Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety. Submitted: Feb. 9, 2015. Accepted: May 29, 2015.

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations. Individuals working in pharmaceutical sterile ...

The European Commission's revision of its Good Manufacturing Practices (GMP) Annex 1 for sterile drug products was released in August 2022, after 14 years of development. The proposed changes will be ...

Aesica and EmulTech have jointly announced the commercial development of ET4ME - an innovative emulsion technology for product formulation. ET4ME, a micro-encapsulation technology developed by the ...

A round 140 surgeries and other invasive procedures take place in our hospital system each week day — and at each one, a surgeon will walk into the operating room and find his or her instruments ...

JENNINGS, La. (KPLC) - The SOWELA-Morgan Smith Campus in Jennings has received more than $316,000 in grant funding dedicated to upgrades in its surgical technology and sterile processing labs. The ...

The following article was originally published in Preventing Infection in Ambulatory Care, the quarterly e-publication from the Association for Professionals in Infection Control and Epidemiology ...

Growing orthopedic (ortho) and spine surgical volume raises an important question: can ASC support structures handle the increased workloads and regulatory requirements without increased financial ...

Montgomery County Community College, in collaboration with Pottstown Hospital, is starting a new Sterile Processing Technician program to prepare students for in-demand roles within the healthcare ...