[RENOLIT] BLOODPROTECT 42plus – REVOLUTIONIZING THE WORLD OF BLOOD BAGS

Blood containers made of glass enabled the storage and thus the indirect transition of blood. After the discovery of cold ethanol fractionation, the first large-scale blood bank was built. The development of the PVC blood bag was a cornerstone for the establishment of blood component therapy. It made blood transfusion significantly safer, and the shelf life of red blood cells could be increased up to 6 weeks. Over time, the manufacturing process of the bags has evolved and helped to make blood transfusion and blood component therapy available to more people in need and above all – to safe more lives. In addition, we are working on even safer polymer solutions further reducing risks to human health.

How blood transfusions became safer and widely available

As John Elliot developed the first blood container in 1940, this was an important breakthrough in the history of blood transfusion. The vacuum glass bottle, which originally contained only sodium nitrate as an anticoagulant, was the first preservative solution for blood. By allowing for blood to be stored in containers for several days, it was aiding the transition from the dangerous vein-to-vein method to indirect transfusion where the recipient receives stored blood from a donor. Together with the discovery of Rh blood groups it made blood transfusions more widely and safely available.

After the discovery of cold ethanol fractionation, Charles R. Drew, an African and American surgeon and researcher, instituted uniform procedures and standards for collecting blood and processing blood plasma into components and products. In 1940 he directed the “Plasma for Britain Project“ – a pilot project to collect blood for shipment to the British Isles. The American Red Cross participates, collecting 13 million units of blood by the end of World War II — America's first large-scale blood bank.

The PVC blood bag – a cornerstone for the establishment of blood component therapy

In 1950 Carl W. Walter (2, 3), a surgeon and a Harvard Medical School professor, and W.P. Murphy, Jr., introduced the PVC bag for blood collection. Replacing breakable glass bottles with durable plastic bags allows for the evolution of a collection system capable of safe and easy preparation of multiple blood components from a single unit of whole blood. The development of the refrigerated centrifuge in 1953 further expedites blood component therapy.

PVC quickly displaced glass bottles. The main reasons were:

• Fragility of glass
• Patient safety: When blood is drawn from glass bottles, air must be supplied, and there is a significant risk of bacterial contamination with this procedure.
• Sterility: Plastic blood bags are very easy to sterilize as a closed system.
• Safe and easy preparation of multiple blood components

1967 – The first blood bag produced in the Netherlands

In 1967 DRAKA Plastics, the predecessor of RENOLIT Healthcare and at that time a company of the Philips Group, developed and started production of films for blood bags in cooperation with the Dutch Red Cross.

At the time of the introduction of PVC blood bags, the Dutch Red Cross was responsible for nationwide blood supply and manufacturing of the blood bag systems. Some years later, the blood bag production was split off and moved to a new company NPBI in the east part of the country. NPBI as a blood bag manufacturer was later acquired by Fresenius Kabi. The responsibility of the Dutch Red Cross for the blood supply has since been transferred to Sanquin, the Dutch national blood bank.

55 years of technical improvements and innovations

Between 1967 and 2023 a lot has changed. The first blood bags were made of tubular film in a manual manufacturing process. As the use of blood bags was increasing over time, the need for automated blood bag production led to the development of the flat blood bag film. The most significant steps in the blood bag film life have been:

• Flat film replacing tubular film to allow for automated blood bag production. The flat film was produced on huge machines called Calendars.
• A new patented production method, extrusion, allowed for significant improvements in blood bag film quality: Film production in clean room to make sure there are no particles on the film.
• Strict control of shrinkage, the phenomenon that blood bags become smaller during steam sterilization at 121 C.
• High-definition embossing (surface structure) on both sides of the film to prevent sticking during the high temperature sterilization process.
• Over the years, this patented RENOLIT TRANSFUFOL production process was further optimized to ensure a highly efficient high speed automated blood bag production process for our clients.

Last, but not least, so-called additive solutions were used for the conservation of the red blood cells. Together with the cell-wall reinforcing effect of the plasticizer, this enabled preserving the quality of the red blood cells during 6 weeks of storage. To our knowledge, RENOLIT blood bag films and related products even allow for storage up to 49 days for red cells, up to 7 days for platelet and under freezing conditions multiple years for plasma.

Blood bags – Todays’ challenges and future outlook

Today, RENOLIT Healthcare is offering a choice of four plasticizers for blood bag use, three of them showing the required “red cell conservation” properties in combination with modifications to the red cell storage solution. In addition, RENOLIT Healthcare is working on a revolutionary new plasticizer that has the potential to be as good as the conservation of red blood cells using the standard storage solution. The new material RENOLIT BLOODPROTECT 42plus could revolutionize the world of blood bags. We still have a long way to go as we are currently in the early stages of prototyping and feasibility studies.