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GMP standard Biopharmaceutical Plant Clean Room features:

2014-08-13 22:24:09

Biopharmaceutical facility features:

      1 , bio-pharmaceutical factory not only the high cost of equipment , the production process is complex , clean and sterile requirements of high -level , but also on the quality of the production staff have strict requirements.

      2 , in the production process will be potential biological hazards , mainly ( the risk of infection , or dead cells and dead cells or components of the human body and other biological metabolic induced toxicity, allergic reactions and other biological products induced toxicity , sensitization and other biological reactions , environmental effects. )


Clean area (Clean Area):
      The need for environment pollution control dust and microorganisms’ room (area), its architectural structure, equipment and the use of both pollutants within the region have introduced to prevent the generation and retention functions.
      Airlock between the (Air Lock):

      Disposed between two or more rooms (e.g., different levels of cleanliness of the room) or door with a two fan isolated space. Purpose airlock between persons or materials in and out during the time of flow control. There are points between the airlock between the personnel and material air lock between the air lock .


The basic characteristics of biopharmaceutical clean workshop: is a must to dust particles and microbes for environmental control object.

Pharmaceutical production plant cleanliness is divided into four levels: local class100 or under class10000 background area up to 100class, 1000class, 10000class and 30000class.
      Clean room temperature: In no special request, at 18 to 26 degrees, the relative humidity at 45% to 65 %.

      Biopharmaceutical clean plant pollution control: pollution control, process control the spread of cross contamination control.

 

Pharmaceutical factory clean room key techniques are to control dust and microorganisms, as pollutants, microbe’s pharmaceutical factory clean room environment control a top priority. Pharmaceutical plant equipment clean area, the accumulation of pollutants in the pipeline can be directly contaminated drugs, did not affect the cleanliness testing, so we say: GMP need air purification technology, and air purification technology does not mean GMP! Cleanliness rating does not apply to characterize the physical properties of suspended particles, chemical, radiological and life. Not familiar with the drug production process and the process, do not understand the reasons for the pollution and pollutants accumulate in place, do not have the removal of contaminants methods and evaluation criteria.

 

GMP pharmaceutical plant engineering transformation prevalence of the following conditions:
      Precisely because of the existence of errors subjective understanding, clean technology in pollution control process adversely, eventually after some pharmaceutical companies invested heavily in the transformation, did not significantly improve the quality of medicines.
      Clean pharmaceutical production plant design, construction, equipment and facilities of the plant manufacturing, installation, manufacturing execution, and this will adversely affect the quality of products with raw materials, packaging materials, quality, and human net material net facility control procedures.

 Construction aspects affect product quality control aspects of the process because there is a problem, leaving hidden in the installation and construction process, there are specific performance:

duct inner wall of the air conditioning system is not clean , the connection is not tight, leakage rate is too large ;
      
color steel containment structure is not tight, clean room with improper technique mezzanine ( ceiling ) of sealing measures , closed the door is not sealed ;
      
decorative profiles and process piping in a clean room to form a corner , dust ;
      
individual position is not in accordance with the design requirements and construction, can not meet the relevant requirements of regulations ;
      
used sealant quality tests, easy to fall off , deterioration ;

Return, exhaust sandwich plate lined interlinked, dust from the exhaust to enter the return air duct ;
      
craft purified water, water for injection and other stainless steel sanitary pipe inner wall of the welding seam unformed ;
      
air duct valve action failure , the air pollution caused by intrusion ;
      
drainage system installation quality , but off , pipe rack , attachments easy dust ;
      
cleanroom pressure tuning failed, failed to meet the production process requirements.

 


Filling Area


cultivate liquid center


Diagnostic reagents

Medical Devices

Hall

GMP standard Pharmaceutical Clean Room Workshop


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