Make a Smarter Medical Device Cleanroom
Hygiene and the need to prevent contamination are critically important in medical device cleanrooms. Bacteria and microorganisms are serious threats to patient safety. We help you get the right products in the right places to end the cycle of contamination.
Most medical device manufacturers come to us for
TSI Real-Time Monitoring Systems and Airborne Particle Counters
Environmental Monitoring Plans
Special pricing is available for your organization
Medical device cleanroom builds and retrofits often call for a large volume of purchases. When your order includes multiple units and multiple instruments, we can offer better pricing. As the size of your order grows, the discount grows.
Contact us to set up preferred pricing for your organization, so you know you’re getting the best value every time you work with us.
Work with partners that make your decisions easier
Medical device cleanrooms are highly regulated. They have to control airborne particles and microorganisms. They have to be monitored for their bioburden rate.
Medical devices like cataract lenses, renal or coronary stents, external defibs and a handful of others (devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury - FDA Class 3 medical devices) must adhere to the most challenging standards, but the standards for FDA Class 1 (stethoscopes, latex gloves, etc...) and FDA Class 2 (catheters, syringes, etc...) medical devices aren’t far behind.
That’s why medical device manufacturers choose to work with specialized expertise for planning, products, and professional advice that can help them find the right technology, the right processes, and the right cost. That’s what we do.
What do auditors critique in medical device cleanrooms?
The WHO, ISO, and FDA all have independent sets of regulations most medical device manufacturers align their manufacturing cleanroom processes with.
There are recommendations for:
Size and location, so mix-ups risking cross-contamination are less likely to occur.
Temperature and humidity in cleanrooms.
Air pressure and air filtration infrastructure.
Cleaning and disinfecting processes and timelines.
Contact us for expert consultation to develop and validate your process, and to find the right technology to support particle removal and monitoring.
Take the pressure off your own shoulders and work with us for
Risk Based Analysis
Get help with your environmental monitoring plan
Your environmental monitoring plan is the foundation for your critical environment. It dictates standards, operating procedures, and other requirements in your medical device cleanroom.
More than 100 medical device manufacturers operating ISO Class 8 cleanrooms or cleaner have built or improved their EM plans with us.
Know you picked the right technology for your medical device cleanroom
Most medical device cleanrooms use HEPA filters to capture 99.97% of all airborne contaminants. And for most, that’s more than enough.
But unique applications call for unique solutions, and we never assume your medical device cleanroom is the same as others. There are cases where an ULPA filter is better, as these capture 99.999% of all airborne particles up to 100 nanometres in size.
We think about the smallest details so you don’t have to.
It’s a relationship, not a transaction
Your business relationships don’t need to be cold. We don’t take your trust lightly, and it’s important to us that you see the value of working with a more human manufacturer’s rep right from the start.
Partnering with us on your medical device cleanroom is all about prevention. Preventing miscommunications. Preventing mistakes. Preventing financial waste. And, of course, preventing contamination, which means using our expertise to find tools and processes that:
Identify the contaminant
Anticipate the contaminant
Minimize internal generation
Control residual contamination
Solutions to the biggest challenges in your medical device cleanroom
Come together with our team to find solutions that make you happy. That let you breathe a sigh of relief, knowing you did the best work you could. You helped your colleagues do their jobs better and you helped the business thrive.
Contact us today to validate your processes, qualify and source your equipment, and connect with the best and most responsive technical support you’ll find from any manufacturer’s rep (and manufacturer too) in the country.