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

• Question E2: I am a Pharmacy Operation Manager at a Children’s Hospital.  I am attempting to provide justification of extending storage periods of certain medium-risk batched CSPs.  My understanding is that if sterility testing is performed, storage periods can be extended up until the expiration dates of the ingredients being used.  I am wondering if sterility testing needs to be performed on each batch or if the process itself can be verified as aseptic.  In our situation, we have an automated pump that will produce 10ml saline-flush syringes from a 2000ml bag.  Other than the set up of the machine, there is no human involvement in the process.  To determine sterility, we would conduct a media fill test by pumping media fill from a bag into syringes and then verify sterilty by determining if there is bacterial growth.  We would also do a one time set of tests to determine the sterility of the saline flushes.  We would send several samples of the batch to the lab and have them tested for sterility over a period of several days/weeks.  We would periodically (quarterly) repeat the media fill test on the pump to recheck the aseptic process, but we would not continue to check the batches of saline syringes for sterility.  We would assume that if the pump continues to produce sterile media fill syringes that it would also continue to produce sterile saline syringes. 
• E2 Answer: If your compounding process involves people (e.g. is not fully automated), a sterility test is required for each batch.  I am not aware of any automated process or piece of equipment that has been aseptically validated by the manufacturer.  It is important that any sterility testing be conducted according to USP Chapter <71>.  There are some commercially-available testing kits on the market that may not comply with USP <71> standards.  Check with the manufacturer of these kits and ask them to provide you (in writing) a statement that states that their kits meet USP <71> compendial requirements.

(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