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Class A high-risk operation areas, such as: filling areas, areas where rubber stoppers are placed, open ampoules, open vials, and areas for aseptic assembly or connection operations A laminar flow console (hood) is usually used to maintain the environmental status of the zone. The laminar flow system must supply air evenly in its working area, with a wind speed of 0.36-0.54m / s (guide value). There should be data to prove the state of the laminar flow and must be verified. In closed isolation manipulators or glove boxes, one-way flow or lower wind speeds can be used.
Level B refers to the background area where high-risk operations such as aseptic formulation and filling are located.
Class C and D refer to the clean operation area with low importance in the process of producing sterile drugs.
Cleanliness level
Maximum allowable number of suspended particles / m3
Static
dynamic
≥0.5μm
≥5μm
≥0.5μm
≥5μm
Class A
3520
20
3520
20
Class B
3520
29
352000
2900
Class C
352000
2900
3520000
29000
Class D
3520000
29000
No rules
No rules
instruction manual:
A grade is 100 grades, the background environment of A is higher, the requirements are stricter.
Grade B is grade 10,000.
Class C is equivalent to one hundred thousand.
Class D is equivalent to class 300,000.
1. Inspection and maintenance of the main structure of the purification workshop of the pharmaceutical factory
1. Monthly inspection of the periphery of the purification plant of the pharmaceutical factory, including doors and windows, lamps and lanterns in the auxiliary room, air curtain, fly killer, mouse repellent and other facilities, if problems are found, report and repair in time and make records.
2. Monthly inspection of the technical interlayer, color steel plate structure, sealed doors, windows and transfer windows, pools, ground epoxy layer, etc. of the purification workshop of the pharmaceutical factory, and found that the leakage and degumming, door and window deformation and air leakage, ground damage, etc. are reported for repair and record. For the facilities that can not be stopped, arrange for maintenance during the shutdown overhaul.
3. Check the lighting, emergency lamps, ultra-clean table, air shower room, sterilizer and other equipment of the purification workshop of the pharmaceutical factory every week, and report and repair the problems in time.
4. Fire-fighting and monitoring systems in the purification workshop of the pharmaceutical factory are routinely inspected every month, and if problems are found, they shall be reported to the maintenance and recorded in time (the safety door shall not be opened arbitrarily without the approval of the quality control department).
5. No open flame shall be used for maintenance in the purification workshop of the pharmaceutical factory. During the maintenance process, it is not allowed to cause pollution to the workshop and drugs.
Second, the maintenance and repair of the purification air-conditioning system in the purification workshop of the pharmaceutical factory
1. The air conditioning system in the clean area should be operated by a special person with a certificate, and the temperature, humidity, wind pressure, water temperature, high and low pressure of the clean air conditioning system should be checked and recorded every two hours.
2. The maintenance and maintenance of air conditioning units and fans must be carried out in strict accordance with the "Air Conditioning Unit Maintenance Regulations".
3. Filters at all levels used in the purification air-conditioning system must be selected from designated manufacturers according to purification requirements and must have the qualification certificate provided by the manufacturer, and must not be polluted and damaged during transportation and installation.
4. The reusable filter should be cleaned in time after being replaced and checked by qualified personnel for safekeeping for reuse. The replacement cycle is as follows:
(1) Change the fresh air filter cloth once a week (the filter cloth can be washed and reused once).
(2) Change the filter cloth of the return air inlet once a month (the filter cloth can be washed and reused again).
(3) Change the medium-efficiency filter bag every six months (the filter bag can be washed once).
5. According to the purification test results and the final resistance displayed by the differential pressure gauge, replace the high-efficiency filter every 1-2 years.
6. The cleaning and replacement of the filter device must be carried out in strict accordance with the assembly and disassembly procedures, on the premise of meeting the requirements of the GMP purification workshop, to avoid pollution, and make a record of filter replacement.
3. The personnel entering the purification workshop of the pharmaceutical factory require that the personnel entering the purification workshop of the pharmaceutical factory must have regular physical examinations, often protect their personal cleanliness, and have no skin diseases or traumas. The rules of the implementation.
4. Cleaning and disinfection of the purification workshop of the pharmaceutical factory The cleaning workshop of the purification workshop of the pharmaceutical factory can be cleaned with chlordiazepam and chlorhexidine acetate, and disinfection is alternately used with propylene glycol and formaldehyde to prevent resistance. "Program" execution.
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