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.

• Risk Mitigation Of Parenteral Packaging With Container Closure Integrity

  Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress.

• 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

• Deconstructing The Blue Dye Leak Test Method

  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

• 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.