Fresenius Kabi On the Way to nonDEHP Blood

Fresenius Kabi On the Way to non-DEHP Blood Bag Systems In our continuous mission to provide safe and efficient medical devices, Fresenius Kabi is constantly working to replace DEHP with alternative plasticizers

On the way to non-DEHP blood bag systems Why? When? What? How? © Copyright Fresenius Kabi AG 22. 12. 2021 2

On the way to non-DEHP blood bag systems Why? When? What? How? © Copyright Fresenius Kabi AG 22. 12. 2021 3

On the way to non-DEHP blood bag systems Why? o DEHP defines the physical properties of PVC foil: high flexibility and robustness leading to a proven low critical defect rate o DEHP is known to protect the red cells’ membrane and increases their lifespan, resulting in low hemolysis rates up to 49 days Why is DEHP in blood bag materials? Why should it be removed? © Copyright Fresenius Kabi AG o DEHP is classified as endocrine disruptor 22. 12. 2021 4

On the way to non-DEHP blood bag systems Why? When? What? How? © Copyright Fresenius Kabi AG 22. 12. 2021 5

On the way to non-DEHP blood bag systems When? o The DEHP ban is not yet decided, but ECHA drafted an Annex XIV Amendment that results in a tentative sunset date end of 2024 When shall DEHP be banned in the EU from the use in blood bag systems? © Copyright Fresenius Kabi AG o The MDR does NOT sunset the use of DEHP, it only mandates a benefitrisk assessment by the manufacturers 22. 12. 2021 6

On the way to non-DEHP blood bag systems Why? When? What? How? © Copyright Fresenius Kabi AG 22. 12. 2021 7

On the way to non-DEHP blood bag systems How? o The European Pharmacopeia introduced in 2018 four alternative plasticizers for DEHP: o DINCH o BTHC o TOTM o DEHT How can DEHP be replaced in blood bag systems? o All alternatives are already used in medical devices and are leaching less to fluids o All alternatives lead to higher hemolysis rates of red cells at end of storage in routine use conditions © Copyright Fresenius Kabi AG 22. 12. 2021 8

On the way to non-DEHP blood bag systems Fresenius Kabi offers as non. DEHP blood bag systems: What? What does Fresenius Kabi do to avoid use of DEHP in blood bag systems? © Copyright Fresenius Kabi AG 22. 12. 2021 o Non-DEHP transfer systems for preparation and storage of pediatric platelet and red cell units o Non-DEHP systems for buffy coat pooling and leukocyte depletion in order to produce platelet concentrates o Non-DEHP storage container for single random donor platelets 10

On the way to non-DEHP blood bag systems Compo. Flex - non-DEHP transfer systems for pediatric red cell units Compo. Flex - non-DEHP transfer systems for pediatric platelet units Non. DEHP Compo. Flex/Select - non-DEHP storage bag for single random donor platelets Compo. Stop - non-DEHP buffy coat pooling system © Copyright Fresenius Kabi AG 22. 12. 2021 11

On the way to non-DEHP blood bag systems In our continuous mission to provide safe and efficient medical devices, Fresenius Kabi is constantly working to replace DEHP with alternative plasticizers © Copyright Fresenius Kabi AG 22. 12. 2021 12