From: Slawomir Janicki <slawomir.janicki**At_Symbol_Here**COMCAST.NET>
Subject: Re: [DCHAS-L] Occupational Exposure Limits for Pharmaceuticals
Date: Mon, 7 Apr 2014 14:53:10 -0400
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Message-ID: 005b01cf5292$9f8d8ab0$dea8a010$**At_Symbol_Here**

One approach I have seen was to use a correlation between OEL and data available as the API is developed. In the order of least-to-most reliable reference point the OEL could be calculated from:

1.       NOAEL (Animal) (pre-Phase I preliminary tox data)

2.       NOAEL (Human) (Phase I data)

3.       LOAEL (Animal) (pre-Phase II 6-mo tox data)

4.       LOAEL (Human) (Phase I and/or II data)

5.       TDmin (Human) (Phase III data)

These values would be adjusted by appropriate factors (Body Weight, species-to-species Uncertainty Factors, adjustments for pharmacokinetics, Breathing Rate, bioavailability).


Not all data is available at all stages of development. There is nothing special about HP-APIs except that the exposure numbers get really small. Below 1 =ECg/m^3 all work needs to be done in isolators (lab scale) or in flexible containment (pilot plant/production scale).


As usually, engineering controls are established first to get the exposure below OEL and PPE is added on top to protect workers in case of a breach of containment.


Slawomir Janicki, Ph.D.


From: DCHAS-L Discussion List [mailto:dchas-l**At_Symbol_Here**MED.CORNELL.EDU] On Behalf Of ILPI Support
Sent: Monday, April 07, 2014 12:31 PM
Subject: [DCHAS-L] Occupational Exposure Limits for Pharmaceuticals


I have a colleague who is working on a consulting project and he is looking for Occupational Exposure Limits for pharmaceuticals.  His request is given below.   Any help is appreciated.




Rob Toreki


Any idea where I can get a list of OELs for pharmaceuticals?  I am specifically interested in the so-called high-potency active ingredients (HPAPI) that are typically Safebridge category 3 and 4. Most of the OEL lists out there have all manner of industrial chemicals, and I'm hoping that you can help me find a more focused list.



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