Complying with Good Engineering Practices for Mechanical Integrity of Process Equipment

In addition to regulation by FDA, a major part of pharmaceutical manufacturing in the United States is also regulated under the US Occupational Safety and Health Administration (OSHA)’s standard for process safety management of highly hazardous chemicals, OSHA 1910.119 (1). According to this standard, mechanical integrity (MI) of process equipment is one of the 14 elements included in process safety management (PSM) for a broad range of industries. Its importance is often overlooked, especially when focus is placed on other regulatory issues. In recent years, the pharmaceutical industry has seen this lack as a gap they must close. 

Best practices for MI programs

When it comes to mechanical integrity, OSHA requires that Recognized and Generally Accepted Good Engineering Practices (RAGAGEP) be followed. The unique challenge to the pharmaceutical industry is that MI programs within industry are relatively immature (meaning that these practices are not fully established) and most recognized standards to draw from come from the oil and gas industry. Basic principles from the oil and gas industry can and should be applied. Pharmaceutical companies need to identify the unique challenges not seen in other industries and write them into their own MI standards. 

It should be recognized that pharmaceutical manufacturing does come closer to resembling how the petrochemical industry adopted oil and gas standards. There is precedence and opportunity to use their approach and reach out to other industry sectors’ experts. If well-defined processes and procedures are established for each owner/user, and acknowledging RAGAGEP is reasonably applied to the industry, then pharmaceutical manufacturing users can be assured that they are compliant with PSM principles. 

One tool developed by the oil and gas industry that can be successful within pharmaceutical manufacturing is risk-based inspection (RBI) processes. What makes RBI a great fit for the pharmaceutical industry is that it employs an inspection planning methodology tailored to the specifics of the owner/user’s process, versus arbitrary rules that might not make much sense otherwise. 

It is crucial that RBI experts (if applicable), corrosion specialists, and certified inspectors be consulted as a part of implementing and maintaining a MI program. Despite the unique nature of the pharmaceutical process, there is much that can be leveraged by using these experts. For example, by using an experienced American Petroleum Institute certified inspector, the owner can be assured that the individual is well versed in inspections planning, non-destructive testing (NDT), and inspection reviews and recommendations. Likewise, corrosion specialists or engineers are accustomed to evaluating unique failure mechanisms by using their education, training, and failure analysis tools and processes. Finally, NDT techniques and applications can be consistently used over a broad range of industries.  

A final best practice for maintenance compliance is taking the owner’s computerized maintenance management system, detached inspection databases, drawing systems, and other legacy systems and implementing them into the latest digital data management processes. The heart of collecting compliance inspections is a mobile solution and digital process controls that ensure rapid, consistent, and real-time results. 

Reference

1.CFR Title 29, 1910.119

About the author

Jonathan Martinez is Director of Operations at PK Technology, which provides mechanical integrity consulting and inspection services and has developed and licenses intelliSPEC, a digital data management system and mobile platform.