Introduction
As per Statista, the healthcare market is valued at US $52.65 billion in 2022. This is further expected to grow at a Compound Annual Growth Rate of 12.31& from 2022 to 2027 to result in US $94.07 by 2027.
There’s no doubt that the healthcare industry is one of the most important sectors in any economy. It’s also one of the most sensitive when it comes to cleanliness and contamination since our health may be at stake if something goes wrong. This means that hospitals need to take extra precautions to ensure that everything is handled properly and nothing gets contaminated.
What Is A Clean Room?
A cleanroom is a controlled environment. The term is used to describe a room that has been designed to keep the air quality and other conditions in a specific range. Cleanrooms are used for manufacturing medical devices, pharmaceuticals, and other products with strict quality requirements.
They can be simple rooms with HEPA filtration systems or highly sophisticated facilities that use computer-controlled machinery and UV lights to eliminate even the most minute contaminants from the air.
Why Do We Need Cleanroom Technology?
Cleanrooms and cleanroom technology are designed to protect devices from contamination. This is because a device can be contaminated by dust, dirt, or liquids that can come from the environment.
Cleanrooms are used in many industries, including medical device manufacturing and pharmaceuticals, where it’s essential to keep your product sterile and free of pathogens.
Cleanrooms play an important role in reducing the risk of infection for patients who use these products, as well as healthcare workers who handle them on a daily basis.
Classification of Medical Devices
Classification is a key part of the FDA’s postmarket surveillance program. The device classification system helps the FDA to determine if a device is safe and effective. It also helps the FDA track medical devices, so they can be recalled if they’re found to be faulty or unsafe. The FDA has created three classifications for medical devices: Class I, Class II, and Class III.
Class I devices are the least complex and the least likely to cause harm. They can be manufactured, sold, and used in the United States without requiring FDA approval or clearance before being placed into commercial distribution. Class I devices include blood collection tubes, blood glucose strips, and blood pressure cuffs.
Class II devices are those that do not require sterilization or cleaning. A Class II device is a medium-risk medical device that requires additional controls beyond those necessary for cleanrooms but not as stringent as those required for Class III devices. Laboratory equipment, such as centrifuges and laboratory glassware, are some examples of Class II devices.
Class III requires the highest level of cleanrooms. Class III devices are the most sensitive to contamination and must be kept in a controlled environment. These devices are used in the most sensitive procedures, such as cardiac pacemakers, implantable defibrillators, and insulin pumps.
According to Fortune Business Insights, the medical devices market is expected to grow at a Compound Annual Growth Rate of 5.5% from 2021 to 2029, reaching a valuation of US $718.92 billion by 2029.
Importance Of Cleanrooms in Medical Devices Manufacturing
Cleanrooms are designed to keep out dust, dirt, and other contaminants. Contaminants such as dust, dirt, and hair can cause damage to the devices being manufactured and thus lead to product recalls. They can also affect the performance of the device during use as well. Such situations can prove fatal for patients if it fails to work properly or if it causes an infection.
Thus, it is important that all precautions be taken before manufacturing a medical device. This can be done by manufacturing the medical device in medical device cleanrooms. These cleanrooms need to meet certain regulatory standards which ensure the quality of the medical device being produced.
How To Decide The Correct Cleanroom Design?
The clean room design depends on the type of product you are manufacturing, the process you are using to manufacture your product, and the volume of product you will be manufacturing on a regular basis. It is also important to consider where your cleanroom will be located in relation to other parts of your facility.
A lot of factors need to be considered when designing a cleanroom, but there are many different ways that they can be done depending on what type of company you have and what kind of products or services they provide.
The clean room design process should be done in a way that will meet your needs while also being cost-effective. If you are looking for a new cleanroom, it is important to consider all of the different factors before making a decision on what type of design would work best for you and your company.
Conclusion
So, as you can see, there’s a lot more to medical device cleanrooms than meets the eye. They are not only essential for ensuring the safety of patients but also for maintaining the integrity of medical devices.
This means that if you have any plans to start manufacturing them in the near future, then it is imperative that you take into account all these factors before making any decision.
