Drug interaction with the containment solution is a critical risk to the drug’s efficacy. Proper evaluation verifies the compatibility of the drug formula with the system’s contact materials. Drug interaction testing serves to:

• Ensure drug efficacy – verifying that the container does not alter the therapeutic effects of the drug.
• Ensure safe storage – confirming the absence of critical toxic by-products from drug-container interaction during storage.

Drug-container interaction testing involves detailed analysis of how the drug interacts with the container, predicting potential chemical and physical changes during storage time. Testing methods include: 

• Delamination studies – assesses the risk of material degradation and its impact on the drug.
• Particle analysis – counts and characterizes particles resulting from drug-container interaction.
• Extractables studies – evaluates potential chemicals that might leach from the container.
• Leachables studies – investigates the impact of leachables on drug stability and patient safety.
• Elemental impurities analysis – ensures no harmful elements are present in the packaging.

Effective container closure integrity is critical to safeguarding the sterility and quality of a pharmaceutical product across its lifetime. Proper testing enables the assessment of a drug product’s packaging for the risk for leakages. CCIT serves to:

• Ensuring drug efficacy and safety – it verifies the system design to support the sterility and stability of a pharmaceutical product.
• Proof regulatory compliance – it aligns with global standards, including FDA and EMA guidelines.
• Confirms robust design – it proves effectiveness against contamination and integrity breaches.

CCIT ensures that containers such as vials and syringes are impermeable to contaminants, which is a vital aspect of patient safety and drug efficacy. CCIT includes the following tests: 

• Dye penetration test – identifies microscopic leaks in container seals to verify seal integrity.
• Headspace analysis – assesses the change in gas composition within sealed containers over time to determine the ability of gas to permeate into the container closure system.

Functional testing validates a product’s design to satisfy the application-specific user requirements and regulatory standards. Functional testing serves to:

• Assure performance – it validates the container’s operational reliability and effectiveness.
• Ensure system compliance – it matches stringent industry and safety regulations.

This group of tests validates the system’s design in providing reliable functionality under the specific conditions of the intended use and across the entire product lifetime. This is especially relevant for combination products such as drugs in prefilled syringes or injection devices. Typical test methods characterize the system for:

• Break loose and gliding force – assesses the ease of dispensing.
• Deliverable and residual volume – for accurate dosage and minimal waste.
• Liquid leakage – ensures container integrity under a variety of conditions.
• Septum resealability – validates the closure’s ability to reseal post-penetration.
• Flange and Luer Cone breakage resistance – tests the mechanical strength against breakage.