Vacuum Sterile Pouch Leak Testing Equipment & Medical Device Package Tester

Zero-Tolerance for Leaks The Sterile pouch leak testing equipment and medical device package tester Manufactured by Burhani Engineering Technology is designed for the most critical of applications: the sterile barrier system. In the medical field, a package leak is not just a quality issue; it is a safety hazard that can lead to patient infection. Burhani's equipment is engineered to detect even the most minute breaches in Tyvek® pouches and medical-grade films. Technical Precision for Medical Compliance Medical device packaging must comply with ISO 11607 standards. Burhani's equipment supports this by providing: High-Sensitivity Vacuum Gauges: To detect micro-pores in seals. Controlled Inflation Systems: For ASTM F2096 "Internal Pressure" bubble testing. Cleanroom Compatibility: Constructed with materials that meet cleanroom hygiene standards. Validation Documentation: We provide IQ/OQ/PQ documentation to assist in the validation of your sterile barrier system. Protecting the Sterile Field Whether it is a surgical kit or an implantable device, the packaging must remain intact throughout shipping and storage. The medical device package tester Manufactured by Burhani Engineering Technology simulates these stresses. It identifies seal creep, punctures, and fractures, ensuring that the sterile barrier remains uncompromised until the moment it is opened in the operating room. Partnering with Burhani Burhani Engineering Technology is a trusted supplier to medical device manufacturers globally. We understand the regulatory landscape and provide the Sterile pouch leak testing equipment necessary to navigate it. Our machines are built for accuracy, providing the peace of mind that every sterile pouch leaving your facility is perfectly sealed.