Sterility testing isolator for aseptic environment
Ensure precise sterility testing and prevent contamination with an isolator that maintains an aseptic environment while seamlessly integrating automated monitoring and leak detection.
Ensures Sterility and Monitors Environmental Conditions
The sterility testing isolator from TRUKING TECHNOLOGY LIMITED is a specialized solution for pharmaceutical and biotech industries, ensuring an aseptic environment during sterility tests. It features a robust SUS316L stainless steel cavity and conforms to stringent ISO and GMP standards. Its integration capability with temperature, humidity, and pressure monitoring systems allows for precise control and documentation. Designed for injectable and API production, it effectively supports applications such as lyophilization and ampoule production. The system supports online leak detection, cleaning, and drying, ensuring minimal downtime. With available configurations for WIP systems and weighing balances, it adapts to diverse operational needs, making it an essential component in high-stakes pharmaceutical environments.
Benefits
- Enhances sterility assurance by preventing microbial contamination in critical processes.
- Integrates seamlessly with existing systems, supporting comprehensive environmental monitoring.
- Streamlines operations with automated cleaning and drying, minimizing manual intervention.
- Ensures regulatory compliance with ISO and GMP standards for pharmaceutical production.
- Adapts to diverse production needs with customizable configurations and online leak detection.
- Applications
- Active pharmaceutical ingredients,Injectable,Solid preparation,Softbag production,Lyophilization production,Traditional chinese medicine,Bfs production,Diagnostic reagent filling,Pre-filled syringe production,Ampoule production,Oral preparation
- End products
- Diagnostic reagent kits for blood tests,Antiplatelet agents,Vaccines,Ampoules for anesthesia,Pre-filled insulin syringes,Active pharmaceutical ingredients (apis) for cardiovascular drugs,Insulin,Traditional chinese medicine capsules,Herbal extracts,Capsules,Iv fluid soft bags,Oral tablets,Bfs saline solutions,Freeze-dried antibiotics
- Steps before
- Extraction,Purification,Separation,Drying
- Steps after
- Sterilization,Sterility Testing,Inspection,Packing
- Input ingredients
- diagnostic reagent,active pharmaceutical ingredient,soft bag,glass bottle,plastic bottle,raw materials for bioreactor,liquid preparation
- Output ingredients
- sterilized pharmaceutical products,lyophilized products,ampoules,vials,pre-filled syringes,solid oral medication,herbal medicine extracts
- Market info
- Truking is known for manufacturing engineered-to-order pharmaceutical equipment, specializing in liquid and solid preparation systems. They have a strong reputation for innovation and quality in the pharmaceutical machinery sector.
- Material
- SUS316L stainless steel
- Visual window material
- 15 mm tempered glass
- Cleanliness
- ISO 4.8
- Leak rate detection
- Online,pressure attenuation method
- Compliance
- ISO 10648,ISO 14644,PDA TR34,21CFR Part11,EU CE certification
- Sterility assurance level (SAL)
- SAL≤10⁻⁶
- Noise Level
- ≤65dB
- Illuminance
- ≥500lux
- Differential pressure range
- -0Pa~+80Pa
- Fissure air speed
- ≥0.5m/s
- Monitoring systems
- Temperature,humidity,differential pressure,air speed,hydrogen peroxide concentration,particle and plankton
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Equipment Material
- SUS316L stainless steel
- Equipment Thickness
- 3 mm
- Visual Window Material
- 15 mm tempered glass
- Control panel type
- Integrated HMI
- Integration possibilities
- Temperature and Humidity Monitoring,Differential Pressure Monitoring,Hydrogen Peroxide Concentration Monitoring
- Monitor system integration
- Particle and Plankton Monitoring System
- Online detection
- Leak Rate (Pressure Attenuation Method)
- Configuration options
- RTP Valve,Waste Bin,Passing Cart,Storage Rack
- Sterility Tester Configuration
- Process Requirement Based
- WIP System Configuration
- Cabin Cleaning,Pipeline Spraying,Drying Online
- Online Weighing Balance Configuration
- System Integrated or Independent