By George Bovenzi, Director of Quality, and Steve Pitolaj, Principal Engineer, Garlock Sealing Technologies
The pharmaceutical industry is global in scope and subject to international standards, such as International Standards Organization (ISO) 9001:2008, which establishes the requirements for quality managements systems. It is based on a number of principles, including strong customer focus, senior management motivation and engagement, process approach, and continuous improvement.
Compliance with this standard is completely voluntary, but increasingly, major global pharmaceutical companies are requiring its suppliers to be registered by an accredited, third-party registrar or certified by self-auditing, the former being preferable. These suppliers include manufacturers of sealing products used in the industry’s production processes.
From a product design perspective, sealing manufacturers must ensure that materials supplied to the pharmaceutical industry are compliant with U.S. Food and Drug Administration (FDA) and U.S. Pharmacopeia (USP) regulations.
The FDA’s Code of Federal Regulations (CFR) Section 177.1550 sets specific requirements for elastomeric materials, such as EPDM and others. U.S. Pharmacopeia (USP) National Formulary (NF) Class VI Parts 87/88 address biocompatibility with strict requirements for leachates; Part 87 addresses in vitro cytotoxicity and biological reactivity, Part 88 in vivo biological reactivity.
Control Of The Supply Chain
Compliance with these regulations is best achieved by assuming full control of and responsibility for the entire supply chain, from raw materials to final compound. This, in turn, requires purchasing resins directly from producers rather compounds from converters, auditing suppliers, and monitoring any material modifications that may not meet original specifications.
For sealing manufacturers, this means validation and full traceability of raw materials; absence of foreign matter and leachates from chemical compounds; chemical certification to industry standards; an auditable trail; and maintenance of the chain of custody. Also important is product consistency in terms of raw material specifications, process control, and performance. In assuming responsibility for the quality and consistency of raw materials, a sealing manufacturer should deal only with ISO-certified suppliers. Process control from the back end to the point of supply provides further assurance a sealing product will provide consistent, stable performance.
ISO In Asia
Initially established in the late 1980s, ISO 9001 has become necessary for U.S. and European suppliers to critical industries such as pharmaceuticals, biotechnology, food and beverage, and others. Registration to this standard should be a prerequisite for both sealing manufacturers and their raw material suppliers. This helps assure consistently high quality products for pharmaceutical manufacturers and, ultimately, the safety of patients for whom their products in turn are prescribed.
This requires robust quality systems and the rigorous disciplines of ISO requirements. Key disciplines focus on raw materials, process controls, and continuous improvement. Prescriptive elements for evaluating and approving suppliers assures the quality of incoming raw materials, and stringent process controls assure the consistency of sealing products, such as gaskets for sanitary, aseptic, and tri-clamp pipe connections, pump diaphragms, and others.
Remaining compliant with the ISO standard also requires evidence of continuous improvement in all aspects of one’s business, not just product-related areas. This might include utilization of Lean and Six Sigma tools in manufacturing operations.
Increasingly, leading pharmaceutical companies are rigorously auditing their suppliers’ production facilities to ensure that consistently high quality supply can be guaranteed across their global operations networks.
In summary, ISO registration is not merely something nice to have, but a credible means of assuring a global industry of world-class quality. As such, the pharmaceutical industry would be well advised to mandate that all its suppliers, not just sealing manufacturers, become registered and maintain their registrations by developing and implementing effective quality management systems. Only by doing this can the industry be assured that its entire supply chain is aligned with its requirements and continue to meet the ever-increasing demands on the quality of its processes and products.
About the Authors
George Bovenzi is Director of Quality for Garlock Sealing Technologies; email: firstname.lastname@example.org. Steve Pitolaj is Principal Engineer at Garlock Sealing Technologies, email: email@example.com.