Formulation of highly actives
At Sever Pharma Solutions, we have the experience and facilities required for working with a range of highly active substances in a safe and contained way. This includes the manufacture of pharmaceutical products containing APIs that are ranked in the highest occupational exposure band (OEB 5). We have various containment options available, including those suitable for small scale to commercial manufacturing processes while also meeting cGMP requirements, as well as facilities for feasibility and early-stage development projects.
Our different options allow us to meet the needs of your product at any stage in the development life cycle. For products at an earlier stage of development, we will work to develop a containment solution with the final commercial process in mind, thereby reducing the need for significant process changes later. We are also experienced in the development of new containment solutions with our customers, through working with partner companies specializing in this field, when conventional containment systems are not adequate.
Our first step when working with a new product that contains a highly active substance is to perform a risk assessment. This is a collaborative process across our Safety, Health and Environment (SHE), Development and Engineering departments. Performance of the risk assessment ensures that we identify the most appropriate way(s) to mitigate the risks associated with working with the substance. This is primarily through engineering solutions and, when necessary, through the use of suitable personal protective equipment (PPE) for our co-workers. We perform regular inspections and sampling (both air and surfaces) in our facilities to ensure that our mitigating actions are sufficient.
Our risk assessments are continually updated as the product and process are developed, in order to ensure that all safety and cGMP requirements continue to be met. Throughout the process, our focus is on ensuring the safety of our co-workers, preventing contamination of products (both your product and those of our other customers) and ultimately producing a quality product that is safe for use by trial participants and/or patients.