Sep 2021

Medical Device Package Inspection using Seal-Scan Technology

Medical Device Package Inspection using Seal-Scan Technology

Medical device packaging plays a fundamental role in safeguarding the product and retaining its quality throughout its shelf life. A package containing medical devices should not only reach the hospital defect free, but it also must withstand sitting on a shelf, possibly for years, without breaking down. Therefore, medical device packaging should be in line with international regulations and quality standards. In order to ensure quality of medical device packages, manufacturers reply on package integrity and seal quality test methods. Although the market offers a complete range of inspection techniques, it is important for manufacturers to choose the appropriate one based on packaging material used and sensitivity levels required.

The ideal solution is a non-destructive method for inspecting the physical properties of the seal and a non-subjective analysis to determine the seal quality. PTI’s Airborne Ultrasound technology (ASTM Test Method F3004-13) uses a transmission of high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced.

Package inspection using Seal-Scan technology

PTI's Seal-Scan® is a non-destructive Airborne Ultrasonic technology (ABUS) that inspects and analyzes pouch seals offline. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis. This technology utilizes the ASTM Test Method F3004 for seal quality and integrity evaluation. .Seal-Scan® is a deterministic, quantitative, high-resolution method that inspects pouch seals for defects and seal integrity for consistency. Testing using a Seal-Scan® is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. PTI has designed several configurations of SEAL-SCAN® for both offline inspections to accommodate various package specifications, test sensitivity and package handling requirements.

Technology overview

Under this method, the pouch seal or package material is scanned between two focused ultrasonic sensors. Ultrasonic waves pass through single or multiple layers of bonded materials. Ultrasonic propagation through different mediums causes reflection of sound waves and reduces/eliminates signal strength. Seal Scan technology can detect different types of defects including leaking and non-leaking, process-related and random are detectable. This technology can produce Opto-Acoustic images as well as detailed statistical analysis by either of two scan modes (L-Scan and C-Scan). An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% on-line seal defect detection.

Benefits of Seal Scan Technology

  • Deterministic inspection method producing quantitative results
  • Works for any material and combinations, regardless of color transparency, print, surface finish and porosity
  • Produces high resolution Opto-Acoustic image of seal
  • Characterizes overall quality and uniformity of the seal
package integrity testing, ccit, container closure integrity testing, airborne ultrasound technology
Sep 2021

OptiPac Leak Detection System for Multi-cavity Blister Packaging

OptiPac Leak Detection System for Multi-cavity Blister Packaging

Blister packs are common packaging formats for solid dose drugs in the form of tablets and capsules. Such packages not only preserve the quality of the drug, but also ensure ease of use to the consumer. Blister packages are commonly used by drug manufactures to ensure protection of the product from oxidation, moisture or other atmospheric pollutants which may lead to product degradation.

However, in recent years, the industry has seen a tremendous increase in the number of high-risk medicines, which are more sensitive to environmental condition than other tablets or capsules. This has further increased blister package integrity challenges. Although the number of environmental contaminants that can enter a package depends on leak size, with blister package, even minute leaks can become troublesome. Therefore, Container closure Integrity Testing (CCIT) of blister packs is extremely crucial.

OptiPac inspection system for non-destructive blister package testing

The OptiPac Leak Detection System is a deterministic non-destructive package integrity testing method created specifically for blister packs. Designed and engineered with One-Touch Technology, OptiPac achieves a rapid test cycle without requiring any changeover or sample preparation. This unique technology can provide rapid detection of sub-5-micron defects depending on blister cavity volume. Although OptiPac system uses similar principles applied in a vacuum-based blue dye test, it applies controlled inputs and measured outputs without the hassle and reliability issues of the dye ingress method. OptiPac uses volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks. The interface is practical and simple to setup with new blister package formats, requiring no complex parameter adjustments experienced with other non-destructive blister package inspection systems.

