Blogs

27
Jan 2021

How can Helium Leak Detection Technology Ensure Pharmaceutical Package Integrity?

How can Helium Leak Detection Technology Ensure 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 manufacturers. For this reason, drug product manufacturers give at most importance to their quality control procedure as well as package integrity tests.

Packaging plays a vital role in preserving product quality and maintaining a sterile barrier against external damaging force. Even a minute breach in the package can cause moisture, reactive gases, or other harmful substances to enter the product- thus compromising its healing properties. Moreover, a contaminated drug product can cause serious health issues to the user, making it more of a threat than treatment. Given the sensitive nature of pharmaceutical products, ensuring Container Closure Integrity holds high relevance.

Container Closure Integrity testing is a leak detection technique for evaluating the ability of container closure systems in maintaining sterile barrier against external contaminations. Such tests can be broadly classified into Probabilistic and Deterministic test methods. Although Probabilistic test methods like Bubble Tests and Dye Ingress were initially popular, with more technical advances, better, non-destructive methods are now the go-to solutions to insure container integrity. Manufacturers are encouraged to switch to more reliable Deterministic test methods that provide guaranteed quantitative results with precision. In this blog we will be discussing in detail Helium Leak Detection Technology.

What is Helium Leak Detection Technology?

Helium Leak Detection Technology is a Container Closure Integrity test method that is used to find leaks in different types of enclosed or sealed systems. The technique uses helium as a tracer gas and its concentration is measured as it escapes through the leaks. Under this method, the package is helium filled and subjected to vacuum. The amount of helium escaping the package is quantitatively measured and stated as a leak rate. Helium is an ideal choice for package leak testing and container closure integrity testing in particular during container closure development for pharmaceutical products, due its key qualities:

  • It is inert, non-toxic, non-condensable and non-flammable.
  • Being inert, it is safe to use as it will not react with other materials being tested.
  • The atom size of helium is really small therefore it can easily pass through leaks.
  • The instrument noise due to environmental helium is inherently low because of its limited presence in the atmosphere at less than 5ppm and thus gives incredibly accurate reports.
  • Helium is relatively inexpensive and is available in multiple cylinder sizes.

Seal Integrity Monitoring System

The Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system for testing rigid containers including vials, syringes, and cartridges and blister cards. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This quantitative approach allows direct comparison across various packaging materials and forms, production line settings and stability storage conditions, supporting the entire lifecycle.

THE SIMS 1915+. features an oil-free detector and power system that is designed for the needs of the pharmaceutical and medical device industries. In addition, this system will enable you to quantitatively analyze package system at a sensitivity level as low as 1 x 10 -11 mbar-L/s and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at room temperature.

Each SIMS 1915+ Helium Leak Testing instrument manufactured by Leak Detection Associates is custom built to client specific standards and package configurations.

Custom Built to Client Specification SIMS 1915+ Leak Detection System with Add -On Components

  • Helium Leak Detector Module (HLDM): Oil Free, Production version in Console Frame Assembly, with Stainless Steel working surface and Dual Test Port Manifold (allows concurrent use of VTFM & HSAM on HLDM unit).
  • Vacuum Test Fixture Model (VTFM) – custom designed for use in testing of vial container samples
  • Head Space Analyzer Module (HSAM) – Model VM-2 that includes three (3) Puncture Probes (two spares) for determination of Helium Concentration in the headspace of vial containers.
  • Integral Calibration Chamber (w/ Calibrant Gas Flow Meter/Controller) provided for HSAM Calibration and a Universal Holder to be used for various vial diameters.
  • Helium Filling Device specific for vial testing sample prep to enable vials to be filled with helium
Readmore...
helium leak detection technology, helium leak testing, helium leak detector, helium leak detection, pharmaceutical package integrity, helium leak detection solutions
127
20
Jan 2021

Why is Airborne Ultrasound Technology Gaining Popularity in Medical Device Package Testing?

