmp clean rooms according to the prescribed methods.
(4) Practice walking without dragging your feet.
(5) Do the cleaning and purification practice of the equipment brought into the gmp clean room.
(6) Practice using firefighting equipment in gmp clean room.
(7) Practice emergency evacuation from gmp clean room.
According to the practice at home and abroad, the following 10 people are not allowed to work in the gmp clean room:
(1) Patients with skin diseases, those with unresolved trauma, and those who have just had their teeth extracted.
(2) Those who have allergic reactions to chemical fibers and solvents.
(3) Those with severe hand sweating.
(4) Excessive nasal secretions.
(5) Those who have a cold, cough or sneeze.
(6) Excessive scalp hair loss.
(7) Those who have the habit of scratching their heads, picking their noses, touching their faces, and rubbing their skin.
(8) Those who did not wash off the cosmetics.
(9) Those who do not rinse their mouths after eating.
(10) Those who fail to wear clean work clothes as required.
According to domestic and foreign practice, personnel entering and leaving the gmp clean room must comply with the following 10 regulations: entering the clean room must be carried out according to the established purification procedures and routes, and must not be changed without permission; coats and clean clothes should be stored in separate places and cabinets. Take off your coat and enter the locker room; at the entrance of the clean area, if there is an air shower room, entering personnel must pass through the shower room, and after closing the door as required, raise your arms in the shower room and turn your body slowly twice; When entering the buffer room, one door must be closed and then the other door must be closed; special shoes must be changed to enter the clean area, and slippers are not allowed to enter the clean room; Then change the sterile clothes; dry the washed hands with a dryer, or dry them with a paper towel with a small amount of dust; wash hands and sterilize after changing into work clothes, and do not operate the purified items with bare hands ; Wear clean work clothes in a standing position, do not let the work clothes touch the ground, workbench and other items that may be dusty; do not wear clean work clothes to go to the toilet, and use the toilet according to the procedures for entering and leaving the gmp clean room.
When working in a gmp clean room, pay special attention to the following 10 items: bathing and changing clothes every day as much as possible; shaving every day as much as possible, especially important for biosafety clean rooms; no contact with powders and solvents that dry the skin ; Wash hands and cut nails often; Be gentle indoors; Wear gloves and finger cots as needed, and do not touch unclean objects, including your own body; Do not walk with feet indoors; When handling clean things, pay attention to It should be carried out on the windward side of the airflow, and unclean and polluted things should be carried out near the return air outlet as much as possible; personal items and items that have not been cleaned according to the regulations should not be brought into the gmp clean room; do not open the zipper on the clothes indoors.
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