Pharmaceutical Bottle
Premium Pharmaceutical Bottles for Safe Medication Storage
High-quality Pharmaceutical Bottles are essential for maintaining medication integrity and ensuring patient safety. Our Pharmaceutical Bottles meet the strictest industry standards while offering superior protection against moisture, light, and contamination.
Key Product Specifications
Standard Features:
- Material: FDA-approved HDPE or PET plastic
- Capacity Range: 5ml to 1000ml options available
- Closure Types: Child-resistant caps, screw caps, flip-top caps
- Color Options: Amber, cobalt blue, clear, or custom colors
- Temperature Resistance: -20°C to 60°C (-4°F to 140°F)
- Sterilization Compatibility: Gamma radiation, ethylene oxide, autoclave
Technical Specifications Table
| Parameter | Specification | Testing Standard |
|---|---|---|
| Water Vapor Transmission | ≤0.3g/100in²/24h | ASTM F1249 |
| Oxygen Transmission | ≤0.2cc/100in²/24h | ASTM D3985 |
| Drop Test Performance | No leakage from 1.2m height | ISTA 3A |
| Chemical Resistance | Passes 72hr exposure to common solvents | USP <661> |
Pharmaceutical Bottle Manufacturing Standards
Our Pharmaceutical Bottles are produced in ISO Class 8 cleanrooms and comply with:
- USP <661> and <671> requirements
- EU Pharmacopoeia 3.2.2 standards
- FDA 21 CFR Part 210/211 cGMP regulations
- ISO 15378:2017 for primary packaging materials
Customization Options
We offer various customization features for Pharmaceutical Bottles to meet specific product requirements:
- Tamper-evident banding systems
- Custom printing (up to 6 colors)
- Embossing/debossing options
- Special UV coatings
- Custom neck finishes and thread designs
Pharmaceutical Bottle FAQs
What materials are used for Pharmaceutical Bottles?
Our Pharmaceutical Bottles primarily use high-density polyethylene (HDPE) or polyethylene terephthalate (PET). HDPE offers excellent chemical resistance and moisture barrier properties, making it ideal for solid dosage forms. PET provides superior clarity and oxygen barrier characteristics, preferred for liquid medications. Both materials are FDA-compliant and meet USP <661> requirements for plastic containers.
How do I choose between amber and clear Pharmaceutical Bottles?
Amber Pharmaceutical Bottles block 99% of UV light up to 450nm, crucial for light-sensitive medications. Clear bottles allow content visibility and are typically used for light-stable formulations. Consider your medication's stability profile and labeling requirements. Our amber bottles meet USP <671> light transmission requirements with consistent color density.
What are the benefits of child-resistant Pharmaceutical Bottles?
Child-resistant Pharmaceutical Bottles feature special closure systems that require simultaneous push-and-turn actions, reducing accidental ingestion risks by 85-90%. These closures meet 16 CFR §1700.20 (US) and ISO 8317 (international) standards. While maintaining child resistance, they remain senior-friendly with proper torque settings (10-20 in-lbs). All our CR designs undergo rigorous performance testing.
Comparative Advantages of Our Pharmaceutical Bottles
| Feature | Standard Products | Our Products |
|---|---|---|
| Wall Thickness Uniformity | ±15% | ±5% |
| Leak Testing | Sample basis | 100% inspection |
| Traceability | Batch level | Individual container |
| Regulatory Documentation | Basic certificates | Full DMF support |
Packaging and Shipping Information
All Pharmaceutical Bottles are packed in clean polyethylene bags with desiccant when required. Standard packaging includes:
- 100 bottles per bag (small sizes)
- 25 bottles per bag (larger sizes)
- 50 bags per carton
- Pallets available (120 cartons per pallet)
Our Pharmaceutical Bottles undergo strict quality control at multiple stages including material inspection, in-process checks, and final quality assurance. Each shipment includes complete documentation including Certificate of Analysis, Material Safety Data Sheet, and Regulatory Compliance statements.
For specialized requirements or technical consultations regarding Pharmaceutical Bottles, please contact our product specialists who can provide formulation-specific recommendations and validation support.