Recirculating modular cleanrooms recirculate the air within the cleanroom and prevent it from mixing with outside air, providing better control of temperature and humidity. Air is recirculated back to the high-efficiency particulate absorbing, or HEPA, filters located in the cleanroom’s ceiling. This is accomplished via air return chambers built in to the room’s walls or through existing walls of the building.
Recirculating cleanrooms will experience less contamination load on the HEPA filters because the system is recycling previously-cleaned air. With less contamination loading, the filters will last longer and perform better.
The pre-filters in your HEPA unit catch the larger particles in the air, what’s referred to as “hardballs and softballs.” They do the heavy work. Generally the pre-filters should be changed every three to six months. It is important to consider your environment in determining the frequency.
If your cleanroom sits in the middle of a warehouse or manufacturing area, your changing cycle is closer to three months, or maybe even more frequently. If your cleanroom sits in a pharmacy area, the environment will be cleaner. You can increase your change cycle to as long as six months.
Yes, you can use filters purchased from one of these outlets. We suggest you consult with a sales representative at the retailer and rely on a brand name filter. This may cost you a little more, but it is worth the investment. It is also important to make sure you get the right size and fit of pre-filter for your HEPA.
Again, it depends on your environment, but we suggest every five to seven years.
Yes, they are. Simplex incorporates proper clearances for all doorways and entrances to allow entry by wheelchairs.
Yes, we offer ADA compliant, hands-free hardware for opening doors and other passages.
Yes. Simplex offers both electric and pneumatic doors that open and close automatically. Ask us about them.
USP 797 does not pre-approve rooms. The regulation sets guidelines as to how the room must perform in order to meet the requirements of the regulation. Simplex builds its rooms to meet the guidelines set down by USP 797.
Simplex cleanrooms will accommodate coving. For best results, let us know in advance. This allows us to make alterations to the wall frame for optimal efficiency in your coving.
Yes. In rooms with walls of polycarbonate, use a jigsaw with a plastic blade. In vinyl, use a utility knife to cut an X where you want the hole. Punch holes in the vinyl at the end of the cuts to prevent them from tearing any farther. Use clear cleanroom grade caulking to seal the holes.
Yes, you can. Like plumbing, the key to success in running electrical in your rooms is to let your Simplex representative know in advance. This allows us to incorporate power posts for wiring and aluminum chases so that you can install duplexes.
Yes, you can. In fact, you can add a sink to all our rooms and enclosures. You will have the most success with this if you let your Simplex representative know where you plan to place the sink. This allows us to design framework into the walls that will support mounts and plumbing. We also offer plumbing chases for routing water delivery throughout your enclosure.
Simplex’s standard HEPA filters allow for changing the media from the outside of the room. Some cleanroom managers prefer HEPAs designed for changing the media from the inside. Simplex can offer HEPAs with this feature. Be sure to ask your Simplex representative if this is your preference.
If you turn of your HEPA filters, then you cannot use the cleanroom until you have done a complete clean, and depending on the level of clean required in your room, this might entail bringing in an outside service. If your cleanroom is going to be unoccupied, at night or on weekends, then leave the filters on at their low setting.
With a 797 room, you will need to install or route air conditioning into the room in order to meet the requirements of the guideline. Generally in cleanrooms, if the outer room is already air conditioned, this will usually provide enough cooling for a comfortable environment. Install diffusers six to eight inches below the HEPA filters for the best results. The need for air conditioning also depends on the number of people, equipment and lighting in the room or enclosure, as all these factors will increase the temperature.
You need to have your cleanroom certified to the level required by the type of manufacturing or procedures that are performed in it. If the product you are manufacturing is regulated by a government agency, or you are contracting with a private firm that requires a certain level of clean manufacturing, they should have the cleanroom standards already documented.
Cleanroom certification is done through a contractor who is licensed to certify cleanrooms. These tests might include airborne particle counts, airflow velocity, airflow volumes and other procedures.