A significant amount of new drugs under development contain high-potency active pharmaceutical ingredients (HPAPIs), which is causing a major growth in demand for their production.
The cytotoxicity of HPAPIs, however, presents handling challenges and requires heavy investment in specialized containment to ensure that employees and their environment are protected from exposure.
The pharmaceutical industry makes an effort to develop voluntary standards for HPAPI production and handling.
The potency of pharmaceutical chemicals is characterized by OELs in μg/m3; The lower the value, the more potent the chemical and the greater the level of containment that is required.
A constant increase in the number of APIs going through development and clinical trials, and into the production environment with OELs well below 10 μg/m3. These processes require specialized containment to ensure that employees and their environment are protected from exposure.
Containment issues are becoming a major important aspect of solid dosage form production, especially for highly potent and toxic active pharmaceutical ingredients (APIs), especially for hormone and oncology applications.
With a more intense focus on health and safety, avoiding operator exposure and preventing cross-contamination is a critical issue.
The most effective containment solution is in a form of rigid type isolators. Ravona Pharma provides a wide range of containment solutions that operate under negative pressure and set with double inlet and double outlet HEPA filters.
Our Rigid Stainless Steel Containment Isolators have been designed for handling potent materials, mostly in powder form that can offer guaranteed levels of operator protection as low as 10ng/m3.
Activities such as sampling, dispensing, mixing, milling and barrel charging and discharging, as well as containing integrated process devices such as filter dryer units, tablet press enclosures, blenders, mills and packing systems.
Some process in the higher bands of substances needs to go through numerous steps of activities and need to be handled through few isolators connected between them.