Blogs

22
Sep 2020

Ensuring Bottle and Container Integrity through VeriCon Technology

Ensuring bottle and container integrity through VeriCon Technology

What is VeriCon Technology?

VeriCon system encompasses a complete line of leak testers for empty bottles and containers. It is a powerful leak detection system that operates round-the-clock to ensure high leak test sensitivity with the capability to measure down to 200 microns. Under this process, the container is filled with pressure to a certain level. The rate of pressure decay is analyzed and measured which corresponds to pressure within the container. The operating panel displays pass/fail results and the defective container is rejected from the line . With PTI’s VeriCon technology, users can choose from a wide range of leak tester configurations, according to different container specifications. Its applications include plastic, blow molding, food, beverage and pharmaceutical industries. VeriCon technology works well for small, medium to large size containers and has inspection rates upto150 bottles/min. range. According to Heinz Wolf, general manager, Packaging Technologies and Inspection “In addition to the basic inspection economics of identifying leaking containers and minimizing false rejects, VeriCon systems offer many additional advantages that increase overall operational efficiency. The Auto-learn feature for example, automates setup of accept/reject criteria. Real time inspection data with reject statistics and test result With reject statistics & test result trends, VeriCon technology ensures on demand analyses of container quality.”

VeriCon technology can be implemented using pressure decay or vacuum decay technology. Plastic containers of almost all sizes use pressure decay technology. In situations where due to specific characteristics of the container, pressure decay technology is not capable of detecting leaks, Vacuum decay technology is applicable. Depending on the line speed/hole size requirement, VeriCon testers are available in one to four station configurations.

VeriCon Configurations

  • Trimmer mount: available in single and dual station configurations, VeriCon trimmer mount systems are designed precisely for indexing systems installations.
  • Linear Leak Testers: available in single or multi-station configurations for standard online linear leak detection with inspection speeds up to 70 bottles/min.
  • Continuous Motion Testers : available in 1 to 4 station configurations with inspection speeds up to 150 bottles/min. Continuous motion inspection’s high speed testing ensures uninterrupted inspection of containers.

Benefits of VeriCon technology:

All VeriCon systems offer the following features and benefits:

  • VeriCon technology uses high-resolution non-drifting transducers thereby ensuring consistent leak detection.
  • Accurate leak testing with repeatable results
  • 24/7 operation
  • Capable of accommodating multiple container specifications and test sensitivity requirement

Ensuring packaging quality is pivotal in all manufacturing. For efficient packaging, it is important for manufacturers to have complete knowledge of packaging material used and test sensitivity desired, so that appropriate package integrity tests can be undertaken.

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pharmaceutical package testing, VeriCon Technology, pharmaceutical package integrity, package integrity testing, pressure decay technology
224
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
213
10
Sep 2020

Automated CCI technologies- Revolutionizing medical device testing

Automated CCI technologies- Revolutionizing medical device testing

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 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.

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CCI technologies, Airborne ultrasound technology, seal integrity testing, Class III medical device package integrity, vacuum decay technology, container closure integrity testing
197
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
193
04
Sep 2020

CCIT - A risk mitigation tool for parenteral products

CCIT - A risk mitigation tool for parenteral products

Today’s healthcare industry assures treatments that were unimaginable a few years ago. As pharmaceutical industry grows in importance, the techniques of primary packaging for healthcare products, especially parenteral products has taken on new prominence. Common parenteral packaging methods include Liquid-filled containers such as vials, ampoules, syringes, blow-fill-seals and auto-injectors and containers filled with lyophilized products. Since these drugs are directly administered into human bodies, high sensitivity integrity tests are required to ensure product quality throughout its shelf life. For reasons of safety, packaging material, integrity and design are regulated by Food And Drug Administration as strictly as the product itself.

Container Closure Integrity Testing is a leak detection test conducted using a non-destructive packaging inspection system to protect the drug from any possible contamination. It is a crucial step in evaluating safety and integrity of the primary packaging so as to maintain a sterile barrier and to avoid leakage resulting in contamination of the drug. Packaging components like bottles, vials, syringes that are in direct contact with the product are called primary components while aluminum caps, cardboard boxes are secondary components as they are not in direct contact with the product. Proper packaging should be a priority for all drug products, but in case of parenteral products, these concerns amplifies several folds as they are directly injected. Hence initiating a proper container closure system is vital for product and consumer safety.

Although Container Closure Integrity Testing can be performed in many different ways, it can be broadly classified into Probabilistic methods and Deterministic methods. Probabilistic test methods including Microbial Challenge by Immersion, Tracer Liquid Tests (e.g. Dye Ingress), Bubble Tests etc. are traditional test methods where result accuracy may be uncertain. On the other hand, Deterministic test methods like Electrical Conductivity and Capacitance Test (HVLD), Laser-based Gas Headspace Analysis, Mass Extraction, Pressure Decay provide quantitative results with high accuracy. The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods.Packaging Technologies And Inspection (PTI’s) Microcurrent HVLD technology and vacuum decay technology are the latest inventions in package integrity testing of parenteral products.

