Static charge is responsible for the vast majority of particulate contamination loss (e.g., internal rejects, customer complaints and returns) experienced in many life science manufacturing facilities. Due to the extensive use of insulative materials, like silicone rubber and plastics, all device products are affected. Recent studies across many companies that manufacture medical devices (e.g., vials, catheters, stents, heart valves, optical lenses, IVs, syringes, hip/knee replacements, pacemakers, blood filters, breast implants and other implantable devices) have shown that substantial yield improvements result when the electrostatic attraction (ESA) problems were eliminated via ionization technology.
This educational presentation will discuss the physics behind Electro-Static Attraction of particles and corona ionization. The CGMP benefits of utilizing air ionization in cleanroom operations and its effect on manufacturing yield improvements in medical device manufacturing will be presented. Several case studies documenting the effect of ionization on manufacturing yields will also be presented and discussed.