The main reason for the design of pharmaceutical clean production plants affecting product quality

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 net facility control procedures will affect the quality of products. The reason for the impact of product quality on the construction is that there are problems in the process control process. There are hidden dangers in the process of installation and construction, and the following specific performances are as follows:

(1) The inner wall of the air duct of the purification workbench system 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 closed door is not closed;

(3) Decorative profiles and process pipelines form dead angles 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;

(5) The quality of the sealant used is not good, easy to fall off, and deteriorated;

(6) The back and exhaust wind color steel plates are connected to each other, and the dust is discharged from the air to the return air passage;

(7) The inner wall weld is not formed when the stainless steel sanitary pipe such as process purified water or injection water is welded;

(8) The airway check valve fails to operate, and air backflow causes pollution;

(9) The installation quality of the drainage system is not good, the pipe racks and accessories are easy to accumulate dust;

(10) The pressure difference of the clean room purification workbench is unqualified and fails to meet the production process requirements.