A blood bag is a medical device used for collecting, storing, and transfusing blood and its components. It plays a vital role in ensuring blood transfusion safety, supporting hematologic therapies, and meeting clinical needs. Traditional blood bags are mostly made of polyvinyl chloride (PVC) and incorporate di(2-ethylhexyl) phthalate (DEHP) as a plasticizer. DEHP imparts excellent flexibility and stability to PVC, thereby effectively inhibiting red blood cell hemolysis during storage. However, recent studies have shown that DEHP may interfere with the reproductive and endocrine systems, raising significant concerns about its safety. With the implementation of Regulation (EU) 2020/1204, restrictions on the use of DEHP in the medical field have become increasingly stringent, driving the industry to actively explore and develop DEHP alternatives.

· July 2021: The EU prohibits the use of DEHP in blood bags for neonates.

· January 2023: All blood bags must be labeled with their DEHP content.

· 2025: Complete ban on DEHP-containing blood bag systems.

The new generation of DEHP-free buffers has emerged as an ideal alternative due to their excellent biocompatibility and safety. These buffers not only comply with relevant regulatory requirements but also effectively eliminate the potential risks of DEHP to blood quality and patient health.

Types of DEHP-Free Buffers

In the new generation of DEHP-free buffers, PAGGSM demonstrates significant advantages in metabolic preservation capacity, extending storage lifespan, reducing storage damage, and safety. With the increasingly stringent regulatory requirements and the continuous improvement of quality standards for blood products, PAGGSM is expected to become the mainstream choice for red blood cell preservation solutions in the future.

Main Components and Functions of PAGGSM

It can be seen from the above ingredient list that adenine and guanosine are indispensable key components in the development of PAGGSM buffers. However, the number of manufacturers worldwide that can stably supply high-quality adenine and guanosine raw materials is very limited, and the risk of production suspension is quite high. As the demand for adenine and guanosine in PAGGSM and other DEHP-free blood bag buffers continues to rise, PanReac AppliChem, a European manufacturer of high-quality biochemical reagents and pharmaceutical raw materials, has quickly responded to market changes. It has now fully upgraded these two products (adenine and guanosine) to the low-endotoxin excipient grade, which complies with the pharmacopoeia standards of multiple countries.

In addition, AppliChem also offers a series of products related to plasma buffers, with specific information shown in the table below. If you are interested in these products, please feel free to contact Beijing XMJ Technology Co., Ltd., the general agent of AppliChem in China, to obtain more information.