Since its promulgation in 1992, China's pharmaceutical industry's "Good Manufacturing Practices" (GMP) has gradually been recognized, accepted and implemented by pharmaceutical manufacturers. Especially in 2001, the State Drug Administration advanced the GMP certification time for pharmaceutical companies to June 30, 2004. GMP is a national mandatory policy for enterprises, and enterprises that fail to meet the requirements within the deadline will stop production.
The core content of GMP certification is the comprehensive management and control of pharmaceutical production quality. Its content is summarized as two parts of software management and hardware facilities. The clean room in the hardware facilities is one of the most capital-intensive parts. After the clean factory is built, whether it can meet the design requirements and whether it meets the requirements of GMP, it will ultimately be confirmed by inspection. During the inspection of the clean room, some of the cleanliness tests were unqualified, and some were part of the plant, as well as the entire project. If the test fails, both parties will pass the rectification, commissioning, and clearing. In the end, the requirements were met, but a lot of manpower and material resources were often wasted, the construction period was delayed, and the GMP certification process was delayed. Some causes and defects are completely avoidable before testing. We found in the inspection work that the main reasons for the unsatisfactory cleanliness are:
1. Unreasonable engineering design
This phenomenon is relatively rare, mainly in the construction of small cleanrooms where the level of purification is not too high. The competition for purification is now fierce. Some construction units have given lower quotations in the bidding in order to get the project. In the later construction, the use of some units that are not very knowledgeable, cut corners, and use the air-conditioned ventilation compressor unit with lower power, so that the supply power and the purification area do not match, resulting in unqualified cleanliness. Another reason is that the use unit has added new requirements and cleaned area after the start of design and construction, which will also make the original design unable to meet the requirements. This congenital defect is difficult to improve and should be avoided during the engineering design phase.
2, replace high-end products with low-end products
In the application of high-efficiency filters in clean rooms, the state stipulates that air purification treatments with a cleanliness level of 100,000 or higher should use three-stage filtration of primary, intermediate and high efficiency filters. There is no shortage of large-scale purification projects using sub-high efficiency air filters instead of high-efficiency air filters on the 10,000-grade purification level, resulting in unsatisfactory cleanliness. The final replacement of the HEPA filter meets the requirements of GMP certification.
3, the air supply pipe or filter seal is not good
This phenomenon is caused by rough construction. It will show a certain room or partial failure in the same system during acceptance. The improved method is to use the light leakage test method to detect the leakage of the air supply pipe, and the filter uses a particle counter to filter the filter. The section, sealant, and mounting frame are scanned to find the leak location and carefully sealed.
4, the return air duct or return air outlet design, debugging is not good
In terms of design, sometimes due to the limitation of space, the "top feed side back" is not used or the number of return air ports is not enough. After the design reasons are eliminated, the debugging of the return air outlet is also an important link. If the debugging is not good, the resistance of the return air outlet is too large, and the amount of return air is less than the air supply volume, which will also cause the cleanliness to be unqualified. In addition, during construction, the height of the return air outlet from the ground also has an impact on the cleanliness.
5. The self-cleaning time of the air-conditioning system is not enough when testing.
The national standard stipulates that the test should be started 30 minutes after the normal operation of the air-conditioning system. If the running time is too short, it will also cause unqualified cleanliness. In this case, it is sufficient to extend the operating time of the air conditioning purification system appropriately.
6, the purification air conditioning system is not cleaned
During the construction process, the entire purification air conditioning system, especially the sending and returning air pipes, is not completed once, and the construction personnel and the working environment will cause pollution of the ventilation pipes and filters. If it is not clean, it will directly affect the test results. The improvement measures are: cleaning while construction, after the pipe installation in the front is thoroughly cleaned, it can be sealed with plastic film to avoid pollution caused by the environment.
7, clean factory cleaning is not thorough
The clean room must be thoroughly cleaned before testing to be tested. The final wiping personnel are required to clean in clean overalls to eliminate the pollution caused by the cleaning personnel. The cleaning agent may be selected from tap water, pure water, organic solvent, neutral detergent, and the like. If you have anti-static requirements, wipe it thoroughly with a cloth dampened with anti-static liquid.
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