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15
Feb 2022

How to Ensure Package Integrity of Medical Devices

How to Ensure Package Integrity of Medical Devices

Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.

Medical device package testing methods offered by PTI

1. Airborne Ultrasound technology

PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.

PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.

2. Vacuum Decay technology

For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

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ccit, vacuum decay, airborne ultrasound, package integrity testing, medical device package testing
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15
Sep 2020

The Importance of Seal Integrity Testing in the Food and Nutrition Industry

Importance of Seal integrity testing

Food and nutrition packaging are much more than attractive containers kept on a retail shelf. Packaging executes multiple functions since it conveys information about the product, educates the consumers, ensures product protection, helps market the product and much more. Therefore, manufacturers of food and nutrition products must keep package quality at the forefront.

Innovations in packaging including the use of flexible packages and shift from plastics to more sustainable materials have accelerated packaging challenges. Hence, ensuring package quality is vital for preventing possible contamination and resultant spoilage of goods. Often, customers may or may not be aware of such contamination, which can cause serious health problems. In case of high-risk individuals such as the elderly or children under 5 years, the consequences may be fatal. Such consequences have a direct impact on company/brand image resulting in product recalls and huge financial losses.

This stresses the importance of implementing appropriate packaging integrity testing solutions in the production line. Among many other techniques available in the market, seal integrity testing is a popular choice for most manufacturers. There are multiple methods of conducting a seal integrity test including destructive and non–destructive test methods. A method applicable in one situation may not be so in other. Manufacturers should choose the appropriate technology depending upon package type, product specifications, defect profile, and testing requirements.

Methods of Seal Integrity Testing

Under destructive testing methods, the sample package may get destroyed and become useless even though the seal passes the test. Demand for such tests has steadily declined due to its inability to detect non-leaking defects. Common test methods under this category include water bath/bubble testing and peel strength test.

To overcome the shortcomings of destructive test methods, non-destructive test methods and technology advancements have been developed. Such methods cause no harm to the package or product and they can be returned to market after testing. 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 methods”. PTI’s VeriPac Vacuum Decay Series and Airborne Ultrasound technology are non-destructive test methods having high applicability in the food and nutrition industry.

PTI’s VeriPac Vacuum Decay technology is a non-destructive package inspection technique, applicable for rigid and flexible packages and with a capability of detecting leaks as small as 10 microns. It has the potential to test different size pouches, stick packs or sachets without any changeover in parts or system settings. VeriPac FLEX Systems, a non-destructive package inspection technique specifically for dry-filled flexible packaging (pouches, stick packs and sachets). The VeriPac FLEX Series are available in several configurations taking into account varied package specifications and test sensitivity requirements.

Pouches are the common form of packaging for many food products like juices, snacks, nuts and coffee. Therefore, ensuring package integrity of such pouches are crucial. PTI’s Airborne Ultrasound technology is a non-destructive seal integrity test that serves as an ultimate solution for pouch seal quality testing, specifically to check that final top seal after filling and sealing the pouch contents. When high frequency sound waves are passed through the pouch seal area, reflections of sound waves are created. Defects are identified by analysing variations of reflected signal strength. It ensures 100% defect detection of pouch seals. PTI’s ultrasound technology can be applied to 100% defect detection of pouch seals as well as for in-depth seal quality testing and analysis.

VeriPac Vacuum Decay technology (F2338) and Airborne Ultrasound technology (F3004) are both ASTM test methods and also FDA consensus standards for package integrity and seal quality inspection. According to the specific nature of the product and package, appropriate testing methods can be selected.

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seal integrity testing, airborne ultrasound technology, seal quality testing, airborne ultrasound, package integrity testing, vacuum decay technology
1291
08
Sep 2020

Airborne Ultrasound Technology-The ultimate choice for Seal Integrity Testing

CCIT - A risk mitigation tool for parenteral products

Seal integrity is the key to ensuring quality of packaging goods. Testing the integrity of package seals helps ensure that packaging provides sufficient product protection. Seal quality test analyses the mechanical strength of the seal thereby securing appropriate material bonding to maintain package quality throughout the product’s shelf life. Any defect in the seal can initiate a leak and will contaminate the product while directly harming its shelf life. With the increasing trend towards flexible packaging, the demand for seal testing has readily grown. Since flexible packaging involves using materials that are sustainable, environment friendly and lower in cost it is essential to ensure that the seals of such package remain intact from the point of manufacture throughout its distribution and use. Seal integrity testing is widely used in different industries including Pharmaceutical, Medical Device, Food & Beverage, Nutrition, Bottles & Containers.

Destructive Vs. Non-Destructive Test Methods

Destructive methods are identified as methods that may damage the product during the assessment and even though the seal passes the test the product becomes useless. Since these tests were incapable of finding non-leaking seal defects, demand for such tests has steadily declined. Traditional test methods like peel strength burst or fish tank bubble come under this category.

Unlike destructive methods, non-destructive test methods are those that do not harm the product and they can be returned to the mark after testing. Reduction in wastage coupled with material cost advantage gives non-destructive methods an edge over destructive methods. 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 methods”. Non-destructive test method can be of the following types:

  • 1. Vacuum decay test
  • 2. Ultrasonic seal test

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.

Ultrasonic seal test is an innovative non-destructive Seal Integrity Test used to examine seal quality for defects. The ultrasonic seal test has wide application and is primarily used to detect any defects in the seal area. PTI uses Airborne Ultrasound technology which is a non-destructive and non-invasive seal quality inspection method. “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. This method is applicable for many materials types such as Tyvek®, paper, foil, film, aluminum, plastic & poly. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals strengths are analyzed

PTI offers two variants of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor. The Airborne Ultrasound testing technology creates a quick analysis of the seal area without tampering with the packaging to identify defects such as incomplete or missing seals, wrinkles, channel defects, and so on. The technology is in high demand due to its applicability across different industries.

Reasons to choose PTI’s Seal Scan and Seal Sensor Method:
  • 1. Provides quantitative results using non-destructive seal quality inspection
  • 2. Accurate and reliable outcome
  • 3. Cost-effective
  • 4. Can be used on materials like Tyvek®, paper, foil, film, aluminum, plastic & poly
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seal integrity testing, airborne ultrasound technology, seal quality testing, airborne ultrasound, seal scan, flexible packaging
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