ISO Class 7 room

[emalsyd]

We are working in a chemotherpay pharmacy which is going to contain to CACI isloators where the chemo drugs are mixed. The owner sent me a brief description of USP 797. It states the CACI islolators need be be installed in an ISO Class 7 room. We are planning on installing fan powered HEPA filters in the ceiling and low wall returns. Air would be cycled through a rooftop unit. Does the return need to be hepa filtered before it goes back into the rooftop or is the supply HEPA filter enough. Can the air in a ISO 7 room be re-circulated if hepa filtered? I can't find any information telling me if it can or can't be.

 

[urgross]

I believe that USP797 allows for up to 15 of the 30 ACH required to be recirculted through HEPA device, with at least 15 ACH provided by outside air unit with HEPA.

Not much info on duct construction with the standard, or dispersion analysis if you don't want to run 10 feet above disharge at highest point of building. Last one I did was before the 2008 change, when 100% OA was required. Maintaining duct velocity and discharge exhaust velocity are two other issues to expect. I assumed the same requirements as for high toxic lab for duct construction, subducting.

 

[SAK9]

There is no rule that ISO 7 room air can not be recirculated.Whether to use recirculatory or single pass air system is process specific.You need to use single pass system only if the process contaminates the air and it is unsafe for recirculation for health reasons.Single pass systems are usally under negative pressure to prevent spread of contamination.

In the couple of radio pharmacy jobs I have worked on, the background room air was recicirculated.The background room for the isolators is a positively pressurized clean room and is not expected to be contaminated under any circumstances(no spillage expected in the room).As such no filtration of return air is required.All radio active operations are to be done in the isolator which is under negative pressure and the exhaust from the isolator is HEPA filtered.You need to allow for sufficent outside air for isolator exhaust and room pressurization.Depending on the number of isolators and the size of the room the percentage of outside air can vary a lot.

 

[urgross]

I expect with chemo drugs you would have a higher risk assessment. That would also depend on the production level.

I believe that the VA was responsible for providing the original criteria (100% outside air for toxic compounding), the interim requirements (changes in vestbule requirements for toxic compounding), and 2008 critera.

We are talking about toxic compounding, I assume. That would mean the ISO 5 PEC, the ISO 7 buffer room, vestibule, and antechamber. The 2008 change, with supplements, includes a limit of 15 ACH on reciculated, if allowed.

 

[emalsyd]

The owner sent over a this from the USP 797 guide.

All hazardous drugs shall be prepared in a CACI that meets or exceeds the standards for CACI in this chapter. The ISO 5 CACI shall be placed in an ISO Class 7 area that is physically separated (i.e. a different area from other preparation areas) and optimally has not less than .01 inch water column negative pressure to adjacent positive pressure IOS 7 or better ante-areas, thus providing inward airflow to contain any airborne drug. A pressure indicator shall be installed that can be readily monitored for correct room pressurization. The CACI optimally should be 100% vented to the outside air through HEPA filtration.
IF a CACI that meets the requirements of this chapter is used outside of a buffer area, the compounding area shall maintain a minimum negative pressure of .01 inch water column and have a minimum of 12 ACPH.

I'm a little confused. The CACI is being installed in a pharmacy room, it's vented directly outdoors. Outside of that room are patient treatments room, exam rooms etc. No vestibule, no ante-chamber. So does this mean the CACI is outside of a buffer area or is the pharmacy considered the buffer area? The owner and their pharmacist is only asking for the 12 ACPH and the -.01 wc but I think the pharmacy needs to be built to ISO 7.

 

[urgross]

If the isolator meets the requirements of USP 797 for "Placement of Primary Engineering Controls" that allows usage outside of ISO 7 area, then only a 12 ACH, 0.1 IWG negative should be needed.

 

[urgross]

Attached may be helpful.

http://www.wbdg.org/ccb/browse_cat.php?c=9

Go to the Design Alert for USP 797.

 

[emalsyd]

Thanks for the help everyone.