Part 3 of #developmentchallenges. This week I am working on ethylene oxide (EO) sterilisation. That is not easy, as regular sterilisation and validation capacity is in shortage. Two suppliers let me know they don’t have any capacity for 2023. One supplier had the capacity for routine sterilisation, but the validation team had only the capacity in 5 months. The last supplier had capacity. I was thrilled. YES!….. I thought. The quotation was so outrageous that I immediately understood why they still had capacity available.
Bringing innovations to the market is not easy. Besides the continuously increasing requirements, resulting in increased expenses, these innovative start-ups face capacity shortages. Shortage in sterilisation capacity, in ISO13485 or GMP certification, technical file review. These shortages are responsible for delays in bringing new products to the patient.
This is a post in a series about our daily #developmentchallenges and #productionchallenges at Vosfox Medical. We perform process development, validations and regular production of medical devices for our customers. Our speciality is low-volume production such as Medical 3D printing. Please visit vosfoxmedical.com for general information, Contract Manufacturing for information about sterilization services, or Services for information about sterilization validation.