Generation Ultrasonic Washing Sterilizing, Filling and Sealing For Ampoule

This production line integrates washing, sterilization, filling, and sealing for 1-20ml ampoules. It offers a compact design, stable performance, and complies with national GMP requirements for aseptic drug production.

Ampoule Production Line Full Detail

This production line integrates several key components for efficient and aseptic ampoule processing:

System Composition and Features

The line comprises a QCLX series vertical ultrasonic bottle washing machine, an SGZ series tunnel-type hot air circulation sterilization oven, and an AGF series vertical filling and sealing machine for ampoules. This compact and aesthetically pleasing setup saves space and offers convenient, clean operation, making it ideal for small-capacity injection filling and sealing of 1-20ml ampoules.

Process Capabilities and Compliance

It automates over 20 critical steps in drug production, including ampoule water dousing, ultrasonic cleaning, flushing (water and air), drying, sterilization, cooling, and precise filling and sealing. With an advanced design, robust structure, and stable performance, this linkage line provides essential equipment and technical support for aseptic drug manufacturing, fully adhering to current national Good Manufacturing Practice (GMP) requirements.

Ampoule Production Line Video

Ampoule Production Line Technical Parameters

Parameter QCLX80+SGZ620/42+AGF8 QCLX100+SGZ600/60+AGF10 QCLX100+SGZ600/60+AGF12 QCLX120+SGZ600/60+AGF16
Product Model QCLX80+SGZ620/42+AGF8 QCLX100+SGZ600/60+AGF10 QCLX100+SGZ600/60+AGF12 QCLX120+SGZ600/60+AGF16
Size Range 1-20ml national standard vials 1-20ml national standard vials 1-20ml national standard vials 1-20ml national standard vials
Output (1-2ml) 16000-22000 pcs/h 22000-28000 pcs/h 26000-34000 pcs/h 35000-40000 pcs/h
Output (5-10ml) 8000-12000 pcs/h 12000-18000 pcs/h 15000-20000 pcs/h 35000-40000 pcs/h
Output (20ml) 5000-7000 pcs/h 6000-9000 pcs/h 9000-12000 pcs/h 35000-40000 pcs/h
Clarity >99% >99% >99% >99%
Breakage Rate ≤1% (the whole line) ≤1% (the whole line) ≤1% (the whole line) ≤1% (the whole line)
Filling Precision ±0.5-2% (according to pharmacopoeia standard) ±0.5-2% (according to pharmacopoeia standard) ±0.5-2% (according to pharmacopoeia standard) ±0.5-2% (according to pharmacopoeia standard)
Water Consumption and Pressure 0.2-0.4MPa / 0.6-1.0 m³/h 0.2-0.4MPa / 0.6-1.0 m³/h 0.2-0.4MPa / 0.6-1.0 m³/h 0.2-0.4MPa / 0.6-1.0 m³/h
Cleaning CA Consumption and Pressure 0.3-0.6MPa / 35-80 m³/h 0.3-0.6MPa / 35-80 m³/h 0.3-0.6MPa / 35-80 m³/h 0.3-0.6MPa / 35-80 m³/h
Sealed Gas Gas (liquefied gas) + oxygen, oxyhydrogen generation gas, natural gas Gas (liquefied gas) + oxygen, oxyhydrogen generation gas, natural gas Gas (liquefied gas) + oxygen, oxyhydrogen generation gas, natural gas Gas (liquefied gas) + oxygen, oxyhydrogen generation gas, natural gas
Oxygen Consumption 0.2-0.3MPa, 1.2-1.5 m³/h 0.2-0.3MPa, 1.2-1.5 m³/h 0.2-0.3MPa, 1.2-1.5 m³/h 0.2-0.3MPa, 1.2-1.5 m³/h
Gas Consumption 0.1-0.3MPa, 1.5-2.5 m³/h 0.1-0.3MPa, 1.5-2.5 m³/h 0.1-0.3MPa, 1.5-2.5 m³/h 0.1-0.3MPa, 1.5-2.5 m³/h
Exhaust Volume 3500-4100 m³/h 3500-4100 m³/h 3500-4100 m³/h 3500-4100 m³/h
Net Weight 7800 (kg) 7800 (kg) 7800 (kg) -
Total Power approx 72KW 380V 50HZ approx 91KW 380V 50HZ approx 91KW 380V 50HZ approx 91KW 380V 50HZ
Outline Size approx 9940 × 2260 × 2445mm approx 10100 × 2260 × 2445mm approx 10600 × 2260 × 2445mm approx 10600 × 2260 × 2445mm

Why choose Yundu's ampoule production line?

Choosing Yundu‘s ampoule production line means investing in a high-efficiency, precision-engineered solution that guarantees compliance and reliability for your pharmaceutical manufacturing needs. Our integrated system streamlines critical processes from washing to sealing, ensuring superior product quality and operational excellence.

Small Volume Product

Unwavering GMP Compliance

Our production lines are meticulously designed and manufactured to strictly adhere to current national Good Manufacturing Practice (GMP) requirements. This ensures that your aseptic drug production meets the highest regulatory standards, minimizing risks and facilitating smooth approvals.

