Blogs CCIT

30
Nov 2021

Evaluating Package Integrity Solutions for Vials

Evaluating Package Integrity Solutions for Vials

Sterile pharmaceutical products including vials are manufactured with extreme accuracy and zero tolerance for error. As a result, pharmaceutical manufacturers place a high value on their quality control procedures. This is to guarantee that the items meet the quality requirements for their intended application. Packaging is essential for maintaining product quality and providing protection from harmful external forces. Package integrity testing, in addition to selecting suitable packing material, is a crucial component in preserving product quality. It prevents external contamination that can have a negative influence on drug quality by ensuring that there are no leaks within the package.

An effective package integrity solution for vials will ensure:

  • The vial is well-protected from external factors that might affect its quality, such as light, oxygen, moisture, and temperature
  • It is safe from contamination

Various Container closure integrity testing (CCIT) technologies are available today. Helium leak detection is one of the leading methods used for testing the container closure integrity of vials.

Helium Leak Detection Technology for CCI testing of Vials

The process of detecting leaks in various enclosed or sealed systems by utilizing helium as a tracer gas and measuring its concentration as it leaves due to leakage is termed Helium leak testing. Simply say, a vial that consists of a container and an elastomeric closure is a good example for package system. The vial is filled with helium and evacuated. The quantity of helium that escapes from the package is quantified and expressed as a leak rate. A prefilled syringe, a foil pouch, or a cold form blister card are another example. Each of these package types is meant to keep the pharmaceutical product enclosed while keeping out potentially harmful environmental pollutants like germs, or even gases.

Helium gas has a number of qualities that make it the best choice for package leak testing

  • As helium gas is one of the smallest molecules, it may reliably and rapidly breach pathways.
  • It is an inert gas that won't react with the components being tested, therefore it's perfectly safe to use.
  • Because of its limited presence in the atmosphere (less than 5ppm), instrument noise from atmospheric helium is intrinsically minimal, resulting in very precise findings.

Following are the advantages of using helium leak detection technology for CCI testing

  • Highly sensitive leak test method for CCI
  • Specially designed for detecting extremely small leaks that other leak test methods failed to detect.
  • The leak test thresholds might be adjusted as low as 1 x 10 -10 cc/s using a high vacuum technique. This allows unique comparison amongst package components.

Sterility of vials is essential for reducing and preventing infection in patients when using the medicine. As a result, package integrity testing is essential for regulatory approval of sterile pharmaceutical products, and medical devices. When it comes to package integrity testing of vials, the terms packaging integrity and container-closure integrity are sometimes used interchangeably.

At CCIT, we provide a wide range of quality leak testing equipment for pharmaceuticals including vials. With our high-grade non-destructive testing equipment, you can ensure that your products meet stringent quality requirements.

Readmore...
container closure integrity testing, container closure integrity, cci technologies, seal integrity testing, seal quality inspection
224
16
Nov 2021

Vacuum Decay Technology for Quality Control Assurance of Parenteral Products

Vacuum Decay Technology for Quality Control Assurance of Parenteral Products

A significant challenge faced by the pharmaceutical industry is insuring the container closure integrity of parenteral products. Therefore, maintaining the quality of parenteral products is critical in order to make sure they are actually sterile and safe for delivery to patients. Parenteral products are often packaged in a variety of formats. Liquid-filled containers, such as ampoules, syringes, and vials are the most prevalent forms. Microbial infection, exposure to gases, and water vapor can all lead to product degradation if the packaging is breached. Pharmaceutical products that save lives might lose their effectiveness or even cause adverse effects. As a result, container closure integrity is an important factor of the lifetime of a sterile pharmaceutical product.

Ensuring quality control with Vacuum decay technology

Vacuum decay is a test technique for determining closed container integrity (CCI) for high-risk packaging applications that provides quantitative and deterministic quality assurance with rapid, consistent, and reliable test results. The Vacuum decay method provides non-destructive and non-invasive leak detection in hermetically sealed containers. This is actually a simple test method and it tests container integrity using basic physical characteristics. It entails drawing vacuum on a package inside a test chamber and checking for any deterioration in the vacuum level, which would indicate a leak. As a non-destructive alternative to the water bath leak test, the approach has gained popularity. It saves money by not wasting items during the leak test.

