European manufacturer of primary packaging components for the pharmaceutical industry
The client produced rubber stoppers for injection vials at high speed. Existing manual AQL checks were too slow, too inconsistent and gave no conclusive assurance of batch quality. Defects such as lamination errors, flash, pits and contamination were occasionally missed. The fear of a large-scale recall was the trigger to invest in automation.
Simac Masic implemented an iM platform, configured for this specific product type and applicable GMP requirements. The system inspects every stopper completely — from inside and bottom to all sides and the top — at speeds of up to 1,200 parts per minute. Our engineers worked closely with the client’s quality team to define all relevant defect classes and validate the inspection system in accordance with IQ/OQ/PQ requirements.
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