Modular dispensing and weighing isolator for pharmaceuticals
Achieve precise dispensing and weighing of high-potency pharmaceutical ingredients while ensuring maximum operator safety and product integrity.
Ensures Safe Dispensing and Weighing of Hazardous Compounds
The MDWI Modular Dispensing and Weighing Isolator from Comecer is engineered for pharmaceutical and biotech companies needing high containment during handling of hazardous compounds. This isolator offers a disciplined approach to dispensing and weighing with its fully PLC-controlled operation, ensuring precise and safe processing of active pharmaceutical ingredients (APIs). It employs a glove box system with OEB5-level containment, ideal for tasks like sampling and manual operations without contamination. Designed to handle cytotoxic drugs, monoclonal antibodies, and vaccines, this isolator ensures compliance with stringent industry standards. Its construction features high-grade stainless steel and optional rapid transfer ports for seamless integration with existing lab systems. Maintenance is simplified with internal washing systems and paperless recording, keeping operations efficient and compliant with GAMP 5 and CFR21 part 11. Customizable configurations and additional upgrades, such as continuous liners and glove leak tests, cater to specific process requirements, making it adaptable to diverse pharmaceutical settings.
Benefits
- Enhances operator safety with OEB5-level containment.
- Reduces human error and labor costs through full PLC automation.
- Ensures product integrity with precise weighing and dispensing under controlled conditions.
- Facilitates compliance with GMP and CFR21 standards.
- Allows flexible process integration with customizable modules and upgrades.
- Applications
- Industrial pharmaceuticals,High active pharmaceutical ingredients (hapis),Biopharmaceuticals,Pharmaceutical compounding,Pharmaceuticals
- End products
- Enzyme replacement therapies,Cytotoxic drugs,Chemotherapy compounds,Vaccines,Monoclonal antibodies,Antibiotics,Hormones
- Steps before
- Material Handling,Formulation Preparation,Raw Material Inspection
- Steps after
- Sterilization,Quality Control,Packaging
- Input ingredients
- High Active Pharmaceutical Ingredients (HAPIs),potentially dangerous products,materials for manual sampling,materials for weighing,materials for dispensing
- Output ingredients
- dispensed pharmaceuticals,weighed pharmaceuticals,handled dangerous products,sample collected products
- 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
- Human Machine Interface (HMI)
- 5.7” 256 color touch screen
- Software Compliance
- GAMP 5 compliant
- Internal Material
- Stainless steel 316L
- External Material
- Stainless steel 304
- Containment Level
- OEB5
- Glove Ports
- 10” oval-shaped
- Glove Material
- Polypropylene,Neoprene
- Cleaning Functionality
- Internal spraygun
- Filter Type
- HEPA filter
- Sampling and Dispensing
- Manual
- Rapid Transfer Ports (RTP)
- Alpha and Beta parts available
- High Containment Valves
- DN100
- Sensor Type
- rH%+T sensor
- Graphic Recorder
- Paperless,CFR21 part 11 compliant
- Glove Leak Test
- Automatic on-board
- Scale and Panel
- Washable
- Automation level
- Fully PLC controlled
- Touchscreen interface
- 5.7” Human Machine Interface (HMI)
- Software compliance
- GAMP 5 compliant
- Containment level
- OEB5
- Manual sampling capability
- Yes
- Weighing and dispensing operations
- High Active Pharmaceutical Ingredients (HAPIs)
- Glove port size
- 10” oval-shaped
- Configuration options
- Multiple glove chamber options
- Internal washing capability
- Spraygun
- RH%+T sensor(s)
- Available
- Paperless graphic recorder
- CFR21 part 11 compliant
- Rapid Transfer Ports (RTP)
- Alpha and beta parts
- High Containment Valves
- DN100
- Cleanability
- Internal washing with spraygun
- Corrosive resistance
- High-grade stainless steel 316L internally
- CFR21 part 11 compliant
- Paperless graphic recorder
- ISO 9001
- Certified Quality System
- ISO 13485
- Certified Quality System
- ISO 45001
- Health and Safety Management System
- ISO 14001
- Environmental Management System
- ISO 50001
- Energetic Management System
- Chamber Configuration
- 1 (4) gloves Chamber and 1 (2) gloves Pre-chamber
- Optional Chamber
- 3 gloves chamber
- Glove Ports
- 10” oval-shaped glove ports
- Material
- Stainless steel 316L internally,304 externally
- Control Panel Type
- 5.7” Human Machine Interface (HMI) 256 color touch screen
- Spraygun
- For internal washing
- Control panel type
- 5.7” HMI 256 color touch screen
- Material of construction
- Stainless steel 316L (internal),304 (external)
- Glove port material
- Polypropylene and Neoprene
- Upgrades available
- Rapid transfer port(s),liner(s),exhaust systems
- Customization potential
- Integration with other equipment case by case
- Chamber configuration
- 1 (4) glove chamber,1 (2) glove pre-chamber,optional (3) gloves chamber
- Glove test system
- Automatic on-board glove leak test
- Containment valves
- High Containment Valves DN100 active/passive
- RTP Types
- Alpha and beta parts with container options
- Platform material
- Tubular sections in stainless steel AISI304