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Airborne Ultrasound is a deterministic test method for seal quality inspection and analysis of material types such as aluminum, foil, paper, plastic, poly, film & Tyvek. In accordance with ASTM F3004-13, airborne ultrasound is a standard test technique for evaluating seal quality and integrity. It has been proven to be one of the most successful non-destructive testing methods for flexible package seals. As per research the standard seal inspection methods are inaccurate because they fail to detect invisible defects and mistakenly reject well sealed pouches. Airborne Ultrasound technology, on the other hand, has been proven in the field of both online and offline solution options

How does Airborne Ultrasound Technology mitigate the risk of food and nutrition packaging?

Packaging has been an integral part of food and nutrition preservation in recent decades. Food is packaged with the intention of being transported and stored. Quality, brand, safety, and value of a product are all affected by packaging. To ensure the safety of their products, food producers pack their products in a way that ensures they are correctly constructed, tamper-proof, defect-free, and complete.

In Airborne Ultrasound technology, sound waves are reflected when ultrasound waves are allowed to travel through the packaging seal. Change in the intensity of the reflected signal is used to identify defects. The seal is positioned in a straight line between a pair of transducers, then moves them along the seal. Transmission and reflection of the ultrasound occur at the transition from one medium to another. When the difference in acoustic properties between two materials is greater, only less sound is transmitted, and more sound is reflected. Thickness variations have a minor impact. It is possible to identify a wide range of defects, including those that are visible and invisible, leaking and non-leaking, process-related and random.

As one of the most successful methods for non-destructive testing of flexible packaging, Airborne Ultrasound technology was awarded the ASTM Test Method F3004-13 in 2013. The flow of gas or liquid through the seal is an example of seal defect. Inability to discover non-leak defects is a basic problem with leak testing methods. However, Airborne Ultrasound technology gives a complete way to evaluating seal quality, even when a seal has a defect but may not leak.

Key benefits of Airborne Ultrasound Technology

• Deterministic inspection technique resulting in quantitative results
• Non-destructive, non-subjective, zero sample preparations
• Detects defects in the final pouch seal in real time
• This method works with any material and combination, regardless of color, porosity, surface finish, transparency, and print
• The subjective manual vision inspection procedures are no longer necessary
• Results are repeatable and reliable
• Testing the final pouch seal integrity at a low cost
• Characterizes the seal's overall quality and consistency

Packaging plays a significant role in the drug delivery system. Packaging provides information regarding the manufacturer’s name, price, date of manufacturing and expiry, dose or strength, ingredients, etc. Blister packaging is a type of packaging format specially designed for tablets and capsules made by heating and shaping a plastic sheet into the 'blister,' which is entirely covering the object, into a bubble or a pocket. Several types of plastic materials like Polyvinyl chloride (PVC), Polyethylene terephthalate (PET), Amorphous polyethylene terephthalate (APET), High-density polyethylene (HDPE), etc. and aluminum sheets or foils are used in blister packaging. Blister packages can offer barrier protection and some tamper resistance to shelf-life requirements.

Tablets and capsules can be packaged in blister packaging in a regulated manner. The hard and solid-sized tablet or capsule is put in a rigid cavity and the flexible cover material is stamped to finish the package. The lines of tablets and capsules can usually handle the product with constant uniformity, making errors unusual. Interestingly, even though each cavity is independent, it also is reliant on blister packaging. If the seal is broken between two cavities, the sterility or quality of the product will not be affected until a blister cavity leaks outside the package.

Overview of OptiPac technology

OptiPac Leak Detection System is a non-destructive technology particularly intended for blister packages. To identify the existence and location of leaks, this technology uses volumetric imaging under vacuum with topographic imaging. Volumetric imaging is a next-generation technology that replaces expensive dye ingress methods of blister package inspection systems. The package is visually examined for blue dye penetration when submitted to a vacuum cycle immersed in dye during the dye ingress test. Although the approach appears uncomplicated, the method has several conditional factors which might contribute to inaccurate findings and less effective quality assurance.

The OptiPac is meant to accomplish a fast test cycle, without changing or sampling preparation, using One-Touch-Technology. The OptiPac applies controlled inputs and measurable outputs using concepts like those employed during a vacuum dye ingress test without the complications and the dependability challenges of the dye ingress procedure.

