Presspart’s Vytal® is emerging as a breakthrough in pharmaceutical packaging technology with its ready-to-use (RTU) snap-fit closure system designed specifically for advanced therapeutics, including biologics, monoclonal antibodies, viral vectors, mRNA therapies, cell and gene therapies, and orphan drugs.
Developed under ISO 13485 and GMP Annex I standards, Vytal® offers a solution to some of the most pressing challenges in small- to medium-batch production of highly complex parenteral drugs from maintaining sterility to improving operational efficiency and reducing time to market.
Reimagining Container Closure for Modern Therapeutics
Traditional vial closures typically rely on crimping and multi-step assembly, which can generate particles and increase contamination risks. Vytal®’s snap-fit design eliminates crimping altogether, enabling stoppering and sealing to occur in a single, ready-to-use action a significant efficiency boost for aseptic filling environments.
This innovation not only reduces particle generation and material degradation during closure but also enhances overall container-closure integrity (CCI) critical for sensitive biologics and other advanced modalities even at ultra-low storage temperatures such as –80 °C.
Key Features Driving Adoption
Vytal® combines several cutting-edge attributes that address pharmaceutical manufacturers’ evolving demands:
- Ready-to-Use Snap-Fit System: Simplifies assembly and accelerates production workflows.
- High CCI Performance: Assured even under extreme cold storage conditions.
- Compatibility with Glass & COP Vials: Broadens applicability across formats.
- Low Residual Volume: Reduces waste and helps maximise drug yields.
- Nested & Bulk Formats: Supports scalable operations, from manual to automated fill–finish lines.
- Anti-Counterfeiting Features: Includes tamper-evident design and laser marking for traceability and compliance.
- CSTD Compatibility: Works with standard closed-system transfer devices, enhancing safety in handling hazardous drugs.
Industry Recognition and Impact
The Vytal® system has already been nominated for a CPHI Pharma Award in the Packaging & Machinery category — a nod to its potential to redefine container closure systems across advanced therapeutics.
By reducing mechanical complexity, minimising contamination risk, and streamlining integration into existing aseptic filling lines, Vytal® positions itself as a benchmark for the next generation of parenteral packaging solutions.
As the pharmaceutical landscape continues to shift toward more personalised and biologically complex drugs, innovations like Vytal® will likely play a pivotal role in helping manufacturers meet regulatory standards, improve product safety, and accelerate access to life-saving therapies worldwide.
