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  2. Containment / Pharma Products

Engineering Controls

Each application must be assessed based on the following criteria:

  1. Product dustiness - the smaller the particle size the more likely it is the powder may get airborne.
  2. Type of product - if the product is cytotoxic/genotoxic and the requirement is in the 1-5 microgram range, consider full containment (isolator) unless the quantity/process is not practical for full isolation. If full isolation is not practical, operators should use additional protective equipment (full air fed suit) and the downflow booth room access must be via an airlock.
  3. The process - if the process imparts high energy to the powder, such as milling.
  4. The time taken to carry out the process - the longer the process time, the higher the potential risk of exposure.
  5. The quantity of powder handled at any one time - the higher the quantity, typically the higher the risk (bearing in mind the above, that is if the powder is granular i.e. sand like, the risk may not be that high).

The following are rules of thumb for guidance only:

OEB OEL Range µg/m3 Toxicological/Pharmacological Properties and potency Esco Containment Technology
1 1000-5000 Not harmful, not irritating, low pharmacological activity Esco Standard Pharmacon Downflow Booth with no additional engineering controls.
2 100-1000 Harmful, possible irritant, mid pharmacological activity Esco Standard Pharmacon Downflow Booth with no additional engineering controls. May require additional engineering controls if the process is extremely dusty (e.g. milling).
3 50-100 Moderate toxicity high pharmacological activity Esco Standard Pharmacon Downflow Booth may require additional engineering controls dependent on quantity handled and the process operation.
4 1-50 Toxic, corrosive, genotoxic, cytotoxic Esco Custom Pharmacon Downflow Booth with additional engineering control:

1.) Drum lifters
2.) Physical Barriers
3.) High containment enclosures with glove ports
4) Architectural features (e.g. airlocks/controlled access) to lower cross contamination risk

Note application would have to be assessed for suitability. Dependent on process/product the use of Isolator (glovebox) technology may be recommended.
5 <1 Extremely toxic, may be corrosive, sensitizing Esco strongly recommends use of Isolator (glovebox) technology at this OEL level.
Can be incorporated as part of custom Pharmacon Downflow Booth.

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