Simply place the blister package on the test plate and click START. The vacuum is drawn into a specified vacuum when the start button is pressed. The blisters spread under a vacuum and cause air to flow from the blister to leak. When the blister leaks, the air rushes into the chamber, leaving a blister packing deflated. A volumetric picture and measurement readings are used to detect which blister cavities are faulty during the dynamic vacuum test process. For each test package, there will be a clear pass/fail status and a quantifiable measurement

OptiPac benefits

• A deterministic non-destructive technique
• Auto-orientation of blister packs – test blister packs in any position
• Auto calibration is an integrated one-touch function
• No modification to test various blister formats
• Completely tool-free
• Identifies defective cavity
• Preloaded Recipe Library with simple recipe creation and new blister forms validation
• Advanced batch reporting with audit trail including image of blister pack and defect results

Container Closure Integrity (CCI) is primarily intended to ensure parenteral bio-pharmaceutical sterility and product quality throughout its shelf-life and usage. Guidelines for initial qualification and standards for validation have been set out and are available in chapter 1207 of the US Pharmacopeia (USP<1207>) (1). Any common CCI testing (CCIT) approach can be used to obtain a method that is suitable for its intended application within an end-use cycle. the principles outlined in USAP<1207>. CCI is an integrative and comprehensive process.

Common challenges faced by the pharmaceutical packaging

Pharmaceutical packaging plays a very important role in ensuring protection and maintaining the quality of pharmaceutical products. As a result, a great number of challenges are faced by pharmaceutical packaging. Let us see some of the challenges.

1. Preserving the medical quality of products

The medicines may lose their therapeutic properties, which is one of the biggest challenges faced by the industry, owing to a continuous exposure to heat and moisture. Pharmaceutical materials must be carefully selected and must not be allowed to alter the product by external elements or the product may become totally waste.

2. Ensuring safe transportation of liquid medications and injections

The other big challenge faced by pharmaceutical packing involves ensuring the safe shipping of non-solid medications such as liquids medications and injections. Due to it’s fluid nature, these non-solid medications are considerably harder to handle, especially with glass packaging. There is a high chance of breaking down. In order to avoid this problem, modern technologies like foam packaging and roto molding cases are integrated into the pharmaceutical packaging industry so that the glass packaging does not break down.

3. Proper information of medicine and dosage

The specified dose consumption of medicine is very much important. Also the package must provide information on the required dose, and information about the medicine it is composed of, expiry date and the serial number in order to avoid any misunderstanding.

Role of CCI testing in reducing pharmaceutical package problems

CCI testing helps mitigate pharmaceutical package issues to a great extent. The capacity to describe elements and chemicals which are able to move through container closure system components and contaminate the therapeutic product is a crucial stage in knowing the biological safety and appropriateness of a container. The US Pharmacopeia (USP) and Food and Drug Administration (FDA) are the main forces behind the safety assessment of materials and container closure systems in the United States. These are complying with high Container Closure Integrity Testing criteria (CCIT).

Many damaging procedures were considered suitable to guarantee that container closures preserve the sterility of devices. Basically blue dye or water bath are the procedures. These procedures were actually time consuming, inaccurate and unreliable. Moreover, test operators may not be able to control some test aspects and the resultant findings may be subjective. As a result, the FDA led the industry to shift away from the probabilistic test techniques in favor of deterministic technologies that make it possible for variables to be checked better, performed in consistent circumstances and reliably detect major leakages. Until the emergence of new technologies such as Vacuum Decay and MicroCurrent HVLD, a proper balance between sensitivity and reliability was a difficult factor. These new technologies can successfully scan containers with a greater sensitive leak detection capacity at a much faster speed than ever before.

Vacuum Decay technology: A non-destructive Container Closure Integrity(CCI) testing method which measures leak by vacuum decay. This technology is usually used for sealed packages. In nonporous, stiff or flexible packaging the vacuum decay test identifies leaks. The vacuum decay leak test method is used to check the packages after they are filled to verify the integrity of the product. This method is mainly used by the food package manufacturer, beverages and pharmaceutical industries. This approach minimizes the number of precious completed medicines needed to evaluate stability because the test is not destructive of the samples. After the vacuum decay test, the same samples may be utilized for additional laboratory tests normally necessary for stability studies.

MicroCurrent HVLD technology: MicroCurrent HVLD is a non-invasive Container Closure Integrity(CCI) technology applicable for a broad variety of parenteral filled liquid goods, including exceptionally injecting low conductivity sterile water and protein-filled products. The test procedure assures CCI by scanning a container that is non-conductive and sealed with electrode samples to identify pinholes, micro cracks, leakage of stoppers/plungers, invisible leaks, etc. The resultant difference of resistance and change in current flow indicates a breakdown in the container. Thus a defect is detected with exact defect location.

In addition to offline laboratory systems for leak detection and package quality testing, CCIT offers configurations that provide the capability of fully automated inspection. These technologies do not compromise the reliability of test measurement and automatic inspections take the perfect time to manage and monitor expensive final goods. Automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technologies provide the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality.

