Small packaging machinery suppliers may be shut out of pharmaceuticals

Some packaging machinery manufacturers and systems integrators have shied away from pharmaceutical customers due to the burden of process and machinery validation. The costs of validation may exceed the costs of hardware and software, and going through the process is not for the faint-of-heart. Costs of 1.5 times the total automation cost have been reported for initial validation and changes to a validated process that may take 2 hours in a food plant could take 3 weeks in a pharmaceutical plant. It is obvious why some machinery suppliers might not want to deal with this. As a result, the pharmaceutical industry may not always be getting the widest array of choices for new machines. Continuous improvement of a validated process is an oxymoron.

Recognizing the problems that validation has created in terms of a manufacturers ability to optimize operations and improve productivity, the FDA has created a new framework called PAT or Process Analytic Technology that manufacturers may voluntarily adopt to move beyond their locked-down validated processes. PAT will rely more upon contemporaneous measurement coupled with a complete understanding of the underlying processes to insure that pharmaceutical processes are performing as expected.

At last month's 11th annual ARC Forum, Kate Waters of Genentech described the metamorphosis of pharmaceutical manufacturing from art to science. PAT, not yet widely adopted, is being piloted by some in areas such as the plant's utility systems. Pharmaceutical companies will need to move from the current quality by inspection to a newer quality by design model.

Standards will play a key role, as they should have already done in validation. The OMAC Packaging Workgroup has been preaching the value of standards such as IEC61131-3, PLC Open motion function blocks and the use of state-based programing models to reduce the time and cost of validation. Standards will be even more important in this new environment. While groups such as Make2Pack are at work learning to apply the S88 batch standard to packaging, others recognize the need to harmonize the QbD quality by design model to S88. For pharmaceutical companies to do business in our flattening world, such standards will need to be harmonized around the world.

Ms. Waters was asked how the evolution from validation to PAT would affect the procurement and implementation of process and packaging machinery in the plant and the relationship with suppliers. The reply was partly one of, "I don't know." But as her answer developed, it became apparent that a tightening relationship between long-term sustainable suppliers who are willing to share risk with the customer would be a part of the new model. Small suppliers, of which there are many in the packaging machinery industry, may very well be shut out.

Packagers and their suppliers must jointly lead, follow, get out of the way or be road-kill. Either they will create the standards upon which concepts like PAT may be implemented or someone else will. It has been done in other industries, and it needn't all be reinvented. Where have you seen it done? What is your company doing to bring these standards to packaging? Are you feeling shut out, or has your company done something to put you on the inside? I'd like to hear from you.

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