เครื่องทดสอบ ความสมบูรณ์ของการปิดผนึกบรรจุภัณฑ์ ประเภท Tablet, Capsule โดยใช้เทคโนโลยี Vacuum Decay + Force Decay

Inspection Technologies for Tablets & Capsules Packaging

Non-destructive seal and leak testing equipment for Tablets and capsules in multi-cavity blister packs, sachets, and induction-sealed bottles
OptiPac

Blister packaging is one of the most practical and convenient packaging formats for tablets and capsules. Blister packaging is specifically used for tablets and capsules to pack them in a convenient and controlled way for easy patient use.

Blister packaging is designed for long and tamper-proof shelf life by eliminating moisture ingress and contamination. In today’s drug delivery systems where certain drugs are extremely sensitive to moisture and Oxygen, it is critical to ensure the package integrity of blister packs to ensure that product quality is not compromised.

Vacuum decay is a non-destructive container closure integrity testing (CCIT) method for blister packaging. PTI offers two technologies for integrity testing of multi-cavity blister packaging.
OptiPac One-touch Tool-less Blister Package Leak Testing
Non-destructive package testing of multi-cavity blisters

The OptiPac One-Touch Tool-less Leak Detection System is a deterministic non-destructive technology designed specifically for multi-cavity blister packs. OptiPac utilizes volumetric imaging under vacuum with topographic imaging to detect the presence and location of leaks. The OptiPac is engineered and designed with One-Touch Technology to achieve a rapid test cycle requiring no changeover or sample preparation. Operators simply place the blister package on the test plate and press the START button. Blister packs can also be placed in any orientation or position. Within seconds, the operator sees a definitive pass/fail result, and a visual identification of blister cavity defects. OptiPac technology is unique in that it can provide rapid detection of sub-5-micron defects depending on blister cavity volume. OptiPac requires no tools for different blister formats.
OptiPac Benefits:

    Non-destructive technology - Pass/Fail results backed by quantitative test data
    Completely tool-less
    No changeover to test different blister formats
    Identifies defective cavity
    Pre-loaded recipe library with easy recipe setup and validation of new blister formats

Inspection Criteria

    Leak detection and seal integrity testing of entire package
    Test sensitivity down to 5 microns

 
VeriPac 410 for All Low Headspace Packaging

The VeriPac 410 inspection system offers non-destructive seal and leak detection for blister packs, sachets, and pouches with low headspace (suture packs, transdermal product packaging).

    Applications include blisters, sachets, transdermal patch packaging, suture packs
    Vacuum decay and force decay measurement technology

Multi-cavity blister packs and low-headspace packaging use a variety of test methods to determine package integrity, with most being destructive, subjective, and unreliable.

The VeriPac 410 utilizes a combination of vacuum decay technology and force decay measurement to identify defective packages. Multiple packages can be tested in a single test cycle, and the 410 identifies which package or cavity is defective. Test results are quantitative and provide operators with a definitive pass/fail, eliminating the subjective and destructive nature of current test methods.

Package quality assurance is achieved by deploying accurate, reliable non-destructive inspection methods, removing subjectivity from the testing process while reducing waste. The VeriPac 410 allows the tested product to be returned to the production line and eliminates the significant costs and waste associated with destructive leak test methods.
Benefits

    Non-destructive, non-invasive, no sample preparation
    Accurate and repeatable results
    Test multiple packages in a single test cycle
    Identifies which package is defective
    Simplifies the inspection and validation process
    Supports sustainable packaging initiatives
    ASTM test method and FDA standard
    Cost-effective with a rapid return on investment

Inspection Criteria

    Leak detection and seal integrity testing of the entire package
    Test sensitivity down to 15 microns

VeriPac 400 Series Non-destructive Vacuum Decay Technology for Induction Sealed Bottles

VeriPac systems can be easily integrated into the packaging process to improve quality, reduce waste, and provide operators with a clear understanding of package quality. Evaluate and analyze package integrity with precision and repeatability. VeriPac test systems are non-destructive, non-subjective and require no sample preparation. Test chambers are designed according to the package/container specification.
Benefits

    Deterministic, quantitative test method
    Defect detection down to 0.2 ccm
    Highest level of repeatability and accuracy
    Cost-effective with a rapid return on investment
    Simplifies the inspection and validation process
    Results have proven superior to dye ingress
    ASTM test method and FDA standard
    USP <1207> Compliant

Inspection Criteria

    Measures seal integrity of the entire container or package
    Measures and verifies container closure integrity

 
Helium Leak Testing

Due to the extreme sensitivity provided, a helium-based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach. The test method detects helium that has been sealed in the package system as it escapes through micro-channels in the package. The package is first put in the test fixture, after which a vacuum is swiftly drawn. Helium escapes through potential holes or cracks in the package as a result of the pressure differential.

Any helium gas that escapes from the blister card is quantitatively quantified in the analyzer cell while under vacuum pressure. The typical test cycle time ranges from 20 to 60 seconds. The test chamber is evacuated to the atmosphere when the test cycle is finished and the measurement is recorded so that a new sample can be tested. Each card's helium concentration value is determined using the LDA HSAM helium concentration device, once testing has been completed for all samples in the given set. Since the helium leak rate is normalized to 100% using this procedure, any test samples throughout the production line setup or the package materials in use may be directly compared.