Process Safety Management is not a program unique to AbbVie; it started in response to multiple catastrophic fires, explosions, and toxic chemical releases that occurred due to industrial accidents in various countries. Many countries now require and regulate PSM programs and AbbVie has pulled it into our Global EHS standard. The program consists of 14 key elements that work in conjunction to maintain proper and effective standards to keep our employees safe!
Process Safety and Tech Transfers
What is Process Safety?
“Zero. Believe It. Achieve It.” That’s the mission statement of the Environmental, Health, and Safety (EHS) team at AbbVie, and is the responsibility of all of us. Zero incidents - whether that’s injuries, environmental spills, waste to landfill, etc., the goal is to have zero. When it comes to the manufacturing environment, that principle comes into play well before manufacturing actually begins through AbbVie’s Process Safety Management (PSM) program. Read on to learn more about AbbVie's PSM program!
Process Safety Management
The 14 Elements of PSM
Employee Participation – Employees need to participate in the elements of maintaining PSM.
Hot Work – Procedures to ensure safety of work that generates sparks/flames like welding and cutting.
Operating Procedures – Procedures that cover all aspects of a process from start to finish.
Mechanical Integrity – Procedures and programs in place to inspect and fix equipment safely, correctly, and in a timely manner.
Training – Initial training for processes and safety practices and risk with refreshers every 3 years.
Emergency Planning & Response – Clear procedures and training for Emergency Response actions.
Process Safety Information – Compiled and maintained info on process hazards, technology, and equipment.
Incident Investigation – Standardized and timely investigation procedures when incidents occur.
Process Hazard Analysis – Asking “What If?” to ensure all potential hazards from a process are evaluated and mitigated/controlled.
Contractors – Ensures contractors are subject to the same safe-work practices as AbbVie employees.
Pre-Startup Safety Review – Reviews before startup to ensure all PSM requirements are in place.
Trade Secrets – Employees must be provided with info to ensure PSM compliance, regardless if a trade secret exists.
Management of Change – Tracking and communication of changes to process, equipment, and operations.
Compliance Audits – Performed every 3 years to certify compliance with PSM standard.
Process Safety During Tech Transfers
Now that we’ve established what Process Safety Management is, how is it put into practice in manufacturing? Tech Transfers are the activity in which a manufacturing process is brought into a manufacturing site, either from another existing site or from R&D. During these transfers, the process is evaluated to determine in which equipment (existing or new) it will run, how big of a batch the process can run, and most importantly – what are the hazards associated with running the process. Read on to see how this plays out in an example.
Drug Substance Example
Let’s take a look at an example of a Drug Substance process and we’ll focus just on a single reaction step. Let’s evaluate some of the potential hazards and controls that could be put in place to ensure employee safety while performing this step!
