Blogs CCIT

29
Jul 2021

Why is Seal Integrity Testing of Medical Device Packaging Important

Why Seal Integrity Testing of Medical Device Packaging is Important

For sterile medical devices, seal integrity testing ensures product efficacy, shelf-life stability, and microbial sterility. Common defects that can threaten the integrity of the seal include voids, wrinkles, dust or other random particles. Hence, inspecting seals after they have been formed is important. Earlier, visual inspection or other destructive testing methods were used for seal quality inspection. However, they lacked accuracy and reliability in test results. But technology is changing. Today, the market offers a range of non-destructive inspection techniques that ensure highly sensitive and reliable seal quality inspection. Even then, the suitability depends on the type of packaging and the size of defect that needs to be inspected.

Relevance of Airborne Ultrasound Technology in Seal Quality Inspection

Airborne Ultrasound technology is a non-destructive container closure integrity testing method, capable of examining seal quality for defects. Such tests are mainly conducted to provide enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analyses and is applicable for multiple packaging materials Tyvek, paper, foil, film, aluminium, plastic and poly. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality testing. According to Oliver Stauffer, CEO of PTI-Packaging Technologies & Inspection, “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are.”

Under this technology, ultrasound waves are passed through the package seal which causes reflections of sound waves. The signal strength is reduced or eliminated in the presence of a leak/ defect. Such variations are closely observed to identify the leak. Inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne Ultrasound technology users can identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

Latest improvements in Airborne Ultrasound Technology are in the form of Seal Scan (Offline) and Seal-Sensor. Both these technologies utilize non-contact airborne ultrasonic testing technology. Seal-Scan® technology has been proven in the field by several online and offline units installed. With the advancements in form of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has been proven to be the most effective method for non-destructive seal integrity testing.

Benefits of Airborne Ultrasound technology

  • Deterministic seal quality inspection technique that assures quantitative and reliable results.
  • Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
  • Eliminates subjective manual inspection methods.
  • Non-destructive, non-subjective, no sample preparation
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
Readmore...
container closure integrity testing, airborne ultrasound technology, medical device testing, ccit
133
02
Jul 2021

How has VeriPac Systems Raised Standards for Container Closure Integrity Testing

How has VeriPac Systems Raised Standards for Container Closure Integrity Testing

What is Container Closure Integrity Testing?

Container Closure Integrity Testing can be understood as a leak detection test conducted using non-destructive package inspection systems to ensure product stability throughout its shelf life. CCIT plays a major part in ensuring that the products are free from possible contamination. While there are multiple ways to conduct a CCI test, it can be broadly classified into probabilistic and deterministic test methods. Traditional test methods like bubble test, dye ingress and microbial challenge by immersion come under probabilistic test methods. However, upon realizing that such tests lacked accuracy and reliability, The United States Pharmacopeia released guidelines in 2016 stating that deterministic methods ae preferred over probabilistic test methods. Vacuum Decay technology and Airborne Ultrasound technology are among the most preferred deterministic test methods.

VeriPac Test Systems for Effective CCI Testing

The VeriPac test methods are non-destructive, non-invasive inspection system for CCI and package integrity testing. They utilize the ASTM approved patented vacuum decay leak test method recognized by the FDA as a consensus standard for package integrity testing.

This ASTM method was developed using VeriPac leak test instruments and has proven its capabilities under GMP regulatory guidelines. Applications for VeriPac technology include stability studies, clinical trials, quality assurance testing and statistical process control (SPC). VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats. Leak detection of high-risk applications requires the highest level of test measurement reliability. The VeriPac series have redefined the reliability and accuracy of test measurement systems.

How do Veripac Test systems Operate?

VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. 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 absolute and differential vacuum indicate the presence of leaks and defects within the package. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package, making it an ideal choice for CCI inspection across industries.

Inspection Criteria

  • Seal quality testing of entire container or package
  • Measures and verifies container closure system integrity
  • Tests for gas leaks for dry products (lyophilized vials, powder filled)
  • Tests for liquid leaks (liquid filled vials, pre-filled syringes)
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seal quality inspection, vacuum decay technology, ccit, container closure integrity
269
03
Jun 2021

Vacuum Decay Technology-A Novel Solution for Nutritional Packaging Inspection

Vacuum Decay Technology-A Novel Solution for Nutritional Packaging Inspection

In today's world, with the popularity of health products continuing to rise, manufacturers must ensure products are packed properly. Because of this reason, the universal health-wise regulation has set a fixed standard for nutritional products packaging process. This is for the elimination of defects happening due to innate chemical reactions within the nutritional products. Such defects can expose products to oxygen, moisture or bacteria- compromising its quality and reducing shelf life.

Nutritional products including dairy products and protein powders are mostly shelf stable in nature. The high fat content in dairy products including cream, butter and ghee is prone to deterioration in its storage process, causing auto-oxidative reactions. The defects in the dairy products can be eliminated through proper nutritional packaging inspection only. Similarly, protein-based powders including soy and casein are extensively used as energy sources. Inefficiencies in packaging of such products can have an adverse effect on consumer’s health. Therefore, conducting package integrity testing of nutritional products are vital to eliminate defects in packaging as well as possibility of product contamination.

Vacuum Decay Technology – The Ideal Nutritional Packaging Inspection Solution

Vacuum Decay technology is a deterministic Container Closure Integrity test method for evaluating quality of nutritional product packaging. The non-destructive testing method improves quality of packaging and reduces wastage compared to destructive test methods. Cost-effective non-destructive testing results in higher return on investments and ensures quality of products.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, with an external vacuum source. A single or dual vacuum transducer technology monitors the test chamber over a predetermined test period. The changes occurring in vacuum levels are analyzed to identify leaks and defects within the package. CCIT’s VeriPac series helps in detecting small leaks before it becomes critical in quality abbreviations.

Benefits of Vacuum Decay technology

  • Non-destructive package inspection technology
  • ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines
  • Accurate, reliable and repeatable test results.
  • Pass/fail results backed by quantitative test data.
  • Completely tool-less with no changeover to test different packaging formats.
  • Eliminates the need for destructive, subjective testing methods.
Readmore...
container closure integrity testing methods, vacuum decay technology, package integrity testing, ccit
196

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