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Bio-pharmaceutical clean room

Bio-pharmaceutical clean room

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Challenge for environment

Good manufacturing practice The aim of GMP is to establish a scientific and rigid aseptic pharmaceutical production environment that 

accord with techniques,operation and management system. Potential biological activity, and dusts, heat source pollution should be 

avoided to the maximum. How to work out the reasonableplanning and construction? How to make sure they will pass GMP or FDA? 

How to reduce the most cost and meet the requirement of GMP and FDA?


 


Solution

With many years’ experience and indepth research on manufacturing environment of bio pharmacy, we know very well the key point to control environment during bio pharmacy industry. 

Energy-saving is a key point to consider in our package solution proposal. 

We are professional in providing the package solution that accord with GMP, FDA, ISO14644, IEST, EN1822.

Our clean room and pollution control techniques are important means to ensure the successful GMP implementation.

 

Design requirement for AHUs in comprehensive preparation workshops:
●The air conditioner complies with Good Manufacture Practice (GMP).
●The cabinet interior is tidy without dust accumulation.
●The cabinet is easy to maintain.
●A flame-proof variable-frequency motor and a spark-proof fan are configured.
●Epoxide resin spraying treatment is applied to the fan.
●Double-layer fireproof and anti-corrosion flexible connection pipes must be connected at the fan outlet.
●Air must be dehumidified completely.
●The dehumidification media: nontoxic, nonflammable, and is highly adsorptive. Secondary return air can be used to reduce energy consumption.
●A heating coil and a dry stream humidifier are provided to adjust air temperature and humidity precisely.

 

 

 

Configuration description:
●Fresh air is transferred through the desuperheating coil section to adjust the air temperature to the dew temperature, which improves dehumidifier efficiency.
●The steam heating coil heats up air using vapor source.
●The secondary steam humidifier provides clean steam to adjust air temperature.
●The variable-frequency motor is directly connected to the unhoused centrifugal fan   
●Prevent contamination by belt spinning.
●Fan speed is adjusted in real time based on the system resistance to ensure stable air pressure
●A disposable cabinet-type efficient filter.
●Reduce contamination caused by harmful materials generated during filter removal.

 

Note: The above configuration is for reference only. The actual configuration of all units must be based on specific customer  requirements. For details, please contact Airkey.