Airkey customises USP 797&800 compliant Fast-Installation Modular Cleanroom

Published: 18-Jul-2024

The China-based company Airkey builds modular cleanroom in compliance with USP 797 & 800 for a Panama pharmaceutical client

Airkey has been dedicated to creating sterile and dust-free space for pharmaceutical-related companies in accordance with GMP, USP, ISO14644 and other regulations. 

Airkey customises USP 797&800 compliant Fast-Installation Modular Cleanroom

Over the past month, Airkey has designed, fabricated, assembled and tested the Fast-Installation Modular Cleanroom in Airkey factory, providing one-stop solutions and guaranteeing high quality.

Airkey customises USP 797&800 compliant Fast-Installation Modular Cleanroom

The cleanroom is designed and manufactured with anteroom and buffer room to segregate different production areas. Pressure gradient between areas of differing ISO classification is properly maintained, positive for sterile compounding and negative for hazardous drugs, realizing isolated preparation to avoid cross contamination.

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 of 18-26℃ and RH 45-60%.

Airkey customises USP 797&800 compliant Fast-Installation Modular Cleanroom

USP also requires a minimum differential pressure of 0.02-inch water column (equivalent to about 5Pa) between each ISO classified area. Airkey prefabricate and validate the air pressure before delivery.

Airkey prefabricates and pre-assembles the cleanroom before delivery, making the installation a piece of cake for customers. Additionally, FAT testes are necessary to make sure customers get what they expected.

Website: www. airkeyx.com

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