THEON LIFESCIENCES

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Vial Line

Vial Line (Liquid Injectables)

Theon Lifesciences implements the latest technologies in aseptic vial filling. We focus on the Automatic Vial Filling & Stoppering Machine by AUSTAR whilst ensuring compliance with the highest EUGMP, USFDA, TGA Australia, Anvisa, and cGMP standards in filling accuracy. Our expertise lies in offering a complete solution of providing liquid injections and several other pharma products

Our injectable vial filling machines have adaptable design that minimizes human participation in the processing area. We enable appropriate integration under isolators or other containment solutions without altering the fundamental machine setup. The external washers round out the vial filling line’s product line and satisfy the growing market need for decontamination solutions that eliminate product particles from vial exteriors.

Key Features

What Process Do We Follow to Make Liquid Injectables

The process of making liquid injectable vial lines (i.e., filling sterile vials with liquid pharmaceuticals or biologics) involves several highly controlled steps to ensure sterility, accuracy, and compliance with regulatory standards (like FDA, EMA, or WHO). Here’s a detailed breakdown:

Preparation & Formulation

  • Drug solution preparation: Preparing a drug solution involves dissolving the active pharmaceutical ingredient (API) in an appropriate solvent (such as injectable water) and adding excipients like buffers or stabilizers.

  • Filtration: To get rid of particles and microbes, the solution is passed through sterile 0.22-micron filters.

 

  • Environmental control: This is usually done in a cleanroom (ISO Class 5) to maintain sterility.

Vial & Closure Preparation

  • Vial washing and sterilization: Glass vials that have been emptied, cleaned, rinsed, and sterilized (usually with dry heat or in an autoclave).

  • Stopper sterilization: Rubber stoppers used to seal vials are treated independently, frequently by gamma irradiation or autoclaving.

 

  • Tray setup: To feed the filling line, vials are placed on trays.

Filling

  • Aseptic filling: Vials are filled under aseptic conditions using automatic liquid filling machines.

  • Volume control: Machines ensure precise dosing for each vial, usually measured gravimetrically or volumetrically.

  • Environmental control: Filling occurs in a laminar airflow workbench or isolator to prevent contamination.

Stoppering & Sealing

  • Insertion of stoppers: After filling, vials are immediately capped with sterilized stoppers.

  • Sealing: Aluminum crimp caps are applied to secure the stopper.

  • Inspection: Machines may detect misaligned or loose caps.

Inspection

  • Visual inspection: Vials are checked for clarity, particulates, color, and fill level.

  • Automated inspection: Many lines use cameras and sensors to detect defects.

  • Sterility testing: Samples are periodically tested in a microbiology lab.

Labeling & Packaging

  • Label application: Vials are labeled with drug information, batch number, and expiry date.

  • Packaging: Labeled vials are packed into cartons or trays for shipping.

  • Final quality checks: Before release, batches undergo final QC testing (assay, pH, endotoxin, sterility).

Storage

  • Controlled conditions: Vials are stored under temperature-controlled conditions (e.g., 2–8°C for many injectables) until distribution.

Why Choose Theon Lifesciences for Liquid Injections?

Theon Lifesciences Pvt. Ltd. is a prominent manufacturer that specializes in sterile injectable formulations. Here are some reasons of relying on us for liquid injectable vials can be:
  • Advanced Manufacturing Facility:
    State-of-the-art infrastructure at Theon Lifesciences operates a modern manufacturing unit designed to meet stringent regulatory standards. Our advanced sterilization techniques make our liquid injectables pure and safe to use.
  • High Production Capacity:
    We have a vast facility boasting an annual production capacity of:

     

    1. 120 Million Liquid Vials per annum
    2. 120 Million Glass Ampoules per annum
    3. 30 Million Lyophilized Injections per annum
    4. 30 Million Ophthalmic Preparations per annum
    5. 30 Million Prefilled Syringes per annum
  • International Certifications:
    Theon Lifesciences follows international regulatory standards like USFDA, TGA Australia, Anvisa, cGMPs, and EU guidelines to ensure the highest quality and safety of its products.
  • Quality by Design: The manufacturing processes adhere to “Quality by Design” principles, focusing on proactive quality assurance during manufacturing.

  • Research & Development Focus: Theon Lifesciences is dedicated to advancing drug discovery, formulation, and manufacturing practices, ensuring they remain at the forefront of pharmaceutical innovations. 

  • Expert R&D Team: Driven by innovation, our eminent researchers are almost continuously working on developing advanced, next-generation formulations that elevate quality and efficacy to a whole new level.

Theon Lifesciences – Innovation. Compliance. Trustworthy

At Theon Lifesciences, we combine cutting-edge R&D, global regulatory compliance, and high-volume capacity to deliver trusted injectable formulations. As a leader in sterile injectable manufacturing, we bring unmatched expertise, advanced technology, and global quality standards to every product.

Reach out now for customized, and reliable injectable solutions.

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