Autoclave unloading isolator for sterile assembly
Ensure aseptic conditions and prevent microbial contamination during the transfer of sterilized items from autoclaves in high-speed pharmaceutical operations.
Maintains Sterility During Autoclave Unloading
The Autoclave Unloading Isolator from TRUKING TECHNOLOGY LIMITED is an essential piece of equipment for pharmaceutical manufacturers, ensuring that sterilized items are transferred without contamination. It features a robust SUS316L stainless steel cavity, equipped with 15 mm tempered glass windows for clear visibility. This isolator integrates advanced monitoring systems for temperature, humidity, differential pressure, air speed, and hydrogen peroxide concentration, maintaining an aseptic environment crucial for injectable, oral preparations and diagnostic reagent production.
With its ability to detect leak rates online via the pressure attenuation method, it adheres to ISO 10648, ISO 14644, and PDA TR34 standards. Designed to meet GMP, ISO, and pharmacopoeia compliance, and certified by the EU CE, this isolator supports the stringent requirements of sterile pharmaceutical processing. Hydraulic interlocks and RTP valves ensure contamination-free operations. The system offers consultation for customization to fit specific process needs, reinforcing operational efficiency within the pharmaceutical, biopharma, and traditional Chinese medicine industries.
Benefits
- Ensures contamination-free transfer, preserving product integrity in sterile manufacturing environments.
- Enhances regulatory compliance with full adherence to GMP and ISO standards.
- Improves operational efficiency by seamlessly integrating with sterilization processes.
- Offers precise environmental control with integrated monitoring systems.
- Supports customizable configurations to meet specific process requirements.
- Applications
- Liquid formulations,Injectable,Pharmaceutical tablets,Oral preparations,Softbag production,Biopharmaceuticals,Traditional chinese medicine,Diagnostic reagents
- End products
- Vaccines,Insulin,Antiviral syrups,Antibiotics,Painkillers,Cough syrups,Chinese herbal tablets,Soft gel capsules,Diagnostic test kits,Nutritional supplements,Herbal extracts,Eye drops
- Steps before
- Sterilization,Autoclaving,Preparation,Bioengineering,Extraction,Purification
- Steps after
- Packing,Inspection,Testing,Storage,Distribution,Warehouse Management
- Input ingredients
- sterilized articles,liquid preparation,active pharmaceutical ingredients
- Output ingredients
- aseptic environment,sterility assurance,microbial contamination prevention
- 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 thickness
- 15 mm tempered glass
- Cleanliness level
- ISO 4.8
- Leak rate detection
- Pressure attenuation method
- Compliance
- ISO 10648,ISO 14644,PDA TR34
- Noise level
- ≤65dB
- Illuminance
- ≥500lux
- Differential pressure range
- -0pa~+80Pa
- Air speed
- ≥0.5m/s
- Sterility assurance level (SAL)
- ≤10^-6
- Compliance with GMP,ISPE,Pharmacopoeia
- Yes
- EU CE certification
- Yes
- Temperature and humidity monitoring
- Integrated system
- Hydrogen peroxide concentration monitoring
- Integrated system
- Automation
- Integrated monitoring systems
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- Cleaning method
- CIP / Manual
- CIP/SIP
- CIP 121°C / SIP 135°C
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Corrosion resistance
- SUS316L stainless steel
- Cleanability
- ISO 4.8 cleanliness
- Biological compatibility
- Pharmacopoeia compliance
- Hydrogen peroxide resistance
- Conforming isolator materials
- Leak detection
- Pressure attenuation method
- Material
- SUS316L stainless steel
- Cavity Thickness
- 3 mm
- Visual Window Thickness
- 15 mm tempered glass
- Visual window material
- 15 mm tempered glass