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
41
23
Jul 2021

CCIT for Pharmaceutical Package Integrity

CCIT for Pharmaceutical Package Integrity

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufactures. For this reason, drug product manufacturers give at most importance to their quality control procedures as well as package integrity tests. All packaging forms, whether pouches constructed of porous or nonporous material, rigid thermoformed trays with Tyvek or film lids, bottles with induction-welded seals, or blister packs, need verification that their sterile-barrier characteristics are not compromised. Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasized the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI).

Relevance of CCIT in pharmaceutical package testing

Container Closure Integrity Testing is an assay to evaluate whether container closure systems can maintain sterile barriers against potential damage. Even a minute defect in the container can cause external elements to enter the product, thereby reducing its shelf life. Common threats that can pass through a defected container closure system include microorganisms, reactive gases, and other substances. Considering the ability of such threat to deteriorate product quality, undertaking appropriate CCI tests are beyond crucial. However, it should be noted that CCI is not a one-time process, rather an integral and comprehensive approach. It is evaluated throughout the manufacturing lifecycle of a sterile drug product -from primary package development until the products are dispatched.

Container closure systems are made up of primary packaging components and secondary packaging components. Components like vials or syringes that are in direct contact with the product are called primary packaging components. Although there are multiple CCI techniques available in the market today, regulatory guidelines have broadly classified methods into probabilistic and deterministic test methods. Under a probabilistic test method, results are generated through a series of events, each with a respective probability distribution. Thus, the accuracy of the results cannot be assured. In contrast to a probabilistic method, deterministic test methods assure quantitative results with higher level of accuracy and reliability. The United States Pharmacopeia in 2016 issued new guidelines stating that deterministic methods are preferred over probabilistic test methods. Container closure integrity testing can be performed in many different ways. All the testing methods have pros and cons. Given below is a list of non-destructive Container Closure Integrity test methods:

  • Airborne Ultrasound technology
  • Vacuum Decay technology
  • Microcurrent HVLD technology
  • Helium Leak Detection
  • Pressure Decay leak testing
  • Force Decay leak testing
Readmore...
pharmaceutical package testing, container closure integrity testing, Vacuum Decay Technology, Airborne Ultrasound technology
46
02
Jun 2021

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Talking about medical devices, ensuring seal quality or seal strength of sterile medical device packaging are extremely crucial as well as highly regulated. Medical device package seal contains a flexible barrier which is joined to the rigid container through an advanced adhesive. A defect in the seal such as an incomplete or weak seal can initiate leaks, contaminating the product and reducing its shelf life. Hence, for quality control purposes, seal quality inspection of medical device packages is mandatory.

Historically, manual inspection was the most popular method used to inspect seal defects. Although this is covered by an ASTM method (ASTM F1886), it lacked accuracy and reliability in terms of test results. “There is a huge shift in the industry towards deterministic and quantitative test methods,” comments 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.”

Airborne Ultrasound technology is a non-destructive seal integrity test method capable of advanced seal quality inspection of pouches and flexible packaging. Seal defects can be of two types- leak defects and non- leak defects. While it is easier to detect a leak defect, detecting non-leak defects can be a challenge for manufacturers. However, Airborne Ultrasound technology allows non-destructive Container Closure Integrity testing of multiple seal defects including visible and invisible, leaking and non-leaking, process-related and random- making it a practical solution for medical device seal quality inspection.

Technology overview

Airborne Ultrasound technology 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. In the presence of a leak, the signal strength is either eliminated or reduced. Such variations in signal strength are analyzed to identify the defects. Seal scan testing is a practical solution to recognize defects, such as inconsistent seals or areas of seals that fail to meet minimum width requirement. Seal-Scan® and Seal-Sensor utilize non-contact airborne ultrasonic testing technology for advanced seal quality inspection. Seal-Scan® technology has been proven in the field by several online and offline units installed.

Benefits of Airborne Ultrasound technology

  • Deterministic seal quality inspection method that produces quantitative results.
  • This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.  
  • Non-destructive and non-subjective test method that requires no sample preparation.
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable, reproducible and reliable results for seal quality inspection.
  • Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal. 
Readmore...
container closure integrity testing, seal integrity testing, seal quality inspection, airborne ultrasound technology
248

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