Blogs

11
Dec 2020

What are the Different Seal Quality Inspection Techniques Offered by PTI?

What are the different seal quality inspection techniques offered by PTI

Seal integrity plays a vital role in ensuring the quality of packaging products. Even a minute defect in the seal can initiate a leak, which can compromise the quality of the product and directly affect its shelf life. It can also result in huge financial losses to the manufacturer. That being said, manufacturers give considerable importance to conducting appropriate seal integrity tests to ensure package integrity at every stage of its lifecycle.

Seal integrity testing methods can be classified into two- Destructive testing methods and Non-Destructive testing methods. Since under Destructive methods, the packages may get destroyed, its popularity has steadily declined over the past few decades due to this waste and high cost. “There is a huge shift in the industry towards deterministic and quantitative test methods,” says Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes vacuum decay and airborne ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Seal quality inspection techniques offered by PTI:

Vacuum Decay technology is a non-destructive Container Closure Integrity test method, used for seal quality inspection in nonporous, rigid or flexible packages. With the ability to detect leaks down to the sub-micron level, , Vacuum Decay technology is identified as one of the most practical vacuum-based leak detection methods. Its ability to provide quantitative, reliable and repetitive test results make it ideal solution for seal quality inspection in Pharmaceutical, Medical Device and Food and Nutrition industries.

Under this method, the sample packages are first placed in a close fitting evacuation test chamber that contains an external vacuum source. The vacuum levels and changes in vacuum over a pre-determined time are closely monitored. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in the absolute and differential vacuum indicate the presence of leaks and defects within the package.Over the past few years, Vacuum Decay technology has seen great advancements in the form of PTI’s PERMA-VAC technology and VeriPac FLEX Series.

The next generation PERMA-VAC technology is a single or dual vacuum transducer technology that has made the VeriPac line of test systems the most sensitive vacuum-based leak tests available in the market. It has higher test sensitivity for providing accurate and reliable results and can be applied to rigid and semi-flexible packages alike. PTI’s PERMA-VAC technology ensures the most stable test measurement ever achieved through vacuum decay.

VeriPac FLEX series is an ideal package inspection solution for dry filled pouches and flexible packaging. To accommodate different package formats and test sensitivity requirements, VeriPac FLEX series is available in several configurations with multiple test chamber sizes.

 

2.Airborne Ultrasound technology:

Airborne Ultrasound technology is yet another seal quality inspection technique, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

 

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seal quality inspection, airborne ultrasound technology, vacuum decay technology, container closure integrity testing, ccit, container closure integrity
189
10
Dec 2020

Role of Vacuum Decay Technology in Medical Device Package Inspection

Role of Vacuum Decay technology in medical device package inspection

Apart from validating the functionality and design of medical devices, ensuring package integrity is crucial to make sure that the product reaches the end-user intact. Packaging and delivery formats available for medical devices range from porous flexible packaging to non-porous rigid containers. Each packaging format has a unique set of characteristics and requirements, which necessitates a comprehensive approach while selecting an appropriate inspection technique.

With increasing innovations in packaging formats and materials, packaging challenges have also increased. Among other medical devices, Class III medical devices pose the highest level of risk associated with ensuring package integrity. Such devices sustain or support life and are implanted. Examples of Class III devices include pacemakers, cardiovascular stents, respiratory ventilators and breast implants. Since these devices are directly placed into human bodies, even a minute breach in the packaging can pose significant risk to patient safety. Hence testing container closure integrity (CCI) of medical devices is crucial.

Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating wide range of high-risk package applications. It can be efficiently incorporated into the packaging process to ensure quality, reduce waste and allow operators to have a proper understanding of package integrity. Multiple vacuum supply types along with single or dual high-resolution transducers configuration enables the VeriPac series to provide fast and reliable test results that are quantitative and deterministic. It is an ideal solution for medical device manufacturers to ensure that the product meets regulatory standards. Based on packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

PTI has revolutionized Vacuum Decay technology with the development of next generation PERMA-VAC technology, that offers increased test sensitivity and repeatable results. The technology is capable of detecting leaks in the MALL range for parenteral packaging and can accommodate a variety of flexible and semi-flexible package formats. The advancements in PERMA-VAC technology has made the VeriPac series the most reliable and practical vacuum-based leak test method available today.

Benefits of Vacuum Decay technology:

  • Non-destructive, non-subjective, no sample preparation
  • Capable of detecting defects down to 0.05 ccm
  • Accurate, reliable, repeatable results
  • Supports sustainable packaging and zero waste initiatives
  • FDA recognized standard for package integrity testing
  • ASTM test method F2338
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vacuum decay technology, medical device package inspection, package inspection technologies, Class III medical devices, CCIT
184
09
Dec 2020

Role of MicroCurrent HVLD Technology in Parenteral Product Container Closure Integrity (CCI) Testing

Role of MicroCurrent HVLD Technology in parenteral product container closure integrity (CCI) testing

Ensuring pharmaceutical package integrity has always been a priority for drug product manufacturers. However, over the past few decades, innovations in health care sector have also accelerated pharmaceutical package integrity challenges. Although testing package quality of all healthcare products is important, in the case of parenteral products it is amplified significantly. Parenteral products are defined as injectible products that can be either liquid or powders. Solutions can contain suspensions, emulsions and be proteinaceous in nature. ”. Since these drugs are directly administered into human bodies, ensuring complete integrity of such packages is crucial. Common packaging formats for parenteral products include Liquid-filled containers such as vials, ampoules, syringes, BFS and auto injectors; Lypholized (powder) products are often packaged in vials. Even a minute breach in the package can cause microbial contamination leading to product deterioration. Hence ensuring container closure integrity is a critical process in the life cycle of parenteral products.

What is HVLD Methodology?

High Voltage Leak Detection (HVLD)) is a non-destructive Container Closure Integrity technique used primarily to evaluate closure integrity of parenteral product packaging. HVLD technology makes use of quantitative electrical conductivity measurement principles. This method operates by passing high voltage micro current signals through sample packages. Under the presence of a leak, the electrical resistance of the sample declines, causing an increase in current. Applications of High Voltage Leak Detection Technology include testing of the following package formats:

  • Pre-filled Syringes
  • Ampoules
  • Drug Product Cartridges
  • Liquid Filled Vials
  • Blow-Fill-Seal (BFS) Container

PTI’S MicroCurrent HVLD technology has revolutionized the conventional HVLD method. MicroCurrent HVLD is a non-destructive, non-invasive CCI technique that can be applied to a wide range of liquid filled products including low conductivity sterile water for injection (WFI) and highly proteinaceous drug products within suspensions. PTI’s E-scan HVLD, a highly sensitive CCI testing process uses electrode probes to scan sealed non-conductive containers. Under the presence of a leak, there will be a change in current flow indicating a defect in the container along with its approximate location. This unique technique uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage. An important feature of E-scan HVLD is its ability to easily shift from the laboratory offline to 100% inline testing applications. With the capability to accommodate multiple packaging formats including glass, plastic or poly laminates, it is an ideal solution for parenteral package testing.

Benefits of MicroCurrent HVLD:

  • Deterministic, non-destructive, non-invasive
  • High level of repeatability and accuracy
  • Ideal package integrity solution for parenteral products
  • Low voltage exposure to the product and environment
  • Offline and 100% online inspection at high production speeds
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CCIT, container closure integrity, container closure integrity testing, parenteral product leak testing, MicroCurrent HVLD, CCI testing
192

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