Sure Torque’s ST-LAB7 is multi-purpose full automatic force-torque-pressure tester with FDA CFR21 part 11 compliant user management and audit logging. The instrument is optimized for performing test on:

- Syringes and containers with Luer Lock - ISO 80369, ISO 11040 including pressure tests
- Injector pen devices (Needle-based injection systems for medical use – ISO 11608)

Besides this above special tests the ST-LAB7 is capable for standard closure torque and force testing applications too.
Sure Torque’s ST-LAB series has always been the most automatic closure Torque Tester on the market with the ability to handle the most different container and closure types with quick and easy change over.

Key advantages of the ST-LAB:

• Audit log, user accounts (with configurable access permission) and data management in compliance with FDA CFR 21 Part 11
• Multi-purpose all-in-one testing of:
    o Torque
    o Force
    o Pressure and vacuum
• Multi-level access – operator cannot change the setup parameters or the calibration
• Batch-based memory structure (Year/Month/Day/Batch/Result)
• Unlimited memory capacity – all results of the machine’s life-cycle is stored
• Fully automatic for 100% operator independent testing and enhanced user experience
• Quick testing
• Flexible configurable testing parameters
• Instantly indicates in / over / under range with colors
• Direct statistics on test type/sample type (average, sigma, cpk, in/under/over range)
• Quick and easy overchange between formats without any tool

Based on the success of Sure Torque’s ST-LAB6 closure torque tester in the pharma industry, we have developed the LAB7 as a special multi-purpose torque-force-pressure tester.
- ST-LAB7 is optimized for following EN ISO 80369-20 tests
    o Annex F (normative) Resistance to separation from axial load test method
    o Annex G (normative) Resistance to separation from unscrewing test method
    o Annex H (normative) Resistance to overriding test method
    o Annex I (normative) Disconnection by unscrewing test method
- ST-LAB7 is capable to be used as a universal test machine for simpler force and torque test purposes
- With further option ST-LAB7 can be upgraded to perform the following EN ISO 80369-20 tests:
    o Annex B (normative) *Leakage by pressure decay test method
    o Annex C (normative) Falling drop positive-pressure liquid leakage test method
    o Annex D (normative) Subatmospheric-pressure air leakage test method

Industries: pharmaceutical
Application sites: laboratory, production
Use: Luer Lock torque testing (torque, force and pressure), Injector pen testing, general clousre torque testing, force testing

o All-in-one tester for many standardised test methods that would require several different appliances for testing:
   • torque
   • force
   • pressure and vacuum
o 100% operator independent testing
o All movements are fully automatic (not just the rotation, but also the container and closure gripping)
o Quick testing – test speed can be set on a wide range
o 20 different test receipts for the different products
o Many included test modes
o Multi-level access – operator cannot change the setup parameters or the calibration
o Direct statistical analysis and report creating
o Possibility of adding custom test modes anytime (upgrade-file can be sent in email)
o Automatic batch statistic and report generating
o User management with configurable access permission
o FDA CFR 21 Part 11 compliant audit log and user account management
o Batch based testing with unlimited memory capacity (memory for the machine’s entire life-cycle). Results storing structure: Year/Month/Day/Batch.
o Results can be exported in standard Sure Torque or customer specific format for data collection.
o All-in-one data manager software for all data management options (data manager, data logger,
audit log logger)

   TBA