Aseptic Enclosures, Sterile Air & Containment Equipment
Whether isolator or clean room based working areas, if were talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk.
The first known, is actually outside of the clean room and is the pre-cleaning station.
In the cleanroom world, the space that you are willing to allocate to your clean operations is what you will have for the next couple of years.
Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018.
There are many complications related to the administration of TPN. Total parenteral nutrition (TPN), also known as parenteral nutrition (PN) is a form of nutritional support given completely via the bloodstream, intravenously with an IV pump.
Many manufacturing processes need the very stringent environmental conditions that can only be provided by a cleanroom.
Making sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP.
Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these facilities are governed by the Veteran Administration.
Compounding medications is essential to patient care. All types of medications can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion.
To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.
Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting.
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