06-06-2017 01:22 PM
Can a pass-through be from the HD negative pressure room directly into non-classified air (general pharmacy area) or does it have to be into the ante room?
I'm reading USP 800 and it says "pass-through chamber between the negative pressure buffer area and adjacent space). We are designing a new facility and are reviewing plans proposed by a company.
06-06-2017 02:05 PM
Good question! I would first make sure that your state board of pharmacy doesn't have limitations associated with pass-throughs. Any pass-through needs to be a well-constructed stainless steel box with interlocking doors. It cannot be a sliding window. Ideally, it should be a HEPA filtered purged pass-through when used between the negative-pressure HD buffer room and the general pharmacy. Pass-through refrigerators between a negative-pressure buffer room and any space are prohibited. Hope this helps.
09-18-2017 09:02 AM
I have an additional question about the passthroughs for HD rooms. If the ante-room is an ISO-7 positive pressure room and it connects separately to the HD buffer room and non-HD buffer room (each buffer room is its own room, do NOT need to walk through the non-HD buffer to get to the HD buffer), should we still have a passthrough from the Ante-room to the HD buffer room for transfer of materials? We do NOT have the set up as noted below but USP 800 does not seem to address the pass through if you do have the recommended room set up?? Am I reading this wrong?
Thank you for your clarification.
USP 800 says this:
"Although not a recommended facility design, if the negative-pressure HD buffer room is entered though the positive-pressure non-HD buffer room, the following is also required: • A line of demarcation must be defined within the negative-pressure buffer room for donning and doffing PPE • A method to transport HDs, HD CSPs, and HD waste into and out of the negative pressure buffer room to minimize the spread of HD contamination. This may be accomplished by use of a pass-through chamber between the negative-pressure buffer area and adjacent space. The pass-through chamber must be included in the facility's certification to ensure that particles are not compromising the air quality of the negative-pressure buffer room. A refrigerator pass-through must not be used. Other methods of containment (such as sealed containers) may be used."
09-18-2017 01:05 PM
In my opinion, it is best to transfer HD material through a HEPA filtered, interlocked pass-through when the pass-through is connected to between the HD room and the anteroom or the uncontrolled main pharmacy. You don't want to transit HDs through positive-pressure rooms and you want to get the HDs into a negative-pressure space with a minimal amount of intervening steps.
09-20-2017 09:05 AM
I know that pass through refrigerators are a no-no in a negative pressure buffer room, but what about if a negative pressure storage room (ISO 7) is connected to the buffer room and separated by a door. Could there be a pass through refrigerator from the negative pressure storage room to the stock drop off room? Just trying to find an easy way to store and retrieve refrigerated hazardous stock.