Sacha van Rheenen is a speaker at the 3D Medtech Printing conference. He will talk about the necessity of validation for medical 3D printing and explain where to start. You can see the announcement here. Sacha will talk about which steps to take (IQ, OQ, PQ) and what is especially challenging with 3D printing. General knowledge on validation can be found in a previously published article, and some thoughts on 3D medical printing can be read in another article. Since writing this article, we have learned more about the process validation of 3D print processes. Also, new ISO standards dealing with 3D printing have been published (e.g. ISO-ASTM 52920), while others will hopefully soon be released. I am happy and optimistic that the ASTM and the ISO organisations worked together on this, so we have a globally harmonised standard that we can all follow.
3D printing has grown to be a professional production method.
Like any production process in medical devices and pharma production, the process must be validated. Join us in life or online to learn more about this dreaded but oh so important topic of validation.
Sacha van Rheenen works since 2020 at Vosfox Medical. He is responsible for the 3D printing processes as a Sr Engineer. Sacha has a bachelor’s in Medicine, a pre-master in Technical Medicine and a master’s degree in Biomedical Engineering. With this versatile education, Sacha developed a wide variety of skills that contribute to the success of Vosfox Medical. He is a specialist in process development, production, and validation of 3D printed medical devices and drug delivery implants.
Vosfox Medical is a contract manufacturing organisation specialising in low-volume production of medical devices or drug delivery implants. Our CMO services include using our facilities and support to develop the production process and produce materials for clinical trials. We offer ISO Class 7/ Class C cleanroom, QA support, production process development, packaging design, process validation etc. We can also support or execute your packaging or sterilisation validation. Contact us if you want to learn more