Aseptic Enclosures, Sterile Air & Containment Equipment
The answer is complicated.
Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials.
As cleanroom experts, we also provide on-site clean room training.
This is the table of contents for our, joint commission evaluated, clean room training manual.
This on-site training can be implemented in several ways.
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.
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