Can Validation Be Exciting? Frankly, it can't. But the results can be.

by Jim Wagner, Contributing Editor

Validation may not be the most glamorous job in the world, but it is very important to packaging engineers. The Institute of Packaging Professionals (IoPP) discovered just how important when it held a seminar on validation last year with the help of Pharmaceutical & Medical Packaging News. IoPP was pleasantly surprised when the seminar sold out. It succeeded partly because FDA's David Pulham was speaking, partly because some heavy hitters were on the program, and partly because few packaging departments are overstaffed with validation experts.

IoPP got the message. In the time since the seminar, it has formed a new group called the Validation Technical Committee to help members with validation. The committee is worth a look because it could become a valuable resource for information about the validation process. It also wants to do something about the lack of guidelines for validating packaging machinery.

Spearheaded by Tom MacMurray and Steve Drucker of Warner Lambert and Howard Leary of Luciano Packaging Technologies, the committee plans to establish validation guidelines and publish them through IoPP. While FDA would be unable to endorse or approve the guidelines, it could monitor them as it did the U.S. standard for the International Organization for Standardization (ISO) medical device packaging requirements. If a problem or a question came up during validation, FDA could refer to the guidelines for answers.

Work is already under way. During the committee's first meeting, groups were established to take the first steps.

First, guidelines will be written for specific types of packaging machines. The guidelines will outline the minimum validation requirements for qualifying each machine component, including how each component is to be documented. The guidelines will also spell out which parameters are to be measured and qualified.

The validation guidelines may also indicate which machines would have to be validated for regulatory purposes. It's a question that nags validation protocols and slows them down. Is it necessary to validate every labeler? Yes. But is it necessary to validate every powered conveyor and accumulator? It depends. That's what the Validation Technical Committee hopes to sort out.

Finally, the guidelines would set up standard practices for integrity testing of different types of packages. The practices would satisfy validation for a package's function. As it stands, every company has its own way of testing package integrity. If the committee succeeds, testing protocols would reference a standard. Plus, FDA would know what to expect, which could ultimately speed up product approvals.

During last year's validation seminar, FDA's Pulham was asked about protocols for validating a cartoner. A motor had burned out, the man explained, and he wanted to know whether the machine would have to be revalidated if the motor were replaced by the same model. Pulham listened to the details, paused, and replied, "Why are you validating a cartoner?"

That's the $10,000 question. FDA may not consider cartoners, palletizers, and case packers critical equipment, yet manufacturers may spend countless hours validating them anyway. The validation committee will help eliminate unnecessary validation by specifying what's critical. It will make validation easier and, ultimately, more of a tool along the same lines as statistical quality control. Now if only someone can make statistics appealing.

For more information, contact Howard Leary at Luciano Packaging Technologies (Somerville, NJ) at 908/722-3222.