Potent Compounds in Pharmaceutical Processing

Potent Compounds in Pharmaceutical Processing

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Description: Containment technology was born in the Nuclear industry to allow safe handling of radioactive materials. La Calhène developed glove boxes with Rapid Transfer Ports. Eli Lilly and Merck were the first major pharmaceutical houses to look at containment of potent compounds.

Over ten years ago Merck began developing a Global Standard for the containment and control of toxic compounds in pharmaceutical manufacturing areas. Current focus has been toward the containment of wet processing facilities.

 
Author: Terry Fay (Fellow) | Visits: 2784 | Page Views: 2962
Domain:  Medicine Category: Biotech/Pharma 
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Contents:
Handling of Potent Compounds in Pharmaceutical Processing

Terry Fay May 12, 2009 Prepared for NJAIChE

History of Containment
Containment technology was born in the Nuclear industry to allow safe handling of radioactive materials.
� La Calh�ne developed glove boxes with Rapid Transfer Ports

Eli Lilly and Merck were the first major pharmaceutical houses to look at containment of potent compounds. Over ten years ago Merck began developing a Global Standard for the containment and control of toxic compounds in pharmaceutical manufacturing areas. Containment of powders with directional airflow and split butterfly valves expanded the options for safe handling. Current focus has been toward the containment of wet processing facilities.

What is OSHA and other global health & safety organizations looking for?
Limit or eliminate reliance on Standard Operating Procedures (SOP) Apply Engineering Controls wherever possible Current technologies are focusing on:

In the United Kingdom, the Substances Hazardous to Health regulations enacted in 1988 require that "so far as reasonably practicable, the prevention or adequate control of exposure of employees to a substance hazardous to health shall be secured by measures other than the provision of personal protective equipment."

Containment at the Source
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Criteria for developing guidelines for safe handling of compounds
Maximum Daily Dose Lethal Dose Lethal Concentration Short Term Exposure Levels Occupational Exposure Levels Nature of exposure problem (i.e. is it dermatologically absorbed or must it be inhaled, effect on exposed skin surfaces, eyes, mucus linings, etc.) Reversible versus non-reversible effects

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Containment Analysis
Containment Categories are determined internally by the company Risk Based Exposure Control (Wyeth)
� RBEC I >100 micro-g/m3 � RBEC II 10 mg/m3 � RBEC III 1 mg/m3 � RBEC IV 100 micro-g/m3 20 mg/m3 5 micro-g/m3 1 micro-g/m3 5000 micro-g/m3 - >1000 mg/m3 � Level 2 100 micro-g/m3 � Level 3 10 micro-g/m3 � Level 4 1 micro-g/m3 � Level 5
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