Weighing the Options for Optimal Chapter <797> Compliance

Complying with the USP 797 (http://www.usp.org/products/797Guidebook/)sterile compounding regulations for IV preparation, there are three basic options for preventing contamination: building a cleanroom (http://www.isotechdesign.com/en/products-pharmacies-rx/modular-cleanrooms-softwall-hardwall.php ) , adding a barrier isolator hoods (http://www.isotechdesign.com/en/products-pharmacies-rx/sterile-compounding-admixtures.php)   or combining the two technologies(http://www.isotechdesign.com/en/products-pharmacies-rx.php) . Each hospitals or pharmacies have to determine the best strategy that makes the most sense based on cost, work flow volume, space and other considerations.

If you mix chemo, you need a biosafety cabinet in a negative pressure clean room (http://www.isotechdesign.com/en/products-pharmacies-rx/modular-cleanrooms-softwall-hardwall.php) or a compounding aseptic containment isolator CACI (http://www.isotechdesign.com/en/products-pharmacies-rx/chemo-compounding.php) to protect the user from the product toxicity and the aerosolization of vapors.

It is also important to have standard operating procedures to ensure that you are maintaining clean air environment such cleaning and disinfecting, gowning  and periodic testing such imprinting the gloved hands in a Petri dish, air testing for particles and bacterial growth, surface testing, performing annual competency testing for admixtures staff and attending  to a cleaning and disinfecting regimen.

To justify the clean room, you need to have the volume, space and budget; otherwise the compounding aseptic isolator CAI (http://www.isotechdesign.com/en/products-pharmacies-rx/sterile-compounding-admixtures.php)   can be another alternative.  The CAI (http://www.isotechdesign.com/en/products-pharmacies-rx/sterile-compounding-admixtures.php)   and the CACI (http://www.isotechdesign.com/en/products-pharmacies-rx/chemo-compounding.php)   can cost less than 70 % of a properly designed clean room with smooth, easy to clean , hard wall surfaces and a defined pressure differential with the outside environment and the operating cost is less than 20 % of the operating cost of a clean room (http://www.isotechdesign.com/en/news-articles/26-article-Barrier-isolators-as-an-alternative-to-a-cleanroom.php). With the CACI (http://www.isotechdesign.com/en/products-pharmacies-rx/chemo-compounding.php ) , when you are manipulating chemo, you also have the added safety benefit because of the barrier between the product and the operator and the operation in negative pressure.

To comply with the USP 797  (http://www.usp.org/products/797Guidebook/) sterile regulations, weigh all the options, check all the vendors cleanrooms and isolators, do a need assessment ( volume, cost, space), calculate all the costs, understand the risk, do the due diligence, consult , verify  and check the references before you make your decision.

This article was written by Thomas Van Hassel, RPh, MPA and published in the Pharmacy Purchasing & Products, Vol.36 No.11 (http://www.pppmag.com).