Aseptic ophthalmic filling isolator
Ensure sterility and precision in ophthalmic solutions with a controlled aseptic environment, designed to seamlessly integrate into your filling process while maintaining critical bio-decontamination protocols.
Ensures Aseptic Filling and Sterility
The Single Chamber 4 Glove Aseptic Isolator from Telstar is engineered for pharmaceutical and biotechnology applications requiring stringent aseptic conditions. This isolator features an integrated H2O2 bio-decontamination system, ensuring a contamination-free environment for the production of preservative-free eye drops, sterile APIs, and injectable syringes. The system’s single working chamber, equipped with adjustable height and comprehensive viable and non-viable monitoring, allows precise handling of pharmaceutical processes. Its automation capabilities, reinforced by integrated monitoring, support seamless insertion into existing production lines, optimizing both throughput and sterility assurance. Constructed with corrosion-resistant materials, the isolator meets GMP standards and is designed for ease of cleaning and maintenance, offering long-term reliability and efficiency in sterile manufacturing environments.
Benefits
- Ensures product sterility with integrated H2O2 bio-decontamination.
- Optimizes workspace with height-adjustable chamber design.
- Enhances operational efficiency through automated integrated monitoring.
- Complies with GMP standards, facilitating regulatory acceptance.
- Minimizes contamination risk, supporting high-quality pharmaceutical production.
- Applications
- Syringes,Api (active pharmaceutical ingredients),Vials,Biopharmaceuticals,Ophthalmic solutions,Pharmaceuticals
- End products
- Preservative-free eye drops,Ophthalmic ointments,Pre-filled syringe injectables,Multi-dose vial formulations,Sterile liquid apis,Ophthalmic gels,Lyophilized (freeze-dried) pharmaceutical powders
- Steps before
- Aseptic preparation,H2O2 bio-decontamination,Viable monitoring
- Steps after
- Product unloading,Freeze drying cycle,API weighing and charging
- Input ingredients
- ophthalmic solutions,H2O2 (hydrogen peroxide),raw materials,lyophilized products,hygroscopic substances,API (active pharmaceutical ingredients)
- Output ingredients
- aseptic ophthalmic products,sterilized vials,filled syringes,decontaminated materials,unloaded products
- Market info
- Telstar is known for specializing in the design, engineering, and manufacturing of advanced vacuum and aerospace solutions, gaining a strong reputation for their innovative and customized equipment in pharmaceutical, medical, and scientific research sectors.
- Chamber Type
- Single Chamber
- Number of Gloves
- 4 glove
- Bio-decontamination System
- Integrated H2O2 bio-decontamination system – ionHP+
- Height Adjustment
- Raise lower frame
- Monitoring Type
- Viable monitoring / Non-viable monitoring
- Room Monitoring
- Room H2O2 monitoring
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch
- Cleaning method
- CIP / Manual
- Integrated H2O2 bio-decontamination system
- ionHP+
- Glove testing
- Integrated Glove Tester
- Height adjustment
- Raise lower frame
- Biological compatibility
- Ophthalmic use
- Cleanability
- H2O2 bio-decontamination
- Corrosive resistance (e.g. acids)
- High resistance
- Single Chamber
- Yes
- Number of Gloves
- 4
- Footprint
- Adjustable height with raise-lower frame
- Glove Ports
- 4 glove ports
- Frame Adjustment
- Raise lower frame for height adjustment
- Bio-decontamination System
- Integrated H2O2 bio-decontamination system – ionHP+
- Monitoring Features
- Room H2O2 monitoring,Viable monitoring,Non-viable monitoring