Process Development

A cardiovascular device manufacturer required documented evidence that their manual terminal crimping process for HLM (Heart-Lung Machine) cable assemblies would consistently produce product within IPC/WHMA-A-620B specifications when operated at nominal conditions across multiple production lots. The challenge involved validating operator-dependent manual crimping across two wire gauges (14 AWG and 24 AWG) with different terminal types and crimp height specifications. Critical concerns included operator variability as the primary process parameter, preventing excessive or insufficient crimping, ensuring crimp form quality, and maintaining dimensional accuracy (crimp height) within tight tolerances (±0.002 inches).

A cardiovascular device manufacturer required documented evidence that their automated terminal crimping process using the AMP-O-lectric Model G machine for HLM (Heart-Lung Machine) cable assemblies would consistently produce product within IPC/WHMA-A-620B specifications when operated at nominal conditions across multiple production lots. The challenge involved validating automated crimping across two wire gauges (14 AWG and 22 AWG) with different terminal types and crimp height specifications. Critical concerns included ensuring the crimp fixture (Auto Crimp Applicator) setup was correct, validating the first piece article process with Precision Adjustment Lever calibration, preventing excessive or insufficient crimping through automation, and maintaining dimensional accuracy (crimp height) within tight tolerances (±0.002 inches).