1. Microcurrent HVLD Technology: Microcurrent HVLD is a unique High Voltage Leak Detection Technology, highly effective across all parenteral products. Its Applications include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to proteinaceous products with suspensions. Its ability to detect small pinholes, micro cracks and seal defect detection down to single-digit microns makes it an ideal choice for testing parenteral products.

2. VeriPac Vacuum Decay Technology: VeriPac Vacuum Decay Technology, based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing, is a non-destructive inspection system, capable of defect detection down to 0.002 cc/min. This system is applicable for empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. Depending on the package type and leak test sensitivity needed, appropriate VeriPac model can be selected.

PTI’s next generation PERMA- VAC technology addresses vacuum decay detection at the very core of physical test measurement by controlling the test system volume and maximizing the SNR between good and defective samples. This makes PERMA-VAC the most reliable vacuum-based leak test available in the market.
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CCIT, parental product leak testing, container closure integrity testing, container closure integrity, package integrity testing, ccit pharmaceutical, hvld
364
01
Sep 2020

Container Closure Integrity Testing (CCIT) - An Ideal Solution for the Pharmaceutical Industry

Container closure integrity testing - An ideal solution for pharmaceutical industry

The global pharmaceutical industry has seen tremendous growth over the last few decades. The complex nature of the industry coupled with frequent breakthroughs has made it a favorite subject of scrutiny. Since any defect in the packaging of drugs can have serious consequences, assuring the quality of the packaging is of prime interest for every manufacturer. Pharmaceutical products are expected to be free from microbial contamination and safe to use right from production throughout their shelf-life. The drug’s stability can be adversely affected through contamination in the form of oxygen, humidity or microbiological ingress. In order to prevent such risks, integrity tests with high sensitivity are required.

Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasised the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI). FDA defines Container Closure Integrity Testing (CCIT) “as the sum of packaging components that together contain and protect the dosage form”.

Container Closure Integrity Testing is a method of leak detection using a non-destructive packaging inspection system to prevent possible contamination. Such a test is essential since any defect in the container can cause external particles to enter the product, thereby reducing its shelf life. Implementing right Container Closure System has been of prime importance for a manufacturer as it affects both the product and the patient. Hence, the relevance of CCI Testing in the pharmaceutical industry has steadily increased over the years. Contaminants that can enter a product include micro-organisms, reactive gases, and other substances. CCIT ensures product quality is maintained from the point of manufacture throughout its distribution and use. Container closure systems include primary packaging components and secondary packaging components. Components such as a glass vial or syringe, which come into direct contact with the product, are primary packaging components. On the other hand, components that are crucial to ensure correct package assembly, such as aluminum caps, over stoppers etc. are the secondary packaging components

CCI Testing Methods

Container closure integrity testing can be performed in many different ways. Each method has its own merits and demerits. A number of factors have to be considered while selecting appropriate testing methods. These factors include, but are not limited to; the reliability of the test method, material of the primary package and inline versus an offline testing requirement. CCI testing methods can also be selected depending on specific desired outcomes. Examples of desired outcome include: identifying the presence of leak paths, understanding leak path’s location, evaluating leak rate for the whole package, and measuring potential for microbial ingress. The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test method.

1. Probabilistic methods: Here, the testing methods are more traditional, and the accuracy of the result is uncertain. The probabilistic methods include the following:
  • Microbial Challenge by Immersion
  • Tracer Liquid Tests (e.g. Dye Ingress)
  • Bubble Tests
  • Tracer Gas (Sniffer Mode)
2. Deterministic methods: Such methods provide quantitative results with a higher level of accuracy. The chances of errors are also minimal. The deterministic methods include the following:
  • Electrical Conductivity and Capacitance Test (HVLD)
  • Laser-based Gas Headspace Analysis
  • Mass Extraction
  • Pressure Decay
  • Tracer Gas (vacuum mode)
  • Vacuum Decay
Readmore...
CCIT, container closure integrity, container closure integrity testing, pharmaceutical product leak testing, pharmaceutical package testing, package integrity testing
360

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    CCIT - A risk mitigation tool for parenteral products

    Sep 04, 2020   |   364

    Container Closure Integrity Testing is a crucial step in evaluating the integrity of the primary parenteral packaging to avoid any leakage resulting in contamination of the drug.

    Container Closure Integrity Testing (CCIT) - An Ideal Solution for the Pharmaceutical Industry

    Sep 01, 2020   |   360

    Container Closure Integrity Testing is a method of leak detection using a non-destructive packaging inspection system to prevent possible contamination in pharmaceutical products.

    Ensuring Bottle and Container Integrity through VeriCon Technology

    Sep 22, 2020   |   224

    PTI’s VeriCon technology ensures pharmaceutical package integrity for retaining product quality and shelf life.

    Automated CCI technologies- Revolutionizing medical device testing

    Sep 10, 2020   |   197

    PTI revolutionized medical device package leakage testing with Automated CCI technologies across their different technology platforms
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