PTI Packaging Systems specializes in packaging machinery solutions for filling and sealing pouches, cups and trays. Applications range from products in individual portion packs up to bulk size bags. Solutions include retort sterilization and integrated downstream equipment. PTI’s supplier partners produce exceptional equipment that provides the performance, reliability, flexibility and versatility customers need. Our team can also bring new and creative package designs to market. We support brand differentiation and help make new packaging ideas and innovations a reality.
PTI is a global leader package testing equipment. We specialize in non-destructive package testing equipment for high risk packaging applications. PTI manufactures solutions for package integrity, leak detection, container closure integrity, and seal integrity testing. PTI's technologies are deterministic test methods that produce reliable and robust quantitative test result data. Our technologies conform to ASTM and other regulatory standards. We specialize in offering our customers comprehensive solutions including feasibility studies, test method development and system validation. We provide solutions for testing vials, ampoules, auto-injectors, cartridges, blisters, pre-filled syringes and many other packaging formats.
PTI's Seal-Scan® and Seal-Sensor® are non-contact airborne ultrasonic testing technologies. In order to use ultrasonic inspection effectively, it must be possible to place the seal in a direct line between a pair of transducers and move it (or move the transducers) along the seal. The ultrasound is transmitted and reflected at the transition from one media to the next. The greater the acoustic difference between mediums (most evident at a gas to solid transition) the more sound is reflected and the less sound transmitted through. The variation of the material thickness has only a minor effect.
Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection method.Advanced approaches for quality assurance of these leading-edge treatments may be needed for a variety of reasons.
PTI has developed a new standard for protecting, storing and presenting data generated from its line of non-destructive leak testers in the form of a software package called PTI Ethos.
VeriPac FLEX Systems are versatile non-destructive package inspection systems designed for pouches and other flexible packaging.
VeriPac 355 is a non-destructive micro leak detection system for container closure integrity and package integrity testing for a wide range of products and packaging formats. This system is specifically designed to test containers for gas leaks for dry products (lyophilized vials, powder filled) as well test for liquid leaks (non-protein based liquid filled vials, prefilled syringes). The VeriPac 355 can be incorporated into protocols at any point in the handling process as it is non-destructive and requires no sample preparation. With the capability to detect leak rates as low as 0.2 cc/min, depending on packaging specifications, the VeriPac 355 is the optimal non-destructive quantitative test method for many pharmaceutical and food applications.
The VeriPac 410 inspection system offers non-destructive seal and leak detection for blister packs, sachets, and pouches with low headspace including transdermal patch packaging
The E-Scan 655 is a revolutionary, deterministic offline microleak testing instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid-filled parenteral products for container closure integrity.
Multicavity blister packs and low headspace packaging use a variety of test methods to determine package integrity, with most being destructive, subjective, and unreliable.
The VeriPac UBV Leak Detection System is a deterministic, nondestructive technology designed specifically for multicavity blister packs. The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence and location of leaks.
VeriPac 455 is a non-destructive inspection system used for highly sensitive micro leak detection of empty and pre-filled syringes, liquid filled and lyophilized vials and other pharmaceutical packaging formats.
PTI’s E-Scan 655 patent pending technology uses a unique mode of MicroCurrent HVLD which applies less than 50% of the voltage used with conventional high voltage technologies.
The E-Scan 655 is a deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity.
The VeriPac UBV Leak Detection System is a deterministic non-destructive technology designed specifically for multi-cavity blister packs for pharmaceutical packaging. The system utilizes volumetric imaging under vacuum to detect the presence and location of leaks.
Seal-Scan® characterizes seals that appear visually acceptable yet possess defects that affect product quality and shelf-life. Seal-Scan systems utilize non-contact airborne ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging. Testing is non-destructive, non-invasive and requires no sample preparation.
VeriPac systems can be easily integrated into the packaging process to improve quality, reduce waste, and provide operators with a clear understanding of package quality. VeriPac test systems are non-destructive, non-subjective and require no sample preparation. Test fixtures are designed to inspect flexible and rigid packaging. Tests can be performed in any sequence and even repeatedly on a single sample. VeriPac’s inspection method is more reliable, cost effective and efficient than destructive methods, plus it eliminates subjective, misleading results that vary from operator to operator.
The VeriPac 410 utilizes a combination of vacuum decay technology and differential force measurement to identify defective packages. Multiple packages can be tested in a single test cycle, and the 410 identifies which package or cavity is defective.
Complementing the high cost of medical device manufacturing, there is a high value placed on the sterility and quality of the final product which are the main reasons for successful integration of Seal-Scan® airborne ultrasound seal inspection for medical device packaging.
Seal-Sensor™ utilizes ultrasound technology that provides non-contact seal inspection solutions for offline laboratory use and high speed 100% online applications. Seal-Sensor is a very rapid, reliable method that provides an instant reading of seal presence and quality.
The VeriPac tester is connected to a specially designed drawer-style test chamber for easy handling and testing convenience. Each VeriPac D-Series model achieves a specific range of test sensitivity and is available with two test chamber drawer sizes depending upon the package size and specifications.
VeriPac 455 is a non-destructive inspection system that offers unique integrity testing approaches, permitting highly sensitive micro leak detection of empty and pre-filled syringes, liquid filled and lyophilized vials, and other rigid containers. Testing these types of products demands the highest level of sensitivity, repeatability, and accuracy, and the VeriPac 455 is up to the task.
