In the cleanroom world, the space that you are willing to allocate to your clean operations is what you will have for the next couple of years.
Making the right decision is hard, costly and requires a lot of thinking before committing to any solution. What we think is the best starting point is deciding on the classification levels the room needs to meet and what regulations you’d like your room to be compliant with.
No matter the space you can allocate for this purpose, always keep in mind that not all rooms are designed to meet the classification levels they are supposed to keep up with. With some of our designs we have proven that no matter what the space allocations are, we can always design a cleanroom that will be suitable for your current and projected productivity needs.
One of the most important things that the regular architecture and contractor specialist are having issues with, is the room design and layout. Our approach assures that when working alongside the contractors or the A/E teams, we’ll come through with the design that will have the lowest operational costs. That’s mainly because we account for the airflow not only by the room design itself but by accounting for all of the equipment that will be placed inside of the room and is a potential airflow disturbance hazard.
Our design team has been involved in the development of some of the smallest rooms that are even USP <797> and USP <800> compliant. The challenges we’ve managed to overcome are far beyond having simple space limitations. Our goal is always to be focused on financial constraints providing the most cost-effective solution. Our approach is to always utilize the existing plumbing, electrical circuits, and ductwork because renovating and upgrading any or all of these is a process that always leads to major downtime of operations due to construction and renovation.
Usually, we are hired to come in prior to, or in conjunction with A&E firms to work with pharmacy staff to provide a good conceptual design for USP797 & 800 compliance and future A&E implementation. Getting us involved in the A&E project assures you that you will get a USP compliant clean room while getting the best workflow for your pharmacy personnel.
One of the solutions we provide that is completely effective for cleanrooms with high production levels is the semi-modular prefabricated units, that can be installed within a couple of working shifts. This types of installs are usually handled by a team that has been trained for the proper cleanroom behavior and gowning techniques, assuring that the installation of the prefabricated units, won’t be a process that will shed a lot of particles and contaminates the clean areas.
On the drawing to the left is a Massachusetts pharmacy that had its primary engineering controls in a noncompliant clean room. The two hoods to the left were sterile hoods and the one hood to the right was a Chemo.
For a very reasonable fee, and in a matter of a few weeks, we can come to your facility for an engineering controls evaluation and provide a conceptual design.
The conceptual design shown to the right was part of out “turn-over” package we submitted prior to getting the order to actually implement and construct the design.
To make this room compliant, we segmented the existing clean area into three rooms.
A large ISO-class VII anteroom (has to be ISO-class VII because it is connected to a negative pressure buffer room), separated into a dirty and clean area. We created a gowning area in the anteroom adding a sterile air shower and low wall return.
We sealed off the Chemo hood making a negative pressure USP 800 grade secondary engineering control and added additional air supply and low wall return to meet the ISO-class VII requirement.
We would recommend the addition of a surveillance system with mobile monitoring capability so that aseptic technique can be evaluated.
We can custom design a clean room for your application in a very short period of time, and the components can be assembled on your site faster than you ever thought possible. We take pride in the fact that our clean rooms are the highest quality available, and best of all, we offer rock bottom clean room pricing that absolutely can’t be beat.
Our clean room company is all about design, shipping, fabrication, and customer service efficiencies that save us money – savings, of course, that we pass on to you. You’re looking for a reliable company that will ship your clean room to you on time, arrange for professional installation on your site, and back it all up with customer service that will make you smile.
Currently, we have approximately 15 such jobs in-house, and we have performed several hundred USP compliance jobs since launching the Aseptic Enclosures division in 2005.
We are contracted with several GPOs providing the most competitive pricing on the market, please do not hesitate to get in touch and request a preliminary meeting.
Typically, by us getting involved in jobs early, we can save facilities a tremendous amount of professional fees, overall project cost, and long-term operational costs.
Aseptic Enclosures first entered into this segment back in 2005 and has been gaining extensive experience with every challenge we are faced with.
Since that time our product line has grown to be the most comprehensive range of solutions for USP 797 and USP 800 compliance.
Please contact us at 1-800-418-9289 and let us know how we can help!
