Isolator for weighing and dispensing of micronized substances
Ensure safe and precise handling of highly potent substances with a controlled environment for weighing and dispensing, ideal for maintaining product integrity and operator safety.
Dispenses and Weighs Micronized Pharmaceutical Substances
The Dispensing and Weighing Isolator from Comecer is a vital solution for managing micronized, high-potency pharmaceutical substances. It offers a fully PLC-controlled environment, ensuring precision and safety throughout the dispensing and weighing processes. This isolator features dual chambers for material inlet and dispensing operations, equipped with multi-stage filtration to maintain air purity. Its integrated CIP system, comprising spray balls and guns, facilitates efficient cleaning and drying in place. A continuous liner port aids in the secure transfer of products, while the Hycoflex® system in the main chamber streamlines product removal. Designed for pharmaceutical, biotech, and nuclear medicine applications, it supports compliance with stringent GMP standards. The isolator’s material options and robust monitoring system, including temperature and humidity sensors, ensure operational excellence and product integrity.
Benefits
- Ensures precise handling of high-potency substances, enhancing product safety and quality.
- Minimizes contamination risk with efficient CIP and drying systems.
- Maintains consistent operational conditions with real-time monitoring of temperature and humidity.
- Optimizes workflow with continuous product transfer and integrated removal systems.
- Complies with GMP standards, meeting pharmaceutical industry regulations.
- Applications
- Highly potent substances,Pharmaceutical powders,Micronized progesterone
- End products
- Micronized progesterone capsules,Progestin hormone therapy formulations,Highly potent pharmaceutical tablets
- Steps before
- Micronization,Powder Storage,Material Ingress Filtration
- Steps after
- Drying In Place,Solvent Mixing,Clean-in-Place (CIP),Package Dispensed Product
- Input ingredients
- micronized highly potent substances,progesterone,material for prechamber
- Output ingredients
- dispensed product,large drum with stored product
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Automation
- Fully PLC controlled
- Compliance
- Software GAMP 5 compliant
- Filtration System
- Inlet single stage filtration,outlet filtration
- Cleaning Method
- CIP system with spray balls,spray guns
- Drying Method
- Drying In Place with independent heaters
- Humidty and Temperature Monitoring
- rH+T sensor
- Pressure Control
- Magnahelic Manometers
- Ventilation Control
- Inverter for fan speed control
- Data Recording
- Paperless recorder Eurotherm
- Automation level
- Fully PLC controlled
- Communication interface
- Pass through door for adjoining chamber
- Environmental monitoring
- rH+T sensor for temperature and humidity
- Pressure monitoring
- Magnahelic Manometers
- Ventilation control
- Inverter for fan speed
- Air flow control
- Automatic valves
- CIP/SIP system
- Integrated Spraygun,spray balls,solvent mixing
- Drying system
- Drying In Place with independent heaters
- Data recording
- Paperless recorder Eurotherm
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Hycoflex® system
- Integrated in main chamber
- Communication door
- Pass through door for adjoining chamber
- GAMP Compliance
- GAMP 5
- Control panel type
- Friendly operator interface
- Compact footprint
- Compact design
- Glove flange size
- 190 mm and 270 mm with gloves
- Continuous film port diameter
- 380 mm
- Chamber configuration
- Pre chamber and main chamber
- Discharge method
- Sliding tray and Hycoflex® system
- PLC Controlled
- Fully PLC controlled
- Operator Interface
- Friendly operator interface
- Communication Door
- Sliding Tray Pass through door
- Glove Flanges
- 190 mm and 270 mm glove flanges
- Port Diameter
- Continuous film port Diameter 380 mm
- Ventilation Control
- Inverter for fan speed control
- Air Flow Interception
- Automatic valves