GIT- P4 / GIT-XA1 Glove Integrity Testers Presented by: Dynamic - - PowerPoint PPT Presentation

GIT- P4 / GIT-XA1 Glove Integrity Testers

Presented by:

Dynamic Design Pharma, Inc. Mission Viejo, California USA

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

GIT- XA1 - Single glove tester GIT- P4 – Four glove tester

Glove Integrity Testers – GIT-P4 and GIT-XA1

• 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

To test the integrity of gloves and/or sleeves of isolator and RABS systems.

Test Environments

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

System environment - Aseptic

GLOVE UNDER TEST GIT-LCA GLOVE INTEGRITY TESTER GLOVE WHILE IN USE BARRIER ISOLATOR SYSTEM ENVIRONMENT SHOWN IN THE ASEPTIC (NEGATIVE PRESSURE TEST) APPLICATION VACUUM CHAMBER DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Glove tester

System environment - Containment

GAUNTLET UNDER TEST GIT-LCA GLOVE INTEGRITY TESTER BARRIER ISOLATOR SYSTEM ENVIRONMENT SHOWN IN THE CONTAINMENT (POSITIVE PRESSURE TEST) APPLICATION DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Glove tester

Systems Description

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

GIT-P4

 Simultaneous test of four gloves  Stainless Steel Control Console  Maneuvering Handle  Polyurethane Casters  Touchscreen Control Panel  Printer  Size: 500W x 630L x 1000H

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Systems description GIT-XA1

 Single glove test  Stainless Steel Control Console  Table Top design  Touchscreen Control Panel  Printer  Size: 400W x 400L x 250H

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

OIT screens and Printing Functions

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

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

NOTE: GIT-P4 system OIT screen are shown – the GIT-XA1 screens are essentially identical

In-Situ Calibration Typical Screens

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Printing Functions

NOTE: GIT-P4 system printing functions are shown – the GIT-XA1 printing functions are essentially identical

Parameter report

• Date stamp
• Leak Test parameters

Leak Test Report

• Date Stamp
• Active Channel
• Pass/Fail Result
• Cycle Duration
• Pressure at end of test

System Test Report

• Active Channel
• Current Pressure
• Elapsed Time

NOTE: Continuous printing at fixed time interval

Calibration Report

• Date Stamp
• Fixed Offset
• Incremental Offset

Summary of Systems Features and Operation

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

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

Principle of Operation

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

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

• f 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.

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)

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

200 400 600 800 1000 1200 1400 1600 1800 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

Leak Test Deflate Stabilization Pressure build up Leak Test End Cycle Time (Seconds) Parameters Stabilization Pressure = 1500 Pa Starting Pressure = 800 Pa Pass/Fail Pressure = 600Pa Cycle time = approx. 3 minutes Pressure

Leak Test – Diagram (Failing Test)

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

200 400 600 800 1000 1200 1400 1600 1 2 3 4 5 6 7 8 9 1011121314151617181920212223242526272829303132333435363738394041424344454647484950515253545556575859

Cycle Time (Seconds) Stabilization Deflate Leak Test Leak Test End Parameters Stabilization Pressure = 1500 Pa Starting Pressure = 800 Pa Pass/Fail Pressure = 600Pa Cycle time = approx. 3 minutes Pressure build up Pressure

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.

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

NOTE: Both Dynamic Design Pharma glove tester models are available in positive or negative pressure test mode

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.

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

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.

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

Glove Interface - Positive Pressure Testing

CUFF SLEEVE FOR CONTAINMENT APPLICATION (POSITIVE PRESSURE TEST) GLOVE ONLY TEST INTERFACE GLOVE CONNECTIONS PNEUMATIC ISOLATOR WALL GLOVEPORT INTERFACE MOUNT INSIDE OUTSIDE

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Gauntlet Interface - Positive Pressure Testing

FOR CONTAINMENT APPLICATION (POSITIVE PRESSURE TEST) SINGLE PIECE GAUNTLET TEST INTERFACE GAUNTLET UNDER TEST INTERFACE GLOVEPORT ISOLATOR WALL CONNECTIONS PNEUMATIC MOUNT INSIDE OUTSIDE DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Glove Vacuum Chamber - Negative Pressure Testing

VACUUM CHAMBER FOR ASEPTIC APPLICATION (NEGATIVE PRESSURE TEST) GLOVE ONLY TEST INTERFACE CONNECTIONS PNEUMATIC GLOVE SLEEVE CUFF DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Gauntlet Vacuum Chamber – Negative Pressure Testing

CHAMBER VACUUM SINGLE PIECE GAUNTLET INTERFACE FOR ASEPTIC APPLICATIONS (NEGATIVE PRESSURE TEST) UNDER TEST GAUNTLET ISOLATOR WALL ADJUSTMENT VERTICAL HORIZONTAL ADJUSTMENT MANEUVERABLE CART STAINLESS STEEL

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Implementation Notes

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Parameters Selection

Method #1 - Manufacturer Suggested

Set up the system per manufacturer’s recommended parameters

Method # 2 - Empirical Method

• Build a pressure profile at steady conditions and a “good” glove
• Build a pressure profile with the same glove and a connected precision
• rifice (100um diameter)
• From profiles, select a time duration and test pressure values that

yield the desired difference between a “Pass” and a “Fail” pressure values

• Repeat tests a number of times to determine level of confidence of

repeated detection (sigma >3)

• Repeat tests with the same parameters and a “good” glove to

determine the level of confidence of “no false positives” (sigma >3) Note: This procedure is described in detail in the instruction manual.

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Documentation

The following documentation package is supplied with the system

• Instruction manual (operator and maintenance)
• Assembly and control drawing package
• Equipment, Functional and Design Specification document
• Functional Test document (executed)
• Factory Acceptance Test (executed)

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Non-Microbiological Validation Principle

• Obtain a glove known to be leak free (multiple gloves can

be used as well)

• Run a minimum of 5 separate tests with and without the

DDP supplied 100um diameter test orifice connected

• All gloves tested without orifice must pass and use the end

pressure values to calculate the passing level of

• confidence. Must be > 3 sigma
• All gloves tested with orifice connected must fail. Use the

end pressure values to calculate the failing level of

• confidence. Must be > 3 sigma

Note: Microbiological validation may be required by internal regulations

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Comparative Analysis

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

DDP GIT-P4 DDP GIT-XA1 GLT (1) GLT2 (1) Number of gloves 1-4 1 1 1- 4 Test methodology

• Press. Decay
• Press. Decay

Gas Detect

• Press. Decay

Test duration < 3 min. < 3 min > 3 min Unknown Detection sensitivity 100um 100um < 100um (2) 100um Operational flexibility High High Low High External utility req’d (3) No No Nitrogen No Positive Press. Test Yes Yes No Yes Negative Press. Test Yes Yes Yes No Cost Low Low High High (1) GLT and GLT2 glove testers are Getinge La Calhene glove tester (2) Higher leak detection sensitivity may result in excessive false positives (3) Electrical connection required for all models

Comparison Chart – DDP vs. GLC Glove Integrity Tester models

Summary

Clean room friendly, easy to operate and maintain Capable of meeting hole size detection requirements Can be validated using non-microbiological methods Highly cost effective

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA

Thank You

Dynamic Design Pharma

DYNAMIC DESIGN PHARMA, INC. - Mission Viejo, California USA