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This has led to an increased need for the development of potent compounds and an increase in conventional drug manufacturing using HPAPIs.
The HPAPI market stood at a valuation of .64 billion in 2014 and, as a result of these trends, it is projected to be worth .11 billion by 2023 (Figure 1).
In this article, Michael Avraam, Global Product Manager at Charge Point Technology, discusses the key considerations linked to containment performance testing, data collection methods and the interpretation of results.
He also describes some technological developments that may help to ensure more efficient and consistent containment performance testing.
It’s well documented that the biopharma market is continuously expanding, largely thanks to the global demand and growth in the oncology market.
By the end of 2024, the cancer segment is projected to reach close to 0 billion in value, expanding at a CAGR of 6.5%.
Subsequently, as these containment strategies evolve, so too does the role of containment verification and there is a clear need to understand the potential variations in testing and differing interpretations of results.
However, there are a number of questions that need to be addressed relating to how this could affect the interpretation of the results: how relevant is the test placebo to the real-life API that will eventually be used and has each supplier tested with the same placebo?
Test equipment: There is the possibility for test equipment with the same performance to show differing results — owing to the considerable differences associated with various samplers when using the same test.
All manufacturing equipment must be validated prior to its use in the manufacturing process.
For example, before a manufacturer can implement a new control device within its process, it should be assessed according to the International Society for Pharmaceutical Engineering (ISPE) SMEPAC (Standardised Measurement of Equipment Particulate Airborne Concentration) guideline for its particulate containment performance.