Product Overview
The V2 Reusable Metal Injection Pen from Vialab Pharmaceutical Packaging Co., Ltd. is a precision-engineered drug delivery device designed for durability, sustainability, and regulatory compliance. Featuring a premium aluminum body with a metal lid, this reusable pen is compatible with standard 3ml cartridges and offers a dosage range of 60IU per injection. Available in multiple color options—Gold, Blue, Green, Black, Pink, Grey, and more—the V2 pen combines functional excellence with aesthetic versatility, making it suitable for pharmaceutical, biotech, and skin care applications including GLP-1 therapies, insulin delivery, peptide treatments, and aesthetic medicine.
CE Certification – Your Gateway to the European Market
The V2 Reusable Injection Pen is CE certified under the European Medical Device Regulation (MDR 2017/745). CE marking represents a product’s compliance with EU safety, health, and environmental protection requirements, serving as the manufacturer’s passport to the European market.
Pen injectors intended for the EU market are typically classified as Class IIa or Class IIb medical devices, depending on factors such as duration of use, method of drug delivery, and whether the device incorporates or administers a medicinal substance. Under MDR, injection pens that interact with drugs and may be used long-term require more stringent clinical evidence and technical documentation. The CE certification process involves:
- Technical documentation preparation covering product design, material composition, and biocompatibility testing
- Clinical evaluation to demonstrate safety and efficacy in intended use
- Risk management per ISO 14971
- Quality management system compliance with ISO 13485
- Notified Body assessment with document review and potential on-site audits
The entire CE certification process typically takes 6 months to 1 year, depending on product complexity. Vialab’s V2 pen has successfully navigated this rigorous pathway, providing customers with immediate access to European and other CE-recognizing markets.
Industry peers have demonstrated the strategic value of CE certification for injection pens. Leading manufacturers such as Ypsomed have achieved CE certification and MDR compliance for their reusable pen platforms, accelerating market access by up to 18 months. Similarly, Go-Pen—a reusable insulin pen—secured CE marking to complement its FDA clearance, enabling market entry across both the U.S. and Europe.
Durable Aluminum Construction – Engineered for Longevity
The V2 pen is constructed from high-grade aluminum with a precision metal lid, delivering exceptional durability while maintaining a lightweight profile of just 50g. Anodized aluminum is the material of choice for premium reusable injection pens—industry leaders such as Haselmeier (Re-Vario™), Ypsomed (ServoPen®), and medmix have all adopted anodized aluminum bodies to provide years of reliable performance.
Aluminum offers several critical advantages for pharmaceutical delivery devices:
- Corrosion resistance ensuring long-term reliability
- Thermal stability maintaining dimensional precision across temperature variations
- Dimensional accuracy preserving dose accuracy throughout the device’s service life
- Aesthetic versatility enabling customized color finishes and laser carving for branding
The FDA recognizes aluminum as an acceptable material for pen injector construction, with multiple devices utilizing aluminum components having undergone human factors testing with no reported issues regarding the forces required to use the device.
The V2 pen measures 16cm × 1.86cm with a compact single package size of 18 × 1.86 × 0.5 cm, offering an ergonomic grip that enhances patient comfort during self-administration—a critical factor for long-term therapy adherence.
Eco-Friendly & Sustainable – Reducing Medical Waste
As the global healthcare industry faces increasing scrutiny over its environmental footprint, reusable injection pens have emerged as a sustainable alternative to disposable devices. Research published in leading journals demonstrates that reusable insulin pens can reduce plastic waste by up to 89% and carbon footprint by 40% compared to disposable insulin pens.
The environmental impact of disposable pen injectors is substantial—an estimated 3.2 million insulin pen injectors were disposed of in 2020 alone. Without national recycling programs for pens in place, switching from prefilled disposable pens to reusable pens represents the most viable pathway to reduced plastic waste. Leading pharmaceutical companies have recognized this imperative; Novo Nordisk, for example, aims for a 30% reduction in plastic use per patient by 2033, with a key strategy being the shift to reusable injection pens.
The V2 pen is designed for long-term reuse with replaceable 3ml cartridges, significantly reducing medical waste compared to single-use alternatives. Each pen supports extended service life, offering:
- Reduced medical waste through long-term reusability
- Lower total cost of ownership for healthcare providers and patients
- Sustainable material selection with durable, recyclable aluminum construction
Unlike reusable pens made of plastic that may degrade over time, the V2’s aluminum construction ensures consistent performance throughout its lifecycle.
ISO 11608 Compliance – Ensuring Dose Accuracy & Patient Safety
The V2 pen is designed and manufactured in compliance with the ISO 11608 series—the international standard for needle-based injection systems (NISs). Over 16 billion needle-based injections are administered globally each year, making the assurance of NIS safety paramount to prevent the transmission of bloodborne pathogens, avoid tissue damage, and guarantee accurate medication delivery.
