The concept of Highly Potent APIs (HPAIs)
is broad and comprises both highly potent compounds with a defined or no-effect threshold level (e.g. imatinib and estradiol) and compounds which are highly sensitising or without a defined threshold level, thus requiring dedicated contained facilities (e.g. ß-lactams, hormones and certain cytotoxics).
While regulators and the industry have not shared official guidelines for safe use and management of HPAIs, the pharmaceutical segment can benefit from the cGMP practices in the FDA risk-based assessment approach, the EMA exposure limit guidance, the ISPE risk-based system (Risk-MaPP) and applicable local regulations on occupational exposure.
An occupational exposure limit (OEL) is defined as the average concentration load of an API in µg/m3
of air acceptable over a long period of exposure (eight-hour day or 40-hour week) without negative impact on workers and the environment. The industry has made several attempts to categorise bands of OELs into ranges, for which appropriate common measures of protection can be defined for APIs with different OELs within a given occupational exposure band (OEB).
Because no harmonisation has been agreed upon in the assignment of OELs to OEBs, different systems co-exist in the industry, examples among which include SafeBridge, Roche, Boehringer Ingelheim and others. However, they all share the common aim of protecting workers from risk.
As a contract development and manufacturing organisation with facilities across Europe and the US, CordenPharma
uses a full range of development and manufacturing equipment covering all scales, with proven containment systems in its laboratory, mid-scale and large-scale production areas. The company has multi-purpose facilities handling small- and large-scale production of highly potent and oncology compounds, bringing many containment challenges over the years.
In order to ensure a robust system, CordenPharma has developed the concept of a ‘containment puzzle’
where all of the pieces must align to achieve both safety and cGMP goals (Figure 1). This system is the basis for the ISO, OSHAS and SafeBridge voluntary certifications in CordenPharma Colorado
(USA), CordenPharma Plankstadt
(DE), and CordenPharma Latina
A successful containment programme builds its foundation on the ‘hard’ elements of robust containment equipment and engineering controls, but distinguishes itself with the ‘soft’ elements of the containment puzzle: a containment culture, process development, occupational health pre-planning and an ongoing containment execution cycle.
Read the full article online in Specialty Chemicals, Sept 2015, p. 18-20 here.