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Engineered for safety and reliability in food and pharmaceutical applications, our High-Density PP Molded Bottles combine excellent chemical resistance with regulatory compliance for sensitive contents. Manufactured from medical-grade polypropylene (PP, USP Class VI, ISO 10993 certified), these bottles offer a sterile, non-reactive environment for tablets, liquids, and nutraceuticals.
Regulatory Compliance: Meet strict standards for food contact (EU 10/2011, FDA 21 CFR 177.1520) and pharmaceutical use (cGMP, PIC/S GMP), with complete lot traceability through blockchain records.
Moisture & Oxygen Barrier: Co-injected ethylene-vinyl alcohol (EVOH) layers reduce water vapor transmission (≤0.5g/m²/day) and oxygen permeability (≤5 cm³/m²/day), critical for hygroscopic drugs and powdered foods.
Tamper-Evident Design: Integral breakable seals and pressure-sensitive induction liners provide visual and physical evidence of package integrity, complying with FDA tamper-resistant regulations.
Autoclavable & Sterilizable: Capable of withstanding repeated autoclaving (121°C, 15psi, 20 minutes) and ETO/gamma sterilization without deformation, maintaining dimensional stability (shrinkage ≤0.3%).
Pharmaceuticals: Used for solid dose packaging (tablets, capsules), liquid medicines, and medical device storage, ensuring compatibility with primary drug packaging requirements.
Nutraceuticals & Supplements: Ideal for powders, softgels, and chewable vitamins, protecting against moisture absorption and cross-contamination.
Food Packaging: Suitable for infant formula, coffee grounds, and dehydrated foods, combining barrier protection with lightweight convenience (5-30g per 100ml bottle).
Cleanroom Manufacturing: Produced in ISO 8 cleanrooms with HEPA filtration, minimizing particulate contamination (<100,000 particles/ft³ ≥0.5μm).
Validation Support: Provide comprehensive validation packages including extractables/leachables testing, shelf-life studies, and compatibility reports for regulatory submissions.
Lean Inventory Solutions: Offer just-in-time (JIT) delivery and consignment stock programs, reducing customer inventory holding costs by 25%.
