ISO 10R Amber Open Sterile Vials, 24x45mm, Nested Tray of 96 pieces

Nested Amber ISO 10R Sterile Vials: Premium Quality for Pharmaceutical Use

Introducing Amber ISO 10R Sterile Vials: Ready to Fill / Ready to Use in Convenient Nested Trays

Our Amber ISO 10R Sterile Vials are designed to meet the highest standards of pharmaceutical packaging and handling. Manufactured from premium USP Type 1 borosilicate glass, these vials are the ideal choice for a variety of sterile applications. Each vial features a standard 20mm crimp finish with a precise 13mm hole opening and a 20mm outer rim diameter, ensuring compatibility with most standard sealing systems.

Product Specifications

• Dimensions: The vials measure 24mm in outer diameter and 45mm in height, conforming to the ISO 10R specification. This size is perfect for a range of pharmaceutical solutions and ensures easy handling and integration into existing filling lines.

• Material: Crafted from USP Type 1 borosilicate glass, known for its exceptional durability and resistance to chemical leaching. This high-quality glass type provides a reliable barrier against external contaminants and preserves the integrity of the stored pharmaceuticals.

Manufacturing Process

Our vials undergo a rigorous manufacturing process to guarantee the highest quality:

1. Formation and Washing: Each vial is carefully formed and washed using USP Water for Injection (WFI) by Gerresheimer®. This ensures that the vials are free from any contaminants that could compromise their sterility.

2. Depyrogenation: Post-washing, the vials are subjected to a high-heat depyrogenation process. This step is crucial for eliminating any pyrogens, which could potentially trigger adverse reactions in patients.

3. Sterilization: The vials are then sterilized using ethylene oxide by SteriGenics®. This method ensures comprehensive sterilization, making the vials safe for use in critical pharmaceutical applications.

4. Packaging: After sterilization, the vials are meticulously arranged in durable nested plastic trays. These trays are hermetically sealed to maintain the sterility of the vials during transit and storage.

Unique Nested Tray Design

Our vials are housed in specially designed nested trays, which offer several advantages:

• Protection: The alveolar-style nested trays prevent the vials from coming into direct contact with each other. This design significantly reduces the risk of scratches or damage during shipping and handling.

• Convenience: The nested trays are also designed to serve as a sterile vial rack during the filling process within your cleanroom. This feature streamlines the workflow and enhances operational efficiency.

• Capacity: Each single-sealed nested tray contains 96 vials, providing an optimal quantity for both small-scale and large-scale operations.

Quality Assurance and Compliance

We uphold stringent quality assurance standards to ensure that every vial meets or exceeds pharmaceutical industry requirements:

• cGMP Compliance: Our manufacturing processes adhere to current Good Manufacturing Practices (cGMP), ensuring that all products are produced under strict quality control measures.

• Testing Documentation: Comprehensive testing reports are available for every lot of vials sold. These include:

  • USP <85> Bacterial Endotoxin Test: This test verifies that the vials are free from bacterial endotoxins, ensuring they are safe for use in drug formulations.
  • USP <71> Sterility Test: This test confirms that the vials meet sterility standards, guaranteeing that they are free from microbial contamination.

Availability of Seals and Stoppers

Please note that the 20mm seals and stoppers for these vials are sold separately on our website. We offer a range of sealing solutions to complement our vials and ensure a complete packaging system.

Why Choose Our Amber ISO 10R Sterile Vials?

Our Amber ISO 10R Sterile Vials are engineered to meet the stringent demands of the pharmaceutical industry. With their robust construction, meticulous sterilization process, and innovative packaging design, they are an excellent choice for any pharmaceutical application requiring sterile, reliable, and high-quality vials.

Order now to benefit from our reliable quality assurance, and rest assured that each vial you receive is backed by comprehensive testing and compliance documentation. For further details or to place an order, please visit our website or contact our customer service team.