Advancements in nanotechnology and highly potent APIs mean pharmaceutical production environments rely on strict engineering controls and procedures to comply with an Occupational Exposure Limit (OEL). Smaller particle sizes present greater drug surface area for reaction and are easier to absorb or inhale. Extract air from the laboratory has to be balanced with fresh, conditioned air from outside, without adversely affecting room pressures and fume hood performance. Specialised UV detection equipment is used to monitor contamination zones and to ensure equipment and surfaces are clean.
The laboratory environment will handle APIs in much smaller quantities than the production environment, but this does not mean that there is less exposure risk to the analyst working with the drug compounds
All API production environments require strict contamination controls but pharma labs require even more contamination awareness, argues Sean Codling, managing director, CTS.
It is a fact that smaller quantities of today’s new potent drugs can have greater pharmacological effects than their predecessors. Because of this, pharmaceutical production environments rely heavily on strict engineering controls and procedures to minimise exposure risk to operators and provide safe working environments for the large-scale handling of active pharmaceutical ingredients (APIs).
Ensuring exposure safety in the laboratory environment, however, presents different challenges. The laboratory environment will, of course, handle APIs in much smaller quantities than the production environment, but this does not mean that there is less exposure risk to the analyst working with the drug compounds. The analyst can carry out a number of different tasks with the drug and, as a consequence, will be in close proximity to it and at increased risk of inhaling airborne contaminants.
Advancements in nanotechnology and the development of drugs for inhalation have made micronised drugs more common. Smaller particle sizes present greater drug surface area for reaction and are easier to absorb or inhale; this is an important patient advantage, but also something of an increased risk to the analyst. The amount of a drug that will have an adverse pharmacological effect on the analyst can be so small that it cannot be seen.. . .
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