GMP Pharma 250ml inhalation Anesthetic Liquid Amber Bottle Filling Capping Machine
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Dane techniczne
Opis
The cartridge filling line is composed of an ultrasonic bottle washing machine, an air-drying silicone oil injection integrated machine, a sterilization dryer, and a cartridge stoppering filling capping machine. Designed to align with EU-GMP Annex 1 aseptic filling requirements, it can complete complex functions such as spraying water, ultrasonic cleaning, air & water flushing of the inner and outer walls of cartridge bottles, air drying, silicone oil spraying, preheating, drying, and sterilization, heat source removing, cooling, stoppering, filling, capping, etc., realizing automatic production of the whole process.
Dane techniczne
| 1 | Zastosowanie | 1ml-5ml |
| 2 | Pojemność | ~12000 bottles/hour |
| 3 | Number of Stoppering Heads | 2-10 |
| 4 | Number of Filling | 2-10 |
| 5 | Dokładność napełniania | ±0.5% to ±1% |
| 6 | Pass Rate of Plugging | ≥99% |
| 7 | Capping Rate | ≥99% |
| 8 | Power | 220V/380V, 50/60Hz |
| 9 | Air Supply | 6-7Bar |
Najczęściej zadawane pytania
1. What is a Sterile Glass Cartridge Filling, Stoppering and Crimping Machine?
It is an automatic pharmaceutical machine designed to fill sterile liquid into glass cartridges, insert stoppers, and apply and crimp aluminum caps in an integrated fill-finish process.
2. How is sterility maintained during cartridge filling?
The aseptic cartridge filling machine can operate with Grade A/ISO 5 protection and can be integrated with RABS or isolator systems to minimize contamination risks and operator intervention.
3. What products can be filled into sterile glass cartridges?
The machine is suitable for insulin, injectable pharmaceuticals, dental anesthetics, biologics, and other sterile liquid formulations, depending on the validated process and cartridge configuration.
4. Can filling, stoppering and crimping be completed automatically?
Yes. A complete cartridge filling and closing machine can integrate precision filling, stopper placement, aluminum cap feeding, crimping, and inline inspection into one automated production process.
5. Does the machine support GMP-compliant aseptic production?
Yes. The machine can be designed with 316L stainless-steel product-contact parts, servo-controlled filling, hygienic construction, aseptic protection, and validation-ready documentation to support GMP pharmaceutical manufacturing.
Feature
1. Performance – Walking beam Nozzle for one time filling to achieve more filling time for gentle filling, Individual Servo Filling pump for highest accuracy.
2. Product Safety – Multiple detection and inspection available, 100% tare in tare out, under torque etc.
3. Conversion – Full Servo Driven with rapid changeover via recipe and minimum change part.
4. Compliance – 15” IPC HMI comply to FDA 21 CFR Part 11 and European safety CE Marked.
5. Digitalization – Ready with OPCUA communication port for MES and ERP , Cloud base real-time OEE Monitoring.
6. Barrier System – LAF , Open RABs or Isolator design to GMP Annex 1.
7. Documentation – Full Validation document DQ(RA, FSDS, HDS, SDS, CSV) , IQ, OQ.
8. Barrier System – Grade A or ISO Class 5 environment, Suitable for Laminar Flow, Open RABs or Isolator, VHP compatible
