The Need for Containment on High Potency Active Pharmaceutical Ingredients
High Potency Active Pharmaceutical Ingredients (HPAPIs) are drugs that represent a pivotal change in the new generation of developing patient therapies. The use of HPAPIs have lead a shift from the conventional use of ordinary medicines, to a pipeline of more effective ones.
An active pharmaceutical ingredient (API) is classified as an HPAPI if the occupational exposure limit is at or below 10 micrograms per cubic meter of air. Their ability to target the diseased cells are more precise and more selective in comparison with APIs. They are considered to be highly effective at smaller doses, therefore are much more efficient in the treatment of certain diseases. With such revolutionary effects, these innovations also lead to new manufacturing challenges.
HPAPIs pose health hazards to workers if there is an occurrence of spillage throughout the production, that checking must be done regularly in the different areas, even with remote substances. Engineering controls should be used as the primary source for the containment and isolation of potent compounds. Particular machinery is required when dealing with HPAPIs and managing air quality. Additional protection, which is PPE, only comes in secondary for minimizing the risk of exposure.
Strict procedures must be employed in every aspect of the HPAPI-handling process, from initial project evaluation, to the disposal of wastes. The opportunities for HPAPI manufacturers will increase with the growing number of potent compounds in the pharmaceutical development area.
With many years of experience and successful product and service delivery, Esco Pharma takes on newer challenges and makes your vision a reality. Together, we can move highly potent compounds to the next level.
Aseptic Containment Isolator (ACTI)provides a premium handling of biopharmaceutical drug products, aseptic cell processing, and high potency active pharmaceutical ingredients. Safety is assured with the provision of an ISO Class 5 environment.
Esco Containment Barrier Isolator (CBI)facilitates the isolation of a product or process while providing the required conditions for a sterile/aseptic environment. This equipment provides a comprehensive range of personnel and product protection in addition to protection for the surrounding work areas and the environment.
Bormett, D. (2018) High-Potency APIs: Containment and Handling Issues. Accessed last 21 February 2018, from http://www.pharmtech.com/high-potency-apis-containment-and-handling-issues?id=&pageID=1&sk=&date=
EPM Magazine. (2016) Keep it all in: How to handle demand for HPAPIs. Accessed last 21 February 2018, from https://www.epmmagazine.com/news/keep-it-all-in/