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.

General


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.

Technical Specifications


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

Operating Characteristics


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

Material Compatibility


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

Physical Characteristics


Material
SUS316L stainless steel
Thickness
3 mm
Visual Window Material
15 mm tempered glass
Cleanliness
ISO 4.8