Basic Cleanroom Requirements and Classifications
It’s said that cleanliness is next to godliness, but most manufacturers would be happy with knowing that their products are free from contamination. This is […]
medical
ISO 15747:2018 – Plastic Containers for Intravenous Injections
The standard for plastic containers for parenterals, ISO 15747:2018 – Plastic Containers For Intravenous Injections, has been revised. Intravenous (IV) medications are often optimal due […]
How the Cloud is Transforming the Way Hospitals Store & Use Patient Data
The massive cloud migration of recent years has spread across a myriad of industries, with healthcare being one of the latest to adopt its systems […]
ISO Health Care Product Sterilization Standards Adopted By AAMI
A health care product is not sterile unless it is free of microorganisms. Sterilization is assured with these products and their materials and components through […]
Amendment to ANSI/AAMI/IEC 62304:2006 – Medical Device Software – Software Life Cycle Processes
ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment has been released. This document is an amendment to the existing ANSI/AAMI/IEC […]
Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
Pharmaceutical excipients are essential to the safety, quality, and efficacy of drug products, as they impact a variety of factors influencing how a drug enters […]