One of the best things about maintaining a long-running publication is that I’m able to track which articles have been most popular with our readers. By far, the most viewed articles on www.cemag.us have been those that contain valuable reference material in regards to standards, cleaning, and compliance. Here is a rundown of some of Controlled Environments’ top articles.
“Understanding Cleanroom Classifications” gives a basic rundown of classification systems, such as those found (and later amended) in ISO 14644-1. Some companies have stuck with the Class 100/Class 10,000/Class 100,000 room classification system from Federal Standard 209E. Meanwhile, in Europe, the Grades A through D system is used. The article talks about how Federal Standard 209E was eventually replaced by ISO 14644-1, which establishes the certification requirements for air cleanliness areas. However, it does not contain specified limits for viable microorganisms present. The European Union’s GMPs contain Annex 1, which applies to drug products manufactured by aseptic processing and/or terminal sterilization; and Annex 2, Manufacture of Biological Active Substances and Medicinal Products for Human Use. http://bit.ly/26kGHDz
“Control Strategies for Fungal Contamination in Cleanrooms” details the different types of fungi that might be found in a cleanroom. The article describes the killing mechanisms of different germicides commonly available, how to select disinfectants, and testing methods. Mold could result in adverse impacts on production, therefore it’s necessary to identify it properly and eliminate it quickly. http://bit.ly/1SVUPch
“Cleaning Protocols for USP 797 Compliance” talks about the techniques and procedures that are necessary to develop a routine for cleaning sterile compounding areas. USP 797 mandates that written standard operating procedures (SOPs) and cleaning logs be developed in order to track the quality of the environment for the preparation of compounded sterile preparations. SOPs should include a detailed cleaning procedure, directions on how frequently to clean the area, and the required supplies. It is vital that sterile compounding areas, counters, and other work surfaces be cleaned and disinfected every day, as should floors in all areas of the cleanroom facility. Of course, proper staff training is crucial. http://bit.ly/1MNQzzx
“Principles of Cleanroom Validation” explains how the validation process ensures that the design of the facility is suitable for its intended purpose. It also describes that is needed for the facility, equipment, and environment to meet User Requirement Specifications and defined regulatory requirements, and that they properly function together as a system to meet the necessary standards. http://bit.ly/1MxeoK5
Finally, “Cleanroom Cleaning 101” serves as a beginner’s guide to the world of controlled environments. It is important to note that procedures for cleaning each individual cleanroom may differ according to the type of facility, the needs of the company, the processes occurring within the clean facility, and cleanliness levels required; however, there are still some universal steps to follow. http://bit.ly/1MNRFey
Editor’s note: The article “Keeping the Future Cool” in the March/April 2016 issue mistakenly said that Century Refrigeration is based in Phoenix. The company is actually based in Pryor, Okla. Controlled Environments regrets the error.