23 August 2017 – Tissue Establishment Accreditation
With pride we can inform you that we have received the formal Tissue Establishment Accreditation from The Dutch Ministry of Health, Welfare and Sports. The Accreditation is dated July 31st 2017.
Having obtained this Accreditation, we are allowed to receive donor material from every EU-Tissue Establishment as well as from USA-based Tissue Establishments. We are allowed to store and process the donor material and to distribute the product to Establishments that apply the product in patients.
The first products that have been manufactured with our fully validated manufacturing process will be distributed soon. The successfully completed process validations include the validation of supercritical CO2-processing, the freeze-drying process, the process simulation of the aseptic process and the sterilisation validation.