Differences between medical purification and electronic purification
The key technology of the clean room of the pharmaceutical factory is mainly to control dust and microorganisms. As a pollutant, microbes are the most important environmental control of the clean room of medical plants. The equipment in the clean area of ​​the medical plant and the pollutants accumulated in the pipeline can directly pollute the medicine without affecting the cleanliness test. Therefore, we say: GMP requires air purification technology, and air purification technology does not represent GMP! The cleanliness level is not applicable. Characterizes the physical, chemical, radiological, and vital properties of suspended particles. Unfamiliar with the production process and process of pharmaceuticals, do not understand the causes of pollution and the accumulation of pollutants, do not master the methods and evaluation criteria for the removal of pollutants, and think that the clean room that meets the requirements for cleanliness can produce high-quality drugs. A big mistake on the ground.
GMP technology transformation of pharmaceutical plant engineering generally exists in the following two situations:
(1) Due to the misunderstanding of subjective cognition, the application of clean technology in the process of pollution control is unfavorable. Eventually, some pharmaceutical companies have invested heavily in the transformation, and the quality of the drug has not improved significantly.
The design and construction of pharmaceutical clean production plants, the manufacture and installation of equipment and facilities in the plant, the quality of raw and auxiliary materials used for production, the quality of packaging materials, and the unfavorable implementation of the control procedures for net facilities of human nets will affect product quality.
After analysis, it is believed that the reason for the impact of product quality on the construction is that there are problems in the process control process, and there are hidden dangers in the installation and construction process, which have the following specific performances:
1 Clean air conditioning system The inner wall of the air duct is not clean, the connection is not tight, and the air leakage rate is too large;
2 The color steel plate enclosing structure is not tight, the sealing measures of the clean room and the technical interlayer (ceiling) are improper, and the sealed door is not closed;
3 Decorative profiles and process pipelines form dead corners and dust in the clean room;
4 The individual locations are not constructed in accordance with the design requirements and cannot meet the relevant requirements;
The quality of the sealant used in 5 is not good, easy to fall off, and deteriorated;
6 times, the exhaust wind color steel plate is connected, the dust from the exhaust air to the return air passage;
7 Process stainless steel sanitary pipes such as purified water and injection water are not formed when the inner wall weld is welded;
8 airway check valve malfunctions, air pollution causes pollution;
9 drainage system installation quality is not closed, pipe racks, accessories are easy to accumulate dust;
10 The pressure difference of the clean room is unqualified and fails to meet the production process requirements.
Therefore, for each professional installation engineering company, regardless of whether the cleanliness is high or low, the clean room construction must be done for the pharmaceutical company to control the process before the pollution source enters.
(2) Most pharmaceutical companies' clean room HVAC systems have poor energy-saving effects, resulting in unnecessary expenditures and increasing the production costs of medicines.
For example, some pharmaceutical purification plants are barely qualified when they are in air or static test cleanliness. Under dynamic testing (production) conditions, the cleanliness is not ideal; therefore, the air conditioning unit has to be set to Max operating conditions (so The number of gas reaches a relative maximum) to achieve indoor cleanliness. The increase in the number of air changes will inevitably lead to increased energy consumption, unnecessary expenditures, and increased production costs of drugs.
Some pharmaceutical investors have reduced the requirements of design requirements to save initial investment, and purchase relatively inexpensive equipment such as chillers, pumps, fans and medicine machines. These seemingly cheap equipments are inefficient and quietly consume energy. Investors are not worth the candle.
Some process equipments have large fluctuations in exhaust air volume during operation, and no variable air volume exhaust fans are used to achieve energy saving; more exhaust air heat is not recovered.
Pongee Fabric,Dyeing And Printing Fabric,Garment Shell Lining Fabric,240 T Pongee Fabric
Zhejiangxingyuanda Textile co.,ltd , https://www.xingyuandatex.com