Pharmaceutical isolator system for aseptic production
Ensure aseptic conditions and operator safety with a robust isolation system designed for precise environmental control, accommodating complex pharmaceutical processes from freeze-drying to sterile filling.
Ensures Aseptic Conditions and Personnel Safety
The Isolation System by TRUKING TECHNOLOGY LIMITED is engineered to provide exceptional aseptic conditions for sterile drug production. Utilizing a fully integrated hydrogen peroxide sterilization system, it ensures a sterility assurance level of SAL not greater than 10-6. This system is indispensable for the production of vaccines, injectable antibiotics, freeze-dried pharmaceuticals, and diagnostic reagents, aligning with stringent GMP and ISO standards. Constructed with SUS316L stainless steel, it features ergonomic design principles and comprehensive monitoring systems for temperature, humidity, and differential pressure. The ease of cleaning is facilitated by an optional WIP system for automatic chamber and pipeline maintenance. Customizable RTP valves and vertical rubber stopper cleaning machines can be configured to support specific industrial production needs. Compliant with 21CFR Part11 and certified by the EU CE, this isolation system offers pharmaceutical manufacturers, biopharmaceutical companies, and diagnostic reagent producers a robust solution for maintaining high standards of sterility and operational safety.
Benefits
- Ensures sterile production environments, safeguarding product quality and worker safety.
- Integrates seamlessly with existing systems for streamlined operations.
- Minimizes contamination risk with built-in hydrogen peroxide sterilization.
- Supports compliance with international regulatory standards, simplifying audits.
- Customizable configurations enhance operational flexibility and scalability.
- Applications
- Injectable, Softbag production, Lyophilization production, Diagnostic reagents, Bfs production, Pre-filled syringe production, Ampoule production, Chinese traditional medicine, Oral preparation
- End products
- Vaccines, Pre-filled insulin syringes, Liquid chinese herbal extracts, Softbag iv solutions, Cough syrup, Injectable antibiotics, Diagnostic reagent kits, Freeze-dried pharmaceuticals, Hormone injections, Blow-fill-seal iv solutions, Liquid ampoules
- Steps before
- Purification, Drying, Extraction, Concentration, Reaction, Crystallization
- Steps after
- Sterilization, Aseptic Production, Packing, Inspection, Leak Testing, Cleaning, Drying, Aseptic Transportation
- Input ingredients
- water injection, powder injection, rubber stoppers, sterile powder, pre-filled syringe
- Output ingredients
- aseptic pharmaceutical products
- 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.
- Cleanliness level
- ISO 4.8
- Leak rate
- Pressure attenuation method
- Sterility assurance level
- SAL ≤ 10⁻⁶
- Noise
- ≤ 65 dB
- Illuminance
- ≥ 500 lux
- Differential pressure range
- -80 Pa ~ +80 Pa
- Air speed
- ≥ 0.5 m/s
- Material
- SUS316L stainless steel, 3 mm thick
- Visual window
- 15 mm tempered glass
- Monitoring systems
- Temperature and humidity, differential pressure, air speed, hydrogen peroxide concentration, glove grating, particle and plankton
- Batch vs. continuous operation
- Batch / Inline Continuous
- Cleaning method
- CIP / Manual
- Automation level
- PLC / SCADA
- Energy efficiency
- 0.5–2 kWh/kg moisture
- CIP/SIP
- CIP 121°C / SIP 135°C
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- GMP Compliance
- Meets GMP standards
- ISO
- ISO 10648, ISO 14644
- CE Certification
- EU CE certified
- 21 CFR Part 11
- Complies with 21CFR Part 11
- Pharmacopoeia Compliance
- Meets relevant pharmacopoeia requirements
- Material
- SUS316L stainless steel
- Thickness
- 3 mm
- Visual Window Material
- 15 mm tempered glass
- Cleanliness
- ISO 4.8