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What cleanroom wall is most common for pharmaceutical cleanrooms?
Pharmaceutical cleanrooms are subject to harsh chemical cleaning of both flooring and walls. Fiber Reinforced Plastic (FRP) walls have good chemical resistance are a common choice.[Learn more]
What is a cleanroom in food manufacturing?
Food manufacturing is an industry where product safety, quality, and integrity are paramount. As such, cleanrooms are vital in the food manufacturing industry to ensure food product quality and to adh[Learn more]
What are USP797/800 cleanrooms?
USP797/800 pharmaceutical cleanrooms are used for compounding drugs at pharmacies. Recommendations come from the USP however final authority lies with state pharmacy licensing boards. USP797/800 pharm[Learn more]
What kind of cleanroom testing is most common for pharmaceutical cleanroom?
Pharmaceutical cleanrooms require both viable and non-viable particle testing. The viable testing is done with settling plates. The non-viable testing is done with laser particle counters.[Learn more]
What cleanroom flooring is most common for pharmaceutical cleanrooms?
Pharmaceutical cleanroom flooring must be chemical resistant, otherwise the aggressive cleaning agents used in pharmaceutical cleanrooms will damage the flooring. The cleanroom flooring minimize join[Learn more]
What is a CGMP pharmaceutical cleanroom?
The FDA mandated CGMP Current Good Manufacturing Practices for pharmaceutical manufacturers which is a higher standard than GMP Good Manufacturing Practices. This is a higher standard for pharmaceutic[Learn more]
What cleanroom classification are pharmaceutical cleanrooms?
Pharmaceutical cleanrooms typically are ISO-5/class 100 for aseptic filling and sterile processes. Less critical area are often ISO-6/class 1000 or ISO-7/class 10,000. The EU GMP Annex puts similar bu[Learn more]
What is a pharmaceutical cleanroom?
A pharmaceutical cleanroom is cleanroom used for manufacturing of pharmaceuticals products such as medicines. They are required by the FDA to ensure the safety and effectiveness of the medicines. Phar[Learn more]
What are requirements if I am manufacturing implantable medical device?
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 manufacture[Learn more]
What is final sterilization in a medical device cleanroom?
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 g[Learn more]
What kind of cleanrooms are used for product that are supplied to medical device companies?
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 componen[Learn more]
Do medical device cleanrooms have air conditioning?
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[Learn more]
What cleanroom classification are medical device cleanrooms?
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 clea[Learn more]
Who regulates medical device cleanrooms?
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, equip[Learn more]
What is a medical device cleanroom?
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 mol[Learn more]
