Differences between OEL and OEB levels in the pharmaceutical industry

The Standard Group of Companies is a leading supplier of equipment in the pharmaceutical industry.

Containment equipment is manufactured in the Schematic Engineering Industries division paying particular attention to the following types:-

• Barrier isolators
• Glove boxes
• Pass boxes
  • Dynamic
  • Static
• Safety and decontamination showers

The use of a containment system is pivotal as to ensure potent compound safety, and is further tasked with the control of personnel exposure.

Active Pharmaceutical Ingredients (API) have the capability of inflicting serious health issues for all employees at very low airborne concentrations.

APIs can be classified into control bands (OEB) based on their potency and are categorised by occupational exposure limits (OEL) as a classification measure.

OEB (Occupational Exposure Band) is a method that will assign chemicals into categories or bands based on their health outcomes and potency considerations.

This mechanism also aligns chemicals in groups based on OEL in order to establish safe handling guidelines.

Hazard Banding (OEB) Criteria:

• Skin corrosion/irritation
• Serious eye damage/eye irritation
• Respiratory and skin sensitization
• Germ cell mutagenicity
• Carcinogenicity
• Reproductive toxicity

OEL (Occupational exposure limit) can be broadly described as the airborne concentration of a compound, where workers can be repetitively exposed 8 hours a day, 40 hours a week, without zero harmful effects.

These are values set to prevent occupational diseases, notably in personnel exposed to harmful chemicals in the workplace.

OELs can be measured in varying units which include: -

• mg/m3 for metals and salts that do not form vapours at room temperature
• Fibres/cc
• PPM (Part per million) for a gas or vapour at normal room temperature and pressure.

The following table shows values based on OEL level and OEB banding

The simplistic way to describe the containment system that should be used is as follows: -

OEB band 1 to 2

• Local exhaust ventilation

OEB band 3 to 5

• Downflow booth
• Cone valves
• SBV (split butterfly valve)

OEB band 6 to 7

• Barrier isolators (flexible and rigid)
• RTP (Rapid transfer ports)

OEB banding is a general guide and is not an exact science whist OEL limits can be quantified and measured quite easily.

Every application must be assessed on its own merits and then addressed appropriately with containment measures.

Factors that must be considered include: -

• Product dustiness
• Type of product – e.g. cytotoxic
• The process – e.g. sieving
• The time taken to carry out the process – extended exposure the greater the risk
• The quantity of powder handled at any one time

The Standard Group supply full turnkey solutions for all containment systems taking into account OEL levels and OEB banding, employees total protection and ensuring a quality product is produced.

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