Blogs

24
Mar 2021

Evaluating Quality Assurance Solutions for Coffee Packaging

Evaluating Quality Assurance Solutions for Coffee Packaging

Fresh coffee is the best coffee. The quality of coffee is directly linked to freshness, and maintaining freshness requires adequate packaging. In simple words, packaging is what holds coffee products and maintains its quality. However, maintaining freshness and shelf life of packaged coffee is often a challenge for manufacturers. The flavors and oils in coffee are oxygen sensitive, while flavor profile being the key differentiator for consumers. External conditions like high temperature, light, or high humidity can increase the rate of staling. Under such conditions, whole beans will lose significant amounts of flavor and develop stale fragrance in 1-2 weeks, while in case of ground coffee the process takes 1-2 days. Compromised package integrity can result in oxidation, flavor degradation, and spoilage. Leaks as small as 10 microns can draw oxygen into the package over its shelf life. If a consumer encounters a product that exhibits oxidation, the bitterness and stale flavor will likely affect the consumer’s decision to repurchase. This explains why manufacturers give prime importance to evaluating integrity of coffee packaging.

Conventionally, water bath was the most popular technique for leak testing coffee products. Although water bath is a simple and effective leak testing method for rigid containers, it fails to meet critical needs associated with flexible coffee packages. Additionally, the cost associated with maintaining standard destructive methods is high. Subjective test results, variable test standards, and higher risks associated with the use of other methods emphasize the need for better alternatives. Hence manufacturers today opt for non-destructive testing methods that eliminate the cost associated with wasted product, and ultimately facilitate better quality control.

Package integrity testing using Vacuum Decay technology

PTI’s Vacuum Decay technology is an ASTM-approved, FDA recognized non-destructive Container Closure Integrity test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. It can detect oxygen critical leaks, providing a more reliable and sensitive solution for a range of packaging formats that is designed to protect oxygen sensitive products. This method involves drawing vacuum on the sample package kept in the test chamber, and analyzing the vacuum level for any defect-indicating a leak. VeriPac systems reliably detect leaks as small as 10 microns, identifying process issues before they become critical, avoiding costly quality deviations.

For coffee sachets, stick packs or pouches, PTI’s VeriPac FLEX series offer the highest level test sensitivity, detecting micro leaks into the single digit micron range. These are versatile non-destructive package inspection systems designed specifically for flexible packages. To accommodate various package specifications, the VeriPac FLEX is available in several configurations. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. Hence, VeriPac vacuum decay is a practical alternative and significant improvement to the destructive test methods commonly used for flexible packaging.

Benefits of Vacuum Decay technology:

  • Reliable and sensitive leak detection of quality critical defects
  • Cost savings
  • Using a non-destructive leak test method allows an increase in the number of product samples tested
  • Rapid test cycle and minimal training required to operate tester
  • Rapid ROI due to substantial cost savings and elimination of product loss
Readmore...
package integrity testing, coffee packaging, ccit, quality assurance solutions, vacuum decay technology, veripac flex series
108
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
11
Dec 2020

What are the Different Seal Quality Inspection Techniques Offered by PTI?

What are the different seal quality inspection techniques offered by PTI

Seal integrity plays a vital role in ensuring the quality of packaging products. Even a minute defect in the seal can initiate a leak, which can compromise the quality of the product and directly affect its shelf life. It can also result in huge financial losses to the manufacturer. That being said, manufacturers give considerable importance to conducting appropriate seal integrity tests to ensure package integrity at every stage of its lifecycle.

Seal integrity testing methods can be classified into two- Destructive testing methods and Non-Destructive testing methods. Since under Destructive methods, the packages may get destroyed, its popularity has steadily declined over the past few decades due to this waste and high cost. “There is a huge shift in the industry towards deterministic and quantitative test methods,” says Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “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.”

Seal quality inspection techniques offered by PTI:

Vacuum Decay technology is a non-destructive Container Closure Integrity test method, used for seal quality inspection in nonporous, rigid or flexible packages. With the ability to detect leaks down to the sub-micron level, , Vacuum Decay technology is identified as one of the most practical vacuum-based leak detection methods. Its ability to provide quantitative, reliable and repetitive test results make it ideal solution for seal quality inspection in Pharmaceutical, Medical Device and Food and Nutrition industries.

Under this method, the sample packages are first placed in a close fitting evacuation test chamber that contains an external vacuum source. The vacuum levels and changes in vacuum over a pre-determined time are closely monitored. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in the absolute and differential vacuum indicate the presence of leaks and defects within the package.Over the past few years, Vacuum Decay technology has seen great advancements in the form of PTI’s PERMA-VAC technology and VeriPac FLEX Series.

The next generation PERMA-VAC technology is a single or dual vacuum transducer technology that has made the VeriPac line of test systems the most sensitive vacuum-based leak tests available in the market. It has higher test sensitivity for providing accurate and reliable results and can be applied to rigid and semi-flexible packages alike. PTI’s PERMA-VAC technology ensures the most stable test measurement ever achieved through vacuum decay.

VeriPac FLEX series is an ideal package inspection solution for dry filled pouches and flexible packaging. To accommodate different package formats and test sensitivity requirements, VeriPac FLEX series is available in several configurations with multiple test chamber sizes.

