Blogs

Evaluating the ability of the container closure system to provide a sterile barrier and prevent leaks resulting from contamination is a crucial step towards maintaining the safety and suitability of primary packaging. United States Pharmacopeia (USP) and Food and Drug Administration (FDA), the driving forces behind container closure systems in the US, enforce strict regulations for Container Closure Integrity Testing (CCIT).

Traditionally, Dye Ingress and Microbial immersion were two popular methods to evaluate container closure integrity. However, they were probabilistic methods that lacked accuracy and provided subjective test results. In 2016, USP issued guidelines that they preferred deterministic test methods over probabilistic test methods. Examples of deterministic test methods include Vacuum Decay technology, Airborne Ultrasound technology, Helium Leak Detection etc. In this blog, we will discuss the role of VeriPac 355, which is a Vacuum Decay technology in testing container closure integrity.

CCI Testing Using VeriPac 355 Technology

The VeriPac 355 is a non-destructive technology based on the ASTM vacuum decay leak test method (F2338-09) and is recognized by the FDA as a consensus standard for package integrity testing. This micro leak detection system is applicable across a wide range of packaging formats and is specially designed to test containers for gas leaks for dry products (lyophilized vials, powder-filled) as well test for liquid leaks (non-protein based liquid-filled vials, prefilled syringes). The non-destructive nature of the technology allows it to be incorporated into protocols at any point in the handling process. VeriPac 355 technology's capability of detecting leak rates as low as 0.2 cc/min makes it an optimal quantitative test method for many pharmaceutical and food applications.

VeriPac 355 Working Principle

The VeriPac 355 leak tester is connected to a test chamber designed specially to hold the package being tested. Vacuum is then applied to the package inside the test chamber. Using a high-resolution absolute transducer technology, the test chamber is monitored for the level of vacuum as well as the change in vacuum over a predetermined test time. Although the test cycle takes only a few seconds, it produces accurate and non-subjective test results. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or semi-automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control.

Inspection Criteria

• Measures seal integrity of entire container or package
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, prefilled syringes)

Benefits of VeriPac 355 Series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Measures seal integrity of entire container or package
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, prefilled syringes)
• Measures and verifies container closure system integrity
• Defect detection down to 0.2 ccm
• High level of sensitivity, repeatability and accuracy
• Short cycle time provides operator with PASS/FAIL result
• Small footprint and modular portable design
• ASTM test method and FDA standard

Medical device industry is crucial to health care system as they play a vital role in the delivery of many health care services. Over the past few decades, tremendous developments in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging. Although testing package quality of all medical devices is critical, in case of Class III medical devices it amplifies several folds. Class III medical devices are understood as devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and respiratory ventilators. Since these devices are directly placed into human bodies, proper packaging is required to ensure the quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, thereby making it more of a threat to the patient than a treatment. Hence appropriate CCI technologies are needed to ensure standardized packaging quality.

Container Closure Integrity Testing(CCIT) is a leak detection test conducted using a non-destructive package inspection system to ensure sterility and product quality throughout its shelf life. Earlier, probabilistic test methods such as bubble test, dye ingress and manual visual inspection were used to test package quality of medical devices. However, these traditional methods lacked accuracy and provided uncertain and subjective results. In order to overcome the shortcomings of probabilistic methods, industries are now moving towards deterministic methods that assures a higher level of accuracy with quantitative results. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “ There is a huge shift in the industry toward deterministic and quantitative test method. 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.”

Packaging Technologies & Inspection-PTI’s VeriPac Vacuum Decay Technology and Airborne Ultrasound Technology have revolutionized automated CCI Technologies.

Vacuum Decay Technology is a CCI testing method that detects leaks in nonporous, rigid or flexible packages. Such tests are conducted by placing a sample in an evacuation test chamber, drawing vacuum and monitoring vacuum level for any decay, indicating a leak. Such tests are known to provide reliable and quick results. PTI’s VeriPac Vacuum Decay Technology is a non-destructive package inspection system based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing. Its applications include empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. PTI’s PERMA- VAC technology, known to provide consistent and reliable results is the latest development in the VeriPac line of test systems. The VeriPac Universal Blister Verification (UBV) system designed for non-destructive blister package leak detection uses a volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks.

PTI’s Airborne Ultrasound Technology is a non-destructive Seal Integrity Test used to examine seal quality for defects. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. Under this method, high-frequency sound waves are passed through the pouch seal area, causing the reflection of sound waves. Variations of the reflected signal strength are used to reflect defects if any. PTI’s Airborne Ultrasound Technology for 100% Inline inspection of pouch seals has been extremely helpful in verifying final pouch seal quality. Any defect in the pouch seal including voids and delamination, foreign materials and inclusions, incomplete seals and misaligned seals can be detected using a Seal-Sensor scan and are automatically rejected from the production line.

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Both methods are established ASTM test methods: Vacuum Decay ASTM F2338 and Airborne Ultrasound ASTM F3004.These technologies are non-destructive methods and can be chosen depending on the characteristics of the product to be tested.