USP<797> & <800>
Are you ready for the deadline?
December 1, 2019 extended
USP<797> and USP<800> are the Federal Mandates that sterile compounding facilities are subjected to adhere to. The most affected are hospital facilities and satellite infusion/compounding sites. Cleanetics has been consulting, designing, building, and certifying USP<797> and <800> facilities since 2004. Working with top hospitals around the globe, we have created state of the art USP<797> & USP<800> cleanrooms that follow the guidelines and ensure passing all state inspections.
Our staff stays up to date on the current USP standards and is dedicated to knowing all the latest developments of USP. Cleanetics does not just build the cleanroom environment. We work closely with the staff to provide functioning cleanrooms that meet ergonomic flow requirements, provide SOP training for gowning/sterilizing, provide plan of actions for events, and provide an open line of communication on all your cleanroom needs.
Don't just trust anyone to your USP<797> & <800> Cleanroom. Trust the ones that have consulted, designed, successfully built, certified, and maintained cleanrooms since the inception of <797> & <800>
Renovation from beginning to end.
Why Do We Need USP797 and USP800?
USP began observing patients affected by tainted compounds as early as 1990. With hundreds of patients being compromised by contaminated injections that could have been prevented, USP<797> developed a standard in 2007. USP<800> was developed to protect all personnel involved with hazardous compounding.
1990- Nebraska: 4 patients die due to contaminated solution.
1990-Pennsylvania: 2 patients lose their vision due to contaminated solution from community pharmacy.
1998-10 Children test positive for enterobacter Cloacae. Traced to contaminated pre-filled syringes due to poor hand-washing/garbing techniques.
2001-Missouri: Pediatric patients become ill from hospital pharmacy. 4 children infected due to poor hand hygiene/garbing and lack of USP797 compliance.
2002- South Carolina: 5 patients receive contaminated IV steroids. 1 dies. Untrained personnel the main cause.
2004- Maryland: Contaminated Radiosotope Equipment causes Hep C in 16 patients during a cardiac stress test. Breaks in aseptic technique to blame.
2007-Study shows that only 13% of Pharmacy Graduates are adequately trained for aseptic protocols.
2007-USP proposes 797 for individual training and evaluation of sterile compounding standards.
2008-USP launches official mandate. Pharmacy industry is slow to act due to budgets.
2010-Pediatric patient dies from hospital pharmacy compound error.
2011-California, Florida, and Tennessee: Multiple patients blinded from Avastin Contamination.Contamination occurred during medium risk compounding. 1 person suffered permanent brain damage.
2012- Fungal Meningitis Outbreak Occurs. Pharmacy was not in compliance. 751 infected. 384 had meningitis and spinal infection.
2013-Connecticut- Hospital Pharmacy identifies contaminated magnesium sulfate. 5 contained mold. Pharmacy was shut down.