VeriPac 455 is a non-destructive inspection system that offers unique integrity testing approaches, permitting highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other types of liquid filled packaging.
VeriPac leak testers provide non-destructive inspection of packaging for offline and online applications and QA/QC process control. VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method recognized by the FDA as a consensus standard for package integrity testing (ASTM F2338-05).
VeriPac micro leak testers evaluate and analyze the integrity of vials with precision and repeatability. Test components are optimized for high sensitivity applications and high resolution requirements of the pharmaceutical industry.
Packaging Technologies & Inspection (PTI) is a leading manufacturer of inspection technologies for the pharmaceutical industry that are non-destructive, non-invasive, and require no sample preparation.
PTI Packaging and Inspection Systems
8 Skyline Drive
Hawthorne, NY 10532
UNITED STATES
Phone: 800-532-1501
Fax: 914-337-8519
PTI Sales Engineer, Rob Zecchin, at the recent Interphex event in New York City, demonstrated PTI’s E-Scan 655 MicroCurrent HVLD technology for Container Closure Integrity Testing.
Seal-Sensor is an Airborne Ultrasonic Technology that inspects the final pouch seal non-destructively 100% online. Seal-Sensor is a deterministic, quantitative, rapid and reliable method to inspect pouch seals for defects, incomplete seals, partial or weak areas in seals, and many common defects in seals that appear visually acceptable yet possess defects that affect product quality, value and shelf-life.
The standards of quality for flexible packaging continue to be a challenge for manufacturers.
The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence of leaks. It’s a simple, rapid 3-step process to test a blister pack.
The VeriPac UBV Leak Detection System is a deterministic non-destructive technology designed specifically for multi-cavity blister packs.
WALDNER solves a packaging challenge for a global pharmaceutical company with an ingenious filling and sealing machine.
This study shows that HVLD can detect leaks down to the Maximum Allowable Leakage Limit (MALL) and arguably makes it one of the most sensitive leak test methods in the market.
The study addresses the common concern that vacuum decay is not a suitable test solution for detecting microleaks in parenteral containers if the product contains large molecule or proteinaceous liquids.
Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products. High product costs and superior quality requirements are two reasons for successful integration of airborne ultrasound seal inspection for medical device packaging. By PTI Inspection Systems
Case Study: How Does Vacuum Decay Leak Testing Cut Waste?
Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products.
Ophthalmic products come in a variety of package formats. The liquid-filled packages are often soft containers with snap-on or screw caps, and include foil lidded blister packs for single-use contacts.
Pharmaceutical parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a significant threat of bacterial ingress as shown in research by Kirsch et al. in 1997. To manage this risk, the industry has continued to pursue leak detection methods that are more sensitive and reliable for vials, ampoules, cartridges and syringes.
Vacuum decay is a test method provides significant savings by not wasting product for a leak test, and generates return on investment in under six months for many products.
New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing.
A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.
Traditional test methods of testing pouch seals are often destructive and can be unreliable. However, ultrasound technology offers a non-destructive means to ensure pouches are airtight.
As more and more packages and processors convert to flexible packaging from more traditional forms of rigid methods including metal cans, PET and glass bottles or jars, they are confronted with the concern and challenge of how do they insure or equal the seal integrity levels from flexible packaging that they have come to expect from these more traditional packaging methods. Submitted by PTI Inspection Systems
Untold millions of medicinal tablets and capsules are produced every year, and many of the over-the-counter varieties are encased in blister packs for protection. Existing manual methods for inspecting these packages are subjective and lack repeatability, while electronic techniques have to date been stymied by the great variation in blister packages.
A pouch seal is a structural element that joins flat film material and a component designed to close a pouch airtight. Traditional test methods (e.g. peel strength or burst), can measure the joint strength of the pouch seal using destructive methods that are often unreliable. Submitted by PTI Inspection Systems
In this article, we highlight our current thinking in an attempt to devise a systematic approach for CCI testing method selection, development, and validation.
The ability to detect leaks is necessary to ensure consistency and integrity of packages. It is also important to detect leaks and defects that are not visibly detectable. VeriPac's non-destructive technology is capable of detecting package leaks and invisible defects using an absolute or differential pressure transducer leak test system. Submitted by PTI - Packaging Technologies & Inspection
Blister package manufacturing for tablets and capsules has process and material parameters that are unique to each product. Barrier properties of blister packaging are primarily designed to eliminate moisture ingress, a result of H2O molecules passing through micro leaks over extended periods of time. By Oliver Stauffer, PTI Packaging and Inspection Systems
Most current test methods for blister packages are destructive, time consuming, not sensitive, unreliable, and dependent on the properties of the package lidding material. Small semi-rigid, flexible, and multi-cavity blister packages do not have enough air inside the package to reliably detect defects by simple vacuum decay methods. Submitted by PTI - Packaging Technologies & Inspection
Leak detection of empty containers — before the filling and sealing process — is an important step to insure container integrity. Applications in the plastic, blow molding, food, beverage and pharmaceutical industries all require some type of online container integrity system. Submitted by PTI - Packaging Technologies & Inspection
The blister packaging process for tablets and capsules is unique to the packaging industry in so many ways. Blister packaging will always exist due to its practicality; but, the things that make blister packaging difficult to work with also make it a desired product presentation. Submitted by PTI Inspection Systems
The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, which enables you to establish or modify recommended storage conditions, retest periods, and shelf life or dating period, as the case may be.
