Automatic Leak Tester PLT Series by Chihō Seiki Co., Ltd.
| (Origin | Japan |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | PLT Series |
| Price Range | USD 14,000 – 70,000) |
Overview
The Automatic Leak Tester PLT Series is a family of non-destructive, pressure-based leak detection systems engineered for high-reliability quality assurance in regulated manufacturing environments. Developed by Chihō Seiki Co., Ltd.—a Japanese instrumentation specialist established in 1959—the PLT platform implements differential pressure decay (DPD) and vacuum decay methodologies to quantify minute leakage rates in sealed packages and containers. Unlike subjective visual or immersion-based methods, the PLT Series delivers quantitative, repeatable pass/fail determinations traceable to ISO 15142-1 (leak testing of medical packaging) and ASTM F2338 (standard test method for nondestructive detection of leaks in packages by vacuum decay). The system architecture supports integration into continuous production lines (e.g., PLT-6000 series), standalone inline inspection stations (PLT-6501-02S, PLT-7706-70), and portable benchtop verification (PLT-3221/FR3221 series), enabling consistent leak integrity assessment across R&D, QC, and GMP-compliant production workflows.
Key Features
- Three configurable configurations: automated inline sampling (PLT-6000), fixed-position parallel-motion inspection (PLT-6501-02S & PLT-7706-70), and handheld portable verification (PLT-3221/FR3221)
- Real-time rejection logic with programmable alarm output (audible buzzer + upstream machine stop signal via dry contact interface)
- Automated product handling: verified good units are returned to the production line; defective units are isolated without manual intervention
- Compact footprint design optimized for cleanroom and ISO Class 7–8 environments—PLT-6501-02S: 1100 mm × 775 mm × 1600 mm (W×D×H); PLT-7706-70 (main unit only): 2600 mm × 1200 mm × 1800 mm
- Portable variant operates on standard AC 100 V input and features integrated battery-ready power management for field use in QA labs, receiving inspection areas, or multi-site audits
- Robust mechanical architecture compatible with frequent cleaning protocols required in pharmaceutical and food-grade facilities
Sample Compatibility & Compliance
The PLT Series accommodates a broad range of primary packaging formats common in regulated industries: pillow-packaged goods, tray-and-cup assemblies, rigid plastic bottles, and glass vials (e.g., serum or lyophilized drug containers). All models comply with electromagnetic compatibility (EMC) standards per JIS C 61326-1 and safety requirements under JIS C 61010-1. The system supports validation documentation packages aligned with FDA 21 CFR Part 11 (electronic records/signatures) and EU Annex 11 (computerized systems), including audit trail generation, user access control, and change history logging. Test parameters—including test pressure, dwell time, stabilization delay, and acceptance thresholds—are fully configurable and stored with timestamped metadata to satisfy GLP and GMP data integrity requirements.
Software & Data Management
Each PLT system includes embedded firmware with intuitive touchscreen HMI for setup, calibration, and real-time result visualization. Optional PC-based software enables advanced data export (CSV, PDF), SPC charting (X-bar/R, Cp/Cpk), and integration with MES or LIMS platforms via Modbus TCP or OPC UA. Calibration certificates traceable to NMIJ (National Metrology Institute of Japan) are provided upon installation. All test logs include operator ID, batch/lot number, test sequence ID, environmental conditions (ambient temperature/humidity), and raw pressure decay curves—ensuring full traceability during regulatory inspections.
Applications
- Pharmaceutical: Integrity verification of sterile barrier systems for injectables, ophthalmic solutions, and biologics vials
- Food & Beverage: Seal integrity validation of modified atmosphere packaging (MAP) and retort pouches
- Cosmetics: Detection of micro-leaks in airless dispensers, aluminum tubes, and laminated sachets
- Medical Devices: Pre-sterilization package testing per ISO 11607-2 and AAMI TIR27
- Electronics: Hermeticity screening of moisture-sensitive component trays and ESD-safe clamshells
- Logistics & Distribution: Post-transit leak verification for temperature-controlled shipping containers
FAQ
What leak detection principle does the PLT Series employ?
It utilizes differential pressure decay (DPD) and vacuum decay techniques—measuring minute pressure differentials over defined stabilization and test phases—to quantify leakage rates down to 1 × 10⁻⁶ mbar·L/s, depending on chamber volume and test duration.
Can the PLT-6000 series be integrated into existing PLC-controlled production lines?
Yes—it provides standard digital I/O (24 V DC), RS-485 Modbus RTU, and optional Ethernet/IP support for seamless synchronization with SCADA and factory automation systems.
Is the PLT-3221 suitable for ISO 17025-accredited laboratories?
When operated with documented calibration procedures and traceable reference standards, it meets the technical competence requirements for routine leak verification testing under ISO/IEC 17025:2017 clause 7.7.
Does the system require compressed air or external vacuum sources?
All PLT models incorporate integrated, oil-free diaphragm pumps and precision pressure regulators—no external utility connections are necessary for basic operation.
How often must the system be recalibrated?
Annual calibration is recommended; however, internal self-diagnostics and daily performance qualification (PQ) checks using certified leak standards ensure ongoing measurement confidence between formal calibrations.
