Cleanroom Supplies Guide

How to Achieve Pharmaceutical Clean Room Standards Approved by the FDA Whether for  processing pharmaceuticals  or for creating tech products, clean rooms are essential to many modern production facilities. When trying to abide by U.S. Food and Drug Administration standards, it's vital to know the regulations and the details contained therein. Contaminants can be introduced during every step of production to make sure you know clean room standards before you even plan your facility. Here are some basics. Understanding the Regulations Requirements for clean rooms are more than just generic or general standards and practices. They're actually part of a regulated set of rules regarding good manufacturing practices.  Current Good Manufacturing Practices  or CGMP regulations involve the manufacture of biological products. These products and drugs produced by manufacturers are regulated by the Code of Federal Regulations. The CGMP for Finished Pharmaceuticals ...

Clean Room Design Made Easy: 4 Key Elements Industries that depend on preventing contamination and particle-induced defects need clean rooms. Some industries that use clean rooms include medical, pharmaceutical, biotechnology, and semiconductor manufacturing. The critical role of clean room design became evident after a  meningitis outbreak  in 2012. A New England Compounding Pharmacy’s product became contaminated with fungus. Over 800 people developed meningitis and 64 people died. Thus, care is essential in designing every aspect of clean rooms. Continue reading to learn about key guidelines to consider. What Is a Cleanroom? The purpose of cleanrooms is to  limit particulate matter  in the environment. Cleanrooms must meet strict regulatory requirements. Cleanrooms are tested for compliance on a scheduled basis. These environments need more energy, air, and advanced technology than in other areas. Key Elements Needed in a Clean Room Design Cleanroo...