OCCUPATIONAL HYGIENE IN THE PHARMACEUTICAL INDUSTRY

Course description / A course giving a specialist insight into the practice of occupational hygiene in the Pharmaceutical Industry; providing an overview of the industry its hazards and processes as well as the describing the industry specific techniques which are used to assess and control exposures.
Course aims / Equip students with the knowledge and skills to practice occupational hygiene at professional level in the pharmaceutical industry.
Learning Outcomes / On successful completion of this module the student should have an understanding of the following in the context of the Pharmaceutical Industry:
  • The structure of the Industry
  • The hazards associated with the Active Pharmaceutical Ingredients
  • Processes used in the Industry
  • Techniques used for exposure assessment
  • Exposure control technologies
  • The management of Occupational Hygiene

Course format / 4.5 days taught course with revision/homework questions each evening and a final xx hour exam.
Target Audience /
  • Professional occupational hygienists who lack experience in the Pharmaceutical industry.
  • Pharmaceutical industry personnel with basic hygiene training who want to progress to more senior hygiene positions.

Ref / Area / Description / Proportion of Time
1 / Industry Structure /
  • Business models for the Pharmaceutical industry and how they evolved in the 20th century.
commercial pressures on the industry (blockbuster model of drug discovery/development patent issues)
Drug development process
research and generic drug companies
Contract Manufacturing Organizations (CMOs)
  • Present and future trends (globalisation, sub-contracting, genetic technologies, targeted therapies)
  • Different Types of Business Units – R&D, Manufacturing (Bulk Manufacture, Formulation/Fill/ Finish, Sales & Marketing, Administration/Offices….Dry products, Parenteral…Small Molecule, Large Molecule. N.B. Biotech growing as part of pharmaceutical industry.
  • Veterinary products, animals and human health.
  • Outline of related industries such as medical devices, vaccines, biotechnology, cosmetics and nutritionals.
/ 5%
2 / Products/Hazards /
  • Active Pharmaceutical Ingredients (APIs) and their significance for exposure
  • Main therapeutic classes and the impact that the drugs have on disease
  • Key examples of each class and their occupational health hazards; examples to include sex hormones, opiates, antibiotics, steroids, cancer therapies and prostaglandins
  • Relationship between occupational hazards and therapeutic dose
  • Potent compounds and the use of unknown hazards (R&D)
/ 10%
3 / Processes and Technologies / Description of main processes and technologies, highlighting likely exposure issues:
  • Research and Development (including high throughput screening, animal allergy issues, novel technologies such as Liquid Dispensing, supercritical fluids).
  • Primary manufacturing processes (including reaction chemistry, evaporation, filtration, drying, packout) and presence of isolated intermediates
  • Secondary production processes (including weighing, sampling, granulation, drying, sieving, film coating, milling, compression, encapsulation, packing etc., fumigation and sterile operations including contamination issues and vial washing
  • Biological processes and issues eg. fermentation, vaccine production and Genetically Modified Organisms, endotoxins
  • Process and equipment selection to limit exposure
/ 15%
4 / Hazard Testing and Interpretation of Toxicology Data /
  • Product development stage gates and timing of hazard testing
  • Testing techniques – QSAR, screening tests, animal tests, clinical trials
  • Timing of toxicology and pharmacology testing and data generated
  • Occupational toxicology testing and data generated
  • OELs and OEL setting – industry standard approach
  • Acceptable surface limits
  • Acceptable daily intake and cleaning limits
  • Hazard Banding
  • Hazard Communication - Potent compound safety awareness training
/ 15%
5 / Exposure Assessment /
  • Current industry practices on
compliance testing and exposure monitoring
sampling equipment and methodology
sampling strategies
development of analytical methods
  • Direct reading monitors and their role in the Pharmaceutical Industry
  • Validation of sampling methods (air sampling and surface sampling methods)
  • Practical issues eg. aseptic technique, flameproof equipment
  • Trends and recent developments
Exposure modelling and the use of Bayesian Statistics
Skin Exposures - discussion on potent compounds and skin exposure
  • Medical surveillance
  • Biological monitoring
/ 20%
6 / Control of Exposure /
  • Industry Control Banding models
  • Controls used for high level containment
  • Laboratory containment techniques
  • Pilot plant containment techniques
  • Validation testing – FAT, SAT and containment performance testing SMEPAC
  • Use of RPE and PPE including decontamination and reuse
  • Control in healthcare settings
  • Risk Communication
/ 20-30?%
7 / Physical Health Hazards /
  • Industry Specific Health Hazards
Noise
Vibration
Ergonomics / 5-10%
8 / Management of Occupational Hygiene /
  • Business processes
auditing, acquisition and divestiture, due diligence, new product development, product transfer, in licensing and outsourcing
  • Corporate Responsibility
Reputation and Ethics
Social issues for the industry such as access to medicines, publication of research data, animal testing
Employee health as a human right
Importance of exposure control to legal and ethical operation of the industry
Health and performance
Trust, transparency and ways of working
  • Environmental Sustainability
containment and environmental releases
climate change (energy and HVAC)
mass efficiency, green chemistry and inherently safe processes
9 / Glossary and Acronym List
© 2009 Hirst Consulting Limited and GSK / Page 1