SIBUR passes certification audit for manufacturers of pharmaceutical packaging polymers

10 March 2026. SIBUR has successfully completed its first certification audit of the medical safety quality management system in compliance with the requirements of GOST R ISO 15378 Primary Packaging Materials for Medicinal Products. The audit recorded no non-conformities, reflecting the Company's strong process readiness and maturity in the medical-grade polymer segment.

The certified entities include Tomskneftekhim, Kazanorgsintez, Nizhnekamskneftekhim, the SIBUR PolyLab applied research centre, and the Company's corporate centre. The certification covers the production of polyethylene, polycarbonate, polypropylene, polystyrene, and ABS plastics, alongside the development of new grades of these products and research activities.

The GOST R ISO 15378 standard establishes requirements for quality management systems for manufacturers of primary packaging materials used in the production of medicinal products. For the pharmaceutical industry, this is a critically important element in ensuring the safety and consistent quality of medicines throughout their journey from manufacturing to the patient.

A certified medical safety quality management system increases the trust of pharmaceutical companies and medical device manufacturers in polymer materials. It confirms that production and laboratory processes are both controllable and transparent, and reduces customer risks associated with the reliability and reproducibility of raw material properties.

Anton Prozumentov, Director of SIBUR's Medicine Division:

"Compliance with GOST requirements is strategically important for SIBUR. We need our customers to be confident that our products meet quality and safety standards. Today, SIBUR is one of the few manufacturers in the country supplying the market with polymer materials for pharmaceutical packaging. Passing the audit with zero non-conformities is a strong testament to our reliability.”

The new certification complements SIBUR's existing quality and safety assurance system for medical and pharmaceutical packaging polymer materials. The Company tests medical grades of polymers – including polyethylene, polypropylene, PVC, PET, and polycarbonate – for compliance with relevant industry standards and pharmacopoeias, including international ones. SIBUR verifies biocompatibility, extractables levels, and resistance to various sterilisation methods for materials used in pharmaceutical packaging and medical devices, while establishing a unified quality framework – from development and pilot testing at SIBUR PolyLab to full-scale production at its enterprises.