Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy.
At the 2022 Nelson Labs Virtual Symposium, we will present examples of radiation sterilization for Ready-to-Use (RTU)...
Archives: Courses
Rubber Manufacturing and Composition of Pharma Rubbers
Rubber closures are a critical component in the primary packaging system of small volume parenterals (SVPs). At...
Combination Products and Parenteral Packaging: A Notified Body (EU) Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of the considerations...
Combination Products and Parenteral Packaging a US Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of drug delivery...
A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
Manufacturers are required to perform a biological evaluation of any medical device as outlined in ISO 10993-1....
FDA Medical Device Inspections in the Post Pandemic World
The FDA is ramping up its inspections of medical device manufacturing facilities. Are you ready? Since March...
2022 State of the Medical Device Industry Quality, Biocompatibility, and Changing Regulations
As another year unfolds with regulatory changes, updated mandates, and the ongoing impacts of the COVID-19 pandemic,...
Preservative Effectiveness Testing – Calling Attention to Burkholderia SPP
Controlling the growth of microbes within non-sterile formulations is critical for ensuring product safety and meeting regulatory...
On the Origin of Extractable Species
The universe of extractables is extremely diverse, encompassing a wide variety of materials used in the construction...
Testing and Risk Management Impacts Changing Medical Device
Change management, particularly related to a medical device’s design, is one of the most commonly cited issues...
Risk Assessment for Single Use Systems: USP 665 vs. BPOG
Disposable plastic components are increasingly popular in biopharmaceutical drug manufacturing systems due to their cost-effectiveness and reduced...
ProDisinfectant Efficacy Testing Coupon/Carrier Method
Disinfectants must be qualified on the surfaces within a pharmacopeial manufacturing environment before their use in the...
Product Adoption for Ethylene Oxide Sterilization
Changes to the design of an existing product or the adoption of a new product into a...
Reusable Advices For Reusable Medical Devices
Ensuring that reusable medical devices can be properly cleaned, disinfected, and sterilized is crucial for patient safety...
What is Cytotoxicity
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel. Dr....
Cleaning Validations for Newly Manufactured Medical Devices
The implementation of ISO 19227:2018, which addresses the cleanliness of orthopedic implants, has set a new standard...
Intro to Pre-Clinical Testing and Biocompatibility
In this episode of the RCA Podcast, host Brandon Miller is joined by Dr. Matthew Jorgensen and...
Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
In this webinar, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, will delve into effective approaches for...
2022 Industry Outlook Medical Device
In this episode, host Brandon Miller is joined by Seyed Khorashahi and Thor Rollins to explore the...
Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...