In January 2004, USP Chapter <797> “Pharmaceutical Compounding-Sterile Preparations”, became the first official, enforceable requirement for the compounding of sterile preparations.  The goal of USP <797> is to protect patients from the harm that can result from microbial contamination or medication errors in compounded sterile preparations.

USP Chapter <797> has been revised and the new revision, which dictates compounding be performed under ISO 5 (Class 100) conditions, became official on 01 June 2008.  Compliance with USP Chapter <797> is a challenging requirement that will be strictly enforced.

Are you in compliance?  You can be sure that Veltek Associates, Inc.’s Innovative Clean Room Solutions will be there to help you with our “Full Circle Approach” to USP <797>.

For Veltek Associates, Inc. it’s simple.  Innovation is about listening to industry challenges and not stopping until we find the answer.  Together with our clients, we’ve been the developing new solutions for the clean room industry for more than 25 years.

From our early days developing the first sterile garments, to our latest innovations, Veltek Associates, Inc. develops products that revolutionize and simplify aseptic manufacturing.  More than 300 pharmaceutical, biotechnology ad healthcare clients around the world turn to Veltek Associates, Inc. because we understand the challenges they face.  Our experience and unsurpassed technical expertise means “real world” solutions from people who have worked in the industry.  And, because our product line is so extensive, a relationship with Veltek Associates, Inc. means a more cost-effective way to buy clean room products.

Veltek Associates, Inc. covers every aspect necessary for full compliance to USP <797> including consultation from industry experts on setting up and maintaining aseptic processes during the compounding of sterile products.  Veltek Associates, Inc. has an extensive sterile cleaning and disinfectant line complete with easy to use sterilizable cleaning systems.  The Core2Clean® Plus System addresses the cleaning and disinfection of surface areas.  The SimpleMIX® System provides easy-to-use disinfectants in a pre-measured container system.  Beyond providing bulk cleaning and disinfection agents, Veltek Associates, Inc. also has a complete line of sterile individually packaged saturated wipes.

To further address the USP <797> requirements, Veltek provides a unique innovative gowning system to address aseptic gowning requirements.  Additionally, the easy to use SMA air samplers are an accepted industry standard that simplifies microbial air testing in aseptic compounding areas.

As the pharmaceutical industry moves forward to require greater control of environmental production areas, be assured Veltek Associates, Inc. is one stop ahead with innovation and support.

Please see the official USP website for complete information and compliance to USP Chapter <797>.