20ml ampoule filling machine sop Sealing Machine with tunnel type hot wind cycle sterlization
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DOP Inspection Interface: Facilitates the testing and verification of filter integrity, ensuring the production of sterile vials.
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Sterilization Function: Eliminates microbial contamination, maintaining product integrity and safety.
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Ultrasonic Technology: Enhances cleaning efficiency by removing tough contaminants from vials, ensuring cleanliness and quality.
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CIP Online Cleaning: Enables automated cleaning of equipment without disassembly, reducing downtime and labor costs.
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Comprehensive High-Pressure Water Rinsing: Provides thorough cleaning of vials, removing residues and contaminants effectively.
These features collectively contribute to improved production efficiency, product quality, and compliance with stringent hygiene and safety standards in vial manufacturing processes.
The ampoule filling machine sop typically consists of several key components, including:
- Ampoule washing machine: Cleans and sterilizes the glass ampoules before filling to ensure product purity.
- Ampoule filling machine: Fills the cleaned ampoules with the desired pharmaceutical product accurately and precisely.
- Ampoule sealing machine: Seals the filled ampoules to maintain product integrity and prevent contamination.
- Inspection system: Checks the filled and sealed ampoules for defects, such as cracks or leaks, to ensure product quality.
- Labeling and packaging equipment: Labels the filled ampoules with necessary information and packages them for distribution.
The pharmaceutical ampoule filling machine sop is crucial for pharmaceutical companies to efficiently and accurately fill ampoules with medications while maintaining high quality and safety standards.
20ml ampoule filling machine sop Spec:
| technical parameters |
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| product model | LYQCL100+LYASMR
620/43+LYAGF8 |
| size range | 1-20ml national standard ampoules |
| Output(1-2ml) | 16000-22000pcs/h |
| Output(5-10ml) | 8000-12000pcs/h |
| Output(20ml) | 5000-7000pcs/h |
| Clarity | ＞99% |
| Breakage rate | ≤1%(whole line) |
| Filling Precision | ±0.5-2%(according to pharmacopoeia standard) |
| Water Consumption and Pressure | 0.2-0.4Mpa / 0.6-1.0m³/h |
| Cleaning CA Consumption and Pressure | 0.3-0.6Mpa / 35-80m³/h 0.3-1.0Mpa / 35-80m³/h |
| Sealed gas | Gas(liquefied gas)+oxygen, oxyhydrogen generation gas, natural gas |
| Oxygen consumption | 0.2-0.3Mpa,1.2-1.5m³/h |
| Gas consumption | 0.1-0.3Mpa,1.5-2.5m³/h |
| Exhaust volume | 3500-4100m³/h |
| Net weight | 7800(kg) |
| Total power | around 72kw 380V 50HZ |
| Outline size | around 9940x2260x2445mm |
20ml ampoule filling machine sop Performance Features
◆ Vertical Ultrasonic Bottle Washer: The 20ml ampoule filling machine sop adopts a combination of ultrasonic online cleaning and separate alternating water and air jet cleaning, making it the most popular and effective cleaning equipment internationally with excellent visible foreign matter detection.20ml ampoule filling machine sop has a wide adaptability and low bottle breakage rate. Throughout the entire cleaning process, water and air are sprayed independently through separate nozzles, with each nozzle fixed for a specific cleaning medium to complete a rinsing or cleaning process, thus avoiding cross-contamination and dead corners, in compliance with the requirements of the new version of GMP.
◆ Tunnel-Type Hot Air Circulating Sterilizing Oven: The oven utilizes laminar flow principles and high-speed hot air sterilization process, allowing containers to achieve A-grade standard laminar flow environment within the sealed tunnel for the complete production process of preheating, drying sterilization, and cooling until the bottles are discharged. It is currently the most popular and effective drying and sterilization equipment internationally, with uniform heat distribution, excellent heat removal effect, and equipped with mesh belt ultrasonic online cleaning, power failure protection, and automatic wind pressure adjustment system.
◆ Vertical Ampoule Filling and Sealing Machine: The 20ml ampoule filling machine sop adopts a balcony-type design structure, and the screw turntable bottle transfer can automatically complete bottle separation, pre-flushing with nitrogen, filling, post-nitrogen filling, preheating, and sealing by pulling. It operates smoothly with a high pass rate for finished products.
◆ The entire 20ml ampoule filling machine sop adopts advanced intelligent electrical control technology and a simple and intuitive human-machine interface, achieving electromechanical integration design. 20ml ampoule filling machine sop can realize both front and rear linkage control and standalone operation, ensuring the normal operation of the entire line. It can display the machine's operating status and fault display, self-diagnosis of faults, fault analysis, and elimination methods, enabling the entire production process to achieve automated control.
Q&A for 20ml ampoule filling machine sop:
Q:How does an 20ml ampoule filling machine sop help pharmaceutical companies meet regulatory requirements?
A:20ml ampoule filling machine sop is designed to meet strict regulatory standards for pharmaceutical manufacturing, ensuring product safety, quality, and compliance with regulations.
Q:What are some considerations when selecting an 20ml ampoule filling machine sop for a pharmaceutical facility?
A:Factors to consider include production capacity, filling accuracy, ease of operation, maintenance requirements, regulatory compliance, and integration with existing production processes.
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20ml ampoule filling machine sop Sealing Machine with tunnel type hot wind cycle sterlization Images
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