 

2.Airborne Ultrasound technology:

Airborne Ultrasound technology is yet another seal quality inspection technique, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

 

Readmore...
seal quality inspection, airborne ultrasound technology, vacuum decay technology, container closure integrity testing, ccit, container closure integrity
189
10
Dec 2020

Role of Vacuum Decay Technology in Medical Device Package Inspection

Role of Vacuum Decay technology in medical device package inspection

Apart from validating the functionality and design of medical devices, ensuring package integrity is crucial to make sure that the product reaches the end-user intact. Packaging and delivery formats available for medical devices range from porous flexible packaging to non-porous rigid containers. Each packaging format has a unique set of characteristics and requirements, which necessitates a comprehensive approach while selecting an appropriate inspection technique.

With increasing innovations in packaging formats and materials, packaging challenges have also increased. Among other medical devices, Class III medical devices pose the highest level of risk associated with ensuring package integrity. Such devices sustain or support life and are implanted. Examples of Class III devices include pacemakers, cardiovascular stents, respiratory ventilators and breast implants. Since these devices are directly placed into human bodies, even a minute breach in the packaging can pose significant risk to patient safety. Hence testing container closure integrity (CCI) of medical devices is crucial.

Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating wide range of high-risk package applications. It can be efficiently incorporated into the packaging process to ensure quality, reduce waste and allow operators to have a proper understanding of package integrity. Multiple vacuum supply types along with single or dual high-resolution transducers configuration enables the VeriPac series to provide fast and reliable test results that are quantitative and deterministic. It is an ideal solution for medical device manufacturers to ensure that the product meets regulatory standards. Based on packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

PTI has revolutionized Vacuum Decay technology with the development of next generation PERMA-VAC technology, that offers increased test sensitivity and repeatable results. The technology is capable of detecting leaks in the MALL range for parenteral packaging and can accommodate a variety of flexible and semi-flexible package formats. The advancements in PERMA-VAC technology has made the VeriPac series the most reliable and practical vacuum-based leak test method available today.

Benefits of Vacuum Decay technology:

  • Non-destructive, non-subjective, no sample preparation
  • Capable of detecting defects down to 0.05 ccm
  • Accurate, reliable, repeatable results
  • Supports sustainable packaging and zero waste initiatives
  • FDA recognized standard for package integrity testing
  • ASTM test method F2338
Readmore...
vacuum decay technology, medical device package inspection, package inspection technologies, Class III medical devices, CCIT
184
09
Dec 2020

Role of MicroCurrent HVLD Technology in Parenteral Product Container Closure Integrity (CCI) Testing

Role of MicroCurrent HVLD Technology in parenteral product container closure integrity (CCI) testing

Ensuring pharmaceutical package integrity has always been a priority for drug product manufacturers. However, over the past few decades, innovations in health care sector have also accelerated pharmaceutical package integrity challenges. Although testing package quality of all healthcare products is important, in the case of parenteral products it is amplified significantly. Parenteral products are defined as injectible products that can be either liquid or powders. Solutions can contain suspensions, emulsions and be proteinaceous in nature. ”. Since these drugs are directly administered into human bodies, ensuring complete integrity of such packages is crucial. Common packaging formats for parenteral products include Liquid-filled containers such as vials, ampoules, syringes, BFS and auto injectors; Lypholized (powder) products are often packaged in vials. Even a minute breach in the package can cause microbial contamination leading to product deterioration. Hence ensuring container closure integrity is a critical process in the life cycle of parenteral products.

What is HVLD Methodology?

High Voltage Leak Detection (HVLD)) is a non-destructive Container Closure Integrity technique used primarily to evaluate closure integrity of parenteral product packaging. HVLD technology makes use of quantitative electrical conductivity measurement principles. This method operates by passing high voltage micro current signals through sample packages. Under the presence of a leak, the electrical resistance of the sample declines, causing an increase in current. Applications of High Voltage Leak Detection Technology include testing of the following package formats:

  • Pre-filled Syringes
  • Ampoules
  • Drug Product Cartridges
  • Liquid Filled Vials
  • Blow-Fill-Seal (BFS) Container

PTI’S MicroCurrent HVLD technology has revolutionized the conventional HVLD method. MicroCurrent HVLD is a non-destructive, non-invasive CCI technique that can be applied to a wide range of liquid filled products including low conductivity sterile water for injection (WFI) and highly proteinaceous drug products within suspensions. PTI’s E-scan HVLD, a highly sensitive CCI testing process uses electrode probes to scan sealed non-conductive containers. Under the presence of a leak, there will be a change in current flow indicating a defect in the container along with its approximate location. This unique technique uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage. An important feature of E-scan HVLD is its ability to easily shift from the laboratory offline to 100% inline testing applications. With the capability to accommodate multiple packaging formats including glass, plastic or poly laminates, it is an ideal solution for parenteral package testing.

Benefits of MicroCurrent HVLD:

  • Deterministic, non-destructive, non-invasive
  • High level of repeatability and accuracy
  • Ideal package integrity solution for parenteral products
  • Low voltage exposure to the product and environment
  • Offline and 100% online inspection at high production speeds
Readmore...
CCIT, container closure integrity, container closure integrity testing, parenteral product leak testing, MicroCurrent HVLD, CCI testing
192
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.
Readmore...
CCIT, parenteral product leak testing, container closure integrity testing, container closure integrity, package integrity testing, ccit pharmaceutical, hvld
656
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
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