High potency capability now available up to OEB4 level pharmaceuticals

Exposure to minute quantities of potent compounds is enough to potentially cause health effects, so managing a safe environment for working with these compounds is of high importance to the pharmaceutical industry. The Control of Substances Hazardous to Health (COSHH) requires employers to control substances that are hazardous to health. This law places a duty of care on employers to take adequate precautions to protect employees working with hazardous substances.

For the treatment of cancer, oncology drugs frequently base their activity on being cytotoxic. All drugs with direct anti-tumour activity are known as cytotoxic drugs, including: anti-cancer drugs, immunosuppressive drugs, monoclonal antibodies and partially targeted treatments.

If your company is developing cytotoxic or hazardous compounds, Tepnel Pharma Services has the capability skills and experience to handle Active Pharmaceutical Ingredients up to and including OEB 4 with barrier isolation technology as required by Occupational Exposure Banding.

Occupational Exposure Banding is a process that quickly and accurately assigns chemicals into banded categories, with each band being based on a chemical’s toxicological potency and the adverse health effects that exposure to the chemical could produce. This process clearly outlines an occupational exposure band (OEB). These have been widely used by the pharmaceutical sector and by some major chemical companies for some time, establishing exposure control limits/ranges for new or existing chemicals that do not have formal OELs. The OEB control levels are highlighted in the table below:

Containment Controls

Exposure limits determine manufacturing safeguards
Occupational Exposure LimitBandProduction Requirements
>1 – 10 mg/m31Good manufacturing safeguards
>0.1 – 1 mg/m32Good manufacturing safeguards (with local exhaust ventilation)
>0.01 – 0.1mg/m33Essentially no open handling (ventilated enclosures required)
>0.001 – 0.01mg/m33+Virtually no open handling (containment systems required)
≤0.001 mg/m34No open handling (closed systems required)
≤0.001 mg/m35No manual operations/human intervention (robotics or remote operations required)
Source: Merck & Co.