Pharma test PT LT100 vacuum leak tester
The Pharma Test PT-LT100 is an advanced, precise, and high-specification intelligent multistage vacuum leak tester designed for pharmaceutical quality control (QC), packaging process control (IPC), and research and development laboratories (R&D). It can accurately evaluate the seal integrity and minor leaks of blister packs, pouches, vials, and various flexible/semi-rigid packaging in automated testing cycles.
I. Fully compliant with international regulations and standards such as the United States Pharmacopeia (USP) <1146>, ASTM D3078, European Pharmacopoeia (EP), and GMP/GLP, providing standardized and highly repeatable testing solutions for the sealing integrity (CCIT) of pharmaceutical and medical device packaging containers.
II. Equipped with a microprocessor-based digital vacuum control system, it supports an original four-stage vacuum programming mode, which can accurately set multiple stages of vacuum level and holding time, greatly improving the sensitivity and realism of micropore detection.
III. Supports dual detection mechanisms (visual staining method/external balance weighing method) and combines with an intuitive three-color indicator display screen to clearly present the test status in real time, effectively reducing human interpretation errors and improving detection efficiency.
IV. Equipped with multi-level user access control and a built-in integrated thermal printer, it can print complete test data and log reports in real time, ensuring that the test results are highly objective and fully traceable to regulations.
Equipment Introduction
Stepped Vacuum Control: Optimal Solution for USP <1146>
Eliminating false expansion and packaging damage : Traditional single-stage vacuuming can easily cause fragile aluminum foil blister packs to rupture instantly; the PT-LT100 features 4-stage programmable pressurization/depressurization, which can gently and accurately simulate different atmospheric pressure environments and detect the finest pinholes and sealing defects.
Automatic constant pressure maintenance : If there is a slight leak or pressure fluctuation during the test, the system will automatically and dynamically adjust to ensure that a strict vacuum is maintained within the set time.
Dual Detection Mechanism (Combining Qualitative and Quantitative Analysis) :
Objective weighing function : In addition to standard visual observation of dye penetration, it supports linkage with analytical balance, which can accurately measure the weight difference of trace liquid penetration or leakage, eliminate the bias of subjective judgment by the naked eye, and provide data-based test evidence.
Exclusive sample pressure plate : The tank is equipped with a stainless steel porous pressure mesh/plate to prevent the sample from floating to the surface of the dyeing solution and ensure 100% immersion contact.
Intuitive HMI & Visual Traffic-Light Status Alert System (Real-time Test Progress Monitoring) :
Traffic light status indicators : The screen backlight changes randomly with the machine status (green: ready/operating, yellow: waiting for confirmation, red: warning/test abnormality), allowing operators to monitor the test progress remotely and greatly improving laboratory work efficiency.
Highly compliant data integrity and full traceability (ensuring compliance during audits) :
Hierarchical permission protection : Supports up to 32 user accounts and multi-level management permissions to prevent unauthorized modification of test parameters.
Real-time reporting and paperless integration : The built-in thermal printer can instantly generate GMP format reports containing timestamps, operator information, and vacuum curve data; it can also be electronically archived via USB or LIMS interface, fully complying with modern pharmaceutical quality assurance requirements.
Modular Compact Body & Space-Saving Laboratory Design :
Compact one-piece design : The printer is built into the body and does not take up extra laboratory table space; the vacuum chamber and pipeline adopt a quick-connect design, making it extremely convenient to clean and change sample liquids.
Product Features
Supports 4-stage vacuum settings; accurately detects minute leaks.
Supports dual modes of "color visualization" and "balance weighing," with intuitive status display via red, yellow, and green backlighting.
Built-in hierarchical access control, all-in-one printer
Supports LIMS connectivity
Ensures data integrity
Overall Specifications
Product Model : PT-LT100
Manufacturer : Pharma Test, Germany
Version Specification : Version 1.2E
Product positioning and operating principles :
Air tightness and integrity tester specifically designed for pharmaceutical blister packs, aluminum foil strips, sachets, and bottled liquids or granules.
A controlled negative pressure is established within the dryer using a built-in vacuum pump and maintained for a set time; combined with dye penetration or a high-precision balance-based weight difference method, minute pores and sealing defects are detected.
International Pharmacopoeia and regulatory compliance :
Fully compliant with the United States Pharmacopeia General Rules for Drug Packaging Integrity and the regulations of various national pharmacopoeias.
The system structure and materials meet the requirements of Good Laboratory Practice and Good Pharmaceutical Manufacturing Practice.
Vacuum control and test parameters :
Final vacuum range: 100 to 920 millibars (depending on ambient atmospheric pressure)
Active vacuum maintenance function: Supported, automatic pressure replenishment can be enabled in the method to maintain the set vacuum level.
Maximum vacuum duration: 99 hours, 59 minutes, and 59 seconds
Multi-stage vacuum step setting: Up to 4 different vacuum levels can be set using a single method.
Multi-stage holding time setting: Up to 4 independent holding time stages can be set in a single method.
Number of consecutive test cycles: A single method can be set to a maximum of 9 test cycles.
Balance connection and weight difference detection :
Optional external analytical balance connection available for automatic transmission and recording of sample weights before and after testing.
The liquid immersion test automatically compares the increase in weight; the bottled liquid extraction test automatically compares the decrease in weight.
User management and method storage :
The built-in memory can store up to 256 test methods.
Supports up to 32 user accounts and multi-level permission settings.
It has a secure login mechanism with username and password.
Provides a quick, login-free testing function for easy routine spot checks.
Operation and display interface :
The color-changing backlit LCD screen uses green, yellow, and red colors to instantly identify the device's operating status.
Shuttle knob with function shortcut keys for quick menu navigation
Data storage and communication interface :
Built-in integrated thermal printer for instant printing of test data, statistical results, and calibration records.
Equipped with a universal serial number port for the host and device, it supports exporting spreadsheet and text file reports from USB flash drives.
Supports USB flash drive firmware upgrades and factory resets without computer firmware.
Equipped with serial communication ports to support connection to balances, external printers, or laboratory information management systems.
Supports smart network adapters, enabling remote printing and data transmission over local area networks.
Calibration and maintenance functions :
Built-in vacuum level and timer dedicated software guidance and calibration program
Programmable and effective periodic reminder function, automatically performs quick self-test upon startup.
Built-in air intake filter allows for quick filter replacement without disassembling the unit.
Vacuum dryer selection specifications :
Inner diameter 150 mm / Effective inner height 135 mm / Volume 2.15 liters (acrylic material)
Inner diameter 200 mm / Effective inner height 175 mm / Volume 4.35 liters (acrylic material)
250 mm inner diameter / 225 mm effective inner height / 9.20 liters volume (acrylic material)
Inner diameter 380 mm / Effective inner height 283 mm / Volume 18.5 liters (glass)
Aircraft specifications and power :
Body structure: Hairline stainless steel body
Power requirements: 100-240 volts, 50/60 hertz
External dimensions: Approximately 32 × 25 × 31 cm (width × depth × height)
Packaging dimensions: Approximately 61 × 42 × 33 cm (width × depth × height)
Instrument weight: Net weight approximately 7.0 kg, gross weight approximately 13.5 kg
Validation and Certification :
All contact parts fully comply with the requirements of the United States Pharmacopeia and the European Pharmacopeia.
Possesses complete electromagnetic compatibility and safety certifications
Standard configuration includes complete original manufacturer installation and operation verification documentation, conformity certificate, and instrument history logbook.