Pharmaceutical packaging plays a key role in the safety and stability of medicines. Effervescent tablets are a special kind of tablets that also have strict requirements on packaging, especially in the production environment. In China's "Administrative Measures for Pharmaceutical Packaging Materials and Containers", the management requirements for the clean area of effervescent tube manufacturers are as follows:
1. 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 basic knowledge of hygiene and microbiology, clean operations, etc.; temporary foreign personnel entering the clean room (area) should be guided and supervised.
2. Buffer facilities must be set up between the clean room (area) and the non-clean room (area), and the direction of people and logistics is reasonable.
3. Various pipes, lamps, seals and other public facilities in the clean room (area) should be designed and installed to avoid difficult-to-clean parts during use. The surface of the equipment insulation layer should be smooth and clean, and no particulate matter should fall off.
4. Sanitary tools that do not fall off, are easy to clean, and are easy to disinfect should be used in the clean room (area). The sanitary tools should be stored in a designated place that does not pollute the product, and the use area should be restricted.
92mm*21mm plastic tube for effervescent tablet
5. The clean room (area) should provide adequate lighting according to production requirements. The illuminance of the main studio should be 300 lux; the production parts with special requirements for illuminance can be equipped with local lighting. The workshop should have emergency lighting facilities.
6. The windows and ceilings of the clean room (area), and the pipes, vents, and connections between lamps and walls or ceilings that enter the room should be sealed. The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5 Pa, the static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 10 Pa, the static pressure between the clean room (area) and the non-clean room (area) The pressure difference should be greater than 5 Pa, and there should be a device to indicate the static pressure difference.
7. The temperature and relative humidity of the clean room (area) should be compatible with the production process of pharmaceutical packaging materials. When there is no special requirement, the temperature should be controlled at 18-26℃, and the relative humidity should be controlled at 45-65%.
8. The number of dust particles, the number of floating bacteria or the number of sedimentation bacteria detected in the clean room (area) under static conditions must meet the requirements, and the cleanliness under dynamic conditions should be monitored regularly. Timely monitor the number of air changes, static pressure difference and other parameters. All monitoring results should be recorded and archived.
9. The pool and floor drain installed in the clean room (area) shall not pollute the products produced. Floor drains are not allowed in the class 100 clean room (area), and operators should not operate with bare hands. When it is unavoidable, hands should be disinfected in time.
10. The transmission equipment used in the 10000 clean room (area) shall not pass through the lower-level area.
11. Clean work clothes above 100,000 level should be washed, dried and sorted in a clean room (area), and sterilized as required if necessary.
12. The air purification system should be cleaned, repaired, maintained and recorded as required.
The above are the management requirements for the clean area of effervescent tube manufacturers. High-quality packaging is not only reflected in the production environment, but strict control of the raw materials used in packaging, production processes, and testing environments must be carried out.
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