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NIOST, SIBUR's R&D centre, has developed new low-density polyethylene (LDPE) grades that can be used in packaging for infusion solutions.
Infusion has become an integral part of clinical routine. Daily volumes of liquids infused in intensive care may reach several litres per patient. Earlier, infusion solutions used to be made at compounding pharmacies and packed in glass vials. But the transition to serial production pushed the share of polymer packaging up to 60–70%. Its benefits include light weight, reliability, resistance to freezing temperatures and easy handling and storage. On top of that, polymer packaging is chemically inert and manufactured using the blow-fill-seal technology, which ensures the highest degree of sterility and protection against counterfeiting.
In 2019, SIBUR developed a special grade aligned to pharmacopeial standards based on the existing PE LD03210 FE product. The grade was tested by leading blow-fill-seal equipment manufacturers in Germany and Italy. It successfully passed the trials at specialised laboratories and proved to conform to the European Pharmacopoeia standards, which further testified to its highest quality and helped obtain a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP). Now, the grade is undergoing large-scale testing by Russian manufacturers of infusion solutions.
In 2020, SIBUR developed an improved grade, LD03270 BM, which successfully passed testing at an Intertek laboratory in the Netherlands and proved to meet the European Pharmacopoeia standards. The near-future plans are to obtain a CEP and test the grade boasting increased density and tolerance to high sterilisation temperatures at customer facilities.
Sergey Komyshan, SIBUR’s Management Board member and Executive Director:
“Our polyethylene grade is the first in Russia to conform to pharmacopeial standards. The new products developed by SIBUR will help phase out imported products, boost domestic production of polymer packaging for infusion solutions and reduce the dependence on foreign-made polymers in this key medical segment.”