Ophthalmic products are sterile preparations that include contact lenses, specific surgical implants, eye gels, lotions, powders, parenteral medications, ophthalmic inserts, prefilled syringes, etc. These products are applied onto the exterior surface of the eye. Ophthalmic products are packaged by various pharmaceutical firms in various ways and in various materials. According to pharmaceutical production and packaging requirements, all ophthalmic products must pass a strict sterility test.

Plastic containers are used to package almost all commercially accessible ophthalmic products. Plastic bottles, which are mainly made of Low-Density Polyethylene (LDP), Polypropylene (PP), High-Density Polyethylene (HDPE), and other materials depending on the specific product demand, are the most widely used materials for packaging of ophthalmic products. These plastic packaging components, which include bottles, fittings, and closures, enjoy universal acceptability due to obvious advantages such as ease of use, reduced spillage, and little breakage. In the late 1940s, Alcon was the first business to produce these packaging components, known as "Drop-Trainers" for ophthalmic medications, and they quickly became the industry standard for packaging topical ophthalmic products.

VeriPac Vacuum Decay Technology

Vacuum decay is a testing process that has been validated over many years and has been improved by new technological advancements. The test method is straightforward in concept, and it tests container integrity using basic physical attributes. It includes drawing vacuum on a package inside a test chamber and checking for any degradation in the vacuum level, which would indicate a leak. It saves money by avoiding wasting product during a leak test, and many products provide a quick return on investment.

Leak testers from VeriPac attach to a test chamber that is specifically constructed to hold the package being evaluated. The package is then placed inside the vacuum-sealed test chamber. The test chamber is monitored for both the level of vacuum and the change in vacuum over a defined test time using single or dual vacuum transducer technology. The presence of leaks and faults within the package is indicated by variations in absolute and differential vacuum. A test's sensitivity is determined by the package design, the package test fixture, and crucial time and pressure test parameters. Manual or fully automated testing systems are available. For QA/QC statistical process control, this inspection method is appropriate for laboratory offline testing and production applications. The test cycle is quick, non-invasive, and non-destructive to both the product and the packaging.

The VeriPac 455 is a non-destructing and quantitative inspection device that enables the very sensitive identification of empty and pre-filtered syringes, liquid filled and freezed vials, as well as other forms of liquid filled packaging, without any preparation of the sample. The VeriPac 455 is adequate to the challenge of testing these types of products, which necessitates the highest level of sensitivity, reproducibility, and accuracy.

Benefits of VeriPac 455

• No sample preparation, non-destructive, and non-subjective
• Highest level of sensitivity, repeatability and accuracy
• Results have been shown to be superior to dye intrusion
• Deterministic, quantitative test method
• Supports zero-waste and sustainable packaging
• ASTM test method and FDA standard
• Capable of detecting leak rates as low as 0.01 cc/min

High Voltage Leak Detection (HVLD) of pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and liquid filled pouches detects pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. The HVLD testing procedure also guarantees the security of the product seal by finding tiny pinholes, micro fractures and screen defects that are not visible. Eventual packing defects lead to resistance differential and changes of current flow in the container and the approximate position of the fault. It is also one of the most affordable methods for testing container closure that requires little adjustments to the infrastructure. This technology is not invasive and does not require preparation of the sample. It is one of the most powerful CCI technologies for all biological and parenteral goods

E-Scan HVLD has a high-speed test cycle, produces highly reproducible results and is easy to handle. Fast changeover and easy adjustments of test parameters for various goods and applications are further advantages. Another advantage of the HVLD technique is that it can readily be moved from the laboratory offline to 100% online testing applications at high production speeds. That is an enormous benefit and makes the inspection and validation procedure globally simpler. E-Scan employs a number of electrode probes to scan a sealed container which is not conductive. Glass, plastic or poly laminate might be the container material.

Working principle of MicroCurrent HVLD technology

In non conductive or semi-conductive packing materials, HVLD works by implementing high voltage potential for electrically conductive goods. When electrical discharges between goods and device electrodes are observed, the pinholes are determined. The two container walls (high voltage side and ground side) offer complete electric resistance when the package is not leaked, and no significant current is detected by flash. If one of the container walls has a microleak or fracture, the barrier to breakup is met and the current passes. HVLD is the only technique for leak detection that requires a crack site without mass, needing just the flow of electricity via a crack. This feature sensitises HVLD to leaks that are not identified by typical leak test systems.

Applications of MicroCurrent HVLD

• Pre-filled syringes
• Vials
• Cartridges
• Ampoules
• BFS
• Bottles
• Pouches

Advantages of MicroCurrent HVLD

• High level of repeatability and precision
• Deterministic, non-destructive, non-invasive
• Product and environmental low voltage exposure
• Offline and 100% online testing at high production speeds
• Simpler inspection and validation procedure
• Most powerful CCI technology for all parenteral and biologic products
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats