ABOUT US

PTI Inspection Systems PTI is a global leader in package testing equipment for the medical device and pharmaceutical industries.  We offer inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI’s inspection technologies are deterministic quantitative test methods.  We specialize in testing solutions for porous and non-porous pouches, Tyvek packaging, Tyvek pouches and Tyvek lidded trays.  PTI offers the entire solution including test method development and equipment validation.

PTI offers two primary technologies to inspect medical device packaging; vacuum decay and airborne ultrasound.  Both technologies aim to offer quantitative and deterministic test results to evaluate package quality.  The two technologies are vastly different in function and performance.  Vacuum decay is focused on package integrity and detection of leak paths.  Airborne ultrasound is focused on seal inspection and seal quality.  Contact us to learn more.

PTI Packaging Systems specializes in packaging machinery solutions for filling and sealing cups, trays, pouches and spouted pouches. Applications include specialized solutions for medical and pharmaceutical packaging.  Contact us to learn more.

HOT PRODUCTS

Tyvek® gives the premium microbial barrier protection for sterilized medical instruments and pharmaceuticals. Apart from protecting the medical devices and pharmaceutical products from physical damages, medical and pharmaceutical packages also should provide an effective microbial barrier and help to maintain the sterility of the products. Bacteria and viruses with sizes varying from 0.002 to 100 microns are a constant threat to pharmaceuticals and medical devices which in turn can be hazardous to the patients.

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. 

A variety of test methods exist to challenge package quality and performance. The goal of a feasibility study is to assure that the right technology and test method are applied to each product application to provide accurate, sensitive, and reliable data for definitive package integrity verification.

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® is an Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively offline.  Seal-Scan® is a deterministic, quantitative, high resolution method that inspects pouch seals for defects and seal integrity for consistency.  Testing is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis.

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.

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 micro leak testers evaluate and analyze the integrity of vials and ampoules with precision and repeatability. Test components are optimized for high sensitivity applications and high resolution requirements of the pharmaceutical industry.

CONTACT INFORMATION

PTI Packaging and Inspection Systems

8 Skyline Drive

Hawthorne, NY 10532

UNITED STATES

Phone: 800-532-1501

Fax: 914-337-8519

VIDEOS

  • Container Closure Integrity Testing Technologies - PTI Packaging Technologies & Inspection

    PTI-Packaging Technologies & Inspection is headquartered in Hawthorne, New York, a Westchester county community close to New York City. We are a team of engineers, scientists and professionals serving the packaging industry as a leading equipment manufacturer of package inspection equipment. PTI’s inspection technologies are deterministic test methods that produce quantitative test result data. Our technologies conform to ASTM and other regulatory standards. We specialize in offering our customers the entire solution including test method development and packaging inspection equipment validation. PTI installations have been successful in globally transferable and validated test methods.

  • Seal-Sensor Airborne Ultrasonic Technology

    Seal-Sensor™ is an Airborne Ultrasonic Technology that inspects pouch seals non-destructively 100% online for defects. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and common seal defects that affect product quality and shelf-life.

  • Automated In-Line Pouch Inspection System Assures Package Seal Integrity For Flexible Packaging

    PTI’s VeriPac LPX automated inline pouch inspection system assures package seal integrity of flexible packaging formats.  Non-destructive vacuum decay technology and ASTM Test Method F2338 provides automated quality control using high speed robotic pick & place handling. 

  • Introducing Seal-Sensor™ – A PTI Airborne Ultrasonic Technology

    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.  PTI is working closely with industry leaders in sealing equipment to integrate Seal-Sensor technology for immediate seal check and seal verification.

  • Testing The Integrity Of Flexible Packaging

    The standards of quality for flexible packaging continue to be a challenge for manufacturers. 

WEBINARS

  • Test Method Migration Considerations For CCIT

    In this webinar you will learn about important and critical considerations when shifting to a new or different inspection test method. Also covered is how to assess the test method accuracy, information, data analysis and how to carefully define method transfer objectives for each application. Site-to-site transfer of test methods will also be discussed in this presentation. 

  • The Importance Of Package Integrity To Shelf Life Of Products

    The importance of Package integrity as it relates to protecting a product’s shelf life from manufacturing, through transportation to the consumer or patient. This video will discuss the importance of protecting package contents from critical contaminants – namely oxygen, moisture and bacteria. The challenges associated with transportation will be reviewed and specifically how altitude and latitude affect various packaging formats when packaging defects are present.

  • Important Considerations When Evaluating Manual vs. Automated Vision Inspection Systems

    This webinar takes a look at the pros and cons of manual visual inspection. Join us in taking a deeper dive into this probabilistic test method.

  • Experimental Design And Statistical Tools For Non-Destructive Package Integrity Testing Systems

    This short podcast focuses on experimental design and statistical tools we use with non-destructive package integrity test systems. PTI’s Veripac inspection systems are deterministic test methods for package integrity testing that produce reliable and robust quantitative test data.

CASE STUDIES

WHITE PAPERS

  • Test Method Development, Experimental Design And Positive Controls For Package Integrity

    Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of  positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

  • Container Closure Integrity Testing: The Importance Of Sensitivity, Automation And Efficiency

    This article will explore the need for sensitive, reliable, and automated container closure integrity (CCI) testing technologies, and how existing deterministic solutions can help achieve optimum quality assurance goals in CCI for pharmaceutical manufacturers.

  • Dye Ingress For CCIT: A Poor Bet In A High Stakes Game

    The dye ingress test method continues to be a widely used test method for Container Closure Integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this paper explains why the dye ingress test method is not a suitable approach.

  • New Guidelines Offer Menu Of Standard Sterile Package Tests

    High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated. 

  • An Introduction To Vacuum Decay Leak Testing

    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.

  • Viscous Products No Match For New Container Closure Integrity Technology

    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. 

  • Container Closure Integrity Testing Of Intravenous Bags

    A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.

  • Understanding Ultrasound Technology To Inspect Pouch Seals

    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.

  • Flexible Insights

    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

  • How Important Is The Physical Integrity Of The Blister Package?

    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.

  • Pouch Seal Inspection — Airborne Ultrasound Technology For Better Process And Quality Control

    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

  • Container Closure Integrity Testing For Prefilled Syringes

    In this article, we highlight our current thinking in an attempt to devise a systematic approach for CCI testing method selection, development, and validation.

  • Understanding Vacuum Decay Leak Testing

    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

  • Technology Overview: How To Leak Test Blister Packaging

    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

  • Understanding Pressure Decay Leak Testing For Bottles And Containers

    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

  • Blister Pack Leak Detection: Protecting Product Integrity

    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

  • Container And Closure System Integrity Testing In Lieu Of Sterility Testing As A Component Of The Stability Protocol For Sterile Products

    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.