PT-LT100

Vacuum Leak Testing Instrument

PT-LT100

Vacuum Leak Testing Instrument

The PT-LT100 leak tester is used to test for the integrity of packed strips, blisters and small sachets containing tablets, granulates, liquids and so on. The instrument is used to test the quality of the packaging process and to check that the seals enclosing the product are perfectly intact. PT-LT100 is designed to find the smallest holes and imperfections in blister packs and other semi-rigid product packaging. It is fully compliant to the current USP <1146> monograph.

PT-LT100 leak tester

PT-LT100 leak tester

Leak testing is widely applied in the pharmaceutical industry to check strips, blisters and bottles containing tablets, capsules, syrups and similar. It also finds application in the food industry, where it can be effectively used to check the airtightness of sweet packets, ready-to-eat pre-packed foods, confectionery packaging, packs of noodles or sauces. Samples are placed into the desiccator’s housing and the lid is placed in position. The pump starts to produce a vacuum inside the desiccators and the vacuum is held for a pre-set time.

The first thing to observe is that he tested package should keep its shape during this test; otherwise, the sealing is not correct. Secondly, as the package is immersed in a colored dye solution (normally Methylene Blue), the venting of the desiccators will allow any holes to be penetrated by the dye and the contents of the flexible packaging will also be stained with the same coloring material. Similarly small bottles can also be tested. A sheet of paper will absorb any leaking fluid.

Operation Principle

Vacuum Level and Holding Time

Set vacuum level and holding time for your test. Up to four different vacuum levels and corresponding holding times can be programmed in a method. This way a product can be tested in a sequence of different vacuum levels, each with their own holding time. The instrument can be set to actively maintain the current vacuum level during the holding time. Besides visual inspection of the sample after test, it also optionally possible to connect a balance to the instrument. This way the sample can be weighed before and after the test.

Testing with Liquids

If the test is performed by immersing the sample in a liquid, the sample weight will increase in case it absorbs liquid through leaks.

If the sample is a container with liquid inside, the sample weight will decrease in case liquid is sucked out of the container through leaks.

User Interface with Click Wheel Navigation

PT-LT100 is operated by using a click wheel to navigate menus on the LCD screen and by functional keys to shortcut frequent operations. The display is backlit in changing colors that show the instrument status in a familiar traffic light system (green, yellow, red). Navigating the menu is quick and simple. The color-changing display makes it easy for the user to see when his input is required to proceed.

Method and User Management System

The instrument has a method and a user management system. Methods can be programmed, edited and stored directly on the instrument. Users can be created and assigned different user levels according to their roles (method or standard user, only one Admin). Access to the instrument is protected by a login with username and password.

Quick Test

Optionally a quick test menu can be accessed without logging in to the instrument first. This way tests can be performed with the instrument in case user access control and testing according to defined methods is not required.

Integrated Report Printer

PT-LT100 features an integrated report printer to document the test and calibration results. An integrated printer saves valuable bench space in your laboratory.

Data Storage and Export

A USB flash drive can be connected to the instrument to save and load methods in .csv-format. Printouts can be stored as text files. Results can be transmitted to external systems such as LIMS via a serial interface. Furthermore, instrument firmware updates can be installed, and factory settings be restored by using the flash drive without the need for any PC or programming tool.

Cleaning and Maintenance

The integrated vacuum pump can be calibrated using an external vacuum meter. The air sucked in by the vacuum pump passed through a filter. The filter can be replaced easily without opening the instrument.

Calibration

PT-LT100 features dedicated calibration programs for vacuum and timer function. The result can be documented by a print-out. The user is guided through each step of the calibration and a report is printed automatically.

The reports are saved on the instrument and can be printed later as well. A programmable qualification interval timer reminds the user to perform the instrument calibration once it is due. Each time the instrument is turned on it performs a quick self-check to ensure it is ready for operation. The result of the self-check can be documented via the integrated printer as well.

Available Desiccators

Desiccators with the following dimensions are available:

One desiccator is required to use the instrument.

Part No. Inner Diameter Useable Inner Height Volume Material
26-02010 150mm 135mm 2,15l Plastic
26-02030 200mm 175mm 4,35l Plastic
26-02020 250mm 225mm 9,20l Plastic
26-02040 380mm 283mm 18,5l Glass

PT-Node Network Adapter for Printing and Data Transfer

PT-Node is an adapter that connects up to two Pharma Test instruments simultaneously to a network using a wired LAN connection. This way you can print test results from the instrument via your web browser on any local or network printer. Furthermore, it is possible to transfer the test results from the instruments to external systems in the same network. PT-Node supports PT-LT100.

Features

  • Fully USP <1146> compliant
  • Test the integrity of strips, blisters, bottles and similar
  • User management system
  • Method management system
  • Integrated calibration programs
  • Connect USB flash drive to copy methods and store test reports
  • Integrated protocol printer

Advantages

  • Ensure the quality of your packaging process, save costs by detecting leaks early
  • Option to use an external balance instead of visual inspection
  • Graphical LCD screen showing actual and target settings
  • Integrated protocol printer reduces bench space requirements
  • Password protected access through user management system
  • Programmable qualification interval timer reminds the user to perform instrument calibration
  • Dedicated calibration programs and reports
  • Copy methods between instruments by using a common USB flash drive
  • Export test reports as text files
  • Transmit test result to external systems such as LIMS
  • IQ/OQ documents included free of charge

Technical Specifications

Parameter Specification
Final vacuum level -100 to 900mbar (desiccators ≥300mm)

-100 to 950mbar (desiccators ≤250mm)

Maintain vacuum level Yes, adjustable in method
Maximum vacuum hold time 99 hrs. 59 min. 59 sec.
Number of vacuum levels Up to 4 vacuum levels per test
Number of vacuum hold times Up to 4 vacuum hold times per test
Number of test runs Up to 9 runs per test run adjustable in method
Method management Up to 256 test descriptions (methods) can be stored on the instrument
User management Up to 32 users with selectable user right levels can be stored on the instrument
Result data storage Store copies of result reports by connecting a USB flash drive
Display LCD with color-changing backlight
Data entry Keypad with function keys and click wheel
Interfaces USB type A host port to USB type B device port to connect flash drives, for serial data export and firmware updates

RS-232 printer port for optional balance or external printer

Instrument housing Brushed stainless-steel housing
Power 100-240 Volt, 50/60 Hz
Instrument dimensions Approx. 32 cm x 25 cm x 31 cm (width x depth x height)
Packaging dimensions Approx. 61 cm x 42 cm x 33 cm (width x depth x height)
Net /gross weight Approx. 7,0 / 13,5 kg
Certification All components certified to USP / EP requirements
CE / EMC certification All CE / EMC Certification provided
Validation All IQ & OQ documents included
We reserve the right to make technical changes without any prior notice.

Standard Scope of Supply

PT-LT100 comes ready to use with the following standard scope of supply:

  • PT-LT100 instrument with integrated vacuum pump
  • Comprehensive documentation included (PDF, hardcopies optional):
    • User manual
    • DQ/QC instrument compliance test certificate
    • IQ documentation
    • OQ documentation
    • Instrument logbook

Options

In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including:

  • PT-Node network adapter
  • Alternative external ticket printer (part no. 29-02200)
  • Recommended spare part set
  • Full range of certified validation tools available

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PT-Node

PT-Node

Network Adapter for Printing and Data Transfer

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