Production of medical appliances is promised to be refined and and boosted following the completion of a new cleanroom, designed, manufactured, pre-tested by Airkey. This is a ISO7 modular cleanroom facility for medical devices, the owner of which is eager to follow the GMP regulation for making devices. In addition, this cleanroom is required to maintain constant temperature and humidity (TEMP18-22°C/RH30-40%)
In terms of structures, the cleanroom adopts sandwich panels and double-sided tempered windows, which have high thermal and noise insulation performance, stably keeping desired conditions. Change room is designed for personnel entrance and exit, and pass boxes for materials, both equipped with interlocking for preventing cross contamination.
According to production needs, the clenaroom is designed with air conditioning units and dehumidifier, which are easy to install and operate. Recirculating filter units (RFU) are installed to recycle the clean air, saving energy.
Components like frames, wall panels, ceilings are all prefabricated and assembled before shipment, making it much easier for installation. In this case, 72 square meters cleanroom can be installed by 4-5 local workers within 4-5 days.
Airkey will conduct pilot tests and, if required, send all necessary documents to the customer such as 4Q documentation, test reports to help pass local GMP validation.
In addition, Airkey also supply the cleanroom furniture for the clients. The cleanroom furniture mainly are movable cart, storage cabinet, work table, office chairs etc to be used in cleanroom. The size and configuration can be negotiated. Airkey will provide the final drawing for confirmation before starting the production.
The Specifications of this project:
Project: Medical Appliance Modular Cleanroom
Area: 72 m2
Inner height:2.4m
Class: ISO 7(Class 10,000);
Design temperature/RH:18-22°C/30-40%
Industry: Medical Appliance
Location: Hungary
Website: www.airkeyx.com
