Mechanical Integrity

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-Risk Based Inspection-

Pharmaceutical and biotech production facilities, and the processing equipment are aging, with many systems aging beyond 20 years. Manufacturers are now beginning to experience problems associated with aging, and are having to develop strategies to respond to the approaching equipment end of lifetime.

Traditionally, manual inspections are used to detect potential issues inside processing equipment, particularly corrosion, rouging, or scratches. External problems, such as leaking jackets, are detectable and reported by operators. These issues commonly result in a 1-2 week production outage while the equipment is being repaired, which has the potential to lead to market supply issues.

As equipment ages and more repairs are performed, the equipment walls thin, and may not have sufficient metal thickness to maintain its pressure rating.  When this occurs, there is an opportunity for the equipment to be de-rated for a lower pressure, repurposed, or may need to be replaced.

Risk Based Inspection program

An inspection program is recommended to measure the thickness of the metal, on applicable processing equipment, such as tanks, in order to predict timing of replacement.   The periodic, routine checks, that are required by such a program, can be scheduled so as to not impact production, and can be merged with the preventative and predictive maintenance programs your organization is likely to already have deployed.   This approach will allow sufficient time to secure the necessary capital for equipment replacement, and allow planning required to avoid adversely impacting the business and market supply.

Since not all processing equipment are exposed to chemicals which may cause corrosion, a Risk Based inspection program may be developed, with more frequent and detailed inspection of high risk process equipment, and a lower frequency and degree of inspection for lower risk equipment.

These types of risk-based, detailed inspections are not typically performed by pharmaceutical companies. However, they are common in industries where hazardous chemicals are used, particularly oil and gas. OSHA has a Process Safety Management (PSM) Program, which includes a Mechanical Integrity program. This program has details on how to set up a Risk Based Inspection Program as part of a Life Cycle Management Cycle.

Improved FDA Interactions/ Reduced Production Outages

Rather than having unexpected failures of process equipment, which can result in deviations, CAPA’s, product outages, and unplanned shutdowns, companies are looking at predictive techniques to determine when equipment needs to be repaired, or replaced, while minimizing production issues.

Minimize Setbacks

Kymanox members have experience of Risk Based Inspection programs across hazardous chemical industries, and the pharmaceutical/ biotech industries. We can help you modify your existing reliability engineering/ Preventative maintenance systems to incorporate a Risk Based Inspection Program, which can predict when equipment needs to be replaced.


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