Usp 797 Clean Room Design
Ups 797 cleanroom compliance for pharmaceutical medical iv compounding. Designed specifically for compounding sterile pharmaceuticals the usp 797 hardwall cleanroom makes use of cleanroom grade polypropylene for the wall panels which significantly lowers the cost of the cleanroom and speeds up installation.
Pdf A Virtual Clean Room To Teach Usp 797 Regulations For
We understand your medical clean room requirements.
Usp 797 clean room design. Usp 800 hazardous drugs clean room design and construction by descco. The revisions to usp 797 and new usp 800 standards will go into effect december 1 2019. Over the course of 2018 the henderson engineers team of experts has evaluated nearly a hundred facilities across the country to prepare their pharmacies for this deadline.
Usp 797 also is recognized by joint commission as a valuable set of guidelinescontemporary consensus based safe practicesthat describes a best practice for. Lasco services offering custom designed and built usp797 compliant cleanrooms and usp 797 cleanroom audits and consulting. Compounded drugs are not mass produced but rather mixed from ingredients in specific doses for individual patients.
What is required for your buffer zone. The united states pharmacopeial convention usp chapter 800 provides standards for handling hazardous drugs to promote patient safety worker safety and environmental protection. Portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance.
Based on a presentation by tom n. Usp 797 800 pharmaceutical compounding sterile preparations. Usp chapter 797 was released to the public in 2004 and has classified sterile compounding into 3 risk groups.
Highlights of usp 797 6108 update many of the revision points are touched on within the post. Usp united states pharmacopeia oversees compounding or preparation of prescription drugs in clinics hospitals and pharmacies. Post written by trish carney.
Low medium and high risk. Quotes within 48 hours.
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