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.
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.
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.
Seal-Scan Medical Device Case Study
High product costs and superior quality requirements are the two single reasons for successful integration of airborne ultrasound seal inspection for medical device packaging. This case study focuses on the use of Seal-Scan® for final seal quality verification for an implantable sterilized medical device.
Innovative Packaging For A Two-Component Device Inhaler
WALDNER solves a packaging challenge for a global pharmaceutical company with an ingenious filling and sealing machine.
Comparison Of Helium vs. Microcurrent HVLD Leak Testing Technologies
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.
Prefilled Syringe Leak Detection With Vacuum Decay vs. HVLD Test Methods
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 Package Inspection
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
How Does Vacuum Decay Leak Testing Cut Waste? A nondestructive integrity-testing method will help an implant maker expand its testing program with little effort.
Seal Inspection For An Implantable Sterilized Medical Device
Medical device manufacturing is a labor intensive process, requiring operator involvement from manufacturing through final inspection of products.
Ophthalmic Product Package Inspection
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.
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.
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.