Technology overview

OptiPac utilizes volumetric imaging under vacuum with topographic imaging to detect the presence and location of leaks. The test begins by placing the sample on the testing area for vacuum-based measurement. After pressing the start button, vacuum is pulled to a defined vacuum. The blisters expand under vacuum, and air is drawn out of the blister through any leaks present. In the presence of a leak, the air escapes into the chamber causing a collapsed blister cavity. A volumetric image and measurement reading is taken during the dynamic vacuum test sequence, that determines which blister cavities are defective. A definitive pass/fail result as well as the quantitative measurement associated with each package test is also displayed. PTI's OptiPac systems provide a definitive result based on accurate and measurable quantitative data, reliably detecting leaks down to 5 microns.

OptiPac’s insightful technology offers a suite of advanced functions:

  • Auto configuration for easy recipe setup and validation of new blister formats
  • Auto orientation of blister packs (test blister packs in any position –no specific orientation)
  • Auto calibration is an integrated one-touch function
  • Advanced batch reporting with audit trail including image of blister pack and defect results

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
ccit, container closure integrity testing, blister packaging, optipac leak detection, optipac
Sep 2021

A Quick Rundown on Medical Device Package Inspection Techniques Offered by PTI

A Quick Rundown on Medical Device Package Inspection Techniques Offered by PTI

Package validations for medical devices play a significant role in ensuring safe and effective use of products when they reach the patient. Packaging for these safety-critical products must withstand the rigors of the manufacturing process, storage, and the distribution cycle. Package integrity is crucial to maintaining sterility for medical devices, especially those that are to be used during medical procedures or implanted into patients. This is because even a minute defect in the package can affect sterility of the device and cause health risk to the patient. Given below is a list of non-destructive package inspection techniques that help maintain highest quality standards.

CCI techniques offered by PTI

Vacuum Decay technology

Vacuum Decay is a non-destructive package inspection technique that offers the ability to inspect both the entire body of the package and seals for micro leaks and defects. The technology proven to provide reliable, reproducible, repeatable, and accurate quantitative results, is recognized by the FDA as a consensus standard for container closure integrity testing (CCIT). Vacuum Decay leak test method is an ASTM Test method (ASTM F2338) that was developed using PTI instruments, it is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

Technology overview

Vacuum Decay test method is simple in practice and challenges container integrity based on fundamental physical properties. The samples are placed in a closely fitting test chamber, equipped with external vacuum source. A pre-determined vacuum level is selected depending on test sample and level of sensitivity required. The next step involves evacuating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor change in vacuum level for a specified period. A pressure increase beyond predetermined pass/fail limit indicates container leakage.

Advantages of Vacuum Decay technology:

  • Non-destructive package inspection system
  • Accurate and reliable results
  • Definite pass/fail result based on quantitative test data 
  • Accommodates multiple packaging formats
  • Eliminates destructive, subjective testing methods 
  • Effective in detecting even minute leaks 

Airborne Ultrasound technology

Airborne Ultrasound technology is a non-destructive Container Closure Integrity test used to examine seal quality for defects. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection technique suitable for many materials including Tyvek, paper, foil, film, aluminum and plastic. Airborne Ultrasound technology offers a comprehensive approach to evaluate seal quality even in conditions where a seal has a defect but may not leak.

Technology overview

Under this method, ultrasonic waves are propagated through the package seals as they move along the sensor head. This causes reflections of sound waves. The signal strength is either eliminated or reduced in the presence of any defect/leak. Such variations in signal strength are closely monitored to identify the defects.

Benefits of Airborne Ultrasound technology

  • Non-destructive, non-subjective, no sample preparation
  • Accurate and reliable results
  • Deterministic package inspection technique 
  • Works on multiple packaging formats and materials 
  • Economical cost-effective solution for seal integrity testing
  • Can be applied to 100% inline seal quality testing
medical device package testing, cci, ccit, airborne ultrasound technology, vacuum decay technology, pharma package inspection

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