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Useful Summary of Facility and Engineering Control Requirements  E-mail

Whether you are in a hazardous or nonhazardous drug compounding facility, understanding the facility and engineering control requirements can be confusing.  CSI Testing, Inc. is one of the premier clean environment certification and testing service providers in the world.  As an educational tool for clients, CSI Testing, Inc. developed a table (pdf) that provides a clear and concise summary of facility and engineering requirements for drug compounding facilities.  This table is valuable to all levels of clean room workers, including directors, managers, supervisors, pharmacists and technicians. 

Through experience, CSI Testing, Inc. knows that a rigorous testing routine reduces down-time and also improves the quality of the compound produced. In short, quality and productivity are in inextricably related to each other. Examples of when the information in this table would be useful include:

  • Designing cleanrooms,
  • Building cleanrooms, and
  • Purchasing ISO Class 5 engineering controls (e.g. Laminar Airflow Workbenches, Biological Safety Cabinets, Compounding Aseptic Isolators, and Compounding Aseptic Containment Isolators) 

At Clinical IQ, we extend our thanks to Carl LaBella, President of CSI Testing, Inc., for making this information available and we are happy to share it with you on out website.  For more information about CSI Testing, Inc., please see their website at http://www.csitesting.com.  Also see the Environmental Monitoring section of Clinical IQ's Knowledge Base for more useful information on this topic.  

 

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