Marya EUGMP/ FDA/ cGMP Vial Filling Production Line for
Modern Pharmaceutical Industry
Introduction:
The vial filling production line is a high-efficient, accurate and safe filling solution and widely used in pharmaceutical, biotechnology, food, cosmetics and other fields. With a quite mature technology and application, it has passed the long-term testing in the market, and recognized by the industry.
Why choose us?
Our production line consists of four equipment, namely a vertical ultrasonic bottle washing machine, a hot air circulation sterilization tunnel oven, a vial filling and stoppering machine and a vial capping machine. Our technical team has relevant experience of more than ten years. It has been exported to dozens of countries or regions and widely recognized in the international market.
Our equipment is highly automated, and can automatically complete the production process from vial loading, washing, drying, filling and stoppering to capping and discharging. It requires less operators and manual intervention, which can effectively improve the production efficiency of customer factories.
1. With good compatibility, every equipment is applicable for 2ml to 100ml vials by replacing change parts.
2. It has high-quality configuration and excellent stability as we use international first-class electrical brands. With stable performance and long service life of functional components, accurate movement of moving parts, interlocking function of upstream and downstream equipment, our equipment has good stability.
3. The equipment design refers to international common standards, such as EUGMP, FDA, cGMP and other industry regulations. All parts of the equipment in contact with products/drugs or clean media are made of stainless steel 316L or medical grade silica gel and the parts not in contact with that are made of SS304 or POM and other clean materials. The software has an audit tracking system with 4-level user access management, and each manual intervention or alarm will be recorded.
4. The production line can be equipped with many optional functions, and be customized and designed according to customer's plant drawings or other needs to a certain extent, which makes our customers more worry-free and satisfied.
Detailed introduction of each equipment
I. Ultrasonic vertical bottle washing machine
Features of ultrasonic vertical bottle washing machine
- It is also often used for cleaning oral liquid bottles and ampoules besides vials. It is applicable to many sizes and easy to replace change parts.
- Take the QCL40 bottle washing machine, which is the most widely used and applicable to the most sizes, as an example, it is applicable to 2 to 100ml bottles and its production capacity is 4000 to 9600pcs/h.
- The multiple cleaning ways ensure the cleanliness of the bottle after cleaning. First, ultrasonic cleaning is adopted to remove the dirt adhered to the vial wall, and then filtered water and air are used to alternately spray and dry the inner and outer walls of the vial for many times, so that the foreign matter in the vial is discharged.
- The stainless steel conveyor belt is adopted to convey bottles with excellent stability. The way of screw separating bottles and use of rotary table fully ensure the smooth vials feeding and discharging and effectively reduce the broken vial rate.
- The water and air pipelines used for cleaning are separated, without cross contamination, which complies with GMP regulations.
- The water temperature for cleaning is maintained at about 50-60ºC. The circulating water tank is equipped with stainless steel heating pipe, which can be set to adjust the circulating water temperature. If the temperature is not raised to the specified value, the equipment gives an alarm and does not start.
- The 10μm circulating water filter and 0.22μm purified water or WFI filter are used, and the brand is Pall (can be adjusted according to customer requirements).
Technical parameters of vertical ultrasonic bottle washing machine
Capacity
|
≥6000 pcs/h Calculated by 10ml vials
|
Compressed air pressure
|
0.6-0.8MPa
|
Compressed air consumption
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About 35-40m³/h
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WFI (purified water) supply pressure
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0.2-0.3MPa
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WFI (purified water) supply temperature
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50ºC~60ºC
|
WFI (purified water) consumption
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About 0.5-0.7m³/h
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Vial breakage rate
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<0.05%
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Machine weight
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About 2500KG
|
II. Hot air circulation sterilization tunnel oven
Features of hot air circulation sterilization tunnel oven
- The oven adopts the hot air laminar flow to sterilize vials at high temperature for a short time, and it is widely used in drying and depyrogenation of antibiotic vials, oral liquid bottles and ampoules after cleaning.
- The highest temperature of the heating section can reach 350ºC or more, and the outlet temperature of the cooling section is less than and equal to room temperature +15ºC.
- The hot air circulation heating mode is adopted to make the internal temperature of each section uniform, which is efficient and energy-saving;
- With the function of preventing HEPA filter burning at the high-temperature section in case of power failure, making operation safe;
- The air speed of each section of the oven is controlled by the fan frequency converter, and the system is sensitive and stable in performance.
- With ultrasonic self-cleaning function of mesh belt, it reduces the labor strength of manual periodic cleaning.
- The high temperature section adopts multi-channel PID control, modular structure, and has more accurate temperature control.
- It is equipped with multiple differential pressure gauges and temperature sensors to monitor the differential pressure and temperature of each section in real time, and with multi-channel temperature recorder to print temperature curves in real time. The brands we used are international first-class.
Technical parameters of hot air circulation sterilization tunnel oven
Capacity
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≥6000pcs/h Calculated by 10ml vials
|
Fresh air supply
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About 2500m³/H
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Outlet vial temperature
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≤room temperature+15ºC
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Vial breakage rate
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<0.01%
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Working temperature difference between each zones
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No load≤±5ºC full load≤±10ºC
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Sterilization temperature
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280ºC-350ºC , adjustable
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Speed regulation of mesh belt
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100-300mm/min
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Weight
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About 3000KG
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III. Vial filling and stoppering machine
Features of vial filling and stoppering machine
- The filling machine is the core equipment of the vial production line and widely used in sterile injection, cosmetic medicine, oral liquid, freeze-dried powder and other fields. It can be said that other equipment of the vial production line is equipped for this machine.
