OEL / OEB

Active Pharmaceutical Ingredients (API) have the prospect to bring about severe to serious health effects in personnel at very low airborne concentrations. The use of containment systems or equipment, as an integral part of an efficient method to potent compound safety, is recommended to control personnel exposure.

APIs can be classified into control bands based on their potency. Generally, API’s are categorized by occupational exposure limit (OEL) as a classification measure.

Terms:

OEB – Occupational Exposure Band, a mechanism used to precisely assign chemicals into “categories” or “bands” based on their health outcomes and potency considerations. It also aligns chemicals in groupings based on OEL in order to establish safe handling guidelines.

***Almost every facility has their own version

Hazard Banding (OEB) Criteria: These include qualitative, semi?quantitative, and quantitative data for each toxicological endpoint.

OEL – Occupational Exposure Limit is the airborne concentration of a compound to which nearly all workers can be repeatedly be exposed 8 hours a day, 40 hours a week, without adverse effects.

These are values set to prevent occupational diseases, notably in personnel exposed to harmful chemicals in the workplace. OELs are often expressed in mg/m3 especially for metals, salts and other compounds that do not form vapours at room temperature and pressure. However, some OELs may be expressed in units such as fibres/cc while a few are expressed in parts per million (ppm) if the substance exists as a gas or vapour at normal room temperature and pressure.

 

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.

 

Additional recommendations:

 

BAND

­OEB 1

OEB 2

OEB 3

OEB 4

OEB 5

OEB 6

OEB 7

OEL

>1000 – 5000 µg/m3

>100 – ≤1000 µg/m3

>10 - ≤100 µg/m3

>1 – ≤10 µg/m3

<1.0 µg/m3 – 0.01 µg/m3  

10 ng/m3 

0.01 µg/m3  to 0.001 µg/m3  

>10 ng/m3< 1 ng/m3

<0.001µg/m3  -

<1 ng/m3

Equipment to Use

Ventilation Containment

Ventilation Containment or Flowhoods without downflow (single pass Fume cabinets)

Downflow Booths or VBEs, Flowhoods

VBEs or DFBs with higher containment, Flowhoods with downflow and inflow for small volume

Isolators recommended however if handling less than 3kg and short task duration, low dust cloud potential reverse oRABs possible.

Isolators

Isolators

Production

OSD

 

 

 

VBEs

DFB with high containment screen

WDCI

DFB with flexible isolator

WDCI

WDCI

Production common application

 

Fume Hoods

- protect the user from inhaling toxic gases (fume hoods, biosafety cabinets, glove boxes)

- protect the product or experiment (biosafety cabinets, glove boxes)

- protect the environment (recirculating fume hoods, certain biosafety cabinets, and any other type when fitted with appropriate filters in the exhaust airstream)

- Secondary functions of these devices may include explosion protection, spill containment, and other functions necessary to the work being done within the device.

Downflow Booths

- Open handling of highly hazardous powders. Most commonly used in the Pharmaceutical, Cosmetic, Fine Chemical and Nanotechnology Industries.

- Operator protection during potent or non-potent manual powder/compound handling operations such as: weighing and sampling of raw materials, manufacture of tablets and capsules, packaging, charging and dispensing.

Isolators

- designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations

- Designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes.

- For handling New Chemical Entities, weighing, dispensing and containing potent compounds during sub-division and sampling processes.

Isolators

- designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations

- Designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes.

- For handling New Chemical Entities, weighing, dispensing and containing potent compounds during sub-division and sampling processes.

Isolators

- designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations

- Designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes.

- For handling New Chemical Entities, weighing, dispensing and containing potent compounds during sub-division and sampling processes.

Isolators

- designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations

- Designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes.

- For handling New Chemical Entities, weighing, dispensing and containing potent compounds during sub-division and sampling processes.

Production

Injectable

If Aseptic needed (with HPV)

 

 

 

ACTI (Aseptic Containment Isolator)

CBI-U (Containment Barrier Isolator Unidirectional)

GPPI (General Processing Platform Isolator)

ACTI (Aseptic Containment Isolator)

CBI-U(Containment Barrier Isolator Unidirectional)

GPPI (General Processing Platform Isolator)

with closed transfer

ACTI (Aseptic Containment Isolator)

With complete closed transfer (RTPs)

 

ACTI (Aseptic Containment Isolator)

With complete closed transfer (RTPs)

 

R&D

Qc/ IPQC

Sampling

 

FHs (Fume Hoods)

EFF (Esco Frontier® Floor)

EFA (Esco Frontier® Acela™)

CYT (Cytoculture™ Cytotoxic Safety Cabinets)

FHs (Fume Hoods)

EFF (Esco Frontier® Floor)

EFA (Esco Frontier® Acela™)

CYT (Cytoculture™ Cytotoxic Safety Cabinets)

 

GPPI (General Processing Platform Isolator)

CBI-T (Containment Barrier Isolator Turbulent)

roRABs (Reverse open RABs) VBEs (if small quantity)

CBI-T (Containment Barrier Isolator Turbulent)

CBI-T (Containment Barrier Isolator Turbulent)

It should be noted that these bands are rules of thumb for guidance only.

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).