High Potent Active Pharmaceutical Ingredient (HPAPI)

 Active pharmaceutical Intermediates & ingredients with a high level of potency are known as highly potent active pharmaceutical ingredients (HPAPIs). These compounds possess greater potency than regular drugs, requiring very small amounts to produce a biological reaction.


High-Potent Active Pharmaceutical Ingredients (HPAPIs) are commonly used to treat cancer-related ailments. A substance is usually determined to be high-potent when its operational exposure limit is under 10 µg/m3 of air as an 8-hour time-weighted average. Oral, injection or topical administration may be employed for administering the drug depending on the source of the illness. Most HPAPIs are composed of small molecules, which possess a known therapeutic property, and have a rapid absorption rate.


Manufacturing of HPAPI presents a challenge due to their high potency, as they require specialised handling and containment. A significant proportion of new drugs in development and production involve HPAPI, necessitating the use of special measures for their handling and containment.


HPAPI production requires stringent safety conditions and containment to be followed. The initial step is to establish an Occupational Exposure Limit (OEL) for the chemical entity, followed by the creation of a containment plan to avoid human exposure and contamination.


An enclosed environment is required to produce HPAPIs, usually with isolators and cleanrooms installed. The cleanroom is pressurized and equipped with HEPA filters, so that no HPAPI is released into the environment.


We use isolators and cleanrooms to meet high safety standards, and we train our employees to handle HPAPIs with great care. Our highly skilled team also provides containment plans required to assess the buffer between no effect and effect from the HPAPI. This helps prevent human exposure and averts contamination.


Our facility is outfitted with isolated environments and cleanrooms that are run under negative pressure and with HEPA filter systems to prevent the emission of HPAPIs. We have trained staff who are experts in handling these projects and have the experience to guarantee that your projects are done to the highest standard of safety.

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