Bio-manufacturing Dustproof Room
Release time:2019-09-27 source:
Characteristics of Dustproof Room in Biopharmaceutical Factory:
1. Biopharmaceutical factories not only have high equipment costs, complex production processes, high requirements for cleanliness and sterility, but also have strict requirements for the quality of production personnel.
2. Potential biological hazards will occur in the production process, including infection risk, toxicity, sensitization and other biological reactions of dead bodies or dead cells and components or metabolism to human and other organisms, toxicity, sensitization and other biological reactions of products, and environmental effects.
Clean area:
The building structure, equipment and use of rooms (areas) that need to control dust and microbial contamination in the environment can prevent the introduction, generation and retention of pollutants in the area.
Air lock room:
An isolation space with two or more doors between two or more rooms, such as rooms with different cleanliness levels. The purpose of setting air lock is to control the air flow when people or materials enter and exit. Air lock room is divided into personnel air lock room and material air lock room.
The basic feature of biopharmaceutical dust-free room is that dust particles and microorganisms must be taken as environmental control objects. The cleanliness of Pharmaceutical Workshop is divided into four levels: 100, 1000, 10000 and 30000 under the background of 100 or 10000.
Dustless room temperature: without special requirements, at 18-26 degrees, the relative humidity is controlled at 45%-65%. Pollution Control of Biopharmaceutical Clean Workshop: Pollution Source Control, Dissemination Process Control, Cross Pollution Control. The key technology of medicine in purification room mainly lies in controlling dust and microorganism. As a pollutant, microorganism is the most important part of environment control in purification room. The contaminants accumulated in the equipment and pipelines in the clean area of the pharmaceutical factory can directly pollute the drugs, but it does not affect the cleanliness test. The cleanliness level is not suitable for characterizing the physical, chemical, radioactivity and life of suspended particles. Not familiar with the production process and process of drugs, not knowing the cause of pollution and the place where pollutants accumulate, not knowing the methods and evaluation criteria of removing pollutants.
GMP technology renovation of pharmaceutical plant engineering generally exists the following situation:
Because of the subjective misunderstanding, the application of clean technology in the process of pollution control is unfavorable. Eventually, some pharmaceutical factories have invested a lot of money to reform, and the quality of drugs has not improved significantly.
The design, construction, manufacture and installation of equipment and facilities, raw and auxiliary materials for production, quality of packaging materials, and unfavorable execution of control procedures for net human and material facilities will all affect the product quality. The reason that affects the quality of products in construction is that there are problems in process control and hidden dangers in the process of installation and construction.
(1) The inner wall of the air duct of the purified air conditioning system is not clean, the connection is not tight, and the air leakage rate is too high;
(2) The enclosure structure of color steel plate is not tight, the sealing measures of dust-free room and technical interlayer (ceiling) are improper, and the sealing doors are not closed;
(3) Decorative profiles and process pipelines form dead corners and dust deposits in the clean room;
(4) Individual locations are not constructed in accordance with the design requirements and cannot meet the relevant requirements.
The quality of the sealant used is not satisfactory, easy to fall off and deteriorate.
_Return and exhaust air color steel plate are interlinked, dust from exhaust air to enter the return air duct;
_The inner wall welds of stainless steel sanitary pipes such as purified water and injection water were not formed during welding.
_The air duct check valve fails to operate and air backfilling causes pollution.
_The installation quality of drainage system is not up to standard, and the pipe racks and accessories are liable to accumulate dust.
_The setting of pressure difference in dust-free chamber is not qualified, which fails to meet the requirements of production process.