Scapa Healthcare UK Leverages Gamma Irradiation and Microbiology Expertise to Provide Training on Healthcare Product Sterilisation
January 2023
Overview
Scapa Healthcare UK, a leading provider of gamma irradiation and microbiology services, has leveraged its vast knowledge to create a training program to educate healthcare companies on methods related to the sterilisation of healthcare products. The training course detailed below was designed to explain critical considerations for bioburden and sterility test method validation and routine testing (as defined by ISO 11737 standards); dose setting/substantiation methods and routine dose auditing programmes; and irradiation processing validation (dose mapping) and routine monitoring (dosimetry) (as defined by ISO 11137 standards / BS ISO 13004).
Approach
The Scapa Healthcare team at the Gargrave UK site approached customers proactively to let them know that this service was available, and based on their business, it would be beneficial for their team to understand the process fully.
The customers agreed and the Scapa team set up a full-day, tailor-made training program to assist them with growing, learning, and understanding the sterilisation process of healthcare products using gamma irradiation. The attendees had a range of backgrounds which all have crossovers to micro-lab and gamma work.
Results
The training assisted the attendees in fully understanding how their products get from a concept to a fully compliant device, with the knowledge of how to demonstrate a sterile label claim. The day’s activity was informative, and the attendees were fully engaged and found this course beneficial to enhance their learning of how these processes work.
As healthcare companies move forward with new product development and grow their business, support, and education on microbiology and gamma irradiation services can be an invaluable part of the medical device product development process. Contact Scapa Healthcare today to learn more about implementing a similar in-depth training session for your team, tailored to support your unique development needs.