Blogs CCIT

16
Nov 2022

A Complete Guide to Helium Leak Detection Technology

A Complete Guide to Helium Leak Detection Technology

The quality of the product and the maintenance of the sterile barrier against outside forces are both critically dependent on the packaging. Even a tiny hole in the packaging might allow moisture, reactive gases, or other dangerous elements to enter the product, limiting its ability to heal. Additionally, a contaminated pharmaceutical product can cause serious health issues to the user, making it more of a threat than a treatment. Maintaining Container Closure Integrity is extremely important due to the sensitive nature of pharmaceutical products.

Container Closure Integrity testing is a leak detection technique for determining how well sterile barriers are maintained against external contamination. These tests may be roughly divided into probabilistic and deterministic test methods. Manufacturers choose deterministic test procedures since they provide precise, guaranteed quantitative results. One such test method is helium leak detection technology.

Helium Leak Detection Technology Overview /h2>

Helium leak testing is the method of identifying leaks in various enclosed or sealed systems by utilizing helium as a "tracer" gas and measuring the concentration of the gas as it leaves due result of a leak. A vial is a good example of package system. A pre-filled syringe, a foil pouch, and a cold form blister card are some other examples. Each of these package types is intended to keep the pharmaceutical product contained while preventing the entry of potentially dangerous environmental contaminants like dust, bacteria, or even gases. Helium leak testing method can evaluate these package types. It is a highly efficient approach for finding leaks that provide quantitative leak rate data considerably beyond the capabilities of existing leak testing techniques.

The following describes how helium leak detection works: The package is initially vacuumed and helium-filled. The amount of helium escaping the package is then measured quantitatively and expressed as a leak rate using a helium leak detector. The technique is also ideally suited for packaging line setup and validation, failure analysis, tool qualification, monitoring product quality, and package design.

Why Use Helium as a Tracer Gas?

There are several reasons why helium is considered an ideal test gas for finding leaks.
  • Deterministic seal quality inspection method that produces quantitative outcomes.
  • Regardless of color, transparency, print, surface polish, or porosity, this method works for all material types and combinations.
  • Non-destructive and non-subjective test technique that does not require any sample preparation.
  • Technology may be used for 100% online final pouch seal defect detection.
  • Seal quality inspection results are repeatable, reproducible and reliable.
  • Cost-effective solution for testing seal integrity and seal analysis that characterizes the overall quality and uniformity of the seal.

Helium Leak Detection Merits

  • Practical and sensitive flow-based leak test method.
  • Enables the discovery of extremely small microleaks.
  • Detects leaks with sensitivity levels as low as 1x10-10 mbar L/sec.
  • Helium is a non-explosive, non-toxic and non-destructive tracer gas.
  • Applicable across package design, failure analysis, packaging line setup and validation.
  • Faster test cycle reduces cost and total processing time.

Applications of Helium Leak Detection

  • Vials
  • Pre-filled syringes
  • Blister packs
  • Combination products
  • Bottles
  • Foil pouches

Helium leak detection is the best option for evaluating the inherent integrity of specific primary container closure systems of pharmaceutical and parenteral products. It is a commonly used technology in early stage pharmaceutical package development and component compatibility evaluation. In comparison to other leak test techniques, helium leak testing has the highest level of sensitivity, making it the most used CCI test method. In accordance with ASTM F2391, helium leak detection is a widely used method in the pharmaceutical industry.

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container closure integrity testing, helium leak detection, cci technologies, helium leak testing, container closure integrity
184
07
Jun 2021

Package Integrity Testing - The Next Big Technologies You Should Know

Package Integrity Testing The Next Big Technologies You Should Know

We all know that the primary function of any package is storing, handling & protecting the product. So, what is package integrity? Package integrity is defined as a package’s ability to protect its contents from potential hazards that include various physical, microbial & chemical factors. Its usefulness may have many nuances depending on the products & content. But industries like pharmaceutical, nutrition & medical device, deal with lifesaving & sustaining products that are shipped across the globe. Any discontinuity in the package can result in the contamination of the product making a life-saving product into a life-threatening one. Therefore, package integrity is imperative to ensure the safety of the products at the time of use.

The selection of the appropriate package inspection method is essential to maintain the quality standards that the regulatory bodies stand by today. Since 2016, the United States Pharmacopeia (USP) released guidance encouraging the use of deterministic, reliable test methods. Package leak test methods offered by CCIT s.a. are all deterministic, non-destructive, quantitative test methods with a specific on the reliability of the test result to assure integrity at the highest level.

VeriPac Vacuum Decay Technology

Vacuum decay is validated as one of the most reliable & sensitive vacuum-based leak detection methods that give quantitative & reproducible results with a pass or fail determination. PTI’s VeriPac inspection method is based on vacuum decay technology. It is one of the most ideal non-destructive container closure integrity testing solutions for different types of package formats that include parenteral packaging and other types of flexible and semi-flexible package formats. This method is non-invasive, non-subjective & requires no sample preparation. VeriPac 400 series can be used in various applications like stability studies, clinical trials, quality assurance testing and production statistical process control.

With PERMA-VAC, PTI redefined the vacuum-based leak detection method and addresses vacuum decay leak detection at the very core of physical test measurement & maximizing the SNR between good and defective samples.

Microcurrent HVLD

PTI has revolutionized the conventional HVLD method with the new HVLDmc – MicroCurrent HVLD, a highly sensitive leak detection method for all Parenteral and Biologic Products. The new E-scan 655 Microcurrent HVLD system exposes the product and environment to less than 5% of the voltage than conventional HVLD solutions. Referenced in USP <1207>, PTI’s HVLDmc has proven to be a highly sensitive leak detection method for applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, pouches.

Airborne Ultrasound

PTI’s proprietary Airborne Ultrasound technology is one of the most reliable seal quality inspection methods that characterize the overall quality and uniformity of the seal. This technology can be integrated for 100% online leak detection of pouch seals. Airborne ultrasound can be used for many material types such as Tyvek ®, paper, foil, film, aluminum, plastic & poly. This technology is referenced in the new USP <1207> Chapter guidance as a deterministic test method for seal quality testing. It is also an ASTM Test Method and FDA-recognized standard for seal quality testing.

Automated Inline Solutions

CCIT provides automated package inspection solutions across all PTI technology platforms – Vacuum Decay, Airborne Ultrasound and MicroCurrent HVLD. The Automated Systems are designed using PTI’s VeriPac, MicroCurrent HVLD and Airborne Ultrasound technologies for applications that include automated statistical process control (SPC) testing and 100% inline testing. The configurations are equipped with the capability of fully automated inspection with robotic pick and place. HVLDmc and Vacuum Decay overlap in capabilities, but more importantly encompass the full parenteral market range. The Airborne Ultrasound Technology for the 100% inline inspection of pouch seals has been an efficacious solution to verify final pouch seal quality.

Helium Leak Testing

Helium leak testing can be used for packaging tests quantitatively using helium as a tracer gas. Helium-based leak testing systems allow comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle. This method is also effective for various package types including cold form blister cards, foil pouches, parenteral vials, syringes, pre-filled syringes and unique medical devices.

The package systems of complex drug and biologic required to be stored at below -20°C, and needs storage and distribution environment that include dry ice (~-78.5°C), or even liquid nitrogen (~-200°C) can be quantitively and accurately tested using helium leak detection technology. This one technology has many applications for container closure integrity testing of pharmaceutical and medical device products.

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package integrity testing, vacuum decay technology, cci. airborne ultrasound technology, helium leak testing
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