This technique is applicable to a wide range of packaging formats. The Food and Drug Administration (FDA) has designated the standard vacuum decay leak test technique (ASTM F2338) as a consensus standard for container closure integrity testing. The test technique is mentioned in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and is listed in ISO 11607.  It may be used to evaluate rigid or flexible packaging, as well as plastic, glass, or metal containers, making it useful in the pharmaceutical and food and beverage sectors.

Benefits of using Vacuum decay technology

  • Non-destructive, non-invasive, no sample preparation
  • Cost effective with rapid return on investment
  • ASTM test method and FDA standard
  • Pass/fail results backed by quantitative test data
  • Capability to test multiple packages in a single test cycle
  • Non-subjective, accurate and repeatable results

CCIT.s.a are leading providers of various CCI test methods including Vacuum Decay, MicroCurrent HVLD, and Helium Leak Detection, manufactured by our affiliate PTI Inspection Systems in the United States. We specialize in test method development for all container closure integrity of pharmaceuticals, medical device and nutritional products and package quality testing projects. Our aim is to provide customers with deterministic non-destructive technologies for container closure integrity and then provide full support in the complete implementation of CCI systems.

Readmore...
container closure integrity testing, container closure integrity, CCI test, seal integrity testing, vacuum decay technology
286
02
Jun 2021

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Talking about medical devices, ensuring seal quality or seal strength of sterile medical device packaging are extremely crucial as well as highly regulated. Medical device package seal contains a flexible barrier which is joined to the rigid container through an advanced adhesive. A defect in the seal such as an incomplete or weak seal can initiate leaks, contaminating the product and reducing its shelf life. Hence, for quality control purposes, seal quality inspection of medical device packages is mandatory.

Historically, manual inspection was the most popular method used to inspect seal defects. Although this is covered by an ASTM method (ASTM F1886), it lacked accuracy and reliability in terms of test results. “There is a huge shift in the industry towards deterministic and quantitative test methods,” comments Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes Vacuum Decay and Airborne Ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Airborne Ultrasound technology is a non-destructive seal integrity test method capable of advanced seal quality inspection of pouches and flexible packaging. Seal defects can be of two types- leak defects and non- leak defects. While it is easier to detect a leak defect, detecting non-leak defects can be a challenge for manufacturers. However, Airborne Ultrasound technology allows non-destructive Container Closure Integrity testing of multiple seal defects including visible and invisible, leaking and non-leaking, process-related and random- making it a practical solution for medical device seal quality inspection.

Technology overview

Airborne Ultrasound technology utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. In the presence of a leak, the signal strength is either eliminated or reduced. Such variations in signal strength are analyzed to identify the defects. Seal scan testing is a practical solution to recognize defects, such as inconsistent seals or areas of seals that fail to meet minimum width requirement. Seal-Scan® and Seal-Sensor utilize non-contact airborne ultrasonic testing technology for advanced seal quality inspection. Seal-Scan® technology has been proven in the field by several online and offline units installed.

Benefits of Airborne Ultrasound technology

  • Deterministic seal quality inspection method that produces quantitative results.
  • This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.  
  • Non-destructive and non-subjective test method that requires no sample preparation.
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable, reproducible and reliable results for seal quality inspection.
  • Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal. 
Readmore...
container closure integrity testing, seal integrity testing, seal quality inspection, airborne ultrasound technology
773

Popular Blogs

Tags

Why Microcurrent HVLD is the most preferred CCI technique for Parenteral Product Leak Testing ?

May 24, 2021   |   924

Microcurrent HVLD is one of the most preferred container closure integrity testing method for Biological & Parenteral Product Leak Testing

Airborne Ultrasound Technology for Efficient Medical Device Package Inspection

May 28, 2021   |   866

Package integrity testing of medical devices is vital to ensure the products maintain quality and sterility throughout its shelf life or until it is administered.

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Jun 02, 2021   |   773

Evaluating quality and integrity of package seal is an important criteria for medical device package inspection. Airborne Ultrasound technology allows non-destructive seal quality inspection of multiple device packages.

Pharma Package Testing CCI of High-Risk Pharmaceuticals

May 21, 2021   |   589

Pharma package testing now has become an integral part of the pharmaceutical industry when it comes to the package integrity of high-risk pharmaceuticals.

How has VeriPac Systems Raised Standards for Container Closure Integrity Testing

Jul 02, 2021   |   544

The VeriPac test methods are non-destructive, non-invasive inspection system for CCI and package integrity testing.
COPYRIGHT 2020, CCIT, ALL RIGHTS RESERVED PRIVACY AND COOKIES TERMS OF USE
Popup