The pharmaceutical industry continues to bring breakthroughs in the field of new vaccines and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.

The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.

PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.

A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).

Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing, is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality integrity testing.

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.

Non-destructive package testing of multi-cavity blisters – completely tool-less for different blister formats.

The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.

Container Closure Integrity (CCI) is defined as whether the container is maintaining a sterile barrier. Intravenous (IV) bags are crucial in delivering fluids or medication quickly. Leaking parenteral packages are considered an extremely high risk as they deliver fluid directly into the bloodstream and have a high potential for microbial growth, requiring the need for sensitive and reliable CCI testing.

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.

This poster presentation explains a new technology for integrity testing/leak detection for all parenteral and biologic products including low conductivity liquids such as sterile water for injection (WFI).

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. 

Multicavity blister packs and low headspace packaging use a variety of test methods to determine package integrity, with most being destructive, subjective, and unreliable.

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.

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. 

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.

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

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.

The VeriPac 310 is a non-destructive, non-invasive inspection system for leak detection and package integrity testing.

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.