GIT- P4 / GIT-XA1 Glove Integrity Testers Presented by: Dynamic Design Pharma, Inc. Mission Viejo, California USA
GIT- XA1 - Single glove tester GIT- P4 – Four glove tester DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Glove Integrity Testers – GIT-P4 and GIT-XA1 To test the integrity of gloves and/or sleeves of isolator and RABS systems. • Test environments • System description • OIT Screens and Printing Function • Summary of Features • Principle of operation • Interface to the isolator system • Implementation notes • Comparative Analysis DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Test Environments DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
System environment - Aseptic BARRIER ISOLATOR GLOVE UNDER TEST GLOVE WHILE IN USE GIT-LCA VACUUM Glove GLOVE CHAMBER tester INTEGRITY TESTER SYSTEM ENVIRONMENT SHOWN IN THE ASEPTIC (NEGATIVE PRESSURE TEST) APPLICATION DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
System environment - Containment BARRIER ISOLATOR GAUNTLET UNDER TEST Glove GIT-LCA GLOVE tester INTEGRITY TESTER SYSTEM ENVIRONMENT SHOWN IN THE CONTAINMENT (POSITIVE PRESSURE TEST) APPLICATION DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Systems Description DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Systems description GIT-P4 GIT-XA1 Simultaneous test of four gloves Single glove test Stainless Steel Control Console Stainless Steel Control Console Maneuvering Handle Table Top design Polyurethane Casters Touchscreen Control Panel Touchscreen Control Panel Printer Printer Size: 400W x 400L x 250H Size: 500W x 630L x 1000H DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Control Console Rear GIT-P4 and GIT-XA1 Power connection Power cord and winding bracket Pneumatic tubing connections Lock-out key switch ID tag DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
OIT screens and Printing Functions DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Power up screens NOTE: GIT-P4 system OIT screen are shown – the GIT-XA1 screens are essentially identical DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
OIT Screens – Typical Navigation NOTE: GIT-P4 system OIT screen are shown – the GIT-XA1 screens are essentially identical DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
In-Situ Calibration Typical Screens NOTE: GIT-P4 system OIT screen are shown – the GIT-XA1 screens are essentially identical DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Printing Functions Parameter report System Test Report Date stamp Active Channel Leak Test parameters Current Pressure Elapsed Time Leak Test Report NOTE: Continuous printing at fixed time interval Date Stamp Calibration Report Active Channel Pass/Fail Result Date Stamp Cycle Duration Fixed Offset Pressure at end of test Incremental Offset NOTE: GIT-P4 system printing functions are shown – the GIT-XA1 printing functions are essentially identical DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Summary of Systems Features and Operation DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Systems Features - GIT-P4 and GIT-XA1 Programmable parameters Clear Pass/Fail test result feedback to the operator Numeric test result feedback (pressure value at the end of test) Print out of Test Results data Positive or Negative pressure test (capability) Self Test capability for cycle development and on-going maintenance In-Situ Calibration capability Capable of testing just the glove or the glove/sleeve assembly Cost effective Simple operation, validation, training and maintenance DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Operation Sequence - GIT-P4 STEP 1: The operator installs the glove interface to the glove to be tested STEP 2: The operator assures that the appropriate channel is enabled STEP 3: The operator starts the leak test cycle Step 4: At the end of the leak test cycle, the operator reviews the results and initiates printing Step 5: The system prints out the test results and the cycle concludes NOTE: GIT-XA1 operation is identical except for the channel selection function DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Principle of Operation DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Principle of Operation – GIT-P4 and GIT-XA1 systems The system detects a leak in the glove under test by comparing the internal pressure of the glove to a pass/fail pressure threshold level after having been pressurized to a set level and held in a sealed condition for a given time duration. This methodology of leak detection is called pressure decay. DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Phases of the Leak Test Cycle GIT-P4 and GIT-XA1 Systems INFLATE Initial pressurization to set point value STABILIZE Maintain pressure at a set level for a programmed time duration to allow glove material to stretch DEFLATE Allow pressure to drop to the leak test starting pressure level LEAK TEST Close off the opening to glove under test for the programmed time duration and monitor the internal pressure level. LEAK TEST END At the end of the Leak Test phase, the pressure internal to the glove under test is compared to the programmed Pass/Fail pressure level. The system then makes the leak test outcome decision and displays the result on the OIT DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Leak Test – Diagram (Passing Test) 1800 Pressure Parameters Stabilization 1600 Stabilization Pressure = 1500 Pa Starting Pressure = 800 Pa Pass/Fail Pressure = 600Pa 1400 Cycle time = approx. 3 minutes 1200 1000 Deflate Leak Test 800 Pressure build up 600 Leak Test End 400 200 0 0 4 9 14 19 24 29 34 39 44 49 54 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 197 Cycle Time (Seconds) DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Leak Test – Diagram (Failing Test) Pressure 1600 Stabilization Parameters Stabilization Pressure = 1500 Pa 1400 Starting Pressure = 800 Pa Pass/Fail Pressure = 600Pa Cycle time = approx. 3 minutes 1200 1000 Deflate 800 Leak Test Pressure build up 600 Leak Test End 400 200 0 1 2 3 4 5 6 7 8 9 1011121314151617181920212223242526272829303132333435363738394041424344454647484950515253545556575859 Cycle Time (Seconds) DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Positive vs. Negative Pressure Testing Positive Pressure Leak Test - Non-Sterile/Containment Testing Glove/Sleeve is pressurized from outside the isolator In the event of a leak being present in the test item, positive pressure inside test item causes air flow into the isolator system. Negative Pressure Leak Test - Sterile Testing Glove/Sleeve placed under vacuum from outside the isolator In the event of a leak being present in the test item, negative pressure outside the test item causes air flow out of the isolator system. NOTE: Both Dynamic Design Pharma glove tester models are available in positive or negative pressure test mode DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
In-Situ Calibration Concept In-situ calibration applies to the system as a whole. After calibration, the pressure transducer instrument’s output is modified by calibration factors that are automatically calculated during the calibration procedure. Calibration Process The calibration process consists of a step by step sequence that is menu driven by the control system via the system’s OIT. The pressure values measured during the sequence are automatically used in an algorithm that calculates compensating factors for the pressure output of the system’s pressure transducer. DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
System Capability Negative pressure, glove only Hole size detection capability = 100 um (0.004 inches) or larger Parameters to achieve above capability (guideline only) • Pressure Threshold = 1500 pa • Inflate time: less than 10 seconds • Stabilization = 60 seconds • Leak test = 120 seconds (< 30 sec. with pressure trending) Aseptic application => glove tested under negative pressure DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
System Capability Positive pressure, gauntlet Hole size detection capability = 250 um (0.010 inches) or larger Parameters to achieve above capability (guideline only) • Pass/Fail Pressure = 600 pa • Inflate time: 60 seconds (approx.) • Stabilization = 120 seconds • Leak test = 240 seconds Containment application => gauntlet tested under positive pressure DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Interface to the Isolator System DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
Interface to the Isolator Containment Applications (Positive Pressure Testing) 1. Glove Interface 2. Single Piece Gauntlet Interface Aseptic Applications (Negative Pressure Testing) 1. Glove Vacuum Chamber 2. Single Piece Gauntlet Vacuum Chamber DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA
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