In the pharmaceutical industry, the requirements of the process are very strict, the first is the clean studio requirements. The clean room of pharmaceutical factory is a complete embodiment of clean technology, which is mainly divided into industrial clean room and biological clean room. The main task of industrial cleanrooms is to control the pollution of non-biological particles, while the main task of biological cleanrooms is to control the pollution of biological particles.
In the field of air cleaning technology, both non-biological and biological particles are collectively referred to as particles. Whether it is dust or anything else, it has the properties of a particle. As long as the clean room is the way to control the particles is common, both effective to prevent outdoor pollution into the indoor (or effective to prevent indoor pollution from escaping to the outdoor).
GMP is the pharmaceutical manufacturing and quality Management Practice, which is implemented to effectively ensure the safety and quality of pharmaceuticals. GMP is a complete concept, which involves every link of drug production and controls all factors affecting drug quality in the production process. Air cleaning technology accounts for 10% of the GMP standard, and is also one of the hardware to implement THE GMP standard.
Although clean technology is not a decisive factor for GMP, it is a necessary condition and an important guarantee for the realization of pharmaceutical technology. Drugs are special commodities, whose production, scientific research, inspection and storage all need to be protected by clean environment. The application of clean technology in pharmaceutical industry is an organic combination of the generality of clean technology and the particularity of pharmaceutical industry. During the design, construction and operation of clean rooms in the pharmaceutical industry, the relevant standards of clean rooms and the requirements of drug production quality management standards should be followed. The following will be based on the "pharmaceutical industry clean plant design code" in the relevant interior decoration provisions, combined with the experience of senior engaged in pharmaceutical engineering design, talk about the pharmaceutical clean plant clean room design, for reference.
I. Problems existing in the clean room design of pharmaceutical clean plant
1 clean room design can't meet the actual needs of production for the new clean room engineering or large clean room renovation, the owners tend to please formal design institute to carry on the design, and the medium and small clean room project, considering the cost, the owner usually sign a contract with engineering company, let engineering company to undertake the design work. Although the state has issued the national standard (Clean Plant Design Code GB50073-2001, simply known as the design code), some medium and small purification engineering companies cannot correctly understand and apply the above design code. The following problems are often found during testing.
Purpose of Clean room Test The performance test and evaluation of clean room is a necessary step to measure whether the design requirements are met (acceptance test) and to ensure the normal working condition of clean room (regular test) at the completion of clean room construction. The acceptance test includes completion commissioning and comprehensive evaluation of clean room performance.
In some newly built clean rooms, the two stages are often mixed together. It is not advisable to use the adjusted test results of the completion acceptance stage to replace the comprehensive performance evaluation test results, or to use the comprehensive performance evaluation test to replace the comprehensive performance evaluation test results of the completion acceptance stage. The purpose of these two stages of testing is different, and the content of testing is also different. The tests at the completion acceptance stage are mostly focused on adjustment and may be repeated several times. This kind of test is mostly carried out by the construction unit alone. The evaluation and measurement of the comprehensive performance of the clean room shall be conducted after the completion acceptance test and shall be undertaken by a qualified and experienced third party.
Problems existing in clean room operation
The layout of clean room is unreasonable
(2) Clean room cleaning is not standard
When testing the wind speed and cleanliness of local one-way flow in some clean rooms, the wind speed of some places in the same local hundred grade area is often very small, almost zero, and the cleanliness is often beyond the standard.