Glove Integrity Tester ZHEJIANG TAILIN BIOENGINEERING CO., LTD

Introduction In pharmaceutical production, barrier systems like isolators or RABS are essential for protecting both personnel and products. A critical aspect of these systems is the thorough and regular inspection of glove integrity. The glove integrity tester is the key equipment used to assess the sealing of gloves. GIT-WLAN （Wireless） Applications Pharmaceutical and Biotechnology Aseptic Production GMP Mandatory Requirements: According to EU GMP Annex 1, glove integrity testing must be performed at defined time intervals, and at least at the beginning and at the end of each production batch....

Features Regulatory Compliance Complies with ISO 14644-7 for repeatable, verifiable testing; Meets 21 CFR Part 11 for electronic records and signatures; CE Certified, CNAS Certified RFID technology automatically identifies the glove number and includes it in the test results Temperature Monitoring The high-precision temperature sensor provides an accuracy of ±0.1℃ in detecting temperature differences during testing Calibr ation Cer tificate 浙江泰林医学工程有限公司Zhej i ang Tai l i n Medi cal Engi neer i ng Co. , Lt d 浙江省杭州市富阳区东洲工业功能区江堤路2号 B座Bui l di ng B, No. 2 Ji angdi Road , Dongzhou I ndust r i al Ar...

Current glove integrity testing mainly uses the pressure decay method, but its accuracy is limited by sensitivity and interference, falling short of pharmaceutical standards. Tailin developed a novel leak detection algorithm based on glove deformation and pressure response. Using dual-control experiments and nonlinear regression, the system compares real-time test curves with reference curves, enabling precise detection of 100pm micropore leaks. Algorithmic Curve

The glove integrity management system can simultaneously monitor multiple glove integrity testers online and is capable of integrated online control with the Tailin RTP integrity tester The system automatically generates batch reports from collected data and supports e-signature technology and audit trail functionality. It is fully compliant with GMP requirements for computer system validation and meets the FDA 21 CFR Part 11 regulations regarding electronic data integrity, e-signatures, and audit trails. Electronic signature Supports e-signature; Optional e-signature module Supports online monitoring...

Main Functions_ Visualized testing process O Compact, portable oesign lor easy use O Supports ouick switching ol Lesl poms lor oilTerenL gloves O MicroconLroller-baseo conLrol with color bCD oisplay © BuilL-in air pump, no external compresseo air reouireo O Quick replacement of sLanoaro 18650 battery for exLenoeo operation O Up Lo 8 hours of sLanoby Lime O Wireless connection Lo moniLoring system © RFID Lechnology for auLomaLic glove ID recogniLion O Upper-level control ano ornta acouisition software for easy observation ano operation O Ultra-fast inflation system with airtight connection aoapter,...

© Touchscreen login, user-traceable records O Test results exportable as PDF directly from the device Q Temperature monitoring for more accurate testing Q Internal/external integrity testing, external mode tests both glove and flange seal O Wireless PC connection and data transmission, supports third-party server integration Q RFID technology automatically identifies the glove number and includes it in the test results O Fully automatic monitoring of glove and seal pressure changes O Monitoring system supports multi-level permission groups O Self-developed glove testing management system meeting...

Main Functions In-situ testing, no sleeve/glove removal Compact, portable design for easy use Supports quick switching of test ports for different gloves Microcontroller-based control with color LCD display Built-in air pump, no external compressed air required Replaceable battery, no need to wait for a recharge Up to 8 hours of standby time Wireless connection to monitoring system RFID technology for automatic glove ID recognition Upper-level control and data acquisition software for easy observation and operation Ultra-fast inflation system with airtight connection adapter, compatible with...

Features O Internal/external integrity testing, external mode tests both glove and flange seal O Wireless PC connection and data transmission, supports third-party server integration O RFID technology automatically identifies the glove number and includes it in the test results O Fully automatic monitoring of glove and seal pressure changes O Monitoring system supports multi-level permission groups O Self-developed glove testing management system meeting industry needs O Optional tablet PC for clean room O Unlimited number of glove integrity testers can be monitored simultaneously O Rigorous...

Main Functions_ O In-siLu LesLing, no sleeve/glove removal O Compact, portable oesign for easy use O MicroconLroller-baseo conLrol with color LCD oisplay © Built-in air pump, no external compressed air reouired O Replaceable battery, no need to wait for a recharge O Up Lo 8 hours of sLanoby Lime O Wireless connecLion Lo moniLoring sysLem © RFID Lechnology for auLomaLic glove ID recogniLion O Upper-level control and drvta acouisiUon software for easy observation and operation O Ultra-fast inflation system with airtight connection adapter, compatible with all standard! and custom glove flanges...

O Internal/external integrity testing, external mode tests both glove and flange seal © Wireless PC connection and data transmission, supports third-party server integration O RFID technology automatically identifies the glove number and includes it in the test results O Fully automatic monitoring of glove and seal pressure changes © Monitoring system supports multi-level permission groups © Self-developed glove testing management system meeting industry needs G Optional tablet PC for clean room © Unlimited number of glove integrity testers can be monitored simultaneously © Rigorous data review...