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...
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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...
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...
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...
Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...