Negative Pressure Isolators
Superior Protection Through Advanced Containment Technology
Negative pressure isolators represent the gold standard in hazardous drug compounding safety. Unlike traditional Biological Safety Cabinets (BSCs), our containment isolators provide unmatched protection for both pharmacists and the surrounding environment while maintaining perfect aseptic conditions.
Complete USP-800 Compliance in One System
Our negative pressure isolator systems uniquely combine:
- Containment Segregated Compounding Area (C-SCA) functionality
- Containment Primary Engineering Control (C-PEC) requirements
- Compounding Aseptic Containment Isolator (CACI) specifications
This comprehensive approach eliminates the need for separate containment systems, saving valuable pharmacy space while enhancing safety protocols.
XLTC 800: The Ultimate Negative Pressure Isolator Chamber
The XLTC 800 represents our flagship containment isolator system, featuring:
- Multi-Chamber Design: Includes negative pressure staging chamber, processing chamber, and direct compounding area
- Enhanced Protection: Materials transfer through progressive pressure zones
- Complete Isolation: Handling occurs exclusively through gloves and sleeves
- Unidirectional Airflow: Maintains particulate-free environment throughout the isolator chamber
- Integrated Storage: Optional refrigeration for temperature-sensitive medications
Regulatory Compliance Guaranteed
Every negative pressure isolator we manufacture is certified to meet or exceed:
- USP <797> Sterile Compounding Standards
- USP <800> Hazardous Drug Handling Requirements
- NIOSH Guidelines for Hazardous Drug Safety
- CETA Certification Standards
- FDA Aseptic Processing Guidelines
Advanced Safety Features
Our pressure isolators include critical safety enhancements:
- Comprehensive containment alarm system requiring manual acknowledgment
- Continuous negative pressure monitoring
- HEPA filtration for both intake and exhaust
- Documented leak rate <0.05% for maximum containment
Applications for Negative Isolators
AsepticEnclosures negative pressure containment isolators are ideal for:
- Hazardous Drug Compounding: Superior protection for chemotherapy preparations
- Nuclear Pharmacy Operations: Safe handling of radioactive materials
- Specialty Pharmacy Applications: Custom containment isolator configurations
- Research Facilities: Controlled environments for sensitive materials
Customization Options
Our aseptic containment isolator systems can be tailored with:
- Automated picking chambers for robotics integration
- Extended staging areas for improved workflow
- Pass-through chambers for efficient material transfer
- Custom dimensions to fit existing infrastructure
Frequently Asked Questions
What safety features are incorporated into negative pressure isolators?
Negative pressure isolators incorporate safety features such as HEPA or ULPA filters for air filtration, airtight seals to prevent leaks, alarms for pressure changes, and secure glove ports to protect operators from exposure to hazardous substances.
How is airflow controlled and monitored in a negative pressure isolator?
Airflow in a negative pressure isolator is controlled and monitored using specialized HVAC systems that maintain a continuous flow of filtered air into the isolator. This creates a negative pressure environment that prevents contaminants from escaping. Pressure gauges and alarms are used to monitor and ensure consistent airflow.
What materials are typically used to construct negative pressure isolators?
Negative pressure isolators are typically constructed from materials such as stainless steel for durability and chemical resistance, glass or polycarbonate for visibility, and specialized seals and gaskets to ensure airtight conditions.
How do negative pressure isolators help in contamination control?
Negative pressure isolators help in contamination control by maintaining a lower pressure inside the isolator compared to the external environment. This ensures that any contaminants are contained within the isolator, preventing their release into the surrounding area and protecting both the product and personnel.
What are the maintenance and testing requirements for negative pressure isolators?
Maintenance and testing requirements for negative pressure isolators include regular inspection and replacement of filters, calibration of pressure gauges, leak testing to ensure airtight conditions, and routine cleaning and decontamination. Performance tests, such as airflow and particle count tests, should be conducted periodically to ensure optimal operation.
How are negative pressure isolators validated for their intended use?
Negative pressure isolators are validated through a series of tests and qualifications, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). These tests verify that the isolator meets design specifications, operates correctly under all intended conditions, and consistently performs to the required standards.
What are the common challenges associated with using negative pressure isolators?
Common challenges with using negative pressure isolators include maintaining airtight seals, ensuring consistent airflow and pressure levels, managing filter replacements, and conducting thorough cleaning and decontamination. Proper training and regular maintenance are essential to address these challenges effectively.
Can negative pressure isolators be used for handling hazardous materials?
Yes, negative pressure isolators are designed for handling hazardous materials. They provide a controlled environment that prevents the release of harmful substances, protecting both personnel and the surrounding environment from contamination.
