VENTILATION SYSTEMS IN PHARMACY INDUSTRY 2

[Welchita]

Hello Fellows!

Suppose you have a not so big pharmacy laboratory of a middle technology level.
On account of a manipulation of several quimical substancies in close rooms, which must be ventilated at the regulamentaries air rates.

Do you know which usual norms/rules are applied? What are the air rates to follow?
Thanks in advance.
Welch

 

[PUHVACr]

You have to find out what they are doing in the Pharmacy. If they are doing compounding of IV's or chemo drugs this will require a "Clean Room". If they are doing this procedure there are different classes of clean rooms.... beginning at 100,000. Class 100,000 usually is 25-35 ACH. There are also class 10,000 which typically is in the range of 55-80 ACH.

ASHRAE has quite a bit of literature on the design of clean rooms.

On the other hand, if the Pharmacy is only a room with a bunch of drugs in it it can be treated as a normal room and only the equipment load in the room would have to be accounted for.

Not sure if I've helped or made things more confusing.

 

[Welchita]

Hi PUHVACr!

Not at all!
You just confirm my thoughts at this phase.
I will have to go deeper in the normative field. I'm just waiting for the up-to-dated chemo drugs list, the related process, to decide the ventilation method, diffusion and fresh air rates concerning.
Your help has been great! Thanks!
Welch

 

[Drazen]

I would advice you that you contact QA department of that pharmaceutical company. They are the ones to give you key input about requirements for their processes.

If they are not sure, they should seek for consultancy, not you.

Why is that? If you show yourself client-sensitive and study specific ASHRAE literature, decide to design "white" or "grey" room, six month later somebody from that company can appear, state that such cost was not necessary and blame you for that unnecessary cost.

Go to QA and push them until they give you their requirements in written!

 

[Welchita]

Hi DRAZEN!
You just pointed out the main aspect,i have to deal with.
I must say that I got already some data you mentioned (in written), an I have to consider those, as enough inputs like the chemo drug list, the layout, to do my study.

The task now, is to get some "grey rooms", I mean to manage some solution, which has to fulfill the actual normative stuff concerning the the legal requirements (you should be aware of it) for the interior QA and exterior QA, as well. My initial question is stand by.
Thank you.
Welch

 

[Welchita]

Again to DRAZEN
Suppose you do nothing in this case, or just the minimal. They will blame you as well. The question is to get here a balanced solution, consider the normative requirements.

The 2nd aspect is to consider the design process in two phases, related to the outside QA, (that implies some significant investment) by monitorizationig in order to know what solution to treat the exaust air.
Welch

 

[quark]

The question should not be vague if you want to get good inputs. It still doesn't occur me, by reading your question, what kind of help you are anticipating. What is a Chemo drug? Do you mean cytotoxic products?

Is it an API plant or formulation plant? If formulation, what dosage form? Are you dealing with any exotic substances?

Have you been to USFDA and EU GMP websites?

http://www.fda.gov/cder/guidance/index.htm

http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm

 

[Drazen]

Well, I can imagine small company with which you have close contact. They give you list of drugs they use and tell you "please do everything to design proper HVAC".

But such situation, if I guessed well, make your task too hard, say impossible.

Big company would give you their developed specs and you'd be able to design according to that. Small company probable doesn't have it and expect you to develop all.

But that's not job for one small project! I was dealing with company specialized in specifications according to USFDA, but even they were not willing to develop some custom specs for one plant, they offered FDA approach or nothing.

You should do something similar: offer client to choose some level of FDA specs, or if he wants to keep it simple, you should find out production rate of diffrent toxical substances, install local exhausts (they are typical for labs), negotiate with client about air exchanges, filter class, type of flow... at the same time looking at standard ASHRAE reqirements.

I see no other approach.

 

[Welchita]

Hi, Fellows!

Drazen, I must say that you got your shoes on the real world. That's right, it's a small company. The approach has to be carefully balanced for a system, which has to fulfill the Interior Air Quality IAQ requirements in the first project phase and leave the conditions, ex.: for doing the monitorization and the characterization of those exaust air emissions. In the second project phase, to design the solution to deal in accordance with the air-legislation.

Hello again Quark! Doesn't mean that are no rigth, but the investment is been enormous for the process equipment, and you know the limitations at this stage.... The client ask me to get an optimal solution.

Thank you, both!
Welch