Premium 13mm Aluminum-Plastic Tear-Off Flip Top Caps – ISO 8872 Compliant, Tamper-Evident, Customizable Colors
Product Overview
The 13mm Green Aluminum-Plastic Flip Top Cap from Vialab Pharmaceutical Packaging Co., Ltd. is a precision-engineered closure solution designed specifically for pharmaceutical glass vials. Featuring a durable aluminum body with an integrated plastic flip-top, this cap provides a secure, tamper-evident seal that ensures product integrity while offering convenient, tool-free opening for healthcare professionals.
Available in a spectrum of colors—White, Green, Red, Yellow, Blue, Gray, and Light Blue—the 13mm cap combines functional excellence with aesthetic versatility, making it suitable for a wide range of pharmaceutical applications including injectable medications, vaccines, and liquid drug products. The 13mm size is one of the industry-standard neck finishes for pharmaceutical vials, alongside 15mm, 20mm, 28mm, and 32mm configurations.
The global Pharmaceutical Caps and Closures Market was valued at USD 16.15 billion in 2025 and is expected to reach USD 32.77 billion by 2030, growing at a CAGR of 15.0%. Key trends include an increased focus on tamper-evident closures and the adoption of sustainable packaging solutions. Vialab’s 13mm aluminum-plastic flip top cap is positioned to meet this growing demand, offering pharmaceutical manufacturers, contract packagers, and CMOs a reliable, compliant, and cost-effective closure solution.
ISO 8872:2022 Compliance – The International Standard for Pharmaceutical Caps
What Is ISO 8872?
The Vialab 13mm Aluminum-Plastic Flip Top Cap is designed and manufactured in accordance with ISO 8872:2022—the international standard for aluminum caps and aluminum/plastic caps for infusion bottles and injection vials. This standard specifies general requirements and test methods for caps used to seal pharmaceutical containers, ensuring consistent quality, performance, and patient safety.
The latest version, ISO 8872:2022, was published in November 2022 and represents the current state-of-the-art for pharmaceutical cap manufacturing. The European adoption, EN ISO 8872:2023, confirms that Vialab’s caps meet both international and European regulatory requirements for pharmaceutical packaging.
Key ISO 8872 Requirements
ISO 8872 defines critical parameters for aluminum and aluminum-plastic caps, including:
- Dimensional accuracy – Ensuring compatibility with standard vial neck finishes (13mm, 15mm, 20mm, 28mm, 32mm)
- Mechanical strength – Withstanding crimping and handling stresses
- Sealing performance – Maintaining closure integrity throughout shelf life
- Tamper-evident features – Providing visible evidence of opening
Aluminum and aluminum/plastic caps are critical components of the container closure system, and their performance directly impacts product sterility and patient safety. The 13mm cap is fully compatible with ISO 8872 and ISO 8362 requirements, guaranteeing a perfect fit on vials.
EU GMP Annex 1 Compliance – Sterility Assurance
The Critical Role of Capping in Aseptic Processing
EU GMP Annex 1 makes the point explicit: an aseptically filled vial is not regarded as fully closed until the aluminum cap has been crimped onto the stoppered vial, and the cap should be applied soon after stoppering. The container closure system for aseptically filled vials is not fully integral until the aluminum cap has been crimped onto the stoppered vial; therefore, the capping step becomes part of the sterility assurance logic.
This regulatory requirement underscores the critical importance of high-quality aluminum-plastic caps in maintaining product sterility throughout the manufacturing process and shelf life.
Sterility Preservation Through Container Closure Integrity (CCI)
Until crimping is completed, the container closure system is not considered integral. Regulatory bodies like the USFDA and EMA expect pharmaceutical companies to demonstrate robust sterility assurance via Container Closure Integrity (CCI) testing.
The Vialab 13mm cap contributes directly to CCI by:
- Applying mechanical compression between the stopper flange and the vial neck
- Ensuring proper compression of the stopper
- Maintaining an airtight, sterile seal
ISO 15378 – GMP for Primary Packaging
ISO 15378 is the GMP-oriented standard specifically designed for primary packaging materials for medicinal products. It identifies GMP principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products.
Vialab’s manufacturing processes are aligned with ISO 15378 requirements, ensuring that every 13mm aluminum-plastic cap meets the highest standards of quality, cleanliness, and consistency.
