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**comcast.net
In-Reply-To


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
To: DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU
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.

 

Thanks,

 

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.

 

  ======================================================

Safety Emporium - Lab & Safety Supplies featuring brand names

you know and trust.  Visit us at http://www.SafetyEmporium.com

esales**At_Symbol_Here**safetyemporium.com  or toll-free: (866) 326-5412

Fax: (856) 553-6154, PO Box 1003, Blackwood, NJ 08012

 

 

 

Previous post   |  Top of Page   |   Next post



The content of this page reflects the personal opinion(s) of the author(s) only, not the American Chemical Society, ILPI, Safety Emporium, or any other party. Use of any information on this page is at the reader's own risk. Unauthorized reproduction of these materials is prohibited. Send questions/comments about the archive to secretary@dchas.org.
The maintenance and hosting of the DCHAS-L archive is provided through the generous support of Safety Emporium.