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.

HOT PRODUCTS

The quality testing of medical device packaging is highly significant in ensuring the safe delivery of medical devices from their place of origin to the market. Guidance documents such as ISO 11607 provide a list of methods that have the capability to improve the package quality testing of today’s capability. PTI offers inspection methods that provide more reliable, sensitive, and traceable data. They offer in-depth feasibility studies, test method development, and test equipment to bring the supreme level of quality to high-value medical device applications. PTI’s inspection solutions are unique in their performance, reliability, and use of sensory technology.

The most current model, the Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Such an approach allows a comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle.

There have been many advances over the past decade in terms of drug product delivery methods. As a result, key developments like unique cartridge based delivery systems have become common. It is well documented that Helium mass spectrometry is most suited for non-porous packaging such as vials and syringes. The same methodology can also be applicable to cartridge based delivery systems. In most cases the key to success is the development of a text fixture device designed and manufactured to the specific cartridge system being testing. These custom fixtures for helium leak detection can be designed to isolate specific areas of interest in the cartridge system.

Integrity testing of foil pouches offers a unique set of challenges. In most packaging processes that involve foil as the product barrier there is a concern about the incidence of punctures in the foil. These defects (typically called micro-voids) can be created as the foil is being rolled in thin sheets and tiny particles are inadvertently rolled into the foil. The most common defect is caused from the handling of the packages during the assembly of the foil and insertion of the drug product.

A helium based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach due to the extreme sensitivity offered. The test method relies on detecting helium sealed in the package system as it escapes through micro-channels in the package. A test sequence begins by placing the package in the test fixture and a vacuum is quickly drawn. The resulting pressure differential causes helium to escape through potential holes or cracks in the package.

Bottles come in a wide array of sizes and configurations, reflective of their diverse use in the health sciences industry. Typically, they exhibit a screw top closure threaded onto the bottle mouth, though sealing properties ranges from elastomeric liners, to o-rings, to induction seals and reliance on plastic-to-plastic contact and compression. One specific trend is the increase in need to test sterile bulk containers or sterile API containers. As the industry continues to move toward outsourcing or even insourcing through a network of suppliers or sites, transport of sterile drug product or API is becoming increasingly common. These types of containers are traditionally challenging to test, but can be qualified prior to use or as a proof of concept using helium leak detection.

With the advent of more advanced drug development for a wide variety of injectable compounds and an increasing preference for self-administration, prefilled syringes are the largest parenteral package growth sector. In many ways, the prefilled syringe is more complex and intricate in comparison to a traditional vial, a sealed ampoule, or bottles with screw top closures. They have multiple sealing sites that require integrity, but there is also a functionality piece associated: the syringe plunger must be able to deliver a dose, and thus, is movable.

Parenteral products, specifically Vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. The primary sealing interface of a traditional vial system is between the elastomeric closure and land seal of a vial, physically compressed together by a crimped aluminum seal.

Helium leak detection (HeLD) is routinely used and widely accepted for applications that require the utmost leak sensitivity.

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.

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.

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

  • Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium based leak detection system. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This quantitative approach allows direct comparison across various packaging materials and forms, production line settings and stability storage conditions, supporting the entire lifecycle.

  • The VeriPac LPX from PTI is the next generation automated inspection system for container closure integrity testing of parenteral products. This product features automated CCI for prefilled syringes and vials using PTI’s vacuum decay technology.  The VeriPac LPX features a dynamic design tailored to fit your production requirements.

  • 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™ 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.

  • 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. 

WEBINARS

CASE STUDIES

WHITE PAPERS

  • Test Method Development, Experimental Design And Positive Controls For Package Integrity
    4/9/2020

    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: Sensitivity, Automation And Efficiency
    4/6/2020

    Explore the need for sensitive, reliable, and automated container closure integrity testing technologies, and how existing deterministic solutions can help achieve optimum quality assurance goals.

  • Dye Ingress For CCIT: A Poor Bet In A High Stakes Game
    3/23/2020

    The dye ingress test method continues to be a widely used test method for Container Closure Integrity. This paper explains why the dye ingress test method is not a suitable approach.

  • New Guidelines Offer Menu Of Standard Sterile Package Tests
    3/5/2019

    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
    10/9/2018

    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
    9/5/2018

    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
    8/21/2018

    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.