Equipment for Sterile Barrier System Validation
Manufactured by Burhani Engineering Technology
Company Overview
Burhani Engineering Technology is a leading manufacturer of precision package integrity testing equipment for medical devices, pharmaceutical products, and sterile packaging industries. Our solutions ensure compliance with global standards and provide reliable validation of sterile barrier systems.
Product Introduction
The Equipment for Sterile Barrier System Validation is designed to evaluate and verify the integrity of sterile packaging systems, ensuring that medical devices and pharmaceutical products remain sterile throughout their shelf life. The system supports rigorous quality control, regulatory compliance, and validation protocols.
Standard Compliance
This equipment adheres to internationally recognized standards for sterile barrier system validation, including ASTM F2096 and ISO 11607, providing confidence in packaging integrity and sterility assurance.
Key Applications
The system is suitable for:
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Sterile medical device pouches, trays, and blisters
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Pharmaceutical packaging requiring sterility assurance
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Flexible and laminated sterile barrier systems
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Quality control and validation laboratories
Working Principle
The system evaluates sterile barriers using controlled pressurization, vacuum decay, and bubble emission or dye penetration tests. Leaks or defects in the barrier system are identified through visual inspection or digital measurement, ensuring compliance with sterility requirements. The process allows standardized, repeatable validation of sterile packaging systems.
Salient Features
Comprehensive sterile barrier system testing
ASTM F2096 and ISO 11607 compliant
Vacuum decay, bubble emission, and dye penetration methods
High-visibility test chambers for visual detection
Adjustable pressure and vacuum controls for accurate testing
Manual and semi-automatic operation options
Industrial-grade construction suitable for laboratory and production use
Technical Specifications
Test Methods: Bubble Emission, Vacuum Decay, Dye Penetration
Standard Compliance: ASTM F2096, ISO 11607
Chamber Material: Transparent Acrylic / Polycarbonate
Pressure/Vacuum Control: Adjustable and calibrated
Operation Mode: Manual / Semi-Automatic
Compatibility: Flexible, laminated, and rigid sterile packaging
Benefits
Ensures sterile barrier integrity for medical and pharmaceutical products
Supports regulatory compliance and validation documentation
Reduces risk of contamination and product recalls
Provides reliable and repeatable results for quality assurance
User-friendly design for routine testing in QC and validation labs
Optional Customization
Burhani Engineering Technology provides optional features including digital monitoring, automated test cycles, data logging, custom chamber sizes, and validation-ready configurations tailored to specific sterile barrier systems.
Industries Served
Medical Device Manufacturing
Pharmaceutical Packaging
Quality Control and Validation Laboratories
Sterile Barrier System Manufacturers
After-Sales Support
Complete installation, operator training, calibration assistance, and responsive after-sales service to ensure consistent long-term reliability and performance.
Manufacturer
Burhani Engineering Technology
+91 9677296252
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