Frequently Asked Questions
Our team of experienced certifiers, technicians and designers compiled a list of frequently asked questions and the corresponding answers. Can’t find what you are looking for? Feel free to send in your question!
USP <797> Pharmaceutical Compounding—Sterile Preparations
You may purchase the chapter through a subscription to the USP Compounding Compendium here.
USP is anticipating publishing a revised draft of USP <797> on September 4, 2018 with a comment period that will extend to November 30, 2018. They anticipate harmonizing USP <797> and <800> and expect a new official date of December 1, 2019.
We offer USP<797> and USP<800> consulting services and can help you get compliant. Click here for more info
You can get status updates by signing up for notifications here.
More information about USP<797> is available here.
USP <800> Hazardous Drugs – Handling in Healthcare Settings
You may download a copy here.
USP has announced their intent to postpone the official date of General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. They anticipate harmonizing USP <797> and <800> and expect a new official date of December 1, 2019. They are continuing to encourage people to early adopt USP <800>.
We offer USP<797> and USP<800> consulting services and can help you get compliant. Click here for more info.
You can get status updates by signing up for notifications here.
More information about USP<800> is available here.
Biological Safety Cabinets
The standard that governs all biosafety cabinets is NSF 49. Effective April 14, 2016 it requires an exhaust airflow alarm to be installed in a BSC with canopy or air-gap connection. The purpose of the alarm is to alert staff in case the building exhaust drops to a potentially dangerous level. Should the building exhaust drop enough, some of the cabinet exhaust can flow back into the room through the gap. Because HEPA filters do not trap fumes, any fumes that are released during compounding could flow through this gap back into the room.
Isolators
The sleeves themselves are not not required to be sterile since there isn’t a way to replace them without exposing them to air outside of the isolator.
The recommended interval for changing sleeves is 6 months.
We offer the option to add a full sleeve service to your certification to help you stay on track!
We will stock your sleeves, bring them with us every 6 months and change them with each certification.
Clean Room HEPA filters
The current requirement calls for HEPA filtration but does not specify where the HEPA filter is to be located. With the new proposed USP<797> coming out in the near future, HEPA filtration will need to be in the ceiling of the Ante Room and the Buffer Room. However, since the new USP<797> is not finalized, the wording regarding the HEPA filters may get changed.
Currently, the USP <797> requirement is that room HEPA filters be tested only when they are installed. The FDA requires ceiling HEPA filters to be tested every 6 months and the certification industry believes that this requirement will make it’s way into USP<797> soon.
In order to test ceiling HEPA filters for leakage, we will need a way to introduce an aerosol challenge into the ductwork for each filter. The test ports are the cleanest, lowest cost way that we have found to accomplish this. Because we must have a way to introduce the aerosol challenge on new construction, we recommend the ports be installed not only for the initial testing, but to allow future testing as well.
We offer HEPA filter test ports and ports for hard duct entry.
Some of the built-in test ports have very small diameter tubing and the aerosol can condensate when passing through this small tubing. When the aerosol condenses back to an oil, it can drip onto the filter media and deteriorate the HEPA media. It is best to avoid that if possible. You should be able to get the exact specs on the built-in ports if you have the manufacturer & model number information.