Blogs CCIT

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
126
03
Jun 2021

Vacuum Decay Technology-A Novel Solution for Nutritional Packaging Inspection

Vacuum Decay Technology-A Novel Solution for Nutritional Packaging Inspection

In today's world, with the popularity of health products continuing to rise, manufacturers must ensure products are packed properly. Because of this reason, the universal health-wise regulation has set a fixed standard for nutritional products packaging process. This is for the elimination of defects happening due to innate chemical reactions within the nutritional products. Such defects can expose products to oxygen, moisture or bacteria- compromising its quality and reducing shelf life.

Nutritional products including dairy products and protein powders are mostly shelf stable in nature. The high fat content in dairy products including cream, butter and ghee is prone to deterioration in its storage process, causing auto-oxidative reactions. The defects in the dairy products can be eliminated through proper nutritional packaging inspection only. Similarly, protein-based powders including soy and casein are extensively used as energy sources. Inefficiencies in packaging of such products can have an adverse effect on consumer’s health. Therefore, conducting package integrity testing of nutritional products are vital to eliminate defects in packaging as well as possibility of product contamination.

Vacuum Decay Technology – The Ideal Nutritional Packaging Inspection Solution

Vacuum Decay technology is a deterministic Container Closure Integrity test method for evaluating quality of nutritional product packaging. The non-destructive testing method improves quality of packaging and reduces wastage compared to destructive test methods. Cost-effective non-destructive testing results in higher return on investments and ensures quality of products.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, with an external vacuum source. A single or dual vacuum transducer technology monitors the test chamber over a predetermined test period. The changes occurring in vacuum levels are analyzed to identify leaks and defects within the package. CCIT’s VeriPac series helps in detecting small leaks before it becomes critical in quality abbreviations.

Benefits of Vacuum Decay technology

  • Non-destructive package inspection technology
  • ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines
  • Accurate, reliable and repeatable test results.
  • Pass/fail results backed by quantitative test data.
  • Completely tool-less with no changeover to test different packaging formats.
  • Eliminates the need for destructive, subjective testing methods.
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container closure integrity testing methods, vacuum decay technology, package integrity testing, ccit
106
28
May 2021

Airborne Ultrasound Technology for Efficient Medical Device Package Inspection

Airborne Ultrasound Technology for Efficient Medical Device Package Inspection

Medical device quality control inspection is considered to be highly significant in ensuring safe delivery of medical devices from their place of origin to the market. However, tremendous development in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging

Adding to that, drug contamination is a serious concern in any medical industry- specifically for Class III medical devices. Class III medical devices are understood as devices that sustain or support life and are implanted, or present potential unreasonable risk of illness or injury. Since these devices are directly placed into human bodies, proper packaging is required to ensure quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, causing major health risks. Hence, appropriate package integrity testing and seal quality inspection of Class III medical devices are required so as to ensure seal quality and sterile barrier integrity are maintained.

Initially, manufacturers heavily relied on visual inspection or other probabilistic test methods to inspect seal quality and integrity. However, such methods lacked accuracy and reliability in terms of test results. Hence, manufacturers are now shifting towards non-destructive method for evaluating seal quality and inspecting physical properties of a seal. One such technique that is increasingly becoming popular among medical device manufacturers is Airborne Ultrasound technology. It is an ASTM test method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. The test is conducted by transmitting high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can also be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced

Airborne Ultrasound technology variants, namely Seal-Scan® and Seal-Sensor provide both, offline and online inspection of packages and accommodate various package specifications, test sensitivity and package handling requirements. Seal-Scan® offline systems offer in-depth seal quality analysis and seal characterization. Seal-Sensor online inspection systems for automated 100% inline scanning of pouch seals can be integrated into pouch production or pouch handling line. They provide 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.

Advantages of Seal Scan and Seal Sensor method

  • 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.
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package integrity testing, seal quality inspection, container closure integrity, medical device package inspection
245

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