Professional Documents
Culture Documents
ADIGRAT UNIVERSITY
2. HAILEMARIAM ASEGEDOM
One of the most serious hazards in the manufacture of oestrogenic pharmaceuticals is inhalation
(and to some extent oral ingestion) of the pure active oestrogenic compound during weighing,
assembly and quality-assurance testing. However, substantial inhalation of the dry, blended dust
(which contains a low percentage of active ingredient) may also occur to workers during
granulation, compression and packaging operations. Skin absorption may also occur, particularly
during the wet phases of granulation, since alcohol solutions are used. Quality-control and
laboratory personnel are also at risk of exposure while sampling, assaying or otherwise handling
pure oestrogenic substances, granulation or tablets. Maintenance personnel can be exposed while
cleaning, repairing or inspecting mixers, hoppers, mills, vacuum lines and ventilation systems, or
changing filters. National Institute for Occupational Safety and Health (NIOSH) investigators
have conducted an in-depth evaluation of engineering controls which have been used during the
manufacturing of oral contraceptive tablets (Anastas 1984). This report provides a detailed
review of controls and an evaluation of their effectiveness for granulation, milling, material
transfers, powder and tablet feed equipment, and general and local exhaust ventilation systems.
The four main elements of hazard control employed in plants using oestrogenic pharmaceuticals
are:
1. Engineering controls. These include isolation of processing equipment rooms, control of air
flow within a facility from least contaminated areas to most contaminated, local exhaust
ventilation at any open transfer points, enclosure of machines, sealed process streams and
enclosed powder feed systems. Frequently, implementation of engineering controls, such as
general or local exhaust ventilation, is complicated by the fact that good manufacturing
regulations (such as those required by the US Food and Drug Administration), which are
designed to ensure a safe and effective product, conflict with the best health and safety practices.
For example, pressure differentials achieved by general ventilation systems, designed to protect
workers outside the hazardous process, conflict with the regulatory requirement to prevent
contamination of the product by dust or contaminants external to the process. Because it
eliminates direct contact between people and the hazardous contaminants, process or equipment
containment is often the best option.
2. Good work practices. These include separate clean and contaminated locker rooms
separated by showers, changes of clothing, washing or showering before exiting contaminated
areas and, where it is feasible and appropriate, systematic rotations of all workers between
exposed and non-exposed areas. Appropriate training and education regarding the hazards of
oestrogens, and good work practices, are an integral part of an effective worker protection
programme. The best engineering controls and personal protective equipment can be defeated if
the operators are not knowledgeable about the hazards and controls, and if they are not properly
trained to take advantage of the controls and to use the personal protective equipment provided.