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Sterile Diluent Manufacturing

High-volume, preservative-free sterile diluent manufacturing in single-dose BFS format. Thirty years of BFS expertise. Multi-jurisdictional regulatory approvals. Supply chain reliability from a geopolitically stable manufacturing base.

What We Handle

Secure Aseptic Manufacturing

Fully enclosed container formation, filling, and sealing in a single automated operation. No open-air exposure at the critical fill point.
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01

cGMP Compliance

FDA, EMA, TGA, Health Canada, and ANVISA approved. Always compliant and inspection-ready across every production run.
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02

Quality Control and
Batch Release

100% inline leak testing as standard. Manual and semi-automated visual inspection. GMP batch release within the same facility as manufacture.
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03

Batch Consistency at Scale

Every batch meets specification across fill volume, sterility, and container integrity across high-volume commercial programs.
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04

    Diluent Formats We Support

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    Water for Injection

    Single-dose BFS ampoule. Luer format 5 to 10 mL. Hermetically sealed, preservative-free LDPE container.
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    Sodium Chloride 0.9%

    Single-dose BFS ampoule. Twist-top 30 mL format for hospital and clinical supply. Shatterproof, tamper-proof, hermetically sealed LDPE container.

    Did you know manufacturing in Australia could fund nearly half your program?

    Learn More
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    Drug Product Manufacturing Track Record

    0+ years
    of Sterile Manufacturing Heritage
    0M+ units
    Annual Capacity
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    0+
    Approved Products
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    Countries Delivered
    Automated machinery used for the secondary packaging and inspection of clinical and commercial drug products.

    Ready to Secure Your Diluent Supply?

    Partner with BioCina for compliant, reliable manufacturing of sterile diluents at scale.