Medical Device Cleanrooms

Class One Modular Cleanrooms is an expert on, pharmaceutical, medical device cleanrooms, nutraceuticals modular cleanrooms and modular medical cleanrooms. Our all-new fully demountable non-progressive design allows easy assembly and easy design changes. Our new modular cleanroom design is the standard in medical device cleanrooms.

Past industry clients have included:

 

 

 

 

 

 

 

 

Class One Modular Cleanrooms has a track record of building modular cleanroom for many world-class medical companies. We deliver on time and on budget at the most competitive prices. Contact us today and help you design the modular cleanroom to meet your requirements within 24 hours.

Most Common Cleanroom Class

Type of Process	Cleanroom Class
Aseptic, wafer fab	Class 100/ISO5
Assembly and packaging of medical  where low particle count on devices is desired	Class 10,000/ISO7
Assembly of medical devices that need to be free of visible particles	Class 100,000/ISO8/controlled environment
Manufacturers that need controlled environment	GMP (Good Manufacturing Practices)
Pharmacy Drug compounding (per USP website)	Class 100 hood in class 10k room

FDA factors to consider when planning and using a controlled environment:

Regulations
Airborne particulate cleanliness	FED-STD-209E
Personnel training	820.25 ( QS)
Buildings	21 CFR 820.70 (QS)
Cleaning Procedures	CFR 820.70 (QS)
Pharmacy Drug compounding	USP797-800

(1) Consider construction materials to be used.

(2) Examine your plans for design, installation, testing, and maintenance

(3) Consider details–such as placement, size, and model–that concern the air purification system

Temperature and Relative Humidity

Except for certain circumstances, the temperature of medical instrument cleanrooms should be calibrated between 18~22℃, with a relative humidity of 45-65%. If you find that you are out of range for these standards, consider what may be causing clean room to be out of spec.

Air Velocity, Air Change Rate (ACR), and Static Pressure

The air change rate of a cleanroom is a function of the volume of air circulated into the cleanroom and the area of the cleanroom. Differences in static pressure result from differences in the amount of air circulating through the air return vs. exhaust system vents. All of these variables can be adjusted by adjusting of fan speed and/or opening/closing the adjustable louvers. These can be adjusted for the entire system or for certain areas depending on the situation.

Keeping Out Dust, Bacteria, and Other Contaminants

Indications that your clean room may not be up to standard include falling out of standard in basic areas such as temperature, relative humidity, and ACR. If these variables are out of standard, it is likely that your cleanroom is contaminated to a degree that is out of standard.

Proper calibration of the above conditions forms a sort of “microclimate” that is inhospitable to contaminants such as dust particles and bacteria. Meeting standards is a result of the proper maintenance of the cleanroom. Regular, thorough testing is the only best practice, especially in a field where product contamination can lead to serious problems. Besides designing your cleanroom, E-Clean can advise on how to implement management systems to maintain your cleanroom and minimize the risk of contamination.

Class One Modular Cleanrooms modular clean room walls made of FRP (reinforced plastic) and HPL (high-pressure laminate) and melamine are often used in pharmaceutical, USP 797-800 compounding rooms, and modular medical device cleanrooms. They can be wiped down with antiseptic. This wall system is a cost-effective method to achieve the FDA  USP 797-800.

Class One Modular Cleanrooms the modular cleanroom manufacturer to meet your exact requirements.