A Guide to USP 825 Compliance
What Does USP 825 Change?
That is the question!
The goal of USP 825 is to maintain radiopharmaceutical sterility so as to provide quality nuclear medicine products.
How Does USP 825 Achieve Radiopharmaceutical Sterility?
By ensuring that radiopharmaceuticals are prepared in a setting that is As Free From Microbial Infestation As Is Reasonably Achievable, or AFFMIAIRA. Just kidding, I made that last part up. But the idea is real!
The prerogative to ensure that radiopharmaceutical products are safe, reliable, and sterile has been an ongoing conversation within Nuclear Medicine for some time now. USP 797 (Revision 1) was published in 2008 and aimed at providing a bridge between the regular pharmacy practices outlined in the original USP 797 from the mid-90’s, and the radiopharmacy practices applicable to Nuclear Medicine.
There was just one problem though, USP 797 (Revision 1) wasn’t any good.
Upon it’s publishing, practitioners expressed discontent with the new regulations. The regulations, quite plainly, didn’t appear to be written by people who actually worked in Nuclear Medicine.
And so, like the birth of a new baby calf, USP 825 was conceived. However, the gestation period of USP 825 would end up being about a decade in order to iron out all of the kinks and ensure full neurological and pulmonary development, to keep with the baby calf analogy.
“There was just one problem though, USP 797 (Revision 1) wasn’t any good”
And Finally To The Point...
Having read both 797 (Revision 1) and 825, USP 825 is more suitable to what actually occurs in Nuclear Medicine and essentially breaks everything down into 2 criteria:
Doses prepared for 1 patient (Immediate-Use criteria)
&
Doses prepared for Multiple patients (Compounding)
Immediate-Use Criteria
Compounding
As one would imagine, the rules for multiple patient doses are more involved as they are at a higher risk for microbial contamination. An in-depth look at the practices of your radiopharmacy could benefit your patients and provide peace-of-mind with the current regulatory requirements.
One of the issues that 825 addresses is the basic attire of personnel in and out of the hot lab that will be preparing radiopharmaceuticals. Prior to 825, technologists would merely don a pair of gloves and get to it. USP 825 wants personnel to don a “Hot Lab Only” lab coat and a pair of gloves that would then get sterilized with sterile IPA spray. To put it plainly, you can’t go pulling doses just after patients having been coughing, touching, smelling, breathing, looking, feeling, etc. all of your outermost garment. Common sense dictates that personnel within the hot lab should be As Clean As Is Reasonably Achievable, or ACAIRA. (Once again, not an actual acronym but they bring me joy so please allow me to continue this practice so as to keep my spirits high. Thank you.) USP 825 seems reasonable in it’s approach and, overall, it seems to be a step in the right direction concerning the sterility of pharmaceuticals as a whole.
To go back to the criteria mentioned above, Immediate-Use vs. Compounding, the main difference between the 2 is simply air quality. 825 looks to clean up the prep area air when something is going to service multiple patients. ISO Class 5 air quality is achievable within a Laminar Flow hood and is the sort of environment that USP 825 deems appropriate for multiple patient preparations, aka. Compounding.
This may all can seem a bit confusing but Olympic Health Physics is here to help. We would be happy to take a look at your current practice and assist in any optimizations USP 825 aims at making. Healthcare needs regulation in order to maintain safety. Our attitudes at Olympic Health Physics reflect this approach as we would be honored to help ensure that things can be as AFFMIAIRA and ACAIRA as is reasonably achievable!
I could probably make another acronym out of that last part but realize that All Good Things Must Come To An End, or AGTMCTAN. Whoops!
Your nuclear pharmacist is a great resource for you when implementing your USP 825 Compliance Program. You can also always reach out to us if you have questions or want more information on USP 825 or want to see why you should partner with us. We also offer USP 825 Compliance Audits to give you confidence in your radiopharmaceutical practices.