479083 Examples of Some PSM Challenges Associated with the Batch Manufacturing of Pharmaceutical APIs

Jeff Grant, South Haven Plant, Albemarle, South Haven, MI

Examples of Some PSM Challenges Associated With the Batch Manufacturing of Pharmaceutical APIs

Federal OSHA regulations for Process Safety Management were developed with continuous operations manufacturing in mind. However, applicability is determined by threshold quantities of specific chemicals or flammables, not by the method of manufacturing, so the regulations apply to batch processing as well as continuous operations.

In some cases, batch operations are those processes that use specified equipment for some needed period of time, and then the same equipment is used for another chemical process. Due to the different processes run in the same equipment, there are many challenges that can arise implementing process safety requirements, such as equipment/utility needs for different processes (i.e. material of construction, relief adequacy, different process requirements for reactor volumes) and charging of chemicals (i.e. hard pipe verses hose for liquids, solids charging methods).

In this presentation, I will discuss several unique challenges we have faced for our batch operations, and the approaches we have had to take to ensure we produce quality pharmaceutical products in a safe manner.


Extended Abstract: File Not Uploaded
See more of this Session: GCPS Electronic Poster Session
See more of this Group/Topical: Global Congress on Process Safety