Challenge for environment

Cleanroom which meets the YY0033-2000 Aseptic Medical Devices Production Management Standard is one of the preconditions 

to ensure the quantity of medical devices and components. From the factory address choosing, layout arranging to people flow and 

material flow planning, how to ensure every key point will meet the demand of FDA or YY0033-2000 Aseptic Medical Devices Production 

Management Standard? Will cleanroom construction meet the requirement of cleanroom planning? How to control the cleanroom condstruction 

during the whole process? How to make sure the cleanroom will pass the check of quality testing department?

Solution
 

Airkey are professional in providing environment solutions that comply with GMP, FDA, ISO14644, IEST and 

EN1822, etc. 

And also Our solutions apply the newest energy-saving techniques. 

We are able to provide GMP cleanroom package solutions including cleaning of personnel and goods, cleanroom air-condition system, cleanroom decoration system, energy-saving renovation, water and electrical system planning, ultra-pure gas pipe system, cleanroom monitoring, cleanroom maintenance, etc. Our clean room and pollution control techniques are important means to ensure the successful GMP implementation.

Design requirement for AHUs in operating rooms：
● The cabinet is easy to maintain.
● The stainless steel internal plate is provided.
● The cabinet interior is easy to clean.
● The multi-level filter has high dust-holding capability and low resistance.
● The head-on air speed of the cooling coil is less than or equal to 2.5 m/s.
● Double-slope design is adopted for the stainless steel water collector to discharge water rapidly.
● Precise control on constant temperature and humidity is provided (humidity has a preference).

Configuration description：
● The cabinet:Easy to assemble and disassemble.
● Internal plate: A stainless steel plate.
● Unhoused centrifugal fan
● Prevent contamination caused.
● Fan speed is adjusted in real-time to ensure stable air pressure.
● A three-level filter (G4/F7/F9):high dust-holding capability and low resistance.
● UV lamp: remove bacteria on the filter.
● An ozonizer or anion generator:on the air outlet section, greatly reduces harmful materials.
● The cooling coil is installed on the positive pressure section. A double-slope stainless steel water collector is installed to discharge condensate water rapidly and control the growth of  bacteria.
● A secondary dry steam humidifier is adopted on the humidifier section so that air exhaust conditions can be precisely controlled.

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.