Process Safety Management for Pharmaceutical Plants

Process Safety Management (PSM) is a framework for managing the integrity of operating systems and processes that handle hazardous materials.

In simpler terms, due to PSM, process-related incidents can be:

• Identified
• Understood
• Controlled
• Prevented

This management system has been widely credited for reductions in major accidents and improved process industry performance.

Often, there is a misconception that PSM is required only for petroleum, petrochemical, and complex chemical plants, and not for pharmaceutical plants and particularly API manufacturing units as they are a simpler form of machinery.

Factually, even the newer generation of API plants designed for multi-product functionality, intended for high capacity functioning, are almost as complex as chemical plants involving hazardous reactions and the use of flammable liquids and gases.

Incidents occurring due to reactive chemicals in API plants have gained prominence in India. With recent losses involving some major players in this business, questions arise: are we giving enough respect to this safety management system? Is the management system compliance-based or are we using the risk-based approach?

When we mention compliance-based, the focus is mostly on:

• Product safety, or
• Environmental safety, or
• Human safety

Often, process hazard analysis or hazard identification and risk analysis (HIRA) also influence these factors. Although these aspects are important, businesses often miss out on analyzing the reason for most of the fire and explosion losses — the critical factor. This is called “Property Protection,” not to be misconstrued with the security system of the site.

Although PSM encourages hazards analysis and management systems to control risks, these (part of property protection) are not adequately addressed in the risk mitigation efforts.

This mainly occurs due to a lack of formal knowledge on:

• Property protection
• Fire protection-engineering principles
• Prevention and suppression practices

For example, if there is a risk involving the spillage of xylene in a process, the conclusion would typically be a loss of product and an impact on the environment. However, the consideration of xylene as a flammable liquid and the fire hazard associated with it is often missed out and hence protection for these areas is often inadequate.

The property protection factors are a blend of engineering controls and management skills focused on preventing catastrophic losses. These engineering controls typically include a passive and active protection system that needs to be complemented with the building, equipment, process design, and infrastructure.

Organizations already practicing PSM but using a different approach (e.g. Occupational Safety and Health Administration or American Petroleum Institute) need not necessarily switch to the risk-based approach in totality; however, they should be aware of the property protection items, which may not be addressed under their present PSM scope.

They should possess the ability to demonstrate that alternative measures are in place for proper protection. The systematic risk-based approach helps companies identify significant risks, rank them, and prioritize steps to address them.

This leads to capital expenditures, operating expenses, staffing, and other resources being better allocated to risks, enabling companies to buy more risk reduction at a similar cost.

While performing audits, we at Marsh Risk Consulting (MRC) have noticed the PSM is primarily focused on product safety and, to some extent, towards human and environmental safety, with property protection limited only to statutory requirements. For example, sprinkler protection may be provided to abide by statutory requirements; however, the advantage of using it as property protection is not completely understood. Hence, no attention is given to its design and installation.

A systematic approach to integrating PSM with a property loss prevention program is needed based on each organization’s risk appetite. With the correct guidance on property loss prevention and proper training, MRC can support our clients in choosing the right strategy and ensuring that the property loss prevention aspect is incorporated in their existing program.

For more information reader could consult Marsh Risk Consulting India @ riskconsulting.india@marsh.com or contact local MRC representative.