The API pharmaceutical market has been increasingly buffeted by winds of global change. Even as new and innovative drugs have been developed and brought to market successfully, manufacturing operations have been increasingly challenged by the need to be more competitive and productive.

The trend has been to move to more efficient operations and lower costs, while at the same time increasing process reliability and the throughput of high purity products. Furthermore, manufacturing operations are shifting to the most desirable locations to meet the increased demands of cost controls and efficiency. Older, lower-volume facilities are being consolidated with larger, higher-volume sites that require ever-tighter process effectiveness. For API pharma manufacturers, this means finding new methods to economize and streamline all production processes. This has led the way to adopting new technologies and more simplified procurement processes, leading in turn to "standardization" as a tool to meet these challenges. And in fact, manufacturing and maintenance simplification, as well as inventory reduction, are achievable goals with standardization.

As process optimization trickles down from the most expensive items, it is reaching into all corners of processing plants that handle chemicals and other aggressive media. For example, there is already a definite trend in the chemical process industry towards the standardization of materials. We believe this will take place in the API pharmaceutical sector as well. Higher-cost items such as pumps and piping systems have seen the rapid advance of standardization. Now the trend is moving to standardization of smaller process components such as mechanical seals, bearings, O-rings, gaskets – and even nuts and bolts. Each of these categories has their own unique standardization challenges.

Gasket Standardization

Gasket standardization is one of the challenges now being addressed by chemical plants and processing units. From recent market research conducted by W. L. Gore & Associates, Inc. among leading North American chemical processors, it was found that approximately 75% of the companies interviewed have a gasket standardization effort in place. In most cases, the processors have standardized on a specific gasketing material for each of the three main piping categories – steel, glass-lined and FRP – while also allowing for some exceptions in the case of abnormal application requirements. Among the gasketing experts interviewed, 80% feel that gasket standardization is a top-level or highly important activity.

What does gasket standardization mean in terms of an "ideal world" to these experts? It means essentially one thing: a single gasket that can be used anywhere and is suitable for practically all applications. Unfortunately, ideal situations rarely exist. Thus, the focus has been to reduce the number of materials rather than to standardize on a single gasket material.

Several gasket materials available today may be categorized as suited for only one pipe class (e.g., for FRP, for glass lined steel, or for steel piping). Now, technology developed by Gore is capable of overcoming this challenge. The GORE™ Universal Pipe Gasket is compatible with steel, glass-lined, and FRP piping. It has been adopted successfully by many CPI chemical companies over the past five years.

The strategic benefits of this type of standardization are significant. Today, cost-effectiveness is integral to the strategic plans of all plants in the chemical and pharma processing industries. Gasket standardization can unlock the long-term strategic value that plants are seeking. Not only will the lowest procurement cost to seal a flange be achieved, but also the total "lifetime cost" of sealing will be optimized, producing continuous annual cost savings.

Gasket simplification of the type envisioned here would facilitate system-wide standardization across piping classes – metal, plastic and glass-lined – while increasing reliability and safety. A Pressure Vessel Research Council (PVRC) study showed that the average plant experienced 180 leaks per year, with 2% being serious enough to cause a process shutdown or worse. Knowing that the primary causes of leaks are improper installation of gaskets and use of the wrong gasket for the service, it's not difficult to conclude that installation effectiveness would be positively impacted with a standard gasket. In the final analysis, gasket standardization is a "win" for every function that is now involved with gasket selection, acquisition and use.

The Right Material

Approximately 95% of all process piping systems operate at less than 450°F and 1,000 psi internal pressure. To enable standardization, the gasketing material must withstand as close to 100% of these operating parameters as possible. This gasket material must achieve a bolt load retention that emulates graphite. It must also have the tightest sealing and lowest emissions, as well as the greatest safety against blowout. In other words, it should be the most reliable gasket. It must work effectively and deliver this performance across all three piping classes -- glass-lined, FRP and steel pipes. It must also support the full range of 0-14 pH service and low stress-to-seal systems.

There are additional, unique benefits available to API pharmaceutical companies with the standardization of gasket materials. The needs of this industry go beyond CPI in that the final products must maintain high purity and are subject to regulatory controls. Every component in the process system that comes into contact with the process fluid must meet the highest purity standards – and many need full traceability to the source of the material as well. The GORE™ Universal Pipe Gasket is the only 100% ePTFE non-contaminating (USPC VI Tested) gasket which can replace all non-metallic gaskets used in applications below 600°F, can effectively seal all types of process piping, and is fully traceable to the source.

Such technology enables API pharmaceutical companies to achieve all the cost reduction benefits of standardization to one gasket material while increasing process reliability, safety and purity.

Cost Considerations

In addition to performance qualifications, the standardization process offers economic advantages as well. Cost reduction is a primary driver of standardization, so obviously a gasket material must be cost-competitive if it is has any hope of becoming a standardization "flag bearer." It is important to look at the complete picture when analyzing the cost impact of standardization.

The initial cost of the gasket is one consideration, but additional cost savings are achieved when the correct gasket is always at hand. Maintenance requires less time, thus lowering labor costs. Fewer errors are made, resulting in fewer interruptions to production. Finally, inventory requirements are reduced.

API pharmaceutical companies can realize many benefits by standardizing on a single gasket material for all processes below 600°F that utilize non-metallic gaskets. In doing so, be sure to choose a gasket material that has passed USPC VI qualification testing and is traceable to the source, while also delivering the reliable sealing performance upon which every processing plant must rely.

Carl Jones and C. P. Ganatra, P.E. are gasket product specialists in the Sealant Technologies Group of W. L. Gore & Associates, Inc. For more information, you may contact them at 410-392-3200 or