| Quantity: | |
|---|---|
Engineering Precision Molded Bottles for Medical Devices are high-quality, custom-designed containers engineered to meet the rigorous demands of healthcare and life sciences. Crafted using advanced injection molding techniques, these bottles offer exceptional dimensional accuracy, chemical resistance, and biocompatibility. Available in materials like polypropylene (PP), polyethylene (PE), and cyclic olefin copolymer (COC), they are ideal for storing pharmaceuticals, diagnostic reagents, and biological samples. The design incorporates features like tamper-evident seals, ribbed surfaces for grip, and precision-threaded necks for leak-proof closure.
Material Excellence:
Choice of FDA-approved, USP Class VI materials with low extractables and leachables, ensuring compatibility with sensitive medical substances.
COC bottles offer superior clarity (light transmittance ≥ 90%) and low moisture permeability, ideal for light-sensitive drugs.
Precision Engineering:
Molded with tight tolerances (diameter: ±0.1mm, wall thickness: ±5%) using CNC-machined aluminum or stainless steel molds for consistent quality.
Surface finish of Ra ≤ 0.2μm on internal surfaces to minimize sample adsorption and facilitate complete product recovery.
Functional Design:
Integrated features: Anti-static coatings to prevent particle attraction, UV-resistant additives for light-sensitive contents, and laser-engraved batch codes for traceability.
Ergonomic shapes designed for easy handling, with optional luer-lock adapters or pour spouts for controlled dispensing.
Sterilization Compatibility:
Capable of withstanding gamma irradiation (up to 50kGy), ethylene oxide (EO) sterilization, and autoclaving (121°C, 15psi for 20 minutes) without deformation.
Pharmaceuticals: Storage of oral liquids, injectable drugs, and topical formulations, compliant with ICH Q7 and cGMP standards.
Diagnostics: Holding reagents for immunoassays, molecular biology kits, and point-of-care testing devices, with low protein binding in PE/COC variants.
Biotechnology: Preservation of cell cultures, DNA samples, and vaccines, thanks to inert materials and hermetic seals that maintain sample integrity.
Medical Devices: Packaging for single-use instruments, such as syringes or catheters, with tamper-evident features to ensure product safety.
Q: What is the minimum order quantity (MOQ) for custom designs?
A: MOQ starts at 10,000 units for standard designs and 50,000 units for fully customized molds, depending on complexity.
Q: Can these bottles be used for long-term drug storage?
A: Yes, materials like COC offer excellent barrier properties against oxygen, moisture, and UV light, with shelf lives exceeding 5 years when sealed properly.
Q: Do you offer validation documentation?
A: Yes, we provide full validation packages including material certificates, sterilization records, and extractables/leachables testing reports upon request.
Q: Are child-resistant closures available?
A: Yes, we offer optional child-resistant caps compliant with ASTM D3475 standards, featuring dual-action mechanisms to prevent accidental opening.
Q: Can the bottles be labeled with adhesive or printed directly?
A: Both options are available. Our surface treatments enhance label adhesion, and we offer in-mold labeling (IML) for permanent, abrasion-resistant graphics.
