High containment isolator for wet analysis in pharma
Achieve high containment and precise wet analysis with this isolator, designed to protect operators while handling potent compounds like HPAPIs and conducting critical processes such as particle sizing, titration, and decontamination in a controlled environment.
Ensures Safe Containment and Precise Wet Analysis
The Quality Control HPAPI Isolator from Comecer is a cutting-edge solution designed to ensure high containment levels for handling hazardous compounds in pharmaceutical and biotech environments. It operates under negative pressure to safeguard operators while maintaining product integrity through nitrogen blanketing. This isolator is particularly adept at wet analysis and material decontamination, crucial for applications involving cytotoxic drugs, hormone therapy, and biotechnology formulations.
Incorporating advanced features such as lateral hinged doors and oval glove flanges, it integrates analytical scales, ultrasonic stirrers, and titration units, facilitating precise particle size analysis and chemical titration processes. Constructed from materials meeting cGMP standards, the isolator’s sanitary design with rounded corners aids in efficient cleaning and maintenance. The system’s compatibility with continuous and batch operations, along with its PLC-controlled processes, enables seamless integration into existing production lines, providing agile and reliable performance for a variety of pharmaceutical and chemical productions.
Benefits
- Enhances operator safety through high containment and negative pressure operation.
- Improves analytical accuracy for wet analysis with integrated precision instruments.
- Simplifies cleaning and maintenance with its cGMP-compliant sanitary design.
- Facilitates seamless production integration with adaptable batch and continuous operations.
- Ensures reliable processing of potent compounds with robust material decontamination capabilities.
- Applications
- Drug formulations,Fine chemicals,Compounding,Apis,Hpapis,Pharmaceuticals
- End products
- Cytotoxic drugs,Clinical trial drug samples,Potent active pharmaceutical ingredients (hpapis),High-potency steroids,Chemotherapy drug formulations,Antineoplastic agents,Biologic drug formulations,Targeted cancer therapies,Hormone therapy drugs,Immunosuppressive drugs
- Steps before
- Decontamination,Materials preparation
- Steps after
- Data Analysis,Waste management
- Input ingredients
- fine particle size products,raw materials for wet analysis,high-potency active pharmaceutical ingredients (HPAPI)
- Output ingredients
- analyzed samples,decontaminated materials,waste liquids via sanitary drain system
- 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.
- Negative Pressure
- -100 Pa for airlocks / -150 Pa for working chambers
- Oxygen Analyzer
- Integrated
- Glove Flanges Size
- 12” (Oval)
- Material
- Polypropylene
- Drainage System
- Sanitary tank bottom valve activated by footswitch
- Slope of Working Plane
- Towards drain valve
- Lighting
- LED lights
- Utility Connections
- WFI,PW,compressed air,vacuum,nitrogen,power/data cables
- Analytical Equipment
- Analytical scale,touch-screen external display,magnetic stirrer
- Stirring Systems
- Magnetic and ultrasonic stirrers
- Titration Units
- T90 with 3 internal bases,3 external dosing units
- Airlocks
- 1 for materials decontamination
- Analysis Process Chamber
- Wet analysis with analytical scale and titration units
- Conformance
- cGMP standards
- Interior Surface Design
- Rounded corners for smooth surfaces and crevice avoidance
- Containment Liner
- Continuous liner system
- Particle Size Analyzer
- Laser diffraction
- Coulometer
- With internal titration stand/base and external hardware
- Negative Pressure Setting
- Airlocks -100 Pa,Chambers -150 Pa
- Automation Level
- Manual / PLC / SCADA
- Containment Type
- High Containment for HPAPI
- Nitrogen Blanketing
- Yes
- Footswitch for Valve Activation
- Yes
- Integration of Analytical Devices
- Scale,Titration Unit
- Working Plane Sloped
- For Drain Valve Accessibility
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- GMP Compliance
- Yes
- CGMP Standards
- Yes
- ISO Certification
- ISO 9001,ISO 13485,ISO 45001,ISO 14001,ISO 50001
- Chamber shape and size
- Oval glove flanges 12”
- Feed/Discharge method
- Sanitary tank bottom valve activated by footswitch
- Internal surfaces
- Rounded corners,crevice avoiding surfaces
- Working plane slope
- Sloped to drain valve
- Control panel type
- Touch-screen external display
- Integration features
- Analytical scale,magnetic stirrer,ultrasonic stirrer,titration units
- Glove integrity testing
- Speedy Gloves
- Drainage system
- Sanitary tank bottom valve with footswitch
- Working plane
- Sloped to drain valve
- Analytical scale integration
- Yes
- Magnetic stirrer integration
- Yes
- Ultrasonic stirrer integration
- Yes
- Coulometer integration
- Internal titration stand/base
- Titration unit integration
- T90 with 3 internal bases
- Power/data cable connections
- Predisposed
- Utility connections
- WFI,PW,compressed air,vacuum,nitrogen
- Led Lighting
- Integrated