Hazard analysis & dust testing
 Mitigate exposure & explosion risks in pharmaceutical workspaces

Hazard analysis & dust testing help you to fully understand the application & the processed ingredients

Created Wednesday, 10 August 2022

To mitigate exposure and explosion risks in pharmaceutical workspaces, you have to fully understand the application and the processed ingredients. Dust testing and a hazard analysis will provide more specific information about particle size and explosive properties of your dust and thereby to determine the right extraction solution for your needs.

Hazard analysis

To determine the methods for proper dust control in pharmaceutical workplaces, you have to understand the toxicological properties of the materials, to review the Occupational Exposure Limits (OEL) and to perform a risk-based exposure evaluation.

The questions that need answering when analysing the potential risks associated with dusts generated in the workplace include the following:

  • Occupational health: Are the generated dusts potentially harmful to the operators health or can they cause allergenic reactions?
  • Environmental impact: Are the emissions harmful when they get to atmosphere and therefore require special containment?
  • Explosion hazard: If you handle explosive dusts or hybrid dust and gas mixtures, you have to undertake a thorough risk assessment of the process to which the dust collector is applied as well as the area in which the dust collector is installed, to mitigate the risk for people and to avoid facility damage in case of a dust explosion.
  • Machinery & process: Can the dust generated cause any damage to your process or machinery?
  • Cross-contamination: Is there any potential for cross-contamination of products?

Health and Safety legislation varies in different countries but it is typically a legal requirement & responsibility for an employer to carry out risk and hazard analysis in the work place including the dust and fume generated during the processes.


Handling of api´s

There is a growing trend for pharmaceutical ingredients, particularly Active Pharmaceutical Ingredients (API’s), to consist of smaller molecules to provide faster reactions and greater potency. Solvents are often used in the processing phases. Whilst providing significant benefits in terms of drug delivery and performance, it creates a number of challenges for pharma manufacturers and their production processes.

The more potent the dust (OEB - Occupational Exposure Band), the lower the Occupational Exposure Limits (OEL) are set for personnel coming into contact with the materials. It is the employers’ responsibility to know and understand these exposure limits for each product they are using, and take the necessary steps to ensure the limits are not exceeded. The information regarding exposure limits is country specific. Using the UK as an example, the information is available via the HSE website: http://www.hse.gov.uk/coshh/basics/exposurelimits.htm

Dust testing

Lab tests on dust samples and simulation of specific challenges help you understand the characteristics of the material you are dealing with, so that you can make informed decisions on equipment, filter cartridges and engineered controls to mitigate dust hazards. There are two types of dust testing:

  • Lab testing, which pinpoints physical properties of the dust that affect filter efficiency and performance (dust particle size analysis).
  • Explosibility testing, which determines combustible and explosive properties of the dust (considering dust explosive characteristics such as Kst – the normalized maximum rate of explosion pressure rise, Pmax – the maximum explosion pressure of a dust cloud, MIE – The Minimum Ignition Energy of a dust cloud by electrical and electrostatic discharges).

Camfil has global laboratories to help clients analyse their dust safely in order to determine the optimum safe, cost effective dust extraction solution.

Selecting the right equipment

To choose and install the system which is the best solution to satisfy the application-specific requirements identified, it is recommended to employ a specialist dust control company who will have the required experience and knowledge to assist at every stage of the project. This will prevent any costly mistakes and ensure the system is specified and installed to fit for purpose with all the necessary levels of protection to satisfy the legal requirements.

A proper designed and installed extraction system guarantees best filtration performance and includes necessary EX-certified explosion protection, safe-change options for filter elements and dust discharge as well as reasonable energy consumption and long filter life to keep the operational costs at a minimum.

Dust collectors for pharmaceutical applications

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