CCI Testing to Support Product Packaging
Employ our container closure integrity (CCI) testing programs to provide accurate, sensitive, and reliable data regarding your product packaging performance. This information enables you to characterize packages and materials, optimize sealing parameters, evaluate package storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages, and support regulatory submission applications. Our testing is well suited for assisting your team in maintaining sterile packages that demand the highest degree of product protection to ensure safety and efficacy for the end patient.
We offer numerous sophisticated programs for assessing package system integrity, including all crucial instrumentation for deterministic test methods as outlined in USP <1207>. Our services range from feasibility assessments to full method optimization and validation programs to stability program storage and routine testing.
Our cGMP, FDA-registered Container Closure Integrity laboratory for USP <1207> technologies is powered by unparalleled experience, leading-edge test approaches, and advanced industry standards to ensure you have a quick and stress-free testing experience.
Key Considerations for End-to-End Primary Packaging Solutions for Pharmaceuticals & Medical Devices
Packaging systems are integral to delivering a safe, intact finished product to the end user. These systems should be carefully selected and developed by assessing product integrity and compatibility throughout the intended lifecycle. Our experts recommend incorporating various analytical tests to gauge the packaging’s ability to withstand environmental conditions and its effects on product strength, purity, safety and efficacy.
In this webinar, we provide guidance about the relevant tests available, what regulatory agencies often expect to be performed, and associated packaging system challenges to anticipate.
Integrity Test Methods
This testing is applicable to any nonporous package containing headspace, including parenteral vial packages, screw-capped bottles, auto-injectors and injection devices, and select syringe package systems, as well as flexible bags or pouches, making it a very versatile CCI technology platform. We conduct all standard vacuum decay tests based on ASTM F2338-09. Our method optimization produces reliable and sensitive test methods suitable for continued stability and release testing usage.
The nondestructive vacuum decay test facilitates the identification of package leaks that may not be visibly detectable. We place the test package into a custom-designed test chamber and expose it to a predetermined system vacuum. Sensitive pressure transducers monitor changes in the chamber pressure resulting from package headspace being drawn through any present leak paths. Using acceptance criteria established through method development and validation, our scientific experts judge the quantitative test results as pass or fail.
We perform high voltage electrical conductivity testing on a range of package systems, including parenteral vials, prefilled cartridges and syringes, and plastic containers. High Voltage Leak Detection (HVLD) testing is used for packaging materials including glass, CZ resin, and plastic, which offers a variety of solutions for liquid product filled packages.
This highly sensitive method detects package defects, such as clogs by product formulation proteins or salts. Stability studies support the use of this technology for nondestructive leak testing for a variety of product formulation types.
High voltage leak detectors reveal the presence of a leak and indicate its potential location in the wall of a nonporous package (whether rigid or flexible) that contains liquid product. When a leak path occurs near an electrically conductive liquid, the electrical resistance drops in the test sample, as evidenced by a spike in the current above the predetermined pass/fail limit. Our expert team is experienced in optimizing HVLD test parameters to produce the best possible test method to achieve a sensitive test method with fully consistent defect detection.
In accordance with ASTM F2391, we use helium mass spectrometry to measure the package and seal integrity of packaging such as vials, syringes, cartridges, bottles, and unique packages. We also apply helium mass spectrometry using appropriate test fixtures and techniques to assess flexible packaging. Using a special cryogenic test chamber, our team performs Helium Leak Detection on package systems at frozen temperatures.
Helium Leak Detection testing accurately assesses the performance of an established package and analyzes the effect of processing variables, such as capping force, residual seal force, capping torque, or the pairing of closure materials, on the performance of a package system.
We report results quantitatively (calculated as a leak rate) or qualitatively (pass or fail) upon completion of method development. With the addition of a method validation, our test methods are also able to be utilized for stability testing. Suitable for use with both empty and filled package systems, Helium Leak Detection offers a wide range of applicable testing options to provide vital information on a package system’s inherent integrity.
Given the nondestructive nature of headspace analysis, we perform it repeatedly over time to provide a quantitative measure of a sample’s leak rate. This technology is especially applicable when verifying the integrity of packages that must maintain a specific gas headspace content due to oxygen- or moisture-sensitive product. In addition, we apply this technology to assess leakage that may occur during ultra-cold or cryogenic storage resulting from conditions below the glass-transition temperature of packaging components.
Laser-based analysis provides a quantitative, nondestructive measure of oxygen, nitrogen, carbon dioxide, water vapor or internal pressure in nonporous, rigid, or non-rigid packaging headspace. The results ensure the sterility, potency, and quality of your product when oxygen, moisture, or frozen conditions are a concern.
As a destructive test, we use dye ingress leak detection to measure the package integrity of nonporous rigid or flexible packaging, such as liquid-filled vials, syringes, cartridges, and bottles. Our innovative sample conditioning approach utilizes UV-Vis technology for dye ingress testing to produce quantitative test results which enables a reliable and sensitive version of the established technique.
Our microbiology experts provide customized and standard microbial tests for container closure integrity inspection. We use microbial ingress leak detection to measure the package integrity of nonporous rigid or flexible packaging, such as liquid-filled vials, syringes, cartridges, and bottles.
Distribution Testing
Distribution simulation testing provides a uniform and repeatable way of evaluating packaged products and packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.
Package Testing
We offer packaging testing across strength, integrity, and performance endpoints, spanning various product types, including pharmaceuticals, medical devices, drug delivery/combination products, and select over-the-counter consumer products.
Integrated Laboratory Services
When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.