Questions and Answers on USP 797: Answers Provided by Eric S. Kastango, MBA, RPh, FASHP:

• E1 Question:  Our inpatient pharmacy recently purchased Barrier Isolators. What are the clean room guidelines with these in place?  I keep getting conflicting information and would like to not have to do a lot of rework.
• E1 Answer:  The answer to your question depends on the isolator that you have purchased.  You can ask the isolator manufacturer if their unit meets the standards in proposed revision of USP <797>.  All of the isolator manufacturers are aware of the new standards and should be able to help you.  There are also other several resources available to you related to this question.  First, if you don't already have a copy of the proposed revisions, visit http://www.usp.org/USPNF/pf/generalChapter797.html and download a free copy.  You can visit the Controlled Environment Testing Association (CETA) website (www.cetainternational.org) to download their application guides on testing and certifying isolators.  There have been several articles written on this subject by Jim Wagner.  If you visit Pharmacy Purchasing and Products Magazine (www.pppmag.com), do an article search for Jim Wagner.   Very shortly, on Clinical IQ's website (www.clinicaliq.com), a table of engineering controls will be posted that should assist you further. 

(Answer provided as a courtesy to usp797.org by Eric S. Kastango, MBA, RPh, FASHP. Please note that usp797.org is not responsible for this answer.)

• About Eric S. Kastango: Since its inception, Eric S. Kastango has been at the forefront of USP <797>. He is an elected member of the United States Pharmacopoeia Sterile Compounding Committee (2005-2010). Over the years, he has held multiple American Society of Health-System Pharmacists chairmanships and committee positions. He was responsible for creating the “Comprehensive Sterile Compounding Compliance Gap Analysis and Risk Assessment Tool.” In this capacity, Mr. Kastango frequents pharmacy events as an expert speaker, contributes to industry journals, and teaches. Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences and a MBA from the University of Phoenix. Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation, which has 72 pharmacies in 44 states. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation, and has made over 100 presentations on a variety of pharmacy practice topics.  Mr. Kastango is the President and CEO of Clinical IQ, and can be reached as follows:

Mr. Eric S. Kastango – President and CEO
Clinical IQ, LLC 
184 Columbia Turnpike, #282 
Florham Park, NJ  07932 
Tel: (973) 765-9393 --- www.clinicaliq.com