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…
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…