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Pharmaceutical compounding clean room

hlfireinspector

hlfireinspector

Silver Member
Joined
Nov 9, 2009
Messages
281
Location
North Mississippi
Does anyone have tips for the installation of a pharmaceutical compounding clean room? This is the first one I have dealt with. I asked for chemicals to be compounded and got a 500 item report for all chemicals in store. Pharmacist says not one within 300 miles(red flag #1) No one is doing this (red flag #2) and nothing hazardous it all goes in the body (red flag #3). Drugs are poisons we administer in limited does to kill virus. It will be a 4 room plex-glass booth in and fully sprinkler building. Pharmacist states no flammables or water reactive chemicals. Have concerns since the Phenol spill at big name store happen and we deaconed 18 people and 8 hr haz-mat clean up.
 
* * * *

Did that ' 500 item report ' provide information on quantities of chemicals

that will be on the site?, ...how do they plan to store those chemicals?



* * * *
 
Yes it does have quantities example: Acetyl Hexapeptide-3 43.000 (GM,ML or UNITS) He said not over a liter of anything. I see acetone, benzyl alcohol , sulfuric acid, ether usp all on the list.
 
I take this to be in an existing pharmacy

So do you want to make it an "H"?????

Any ventilation???

We have one and have not yet has a problem
 
* * * *

Have they submitted a workable plan of compartmentalized fire areas

for the chemicals / other materials planned for use, ...in approved storage

containers?

FWIW, any submitted plans should NOT be ' examples', but rather, the

actual, planned amounts.

* * * *
 
Existing is correct. They do not want to make it a H. I am waiting on plans now for clean room. Ventalation is being done with existing AC system and HEPA filter from all I have been told. I asked about return air and that question is yet to be answered. Most info I have found on internet the fire suppresion was done with clean agent but they just want to use sprinkler system. I have been looking at req. for wet bench and it is driven by flammable compounding only. Am I on right track?
 
Is this compounding for a Pharmacy in a health care setting, like a hospital or cancer center; or in a manufacturing setting?

I am familiar with the health care version, and they indeed do have some nasty chemicals, but in extremely small quantities and generally used in fairly "closed" processes. I would believe that they have the potential for 500 items, but most are delivered "just in time" for a specific patient's prescription. I have designed several, and they never had the quantities requiring H occupancy or even a specific control area. Never seen clean agent applied in this setting - it's always wet sprinkler off the rest of the system (it is never "clean agent instead of wet pipe" anyway, it's always "clean agent to supplement the wet pipe".
 
This is a drug store in a strip mall. They are doing compounding already for external compounds.(Wart remover ect.) They want to do internal drug compounding.(IV's ect.) I just got plans and the booth is 269" by 102" /4 rooms /polycarbonate panels/ slider doors. Fans on top of ceiling panels and air grills at floor level. I do not see the MAQ being exceeded unless I missed something. Same chemicals as already there just sterile enviro. is what I have been told.
 
Do not have the book but first look at the limits on exempt amounts, more then likely they will not be over them
 
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