Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Performance-based exposure control limits for pharmaceutical active ingredients

B D Naumann1, E V Sargent, B S Starkman

  • 1Merck & Co., Inc., Whitehouse Station, NJ 08889-0100, USA.

American Industrial Hygiene Association Journal
|January 1, 1996
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Search for secular trends in calvarial diameters, cranial base height, indices, and capacity in South African Negro crania.

American journal of human biology : the official journal of the Human Biology Council·2017
Same author

Genetic basis for variation in plasma IL-18 levels in persons with chronic hepatitis C virus and human immunodeficiency virus-1 infections.

Genes and immunity·2017
Same author

Admixture analysis of spontaneous hepatitis C virus clearance in individuals of African descent.

Genes and immunity·2014
Same author

The human relevant potency threshold: reducing uncertainty by human calibration of cumulative risk assessments.

Regulatory toxicology and pharmacology : RTP·2011
Same author

Description and evaluation of a serious game intervention to engage low secure service users with serious mental illness in the design and refurbishment of their environment.

Journal of psychiatric and mental health nursing·2011
Same author

Development of resistance to streptomycin by Aerobacter cloacae.

American journal of clinical pathology·2010
Same journal

Barrier durability of latex and vinyl medical gloves in clinical settings.

American Industrial Hygiene Association journal·2001
Same journal

Microwave emissions from police radar.

American Industrial Hygiene Association journal·2000
Same journal

Assessment of magnetic field exposures for a mortality study at a uranium enrichment plant.

American Industrial Hygiene Association journal·2000
Same journal

An assessment of occupational noise exposures in four construction trades.

American Industrial Hygiene Association journal·2000
Same journal

Prediction of rectal temperature by the Questemp II personal heat strain monitor under low and moderate heat stress.

American Industrial Hygiene Association journal·2000
Same journal

Indoor airborne fiber levels of MMVF in residential and commercial buildings.

American Industrial Hygiene Association journal·2000
See all related articles

Pharmaceutical companies now use a performance-based approach to set employee exposure limits for potent drugs. This method categorizes compounds by hazard, guiding containment strategies for worker safety.

Area of Science:

  • Occupational Health
  • Pharmaceutical Science
  • Toxicology

Background:

  • Traditional risk assessment methods for setting employee exposure limits are becoming insufficient for increasingly potent pharmaceutical compounds.
  • Difficulty in establishing no-effect levels for certain drugs necessitates a new approach.

Purpose of the Study:

  • To introduce a novel performance-based approach for establishing employee exposure limits.
  • To categorize pharmaceutical compounds based on toxicological and pharmacological properties to guide containment strategies.

Main Methods:

  • Developed a performance-based approach assigning materials into five hazard categories (PB-ECL Categories 1-5).
  • Criteria for categorization focus on the impact of exposure on human health.
  • Created matrices to guide engineering controls and safe handling practices for laboratory and manufacturing operations.

Related Experiment Videos

Main Results:

  • The performance-based exposure control limit (PB-ECL) system categorizes compounds from low potency (Category 1) to extremely potent (Category 5).
  • Containment strategies range from conventional handling to advanced closed systems with robotics.
  • Assignments dictate necessary engineering controls and safe handling practices to ensure employee safety.

Conclusions:

  • The performance-based approach provides a structured method for setting exposure limits for diverse pharmaceutical compounds.
  • This system ensures appropriate containment measures are implemented based on inherent material hazards.
  • It supports the safe development and manufacturing of increasingly potent pharmaceutical agents.