Ampoule Line (Liquid Injectable)
Theon Lifesciences delivers precision and sterility through its fully automatic, PLC-based Ampoule Filling & Sealing Line. Engineered for minimal manual intervention, the system ensures smooth transfer of ampoules from tunnel to buffer table using an advanced interlocked setup. This automation not only enhances efficiency but also reduces contamination risks, making it ideal for large-scale pharmaceutical production.
With cutting-edge machinery and strict adherence to EUGMP, USFDA, TGA Australia, Anvisa, and cGMP guidelines, our ampoule line guarantees accuracy, safety, and compliance. By combining speed, precision, and global quality standards, Theon Lifesciences provides a reliable platform for manufacturing injectable ampoules that meet the highest international benchmarks.
Key Features of Our Ampoule Line
How Do We Manufacture Ampoules with Precision?
Producing sterile injectable ampoules is a highly controlled and carefully monitored process. Every stage is designed to maintain purity, achieve exact dosing, and comply with the world’s most rigorous pharmaceutical standards (FDA, EMA, WHO, and more). Below is a step-by-step look at how Theon Lifesciences ensures accuracy and reliability in its ampoule line
Solution Preparation
- Formulation of the drug: Active pharmaceutical ingredients (APIs) are blended with Water for Injection (WFI) and suitable excipients such as stabilizers or buffers to create a stable formulation.
- Sterile filtration: The solution is passed through 0.22-micron-grade filters to remove any particles or microbial contaminants.
- Aseptic environment: All operations are performed in ISO Class 5 cleanrooms to maintain a contamination-free setting.
Ampoule Readiness
- Cleaning: Empty glass ampoules are rinsed internally and externally using purified water, followed by WFI to remove residues.
- Depyrogenation: They are then heat-treated in sterilizing tunnels at high temperatures to eliminate pyrogens and ensure sterility.
- Quality checks: Each ampoule is inspected for cracks, chips, or deformities before moving to the filling section.
Filling Process
- Sterile filling: Automated filling machines dispense the prepared drug solution into ampoules under continuous laminar airflow.
- Nitrogen purging: For oxygen-sensitive drugs, nitrogen gas may be introduced to improve stability before sealing.
- Dose accuracy: Advanced pumping systems ensure precise dosing with a tolerance of ±1% across multiple fill volumes (1 ml–10 ml).
Sealing
- Hermetic closure: Directly after filling, ampoules are flame-sealed using precision burners to create an airtight and tamper-proof seal.
- Seal validation: The sealing quality is continuously monitored to prevent weak closures that could compromise sterility.
Inspection & Testing
- Manual and visual inspection: Operators verify clarity, fill level, and absence of visible particulates.
- Automated inspection systems: High-speed vision technology detects micro-cracks, improper fills, or cosmetic defects.
- Microbiological safety checks: Random samples are subjected to sterility, endotoxin, and particulate testing in a controlled lab environment.
Labeling & Packing
- Labeling: Each ampoule is labeled with product details, batch codes, and expiry dates in line with regulatory requirements.
- Secondary packaging: Ampoules are packed into trays or cartons, designed to protect them during handling and transportation.
- Final release testing: Before shipment, batches undergo final analysis including potency, pH balance, and stability verification.
Storage & Distribution
- Temperature-controlled storage: Depending on the product, ampoules are stored under specified temperature and humidity conditions, often between 2–8°C.
- Regulated logistics: Theon Lifesciences ensures that during shipping and delivery, ampoules remain under validated, compliant storage conditions to preserve their efficacy.
Why Choose Theon Lifesciences for Ampoules?
- Advanced Technology: Cutting-edge ampoule filling & sealing machines with minimal human intervention.
- High Production Capacity: Annual capability of 120 Million Glass Ampoules alongside other sterile injectables.
- International Certifications: Compliant with EUGMP, USFDA, TGA Australia, Anvisa, and cGMP standards.
- Quality by Design: Manufacturing processes rooted in QbD principles for reliability and consistency.
- Expert R&D Team: Innovating next-generation formulations for global healthcare needs.
Theon Lifesciences - Precision. Purity. Reliability.
At Theon Lifesciences, we bring together advanced technology, strict international compliance, and large-scale production capacity to manufacture world-class injectable ampoules. Our expertise in aseptic processes, combined with automated filling and sealing systems, ensures consistency, safety, and accuracy in every batch.
As a trusted partner in sterile injectable manufacturing, we stand for innovation, operational excellence, and global quality benchmarks. From formulation to final packaging, every ampoule produced at Theon Lifesciences reflects our commitment to patient safety and healthcare progress.