Tamper-Evident Flip-Off Design – Patient Safety First
The Flip-Off Mechanism
The Vialab 13mm cap features a flip-off (tear-off) button top design that provides:
- Tamper-evident security – The plastic button must be flipped or torn off to access the aluminum seal, providing visible evidence of opening
- Easy removal – Healthcare professionals can quickly access the vial contents without specialized tools
- Non-deformability – The cap maintains its structural integrity during storage and transport
Flip-off seals are specifically designed to seal vials containing injectable drugs. The combination of an aluminum outer cap with a plastic flip-top button creates a closure system that is both secure and user-friendly.
FDA Recognition
The FDA recognizes aluminum flip-off seals as a standard component of pharmaceutical container closure systems. FDA-registered drug products routinely utilize flip-off aluminum seals as the primary closure for glass vials. Each single-dose vial is closed with a rubber stopper and sealed with an aluminum cap. The industry-standard configuration—a bromobutyl stopper with a flip-off tear-off aluminum vial seal—is widely documented in FDA submissions.
High-Quality Materials – Durability & Performance
Aluminum Body with Outside Lacquering
The Vialab 13mm cap features a high-quality aluminum body with outside lacquering that provides:
- Corrosion resistance – Ensuring long-term durability
- Structural integrity – Withstanding crimping forces without deformation
- Tamper evidence – Visible signs of tampering when opened
- Optimal machineability – Outside lacquering ensures optimal performance on high-speed filling lines
Aluminum-plastic caps combine aluminum as the cap body with plastic as the sealing component. They possess corrosion resistance, elegance, sealing ability, and flexibility.
Plastic Flip-Top Component
The integrated plastic flip-top button offers:
- Ergonomic operation – Easy opening for healthcare professionals
- Color customization – Available in multiple colors for branding and identification
- Durable performance – Resistant to wear and repeated use
Color Options for Branding & Identification
The 13mm cap is available in a range of colors:
- White – Standard, neutral option
- Green – For product differentiation
- Red – High-visibility identification
- Yellow – Distinctive branding
- Blue – Professional appearance
- Gray – Understated design
- Light Blue – Soft, recognizable option
Custom colors are also available upon request for brand differentiation and product identification.
High-Speed Line Compatibility
The Vialab 13mm cap is manufactured for and designed for high-speed lines, ensuring:
- Seamless integration with automated filling and capping equipment
- Consistent performance at high production speeds
- Minimal downtime due to cap-related issues
- Optimal crimping results on standard pharmaceutical capping machines
Outside lacquering provides optimal machineability and crimping results, ensuring that the cap performs reliably on high-speed production lines.
Customization & Branding – OEM/ODM Services
Vialab offers comprehensive OEM and ODM customization services for the 13mm aluminum-plastic flip top cap:
Color Options
- Standard colors – White, Green, Red, Yellow, Blue, Gray, Light Blue
- Custom colors – Available upon request for brand differentiation
Logo Printing
- Custom logo – Brand identity can be applied to the cap surface
- Color matching – Consistent with brand color schemes
Packaging Options
- Carton packaging – Standard packaging for bulk distribution
- Custom packaging – Tailored to specific customer requirements
Low MOQ for Trials
With a minimum order quantity (MOQ) of 10,000 pieces, pharmaceutical companies can easily trial the Vialab caps in small-batch production before scaling to commercial volumes.
Free Sample Available
Vialab provides free samples for customer evaluation, allowing buyers to test the cap’s fit, performance, and appearance before placing an order.
Applications
The Vialab 13mm Aluminum-Plastic Flip Top Cap is suitable for a broad spectrum of pharmaceutical applications:
Injectable Pharmaceuticals
- Vaccines – Sterile sealing for vaccine vials
- Insulin – Diabetes management products
- Biologics – Protein-based therapeutics
- Peptide therapeutics – GLP-1 therapies and other peptide drugs
- Antibiotics – Parenteral administration
- Generic injectables – Large-volume production
Infusion Products
- IV infusions – Parenteral drug delivery
- Infusion bottles – Closure for IV containers
Liquid Pharmaceuticals
- Liquid drug products – Sealing liquid formulations
- Ophthalmic products – Eye drops and intraocular preparations
Research & Development
- Clinical trial materials – Small-batch production
- Laboratory reagents – Chemical and biological reagents
Regulatory Compliance & Quality Standards
The Vialab 13mm Aluminum-Plastic Flip Top Cap meets all current requirements of applicable ISO standards and regulatory frameworks:
International Standards
- ISO 8872:2022 – Aluminum caps and aluminum/plastic caps for infusion bottles and injection vials – General requirements and test methods
- EN ISO 8872:2023 – European adoption of the standard
- ISO 15378 – GMP-oriented standard for primary packaging materials
- ISO 8362 – Injection vials and closures
Regulatory Compliance
- EU GMP Annex 1 – Sterility and capping requirements
- FDA 21 CFR – Container closure integrity requirements
- USP <660> – Containers—Glass (for compatibility)
- USP <1207> – Package integrity testing
Quality Management
- GMP-compliant manufacturing – Aligned with pharmaceutical industry standards
- ISO 9001 – Quality management system foundation
- Certificate of Analysis (COA) – Each shipment includes a COA
Vialab’s manufacturing facilities include advanced production lines and controlled environments, ensuring consistent quality, integrity, and compliance for global healthcare partners.
