Working in an aseptic cleanroom facility requires workers to wear a over their clothes. The goal is to cover all surfaces of the worker to ensure any loose particles won鈥檛 be released into the clean environment. Cleanroom Connection has many options for sterile lint-free cleanroom suits.
Depending on the person, some prefer a sterile coverall with an attached hood and boot cover, while others prefer elastic wrists and ankles. Breathability, cleanliness, overall fit and pricing vary between the sterile cleanroom coverall options. Let’s take a closer look below.
Sterile garment materials and styles
Sterile coveralls are worn in many different industries including pharmaceutical, healthcare, research, medical device manufacturing and other strict applications. Depending on the cleanliness of the area and the standard operating procedure (SOP), certain cleanroom suit materials are preferred. Most sterile applications take place in ISO5 Class 100 areas. When working in Class 100 ISO5 areas, this is a cleanliness threshold that requires a certain level of cleanliness. All apparel and cleaning supplies used in Class 100 areas must be specifically approved for ISO5 and labelled accordingly.
For these more strict ISO5 Class 100 cleanroom environments, Cleanroom Connection recommends the , and . The materials for these sterile suits do not shed any particles and are smooth and breathable. These three suit options are clean-processed and sterile, which means any loose particles have been mechanically removed from the suits prior to being packaged. This ensures that when you use these suits in your clean room, no contamination will be introduced.
For example, a Class 100 ISO 5 cleanroom requires that the air cleanliness level be at a maximum of 100 particles (鈮�0.5碌m) per cubic foot, with a minimum of 300 air changes per hour. With such strict air quality requirements, all of your sterile cleanroom apparel and cleaning supplies must be specifically labeled for use in ISO5 Class 100 environments.
A common misconception is that ‘sterile’ and ‘clean and sterile’ are both okay for use in cleanroom environments, when in fact, only cleanroom suits labelled ‘clean and sterile’ are suitable for use in your cleanroom. If an item is not ‘clean’, it has not been clean processed and therefore will have particles on it, albeit sterile particles that will be released into your air and contaminate your environment.
Receiving and using your sterile cleanroom suits
When you receive your sterile suits from Cleanroom Connection, be careful when opening the box. Since these are sterile, each suit is individually packed, and then the 25 sterile suits are inside one master plastic liner inside the box. Be careful not to cut the master liner when opening the box. You also will find the certificate of sterility and certificate of analysis either inside the box or taped outside in an envelope.
Many customers will store these sterility certificates in case they are needed for facility inspections or validations. Depending on the style you have chosen, your suit will be one piece with attached hood and boots, or you will have separate hood and separate boot covers to put on. The majority of our customers choose the one piece sterile suit with attached hood and boots.
Choosing the proper cleanroom apparel
Working in a cleanroom is not a straightforward process. There is a lot of preparation and planning that goes into a successful cleanroom. Oftentimes consultants, training companies and the like are brought in to prepare the facility, staff and management on the correct way to garb, clean and operate in your new cleanrooms. Check out our page for some basic guidance.
Cleanroom Connection has been supplying clean rooms in all industries for two decades. Reach out to us for pricing, availability or guidance in choosing the proper sterile apparel for your business. We offer free samples, a best price guarantee and personal cleanroom-trained customer service that stands out from other suppliers.