Medical device cleanrooms produce products that must be safe to bring to the market to be used in settings where hygiene is the highest priority.

Vernick is a go-to source for the design and construction of custom medical device cleanrooms. Generally, medical device manufacturing cleanrooms must meet ISO Class 5 specifications, and medical device packaging cleanrooms must meet ISO Class 7-8 specifications. We are prepared to meet and exceed these and any other standards that pertain to your medical device cleanroom.

Why do I Need a Medical Device Cleanroom?

The manufacturing of medical devices, especially when they are implantable or a part of an invasive procedure, must be conducted within a cleanroom environment. Any particulates, contaminations, or inadequate sterilization can lead to infection or death.

Medical Device Cleanroom Applications

Many medical devices are created with injection molding, a process that often occurs within a cleanroom. In addition to the creation of injection molded medical devices, applications that take place within medical device cleanrooms include:

  • Medical research
  • Pharmaceutical manufacturing & packaging
  • Implantable device manufacturing
  • Surgical device manufacturing
  • And more.

Advantages of Manufacturing in Medical Device Cleanrooms

Medical devices must be manufactured within cleanrooms as they are used in applications involving implantation, surgery, and other critical procedures involving the human body. Medical device cleanrooms ensure components are kept sterile throughout every step of the manufacturing process.

At Vernick, we create adaptable, cost-effective, and fully customized medical device cleanrooms. We can return at any time to change the layout of your medical device cleanroom to meet your business’s changing requirements, and you have complete control over your cleanroom construction.

Medical Device Cleanroom Design & Construction Considerations

Medical device cleanrooms must contain surfaces that are easily sterilized. The air must utilize HEPA filtration, and all equipment must remain in aseptic conditions. The facility must have enough space and intentional design to keep cross-contamination and confusion from happening.

Vernick takes these considerations and more into account during the design and construction of your custom medical device cleanroom. We use our 8-Step Process to create the best hardwall or softwall medical device cleanroom to realize your goals.

Turnkey Medical Device Cleanroom Solutions

Vernick’s medical device cleanrooms all come with a turnkey option. We take care of everything from design to installation, and we give you the exact amount of input and control that you require throughout the process. We meet all federal, state, and local agency guidelines while saving you time and money. Everything is set up and ready to begin at the start of your medical device manufacturing project. All you need to do is “turn the key.”

To learn more about Vernick, check out our FAQ page or read our blog. If you’re ready to get started on your custom medical device cleanroom, or if you have further questions, contact us today. Our experts look forward to hearing from you.