- The machine's construction and materials comply with GMP standards. The parts in direct or indirect contact with the product such as filling needle and stopper hopper are made of stainless steel 316L or medical-grade silica gel, while non-contact parts such as exterior parts and laminar flow supports are made of SS304 or POM.
- An O-rabs system is equipped, which includes class A laminar flow, glove ports, and interlocking safety doors, and door-opening alarm to restrict operator's operation and access; it also has built-in ports for dust particle, airborne viable bacteria, and air speed detection.
- The equipment is designed for excellent stability. The high-precision servo motor or speed regulating motor is adopted for the moving parts, which has simple structure, low failure rate and more stable operation.
- With alarm and shutdown function: in case of abnormal phenomenon in operation, it can give an alarm and stop running in time, display fault point, and record and export various data when fault occurs;
- We use international first-class electrical brand with long service life and stable performance.
- The adopted rotary stoppering is stable and high-efficient with fast speed. It also has function of no bottle no stoppering.
- With multiple detection stations such as stoppering overload protection, stopper missing detection, filling overload protection, out-pf-limit air speed of dust particles, it greatly reduces abnormal conditions which affect normal production;
- It has high filling accuracy. The full servo control is adopted for the filling system, the filling volume of each pump can be adjusted independently, and the optional online weighing system can realize the self-calibration of the pump;
- The ceramic plunger pump used is more wear-resistant. The equal-volume filling principle is adopted to make filling volume adjustment more precise;
- It has the function of sucking back which prevents overflow, and never drops extra liquid medicine.
- During filling, the needle remains in contact-free with the liquid surface. The insertion depth rises synchronously with the liquid level, maintaining a relatively stationary synchronous movement to avoid liquid splashing.
- The software system complies with GMP and FDA CRF21 part11 requirements. It can be equipped with an international premium brand's IPC and an audit trail system that tracks key operations during the production process, records specific details such as date, time, operator account, operation content, and notes. The system features a 4-level user access setup, including different levels for operators, technicians, managers, and maintenance personnel.
- Each account can be set up at least 50 operators, and each with a unique password and customizable name.
- The operation on the HMI is simple and convenient, with its bilingual interface and ergonomic structure design. Its control system can achieve fully automatic operation of production, monitoring, detection and recording; with recipe generation and storage functions, it supports one-button calling of production parameters.
- It adopts modular design, with good compatibility. It is applicable for various filling volumes and methods by replacing change parts. It also can be used alone or connected with labeling machine, light inspection machine and other equipment to form a production line. The filling pump unit can be disassembled and replaced or expanded according to production requirements, and 12 pumps can be installed at most, which greatly improves the equipment capacity.
- The machine offers a high degree of customization with a variety of optional functions. It can be equipped with nitrogen filling to stabilize and protect drugs; CIP/SIP also can be optional to save labor and time associated with cleaning and sterilization before and after production, and to reduce the risk of contamination during the transport of sterilization instruments; and online sampling and weighing functions that support multiple weighing modes can be added. Other specific requirements can be discussed and confirmed during technical consultations to find solutions.
Technical parameters of vial filling and stoppering machine
Capacity
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≥7200pcs/h Calculated by 2ml vials
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Voltage
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380V, 50Hz
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Power consumption
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About 12kw
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Filling head
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4
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Filling error
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≤±1% (for filling volumes over 2ml);
≤±1.5% (for filling volumes between 1ml and 2ml);
≤±2.5% (for filling volumes between 0.5ml and 1ml); (depending on the filling volume and properties of the medicine).
|
Counting error
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≤0.05%
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Stoppering success rate
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≥99.9%
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No bottle no filling rate
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≥99.9%
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IV. Capping machine
Features of capping machine
- The capping machine is used for the last sealing process of 2 to 100ml vials as the last equipment of the vial filling production line.
- The machine adopts the way of rotary tracking capping and rolling aluminum cap, which has fast capping speed, high productivity, firm and smooth capping mouth without scratch and high qualified rate.
- The whole machine adopts modular design, and the mold and parts in contact with product are easy to disassemble and replace. It is also applicable to many vial sizes.
- It is equipped with O-rabs and class 100 laminar flow hood and can provide local class A environment to protect products. The equipment working environment is recommended for class C or B.
- With multiple sensors interlocked with the filling machine, it can realize the functions of no bottle no capping, no stopper no capping, no cap alarm, etc.
- With the cap detection function, uncapped bottles will be rejected.
Technical parameters of capping machine
Capacity
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Designed according to the capacity of the filling machine.
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Voltage
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380V, 50Hz
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Power consumption
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About 10kw
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Capping qualified rate
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≥99.9%
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Vial breakage rate
|
<0.05%
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Weight
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About 1000KG
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Direct Manufacturer Supply Vial Liquid Filling Production Line Including Filling Sealing Machine
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