Current Edition

Sterile, High-quality Components for Increased Patient Safety

Quality-wise, the main focus in pharmaceutical manufacturing has been primarily on the drug product and its primary container. Many pharmaceutical and packaging manufacturers have placed emphasis on those materials in direct contact with the drug product itself, such as the glass vial, plastic syringe and elastomeric stopper or plunger. Additional packaging elements, such as caps and seals, have not been the primary focus. However, in recent years, regulatory guidelines have influenced the requirements for crimping processes significantly. Sylvia Marzotko at West Pharmaceutical Services, Inc. reports on the production of sterile, high-quality components for increased patient safety.