SAMPLE POUCHES FOR QUALITY MONITORING

Tender description

Sample pouches will be used in conjunction with blood components that have been produced as a result of initial separation from whole blood or apheresis collection packs and where those collection packs have met the requirements of the applicable documents listed herein. Sample pouches must be capable of taking a representative sample of the blood in the component pack whilst not affecting the originating blood component pack’s ability to continue to meet its compliance with the applicable documents listed herein. Suppliers are responsible for ensuring that their own implementation of the generic specification meets the requirements of the Participating Authority. This specification must be a controlled document within the Supplier’s quality system, which must ensure that updates are notified to the Participating Authority for amendment through a change control system. Suppliers will be required to provide the Participating Authority with a data set to support any claims made for this product.