Why is Airborne Ultrasound Technology Gaining Popularity in Medical Device Package Testing

The World Health Organization (WHO) has stated that healthcare associated infections pose the highest risk in the delivery of healthcare services globally. This causes a serious threat to millions of patients worldwide every year. Therefore, ensuring sterility of medical devices is an important way to reduce the risk associated with faulty medical devices in hospitals and other healthcare settings.

Appropriate packaging and packaging materials are crucial to help preserve sterility of medical devices. Conventionally, medical device manufacturers relied on manual visual inspection as a method for assuring quality. However, such methods lacked accuracy and reliability in test results. To overcome the limitations of traditional test methods, manufacturers moved towards deterministic Container Closure Integrity testing methods that ensured quantitative and accurate test results.

PTI’s Airborne Ultrasound technology is a seal quality inspection test method, capable of non-destructively examining seal quality for defects. It is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality testing. 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. 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 are able to identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

PTI has redefined seal integrity testing with its latest improvements in the form of Seal Scan (Offline) and Seal-Sensor. Both these technologies utilize non-contact airborne ultrasonic testing technology. 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, in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

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...
Airborne ultrasound technology, seal quality inspection, seal quality testing, Seal Scan, Container Closure Integrity testing, CCIT
150
19
Jan 2021

Ensuring Integrity of Blister Packages with PTI’s VeriPac UBV Inspection System

Ensuring Integrity of Blister Packages with PTI’s VeriPac UBV Inspection System

Blister packs also known as press through packs are common packaging formats for drugs in the form of tablets and capsules. Such packages not only preserve the quality of the drug, but also ensure ease of use to the consumers. Blister packages are commonly used by drug manufacturers to ensure protection of the product from oxidation, moisture or other atmospheric pollutants which may lead to product degradation.

However, in recent years, the industry has seen a tremendous increase in the number of high-risk medicines, which are more sensitive to environmental condition than other tablets or capsules. This has further increased blister package integrity challenges. Although the amount of environmental contaminants that can enter a package depends on leak size, with blister packages, even minute leaks can become troublesome. Therefore, ensuring blister package integrity is extremely crucial.

Earlier traditional destructive methods such as the dye ingress method was used to test blister packages. But these methods were subjective, probabilistic and lacked accuracy in test results. This encouraged manufacturers to use non-destructive Container Closure Integrity test methods that were accurate and produced quantitative results with measurable result data.

PTI’s VeriPac Universal Blister Verification (UBV) system is a reliable and hassle-free technique to ensure blister package leak detection. These are deterministic non-destructive solutions specifically designed for multi-cavity blister packs. PTI’s VeriPac UBV utilizes volumetric imaging under vacuum to identify the presence and location of leaks.

Under this method, sample packages are placed inside the test chamber. After pressing the start button, vacuum is pulled to a pre-determined level. If any leaks are present, the packages expand under vacuum, and air escapes into the chamber causing blister packages to collapse. Volumetric measurement readings are taken during the vacuum test, that analyzes which blister cavities are defective. It is a rapid test that allows operators to get quantitative measurements associated with each package test in addition to definitive pass or fail results.

The UBV technology offers leak detection down to 10 microns with minimal test time, averaging 10-30 seconds depending on blister cavity volume. Test system requires no tooling changeover or other complex adjustments with simple interface for testing various blister package formats. This technology is specifically useful for tiny blister cavities which are quite difficult to detect using standard vacuum systems due to its low headspace.

Benefits of VeriPac UBV technology:

  • Non-destructive package inspection system
  • Accurate and reliable results
  • Definite pass/fail result based on quantitative test data
  • Accommodates multiple blister packaging formats with no tooling changeover
  • Eliminates destructive, subjective testing methods
  • Effective in detecting even minute leaks
Readmore...
blister package inspection technologies, blister packaging, container closure integrity testing, blister package integrity, blister package leak detection
148

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