LVP Mould

Fully Integrated Automated Solution

The Yundu ampoule production line offers a seamless, one-stop solution by integrating vertical ultrasonic bottle washing, tunnel-type hot air circulation sterilization, and vertical filling and sealing. This comprehensive linkage allows for the joint operation of over 20 process steps, optimizing workflow and reducing manual intervention.

Cutting Station

Superior Aseptic Production Capabilities

Engineered specifically for aseptic drug production, our line provides essential equipment and technical support to maintain a sterile environment throughout the entire process. This critical feature is paramount for pharmaceutical products, safeguarding against contamination and ensuring patient safety.

CIP Cleaning

High Precision and Efficiency

Benefit from exceptional filling precision (±0.5-2% according to pharmacopoeia standards) and a remarkably low breakage rate (≤1% for the whole line). Coupled with high output capacities ranging from 16,000 to 40,000 pieces per hour for various ampoule volumes, our line significantly boosts your production efficiency and yield.

Food Grade

Optimized Space and Operation

Designed with a simple and beautiful appearance, the Yundu production line occupies less space, making it an ideal choice for facilities with spatial constraints. Its convenient and clean operational features contribute to an organized work environment and ease of maintenance.

PLC Control

Advanced Design and Stable Performance

Our linkage line boasts an advanced design concept and reasonable structure, leading to consistently stable performance. This robust engineering translates into reliable operation, reduced downtime, and a long service life for your investment, providing sustained technical support for your manufacturing success.

Ampoule Production Line FAQ

Transparency is the cornerstone of our Yundu team. That’s why below, you can find the most common questions and answers we receive surrounding our ampoule production line.

Ampoules are primarily made from short lengths of glass tubing, which are heated by gas torches and gravity, then shaped into the desired form in automated production lines. They are hermetically sealed by melting the thin top with an open flame after filling.

A pharmaceutical production line is an automated system comprising various machines that handle sequential processes like washing, filling, sterilizing, and packaging of pharmaceutical products. Its purpose is to increase productivity and ensure consistent quality and compliance with regulatory standards.

The typical procedure involves filling glass tubes into carousels, shaping them into ampoules (from base to tip, including color coding), then separating them. After shaping, ampoules are cleaned, filled with the pharmaceutical product, and hermetically sealed using an open flame. Quality control checks are performed throughout the process.

Ampoules are small, hermetically sealed glass containers primarily used to contain and preserve sensitive pharmaceutical liquids or chemicals. Their airtight seal protects the contents from air, moisture, and contaminants, making them ideal for single-dose injectable medications that require high sterility.

Many injectable medications are packaged in ampoules, especially those requiring strict protection from air or light. Common examples include various vaccines, antibiotics, pain medications (like morphine or tramadol), local anesthetics, some hormonal agents, and solutions for rehydration or specific medical conditions (e.g., glucose, sodium chloride).

The main difference lies in their closure and reusability. A vial is typically a glass bottle with a thin rubber stopper sealed by a metal or plastic cap, designed for multiple dose withdrawals using a needle. An ampoule is a completely sealed glass or plastic container with a thin neck that must be broken open, making it a single-use device.

Medications come in ampoules primarily to ensure maximum sterility and protect sensitive contents from oxidation, contamination, and light. The hermetic seal provides superior protection compared to a resealable vial, crucial for medications administered into high-risk areas like the central nervous system or those that are less stable.

Ampoules are generally single-use and should be used immediately after opening due to the compromised sterility and exposure to air. Once opened, any remaining contents should be discarded appropriately.

During ampoule filling, critical precautions include maintaining strict aseptic technique, ensuring proper hand hygiene, using sterile equipment, avoiding contact between the needle/syringe and non-sterile surfaces, and preventing distractions. For light-sensitive drugs, dark glass ampoules are used.

To prepare an injection from an ampoule, first ensure proper hand hygiene. Use a gauze pad or an ampoule opener to snap the neck of the ampoule away from you. Then, insert a filtered needle into the ampoule (often tilting it gently) to withdraw the medication into the syringe. A filtered needle is crucial to prevent drawing up any tiny glass particles.

Yes, ampoules are designed for single use. Once the neck is broken to access the contents, the hermetic seal is compromised, and the remaining solution cannot be safely stored or reused due to the risk of contamination.

Disadvantages of ampoules include the risk of sharps injuries to healthcare workers during opening, the potential for microscopic glass particles to enter the medication (though filtered needles mitigate this), and the inability to reseal, leading to waste if only a partial dose is needed.

While it’s generally not recommended to mix the contents of multiple ampoules unless specifically directed by a healthcare professional or product instructions, some cosmetic ampoules are designed to be layered (used one after another) for different skin concerns. For pharmaceutical products, mixing typically requires strict protocols to ensure compatibility and sterility.

The cost of ampoules can be attributed to the highly specialized manufacturing process, which includes precise glass forming, strict quality control, and aseptic filling and sealing. Additionally, the concentrated and often complex active ingredients they contain, coupled with the rigorous regulatory compliance required for pharmaceuticals, contribute to their overall expense.

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