The ISO 11608 series defines functional and test requirements for needle-based injection systems, including mechanical and electronic performance tests. The V2 pen specifically addresses:
- ISO 11608-1:2022 – Requirements and test methods for needle-based injection systems for single-patient use intended to deliver discrete volumes of medicinal product
- ISO 11608-3 – Requirements for containers used with needle-based injection systems
3ml Cartridge Compatibility
The V2 pen is compatible with standard 3ml cartridges as specified in ISO 11608-3. This standardization offers significant advantages:
- Interchangeability – Cartridges from major manufacturers can be used interchangeably
- Ready-to-Use (RTU) options – Pre-washed, pre-sterilized, and pre-siliconized cartridges are available
- Simplified supply chain – Eliminates the need to draw medication into a syringe
- Cost efficiency – Standardized cartridges are widely available at low cost
The pen is also compatible with ISO 11608-2 double-ended pen needles, including those from leading manufacturers such as B|BRAUN®, Novofine®, and Becton, Dickinson and Company.
Customization & Branding – OEM/ODM Services
Vialab offers comprehensive OEM and ODM customization services for the V2 pen platform, enabling pharmaceutical companies, biotech firms, and healthcare brands to differentiate their products in competitive markets.
Customization Options Include:
- Logo printing – Laser carving for permanent, high-precision branding
- Color options – Gold, Blue, Green, Black, Pink, Grey, and custom colors
- Packaging solutions – Blister + box + carton box configurations
- Accessory customization – Pen cases and complementary packaging components
Leading reusable pen manufacturers in the industry support similar customization capabilities, with some requiring minimum order quantities of 10,000 units for full brand tailoring. Vialab’s flexible OEM/ODM services allow partners to create a unique market presence while leveraging Vialab’s regulatory-compliant manufacturing infrastructure.
Quality Management & Regulatory Compliance
Vialab Pharmaceutical Packaging Co., Ltd. operates under comprehensive quality management systems aligned with internationally recognized standards:
- ISO 13485 – Medical device quality management
- GMP (Good Manufacturing Practice)
- CE certification under MDR 2017/745
- ISO 11608 compliance for needle-based injection systems
Biocompatibility & Material Safety
All materials used in the V2 pen that contact the patient or the drug product are assessed for biological safety per ISO 10993-1. This evaluation covers cytotoxicity, sensitization, systemic toxicity, and other endpoints depending on the type and duration of contact. Chemical compatibility testing for extractables and leachables (E&L) is also conducted to ensure device reliability and global regulatory compliance.
Manufacturing Excellence
With advanced production lines and cleanroom facilities, Vialab ensures consistent quality, integrity, and compliance for global healthcare partners. Our manufacturing processes incorporate:
- Dimensional tolerance control – Materials such as aluminum maintain dimensions under stress and across the device’s claimed lifetime to preserve dose accuracy
- Environmental resilience testing – Temperature and humidity cycling tests verify retained function
- Long-term reliability validation – Lifecycle and accelerated ageing tests demonstrate reliable operation throughout the claimed use period
Applications & Therapeutic Areas
The V2 Reusable Metal Injection Pen is suited for a broad spectrum of applications:
Pharmaceutical Applications
- GLP-1 receptor agonist therapies (e.g., semaglutide, tirzepatide) for diabetes and weight management
- Insulin therapy for diabetes management
- Peptide-based therapeutics for various chronic conditions
- Growth hormone therapies requiring precise, repeatable dosing
- Fertility treatments
- Osteoporosis therapies
Skin Care & Aesthetic Applications
- Hyaluronic acid and dermal filler injections
- PDRN (polydeoxyribonucleotide) therapies for skin rejuvenation
- Custom compounding for boutique skin care formulations
Technical Specifications
| Parameter | Specification |
|---|---|
| Product Name | V2 Reusable Metal Injection Pen |
| Body Material | Aluminum |
| Lid Material | Metal |
| Compatible Cartridge | 3ml (ISO 11608-3) |
| Dosage Range | 60IU |
| Dimensions | 16cm × 1.86cm |
| Weight | 50g |
| Color Options | Gold, Blue, Green, Black, Pink, Grey, and custom |
| Customization | Laser carving for logo printing |
| Packaging | Blister + box + carton box |
| Compliance | CE Certified (MDR 2017/745), ISO 11608, ISO 13485, GMP |
| Built-in Battery | No |
| Service | OEM / ODM Accepted |
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)
- Aluminum & Aluminum-Plastic Caps (Tamper-Evident, Various Sizes)
- 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 V2 Reusable Metal Injection Pen from Vialab represents the convergence of durable engineering, regulatory compliance, and environmental sustainability. CE certified and ISO 11608 compliant, the V2 pen delivers consistent, reliable, and patient-friendly drug delivery while significantly reducing medical waste compared to disposable alternatives.
Whether deployed in pharmaceutical settings for chronic disease management or in aesthetic practices for skin care treatments, the V2 pen—with its premium aluminum construction, 3ml cartridge compatibility, and comprehensive customization options—stands as a trusted choice for healthcare partners worldwide.
For inquiries about the V2 Reusable Metal Injection Pen, OEM/ODM customization, or other pharmaceutical packaging solutions, contact Vialab Pharmaceutical Packaging Co., Ltd. today.