The nondestructive tester provides the company cost savings and increases packaging integrity, according to QA lab manager David Derrick.
Following a directive for Derrick to streamline or eliminate testing without compromising product quality, the PTI 225 tester was used starting in late 2003 in Mentor’s QA testing lab to check package integrity.
“A package testing process should include integrity testing and seal testing, two very different procedures,” Derrick points out.
Used on finished lots of sterilized device packs, the tester is “validated to detect a 0.010 inch hole in a polycarbonate tray or the adhesive seal,” Derrick says. The test takes no more than 15 seconds, he adds.
Derrick likes the tester’s sensitivity and accuracy, ease of calibration, and adaptability to the company’s different packaging configurations. The equipment’s ease of use “provides a pass-fail result, so almost anyone can operate the system with very little training,” Derrick says. He calculates a payback of less than six months. —RL
