HomeParenteral Solutions

Parenteral Solution Manufacturing Facility

Introduction

We specialize in the development and production of parenteral solutions, operating under the highest standards of sterility and quality control. Parenteral solutions are sterile, pyrogen-free preparations designed for administration via injection through the skin or other boundary tissues. This dosage form enables immediate systemic availability by bypassing the gastrointestinal tract, ensuring precise and controlled delivery.

Injectable Vials

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    Types of Parenteral Solutions

    Vials

    Manufactured in glass or plastic containers, sealed with a rubber stopper and aluminum cap, these vials are designed for multiple dosing applications while maintaining sterility and integrity.

    Pre-filled Syringes

    These are sterile syringes pre-loaded with a fixed dose of medication, designed to ensure precision, safety, and convenience in parenteral administration.

    Small-V Parenterals

    Sterile parenteral solutions packaged in containers of 100ml or less, designed for precise dosing and diverse clinical applications.

    Lyophilized Products

    These are freeze-dried powders packaged under sterile conditions, requiring the addition of a diluent before injection. This format helps maintain stability and shelf life of sensitive formulations.

    Sterile Parenteral
    Prefilled Injections
    Sterile Parenteral
    Lyophilized Products

    Packaging, Labelling & Special Content

    Primary Packing

    Glass Containers– Type I borosilicate glass ampoules and vials are widely used for their chemical stability, durability, and inertness, ensuring product integrity.

    Plastic Containers– For large-volume parenterals (LVPs), IV bags are produced using polypropylene (PP), polyethylene (PE), or polyvinyl chloride (PVC), offering flexibility and sterility.

    Rubber Stoppers– Vials are sealed with butyl or halo-butyl rubber stoppers, engineered to maintain tight closure and withstand processes like lyophilization.

    Prefilled Syringes– Complex assemblies featuring glass barrels, rubber plungers, and protective needle shields, designed for convenience, sterility, and precision dosing.

    Box Packaging

    Cardboard Trays & Boxes- Designed to securely hold vials and ampoules, these packs provide essential physical protection during handling and distribution.

    Package Inserts- Every pack includes mandatory informational leaflets for healthcare professionals, ensuring safe and compliant use of the product.

    Mandatory Content- Labels and inserts clearly state: Product Name, Strength per volume, Batch Number, Manufacturing & Expiry Date, Route of Administration, Fill Volume, Manufacturer details, Warning Statements, and Storage Instructions.

    Technical Details- Additional data such as osmolarity, pH values, and complete solution composition are often included to meet regulatory requirements.

    Special Content- May highlight key notes such as “Single-use only,” “Lyophilized Powder – See Reconstitution Instructions,” “Preservative-Free,” or QR Codes for digital traceability.

    Manufacturing & In-Process Control

    Primary Packing

    Dispensing
    All ingredients are precisely weighed in controlled environments and logged in the Dispensing Record for traceability.

    Solution Preparation
    Formulation is compounded in stainless steel vessels using Water for Injection (WFI) under strict quality standards.

    Filtration
    The solution undergoes sterile filtration through a 0.22 micron filter into a holding vessel—an essential step to ensure sterility.

    Aseptic Filling & Sealing
    Filling is performed in an ISO 5 cleanroom using isolators or RABS, with operators in full sterile gowning.

    • Ampoules: Sealed by fusion.

    • Vials/Bags: Stoppered and secured with an aluminium crimp seal.

    Lyophilization
    Vials requiring freeze-drying are transferred to a lyophilizer, where water is sublimated under vacuum, producing a stable, freeze-dried powder.

    Documentation
    Every stage—weighing, mixing, filtration, filling, sealing, and lyophilization—is documented in Equipment Logs and the Batch Manufacturing Record to ensure full compliance and audit readiness.

    Manufacturing alliance with following certifications:​
    ISO Certified Personal Care
    GMP Certified Manufacturing
    ISO Healthcare Certified
    Kosher Certified Healthcare Products
    cGMP Certified Manufacturing
    ANSI 305 Healthcare Products
    COSMOS Organic Certified Products
    EAC in EAEU Approved Products
    ECO CERT Cosmetic Products
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