Aluminum Bio-Clean Cleanroom
The Aluminum Bio-Clean was specifically designed to meet the requirements of the Medical and Pharmaceutical industries as well as the specifications found in USP 797. The Aluminum Bio-Clean design emphasizes particle infiltration as well microbial contamination protection. The Aluminum Bio-Clean can be designed and certified to as clean as Class 10 (ISO 4) up to Class 100,000 (ISO 8) as well as Class 10,000 for USP 797. Each Aluminum Bio-Clean cleanroom can also be outfitted with Class 100 (ISO 5) work zones eliminating the need for (ISO 5) Clean Benches/Hoods. A 30” x 8’ Class 100 work zone which includes HEPA filters, light fixtures, clear vinyl shield (to direct air flow), wall mounted IV bar and a stainless steel table cost ½ the price of a typical 6’ Class 100 (ISO 5) Horizontal Laminar Clean Bench.
The Aluminum Bio-Clean’s design allows it to be used as a totally free standing room, or in a combination with your existing walls and, when available, the ceiling. Each Aluminum Bio-Clean room comes completely factory prefabricated for minimal on-site installation time and is totally self-contained with all components factory-finished. All you have to do is supply electricity and A/C. Average installation time is 2 to 3 days from start to certification.
The Aluminum Bio-Clean cleanroom and its components have the ability to be changed in size and cleanliness levels on site and is almost 100% reusable. So if the need arises, you can take the room (and the investment) with you. Depending on your specific needs, the Aluminum Bio-Clean can be supplied with interior or exterior Gowning/Anti rooms. Interiors walls can be added to separate or enclose equipment or processes as dictated by your needs.
Each Aluminum Bio-Clean can be designed with manual or powered doors as large as 4’ x 8’, double doors and automatic sliding doors. To assist in controlling contamination within the cleanroom, walls can be fitted with a standard Pass-Thru(s) or larger Cart Pass-Thru(s).
Vertical aluminum component posts are hollow and can be fitted with surface mounted light switches and 110v outlets. Phone and data lines can also be installed during the construction or later.
The Aluminum Bio-Clean room can accommodate either fan powered or ducted HEPA filters. (99.99% min. on .3 microns). In cases where ceiling height or obstructions at the ceiling are an issue, HEPA filters can be installed and attached to the wall in a horizontal position. Rooms with the side mounted option have been tested and passed cleanliness levels of CL.1,000 and better.
An option recommended in USP 797 is “Room Side Replaceable HEPA filters (RSR), a popular option that allows the HERP to be replaced without breaking the seal within the Cleanroom. Filters can also be supplied with A/C collars allowing ducted return air or direct connection to air conditioning.
Light fixtures are specifically design to meet the contamination control requirements found in all cleanrooms from Class 100,000 (ISO 8) to Class 10 (ISO 4) and come sealed on the top and have gasketed doors to access light bulbs.
Air flow patterns and room pressurization is controlled with dampered control exhaust louvers. The louvers are typically located low on the wall panels and aid in the control of dead air spots, can be adjusted to restrict air from exiting the room and reduce the chance of infiltration from either fan or power failure.
While the Aluminum Bio-Clean room addresses the need to remove particles from the air, it also has options that reduce or eliminate the chance of contamination from being introduced inside of the room. The addition of a Pass-Thru in the wall allows products to be passed in and out of the room without the need for the technician to leave the cleanroom. The Aluminum Bio-Clean is one of the only cleanrooms that offers a Scrub Panel – this panel is manufactured from the same materials of a standard panel, except the clear acrylic panel is replaced with a ridged panel that is easily cut to allow access of piping and can support the weight of a pedestal sink. You can also attach an automatic Hands Free Soap Dispenser, and or Hands Free Hand Dryer.
The Bio-Clean is a semi-rigid, modular, softwall cleanroom designed around the concerns found in the medical industries for microbial contaminants as well as the more stringent airborne particulate requirements found in the Micro-Electronics, Aerospace and Hi-Tech Markets. The Bio-Clean has been specifically designed to meet and exceed the standards required in the IV, Home infusion and Compounding pharmacy markets. Rooms have been installed in Pharmacies, Hospitals and in Hi-Tech companies all over the North and Central America and in Europe.