03.23.23 -- ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions

Read how medical device, pharmaceutical, or single-use system manufacturers can manage short-term interruptions to the supply chain without shutting down production.

Class III medical devices must maintain product sterility for the duration of the product’s shelf life and be easy to open. Learn about nondestructive detection methods of seal quality issues.

Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Learn about a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in the molding process.

Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations. 

Quality management is a mission-critical function of all medtech manufacturers. Attention to quality issues when selecting vendors and partners can help manufacturers prevent downstream issues.

Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost reduced if the cleaner supplier can provide support.

In this article, Young Kim, Ph.D., senior principal engineer/chemist; Don DeMello, principal engineer field development; and Philip Wilson, Ph.D., marketing director medical, all of Celanese, discuss the benefits of recent advances in liquid crystal polymer for connected medical devices.