Active pharmaceutical ingredient isolation system
Ensure the aseptic production of pharmaceuticals while protecting personnel from hazardous substances with a versatile isolation system that integrates sterility assurance, leak detection, and explosion-proof capabilities.
Ensures Sterility and Operator Safety
The Pharmaceutical Isolator System from TRUKING Technology ensures aseptic conditions and safeguards operator health during drug production processes. Constructed from robust SUS316L stainless steel, it integrates a comprehensive monitoring suite, including temperature, humidity, and differential pressure systems. Designed for applications like monoclonal antibody and lyophilized vaccine production, it complies with GMP, ISO, and 21 CFR Part 11 standards, guaranteeing reliability and safety. The system features online leak detection and cleaning capabilities, accommodating various process requirements such as RTP/Glove leak detection and nitrogen systems. Certified by EU CE, it also supports explosion-proofing and is adaptable for both pharmaceutical and biotech industries.
Benefits
- Enhances operator safety by containing toxic production substances.
- Ensures product sterility with integrated environmental monitoring systems.
- Saves operational costs with online leak detection and cleaning capabilities.
- Meets stringent international regulations, reducing compliance concerns.
- Customizable features accommodate diverse pharmaceutical production needs.
- Applications
- Active pharmaceutical ingredients,Injectable,Pharmaceutical tablets,Pharmaceutical powder,Oral liquid,Softbag production,Lyophilization production,Biopharmaceuticals,Traditional chinese medicine,Bfs production,Pre-filled syringe production,Ampoule production,Diagnostic reagents
- End products
- Adrenaline ampoules,Traditional herbal extracts,Monoclonal antibodies,Saline soft bags,Reconstituted lyophilized vaccines,Penicillin active ingredient,Covid-19 diagnostic kits,Vitamin d oral liquid,Insulin injectables,Ginseng extract,Aspirin tablets,Paracetamol tablets,Epinephrine pre-filled syringes,Iv glucose lactate solutions
- Steps before
- Extraction,Concentration,Purification,Drying,Preparation System,Bioreactor System,Reaction Tank,Crystallization Tank
- Steps after
- Sterility testing,Secondary Package,Inspection,Leakage Testing,Packing,Tablet Pressing,Coating
- Input ingredients
- liquid preparation,active pharmaceutical ingredient,toxic products,water,raw materials for sterilization
- Output ingredients
- drugs,aseptic drugs,pharmaceutical products,sterile drugs,packaged pharmaceuticals
- 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
- Material thickness
- 3 mm
- Window material
- 15 mm tempered glass
- Cleanliness level
- ISO 4.8
- Leak rate
- Online detection
- Differential pressure range
- -80pa~+80Pa
- Air speed
- ≥0.5m/s
- Noise
- ≤65dB
- Illuminance
- ≥500lux
- Sterility assurance level
- SAL≤10-6
- Automation
- Integrated monitoring system
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Material of construction
- SUS316L stainless steel
- Window material
- 15 mm tempered glass
- Equipment thickness
- 3 mm