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.
PTI Packaging and Inspection Systems
8 Skyline Drive
Hawthorne, NY 10532
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.
Non-destructive package integrity testing and leak detection of dry-filled flexible packaging, pouches, stick packs and sachets. More efficient and cost effective than destructive test methods. Non-destructive, non-subjective results, no sample preparation, zero waste. PTI’s vacuum decay leak testing technology (ASTM F2338). Test multiple packages in a single test cycle. Rapid pass/fail results and quantitative test data.
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.
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.
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.
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
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.