Validation efforts need to incorporate machine operators

C.R.S. Ravishankar, a guest from India at IoPP's Chicago Chapter meeting May 10, offers insights into validating pharmaceutical packaging processes.

"Without trained personnel, your product and package is not going to be validated properly, and you're going to lose out on efficiency and output," Ravishankar said at the meeting, held in conjunction with the inaugural Packaging Services Expo in Rosemont, IL.

His comments trace back to a discussion about pharmaceutical validation during a presentation by Richard Price, president of systems integrator Automation Horizons. Ravishankar's basic message: If a company validates its packaging processes but doesn't include machinery operators, it's doing itself a disservice.

Ravishankar is the packaging development manager-marketing with BP-Castrol India Ltd. He is a certified packaging professional and mechanical engineer in India, with 15 years of packaging experience, including five in a pharmaceutical capacity with Johnson & Johnson in India.

He said training differs from validation, but there is a connection. " In the validation process, apart from machine operators, we also need to engage packaging, operations, and QA engineers, as well as the bottles, closures, caps, pumps, and other packaging components to comprehensively evaluate the packaging process. Every machine on the line has to be validated," he adds, focusing particularly on reducing operating cycle times to maximize the output and speed of each machine in a repeatable, consistent manner.

"This entire process of how bottles are cleaned, filled, packed, and the packaging environment needs to be validated, not just the packaging machinery and materials." That, he says, means that "when the Food and Drug Administration [or in his country, the Indian Drug Administration] asks, you have a process for each step that is documented."

--By Jim Butschli, Editor
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