USP 797 Clean room & USP 800 Clean room- FastIns Modular Cleanroom Project
Project: USP797&800 compliant modular cleanroom Design temperature/RH: 18-26℃/45-65% Industry: Pharmaceutical Cleanroom |
Characteristic:
1.1.USP 797 Cleanroom & USP 800 Cleanroom compliant:
Cleanroom is designed and manufactured as per USP 797&800, with anteroom and buffer room and pressure gradient between areas of differing ISO classification, positive for sterile compounding and negative for hazardous drugs, realizing isolated preparation to avoid cross contamination.
2.HVAC system to maintain proper Temp. and RH:
As required by USP, cleanroom suite should be maintained at a temperature of 20℃or cooler and a relative humidity below 60% to minimize the risk for microbial proliferation and provide comfortable conditions for compounding personnel attired in the required garb. This cleanroom is designed with HVAC system to keep stable working conditions.
3.Custom-made double-deck pass box
As per USP, before any item is introduced into the cleanroom, it should be placed into pass-through(s).
This cleanroom is equipped with pass box and custom double-deck pass through to separate the transfer in a space-saving way.
4.Pressure gradient as per USP:
As written in USP, a minimum differential pressure of 0.02-inch water column(5Pa) is required between each ISO classified area. Airkey prefabricate and calibrate the air pressure before delivery.
5.Excellent performance, up to standard
All parameters (class, pressure, etc.) have passed the tests, well accepted by customers