ISO 8 Softwall Cleanroom

The ISO 5 Softwall Cleanroom from Deiiang is used by several of our customers for aseptic filling of pharmaceuticals, medical device packaging and for compounding pharmacy. Like the hardwall rooms the ISO 5 Softwall Cleanroom is able to deliver the same air cleanliness in terms of particles, airflow and pressure differential. But that's where the similarity ends and in fact the Softwall Cleanroom has several advantages above the hardwall versions. Chief among these advantages is flexibility – softwall versions are generally easy to move around to accommodate other pieces of equipment. Because we design these rooms to be validated in terms of particle counts, airflow, pressure differentials etc., as with any other classified space, they can be used for GMP (Good Manufacturing Practice) pharmaceutical/medical device work and USP (United States Pharmacopeia) type applications.

In terms of our clients are surprised at how fast they can be up and running in an ISO 5 Softwall Cleanroom. Typically, a small team of people can have a standard ISO 5 Softwall Cleanroom set up in a day or two, or even in under 8 hours. This is because the Softwall Cleanroom is a modular softwall system that can be bolted together in an empty room to form a clean zone. The frames are made of aluminum and the anti-static PVC curtains are then hung from the frame. The Fan Filter Units (FFU's) can then be integrated into the Softwall Cleanroom.

Of course there is Static generation. We can use anti-static PVC. We have tested this material for Surface resistivity. Typical readings for our curtain material are between 10⁶ and 10⁸ ohms/square (it safely dissipates static electricity, rather than storing it and thus attracting dirt & dust). The static from people is also dissipated by grounding during installation. We can give step-by-step instructions for how to do this.

As mentioned previously, airflow is directed downward through FFUs from the ceiling of the clean room, providing a unidirectional flow of HEPA-filtered air, which pushes all particles in the room toward the floor and out of the room. In softwall clean rooms, the walls are not a hermetically sealed enclosure, but rather a means of containing a positive air pressure within the clean zone. This pressure can be greater than the surrounding area by as much as 2.5 Pascal. Even with slight leaks through the seams of the curtain, the air leaking out of the clean room through the walls will be clean air, not contaminated air entering the clean room through the leaks. As a result, the containment provided by the softwall will be effective as long as the design provides adequate air velocity and adequate pressure.

This is not a temporary solution for a short period of time. Many of our customers use softwall cleanrooms for years, some even up to 7 years for aseptic filling, others for packaging of medical devices, or for preparations in a pharmacy. The aluminum frame is robust and made for long term use. Also the curtains used for the softwall are very durable and can be replaced, if needed. Because a softwall cleanroom is made of modules, it is easy to change the configuration, to move it to another location or to upgrade the filtration. For many users a softwall cleanroom is a permanent part of their lab or production site.

First of all, softwall cleanrooms can be significantly cheaper than hardwall cleanrooms. The cost savings of an ISO 5 Softwall Cleanroom can stem from two areas: 1) lower material cost, and 2) lower labor cost for construction. High quality PVC softwall cleanroom curtains are generally much less expensive than solid acrylic or sandwich panels used in hardwall cleanrooms. But the bigger cost savings is the reduction in construction time and associated labor costs. A typical ISO 5 Softwall Cleanroom can be completely installed and operational in a matter of hours as opposed to weeks for a hardwall cleanroom. And once installed, a Softwall Cleanroom can be easily disassembled and relocated to another part of the facility or to a different facility if needed. This makes a Softwall Cleanroom a very cost effective solution for companies with limited space or that need to move frequently from place to place.