Pharmaceutical Compliance: USP Type I, II, & III Solutions
Patient safety begins with the package. Thousand Peak Glass manufactures pharmaceutical containers that strictly adhere to USP (United States Pharmacopeia), EP (European Pharmacopoeia), and ISO 8362 standards. Our portfolio supports the entire drug lifecycle, from Tubular Injection Vials for vaccines and biologics to Molded Syrup Bottles for oral medications. We offer full documentation support (TDS, CoA) to assist our clients in their regulatory filing processes.
TECHNICAL SPECS & GUIDE
1. Decoding USP Glass Types
Type I (Neutral Borosilicate): The most resistant glass. Essential for parenteral (injectable) drugs, vaccines, and blood products. It prevents "delamination" (glass flaking).
Type II (Treated Soda-Lime): Soda-lime glass with a sulfur-treated inner surface to improve hydrolytic resistance. Suitable for acidic/neutral aqueous infusion fluids.
Type III (Soda-Lime): Standard glass for oral liquids (syrups, tablets) and external use products where chemical interaction is less critical.
2. Lyophilization (Freeze-Drying) OptimizationFor lyophilized drugs, heat transfer is key. Our Lyo Vials feature a controlled bottom concavity and uniform wall thickness to ensure efficient thermal transfer during the freeze-drying cycle, reducing breakage and energy costs.
3. Neck Finishes: ISO Crimp StandardsWe adhere to ISO 8362-1 for injection vials.
13mm Crimp: Standard for small volumes (2ml - 5ml).
20mm Crimp: Standard for larger volumes (10ml - 100ml).
We guarantee the "Blowback" geometry to ensure the rubber stopper stays seated during the lyophilization process before capping.