Detecting Gross Leaks in Medical Pouches With ASTM F2096
Manufactured by Burhani Engineering Technology
Company Overview
Burhani Engineering Technology specializes in manufacturing precision package integrity testing solutions for the pharmaceutical and medical device industries. Our systems support regulatory compliance, quality assurance, and process validation with reliable, standards-compliant methods.
Product Introduction
This system is designed to detect gross leaks and seal defects in medical pouches using ASTM F2096 methodology. It provides a standardized, repeatable, and highly sensitive approach for verifying package integrity in sterile medical packaging.
Standard Compliance
The testing process is fully compliant with ASTM F2096 – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test), ensuring results meet international regulatory requirements and quality standards.
Key Applications
The method is ideal for:
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Sterile medical device pouches
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Pharmaceutical packaging requiring leak integrity verification
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Flexible and laminated pouches used in hospitals and laboratories
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Quality control and validation laboratories
Working Principle
Medical pouches are internally pressurized and submerged in a transparent water-filled chamber. Leaks are identified by the formation of visible bubbles escaping from the package, providing immediate visual confirmation of gross leaks or seal failures. This method allows standardized, repeatable detection for quality assurance.
Salient Features
ASTM F2096 compliant gross leak detection
High-visibility transparent chamber for easy observation
Controlled internal pressurization for accurate results
Quick and repeatable test procedure
Manual and semi-automatic operation options
Durable construction suitable for laboratory and production use
Technical Specifications
Test Method: Internal Pressurization Bubble Leak Test
Standard Compliance: ASTM F2096
Chamber Material: Transparent Acrylic / Polycarbonate
Pressure Control: Adjustable and calibrated
Operation Mode: Manual / Semi-Automatic
Compatibility: Flexible and sterile medical pouches
Benefits
Ensures accurate detection of gross leaks and seal failures
Supports regulatory compliance and validation documentation
Enhances product safety and sterility assurance
Reduces risk of product failures and recalls
User-friendly operation suitable for routine quality control
Optional Customization
Burhani Engineering Technology offers optional features including automated pressurization cycles, digital pressure gauges, data recording, custom chamber sizes, and validation-ready configurations.
Industries Served
Medical Device Manufacturing
Pharmaceutical Packaging
Quality Control and Validation Laboratories
After-Sales Support
Complete installation support, operator training, calibration assistance, and dependable after-sales service to ensure consistent, long-term performance.
Manufacturer
Burhani Engineering Technology
+91 9677296252
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