Functional Suitability Testing

Functional Suitability testing is essential in determining the physical properties of materials used in pharmaceutical products. ThisĀ process evaluates how a material will react under different loads and stress conditions and is essential in the design andĀ development of products. Our comprehensive testing methods include compression and tensile, leak, penetration, glide force, break-loose force testing, and beyond.

Gateway Analytical specializes in functional testing for pharmaceutical applications, focusing on materials used in drug delivery devices and packaging systems. This includes testing for syringes, vials, and cartridges, ensuring they meet the rigorous demands of the industry. Our advanced suite of Functional Suitability testing services are designed to rigorously evaluate the resilience and performance of your pharmaceutical products and packaging. For comprehensive Functional Suitability testing services that enhance the quality and performance of your pharmaceutical products, choose Gateway Analytical.

Where precision is non-negotiable; functional suitability testing services from Gateway Analytical provide the assurance of excellence and reliability.

Gateway Analytical - Analysis Solutions

Standard Functional Suitability tests used in the pharmaceutical industry include:

1. Compression & Tensile Testing: These tests evaluate the strength and durability of drug delivery devices, such as syringes and inhalers.

2. Leak Testing: This test assesses the container closure integrity of drug packaging systems, such as vials and cartridges, to ensure they are properly sealed and leak-free.

3. Needle Penetration Testing: This test is used to evaluate the penetration force required to insert a needle into a drug delivery device, such as a syringe or a pen injector.

4. Glide Force Testing: This test evaluates the force required to move a plunger within a syringe or pen injector.

5. Break Loose Force Testing: This test is used to evaluate the force required to initiate the movement of a plunger within a syringe or pen injector.

Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.