Primary packaging material compatibility study for human immunoglobulin

Abstract

Objective To study the compatibility of human immunoglobulin products and borosilicate glass in direct contact with products, providing basis for appropriate primary packaging material selection. Methods Neutral borosilicate glass bottles provided by different manufacturers were chosen to carry out product compatibility tests. Influence on product quality by different primary packaging materials was compared. Results As contact time with products increased, trace elements and substances dissolved from primary packaging materials migrating into products did not exceed regulation limits. Product qualities met requirements. In products stored for 24 months, the pH was 6.6-6.8, and monomer plus dimer IgG was >95%. Conclusion The neutral borosilicate glass bottles are suitable for the storage of human immunoglobulin products, and do not affect product quality. Key words: Immunoglobulins, intravenous; Glass; Product packaging