GMP CE ISO Certified Pharma Glass Bottle Vial

These USP Type I borosilicate glass vials are manufactured in our own GMP-compliant factory in Shandong, China, where the complete production chain from glass tube cutting, forming, annealing to final inspection is carried out on site. As a genuine physical factory rather than a trading company, we control every process step and deliver pharmaceutical grade glass containers at direct factory prices. The vials are produced from low expansion borosilicate glass tubing conforming to USP Type I and ISO 8362-1 requirements, which guarantees excellent hydrolytic resistance and thermal shock stability. Available in 2ml, 5ml and 10ml fill volumes with 13mm or 20mm crimp necks, these injection vials are widely adopted by vaccine, antibiotic and injection solution manufacturers around the world.

• USP Type I Hydrolytic Resistance: The vials are made of low expansion borosilicate glass with a hydrolytic resistance class that meets the strictest USP Type I requirements. The glass surface releases only negligible amounts of alkali ions, keeping the pH of stored injection solutions stable over long shelf life periods.
• GMP Certified Factory Direct: We operate a complete physical glass manufacturing plant with forming, annealing, inner surface treatment and packaging lines under GMP guidelines. Buying factory direct removes middlemen, shortens lead times and reduces unit costs for volume buyers.
• ISO 8362-1 Dimensional Accuracy: Every vial is formed to the dimensional tolerances defined in ISO 8362-1, ensuring trouble-free running on high speed filling and capping lines. Neck finish, flange geometry and body straightness are verified with automated optical inspection equipment.
• Low Extractables Clean Surface: The inner surface is treated to minimize extractables and particulate shedding. Vials are manufactured in a clean workshop environment and are ready for washing, sterilization and depyrogenation in the customer filling line.
• Thermal Shock Resistance: The low expansion coefficient of borosilicate glass allows the vials to withstand rapid temperature changes during autoclaving, dry heat sterilization and freeze drying cycles without cracking or deformation.
• Custom Decoration Options: Clear or amber vials can be supplied with silk screen printing, hot stamping, frosting or spraying according to customer artwork, including logos, dosage markings and batch coding areas.