Time to Start Using Polypropylene Vials in the Industry

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• Validated Sterilization Compatibility: PP vials withstand standard steam autoclave cycles (121 °C, 15 + min) and gamma/ethylene‑oxide sterilization to achieve a sterility assurance level (SAL) of 10⁻⁶—fully meeting USP <797>/<800> compounding requirements—whereas PET cannot reliably endure autoclaving, limiting sterility options and increasing contamination risk. 

• Chemical Inertness & Low Leachables: Manufactured from 100% virgin polypropylene resin, PP vials exhibit extremely low extractables/leachables—even under extreme pH or heat—safeguarding drug potency and reducing recall potential. PET vials, often made from mixed or recycled feedstocks, carry higher variability in impurities and extractables. 

• Breakage Resistance & Safety: PP’s superior impact strength and resistance to stress cracking virtually eliminate breakage and particulate contamination during handling and transport. In contrast, PET’s greater brittleness raises the risk of fractures, product loss, and patient harm. 

• Optimized Moisture Barrier: PP vials deliver a lower water‑vapor transmission rate (9.8 g/m²·24 h) than PET (27.3 g/m²·24 h), critical for maintaining the stability of moisture‑sensitive injectables; PET’s stronger oxygen barrier is less relevant for parenteral formulations.  

• Regulatory‑Ready, Ready‑to‑Use Format: PP vials are available as pre‑sterilized, container‑closure–integrity–tested units, streamlining qualification and reducing QA workload. PET vials lack broad regulatory precedent for injectable use, complicating validation. 

• Total Cost Efficiency: Ready‑to‑use PP vials eliminate pre‑fill washing, depyrogenation, and inspection required for PET, reducing fill‑line downtime, breakage losses, and overall total cost of ownership while improving throughput. 

• Patient Safety & Handling Ease: Lightweight, non‑shatter PP vials minimize sharps hazards and allow tamper‑evident closures, improving dispensing accuracy and reducing administration errors—PET’s brittleness complicates handling and elevates risk. 

• Broad Formulation Compatibility: PP is inert across a wide range of injectable formulations (acidic, alkaline, lipid emulsions, lyophilized), avoiding drug‑container interactions; PET requires extensive compatibility testing and may degrade under extreme conditions. 

• Supply Security & Sustainability: PP vials’ scalable, multi‑source manufacturing mitigates supply disruptions; virgin PP is fully recyclable and lighter, reducing carbon footprint and shipping costs, whereas PET’s mixed materials complicate recycling and quality consistency.