American Cleanroom Systems® is an expert on medical device, pharmaceutical, nutraceuticals and medical supplier cleanrooms.
American Cleanroom Systems® has a track record of delivering clean room solutions for a large number of world-class medical related companies. We deliver on time and on budget at very competitive prices. Contact us today and we’ll discuss your requirements and submit a project quote within 48 hours.
American Cleanroom Systems® modular clean room walls made of FRP (reinforced plastic) and HPL (high pressure laminate) are often used in pharmaceutical, USP 797 compounding rooms, and medical device clean rooms. They can be wiped down with antiseptic. This wall system is an economical and cost effective method to achieve the FDA GMP 9 (QS) and USP 797.
American Cleanroom Systems® also offers standard built seamless epoxy coated cleanroom walls with coved flooring to handle more robust mop down wall cleaning/disinfectant procedures.
FAQs About Medical Device Cleanrooms
Q: What is a medical device cleanroom?
A: A medical device cleanroom is a cleanroom where medical devices – both implantable or for external use – are manufactured. It also can refer to the cleanroom of suppliers (like a plastic injection molder) to the medical device company.
Q: Who regulates medical device cleanrooms?
A: The FDA requires that medical devices be manufactured under FDA GMP (Good Manufacturing Practice) rules. Some medical device is subject to FDA validation which includes manufacturing processes, equipment, and facilities (like cleanrooms).
Q: What cleanroom classification are medical device cleanrooms?
A: Medical device cleanrooms classification can range from ISO-5 to ISO-8 depending on the criticality of the product, whether it is implantable, and sterility requirements. Determination of correct cleanroom classification is done under FDA GMP rules. Most common cleanroom classification are ISO-7 and ISO-8.
Q: Do medical device cleanrooms have air conditioning?
A: Yes. GMP requires a controlled environment. Typically, there is some kind of medical device manufacturing specification for allowable temperature and humidity that can only be achieved with cleanroom air conditioning.
Q: What kind of cleanrooms are used for product that are supplied to medical device companies?
A: Plastic injections molders are typically ISO-8. Supplier cleanroom requirements are dictated by the medical device company depending upon what cleaning and sterilization steps are done to the components after they arrive at medical device company. Suppliers to implantable device medical device companies typically are required to have the higher classification cleanrooms.
Q: What is final sterilization in a medical device cleanroom?
A: Often the final step of medical device manufacturing is sterilization prior to packaging. The packaging step is often done in an ISO-5/class 100 cleanroom environment to ensure that no contamination gets on the product during packaging.
Q: What are requirements if I am manufacturing implantable medical device?
A: Implantable medical devices come into contact with tissue and membrane. They must be sterile and contaminant free to protect the patient from infection. Implantable medical devices must be manufactured in minimum ISO-7/class 10k cleanroom to ensure cleanliness and quality.
Spanish