Technical Specifications
| Parameter | Specification |
|---|---|
| Product Name | 13mm Aluminum-Plastic Flip Top Cap |
| Type | Flip-off / Tear-off cap |
| Size | 13mm |
| Material | Aluminum body with plastic flip-top |
| Shape | Round |
| Color Options | White, Green, Red, Yellow, Blue, Gray, Light Blue (custom colors available) |
| Feature | Tamper-evident, non-spill |
| Application | Pharmaceutical vials, infusion bottles |
| Industrial Use | Pharmaceuticals |
| Custom Order | Accepted |
| Logo | Custom logo available |
| MOQ | 10,000 pieces |
| Sample | Provided freely |
| Service | OEM / ODM Customized |
| Packaging | Carton |
| Compliance | ISO 8872:2022, EN ISO 8872:2023, ISO 15378, EU GMP Annex 1 |
| Line Compatibility | High-speed filling lines |
Key Benefits for Pharmaceutical Manufacturers
1. Tamper-Evident Security
The flip-off design provides visible evidence of tampering, ensuring patient safety and product integrity. This feature is increasingly important as regulators focus on tamper-evident closures.
2. Regulatory Compliance
Manufactured to ISO 8872:2022 and ISO 15378 standards, Vialab’s caps support customers in meeting global regulatory requirements for pharmaceutical packaging.
3. Sterility Assurance
As required by EU GMP Annex 1, the cap ensures that the container closure system achieves full integrity only after crimping, contributing to the overall sterility assurance strategy.
4. High-Speed Line Compatibility
Designed for high-speed filling lines, the cap ensures seamless integration and consistent performance in automated pharmaceutical manufacturing environments.
5. User-Friendly Design
The flip-off mechanism enables easy, tool-free opening for healthcare professionals, improving workflow efficiency in clinical settings.
6. Brand Differentiation
Multiple color options and custom logo printing enable brand identification and product differentiation in competitive markets.
7. Low MOQ & Free Samples
With an MOQ of just 10,000 pieces and free samples available, manufacturers can evaluate the cap’s performance before committing to large-volume orders.
Why Choose Vialab?
Vialab Pharmaceutical Packaging Co., Ltd. specializes in the design and manufacture of high-quality drug delivery and packaging components. From injection pens to sterile vials, every product is engineered to meet strict pharmaceutical standards. Our comprehensive product portfolio includes:
- Injection Pens (Disposable & Reusable)
- Glass Vials & Tubes (Parenteral Grade, Precise Dimensions)
- Sterile Vials (Ready-To-Use, Washed & Sterilized)
- Amber Glass Vials (For Light-Sensitive Pharmaceuticals)
- Aluminum & Aluminum-Plastic Caps (Tamper-Evident, Various Sizes: 13mm, 15mm, 20mm, 28mm, 32mm)
- Customized Packaging Solutions (Pen Cases, Accessories, Etc.)
- Strict Quality Control (ISO/GMP Compliant)
With advanced production lines and cleanroom facilities, we ensure consistent quality, integrity, and compliance for global healthcare partners.
Conclusion
The Vialab 13mm Green Aluminum-Plastic Flip Top Cap represents the convergence of regulatory compliance, tamper-evident security, and high-speed manufacturing compatibility. Manufactured to ISO 8872:2022 standards, compliant with EU GMP Annex 1 requirements, and designed for optimal performance on high-speed filling lines, this cap delivers the quality, consistency, and performance that pharmaceutical manufacturers and contract packagers demand.
Whether you are sealing vaccines, biologics, injectable medications, or infusion products, Vialab’s 13mm aluminum-plastic flip top cap provides the secure, tamper-evident closure you need—with multiple color options, customization capabilities, low MOQ, and free samples to support your product development and commercialization efforts.
For inquiries about the 13mm Aluminum-Plastic Flip Top Cap, OEM/ODM customization, or other pharmaceutical packaging solutions, contact Vialab Pharmaceutical Packaging Co., Ltd. today.