Aseptic syringe filling isolator system
Ensure product sterility and precision with a cutting-edge solution for aseptic syringe filling, designed to optimize airflow and contamination control, while maintaining stringent environmental parameters for your sensitive processes.
Ensures Sterile Syringe Filling and Decontamination
The Aseptic Syringe Filling Isolator System from Telstar is engineered to enhance sterility in biopharmaceutical and pharmaceutical production, specifically designed for aseptic syringe filling. This system features a multi-chamber design that enables seamless integration into pilot-scale production lines, ensuring sterile conditions with ISO Class 4.8 (grade A) air cleanliness. Equipped with a recirculatory unidirectional airflow system and an independent decontamination chamber, it provides robust contamination control. Ideal for producing sterile injectables, pre-filled syringes, ophthalmic solutions, and pilot-scale sterile batches, it utilizes Integral Telstar ionHP+ bio-decontamination for high purification levels. With automated air temperature and humidity control, it maintains <3% RH, enhancing process consistency. RFID glove testing and viable/non-viable monitoring ensure compliance with stringent GMP standards. The system supports easy integration with existing equipment through its configurable design, facilitating efficient transitions and minimal downtime.
Benefits
- Ensures sterility and product integrity with ISO Class 4.8 cleanliness.
- Enhances operational flexibility with independent decontamination chambers.
- Minimizes contamination risks through advanced airflow management.
- Reduces operational costs with efficient humidity and temperature control.
- Complies with stringent GMP standards for pharmaceutical applications.
- Applications
- Aseptic syringe filling,Pharmaceuticals,Biopharmaceuticals,Hygroscopic products,Pilot scale production,Ophthalmic products
- End products
- Sterile injectables,Hygroscopic pharmaceutical powders,Ophthalmic solutions,Pre-filled syringes,Pilot scale sterile drug batches,Vaccine doses
- Steps before
- Bio-decontamination,Equipment Introduction
- Steps after
- Product Protection,Sterility Testing,Packaging
- Input ingredients
- syringe,aseptic containers,medical solutions,raw pharmaceutical substances
- Output ingredients
- filled syringes,sterile syringe 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
- Sterile Multi-Chamber
- Airflow Type
- Recirculatory Unidirectional
- Pressure Environment
- Positive
- Air Cleanliness
- ISO Class 4.8 (Grade A)
- Bio-decontamination System
- Telstar ionHP+
- Monitoring Equipment
- Viable / Non-viable
- Humidity Control
- <3% RH
- Glove Testing
- RFID Glove Tester
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Batch
- Airflow control
- Recirculatory unidirectional airflow
- Cleaning method
- Bio-decontamination
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Chamber type
- Multi-Chamber (1 x transfer chamber,2 x working main chambers)
- Airflow design
- Recirculatory unidirectional airflow
- Pressure environment
- +ve pressure aseptic process environment
- Air cleanliness
- ISO Class 4.8 (grade A)
- Humidity control
- Temperature and RH system controlling humidity to <3%RH
- Integration
- Filling equipment integrated into the Isolator floor
- Control panel type
- HMI/Touchscreen
- Integration possibilities
- RFID
- Bio-decontamination system
- Telstar ionHP+
- Chamber configuration
- Multi-chamber with transfer chamber
- Airflow system
- Recirculatory unidirectional airflow
- Pressure environment
- +ve pressure aseptic process environment
- Humidity control
- Temperature and RH system controlling humidity to <3%RH