There are many risk factors to be considered when it comes to the development and manufacture of highly potent active pharmaceutical ingredients (HPAPIs).
These risks can have a significant impact on the health and wellbeing of employees handling these products, the environment and other products being manufactured in the shared facility.
A robust containment strategy is essential, taking various factors into account such as dosage form, potential dust generation, operator exposure levels, volume being handled, and more.
Containment strategies must also consider the specific manufacturing processes being employed, such as process energy, scale, and level of operator intervention required.
Containing an HPAPI
There are three core components to be managed in a potent pharmaceutical manufacturing facility:
Containment is the effective isolation of the first component from the other two components, and to achieve it, manufacturers must prioritize the following:
Limiting worker exposure
First and foremost, it is essential that all workers handling the HPAPI are protected against exposure to the material. This must be done through robust engineering controls that keep the drug substance and drug product contained and reduces the reliance on respiratory protective equipment (RPE) as a primary hazard control.
These measures include preventing airborne cross-contamination through the use of dedicated rooms/suites that are specifically designed to handle HPAPIs.
The key to managing containment is to manage it from the source. Each HPAPIs has its unique properties, and there is no universal solution that can be applied as a blanket measure to all of them.
Instead, it’s important to assess each HPAPI and the corresponding unit operations involved in manufacturing the drug product on a case-by-case basis and design an appropriate containment strategy. Sometimes, assessments may conclude that a project should not be undertaken for various technical and cost reasons.
Assessment of the feasibility and appropriate solutions required for new HPAPI introductions should be conducted and established as early in the project as possible.
Doing so will allow development and manufacturing partners to better inform their customers on containment strategy plans and prevent any last-minute, costly changes.
Ensuring effective containment
By following these steps to inform HPAPI containment strategies, manufacturers will be able to plan and design solutions more effectively for the safe handling of potent drug products while ensuring quality and commercial viability.
Following these steps to inform containment strategies will also give partners the flexibility to handle HPAPI products at various potencies and scales. In turn, they will also be better positioned to offer alter or flex their processes according to client needs and specific HPAPIs.
Determine the potency of your API and start strengthening your containment methods by taking our HPAPI quiz.