Container Testing

A critical step in understanding the biological safety and suitability of a packaging system is the ability to characterise the materials and chemicals that have the potential to migrate through the barriers of a packaging component or system, resulting in contamination or degradation of the medical device, altering its chemical composition or functionality.

Eurofins Medical Device Testing performs testing on a multitude of packaging systems and components. There are a number of compendia procedures and FDA guidelines designed to ensure that the composition and functionality of the packaging component or system is appropriate for medical devices in various phases. We utilise these regulations and guidelines to ensure packaging systems and components meet these requirements.

Choose Eurofins Medical Device Testing to help you:

• Provide the expertise to successfully complete testing per various regulatory requirements and client-specific test procedures.
• Utilise general platform methods to support a variety of testing and streamline your testing approach.
• Gain access to a full scope of testing to identify, characterise, and evaluate the suitability and functionality of packaging systems and components.

Common Types of Materials Tested

Plastic Materials

Our service offering extends further to cover a full evaluation of the elemental and biological compositions of the materials. We have the capability to test plastic packaging systems and components of various shapes, sizes, thickness, and composition.

Sample Types

• Container-Closure Systems
• Resins
• Bottles and Bags
• Films and Foils
• Finished Products
• Components

Test Methods and Procedures

• USP <661> Plastic Packaging systems and Their Materials of Construction
• USP <661.1> Plastic Materials of Construction
• USP <661.2> Plastic Packaging System for Pharmaceutical Use
• USP <85> Bacterial Endotoxins Test
• USP <87> Biological Reactivity Tests, in Vitro
• EP 3.1 Material used for the Manufacture of Containers
• EP 3.2.2 Plastic Containers and Closures for Pharmaceutical Use
• JP 7.02 Test Methods for Plastic Containers
• Eurofins General Platform Methods
• Client Supplied Analytical Standards/Test Procedures

Technique Highlights

• Performance Testing
• Moisture Vapor Permeation Testing
• Desiccant Classification Testing
• Spectral Transmission Testing

Rubber Materials

This scope of testing includes a complete service offering for fitness-for-duty suitability assessments. In addition, the chemical and biological suitability of rubber closures can be evaluated using compendia test methods. We have the capability to test rubber closures of different configurations and compositions.

This would apply to coated and uncoated rubber materials.

Eurofins Medical Device Testing provides additional miscellaneous services to determine the biological reactivity and biological suitability of rubber materials.

Sample Types

• Closures
• Plungers
• Tip Caps and Needle Shields
• Injection Ports
• Seal Liners
• Components in Delivery/Injectable Systems

Test Methods and Procedures

• USP <381> Plastic Packaging systems and Their Materials of Construction
• USP <382> Elastomeric Component Functional Suitability in Parenteral Product/Delivery Systems
• USP <788> Particular Matter In Injections
• USP <71> Sterility Test
• USP <87> Biological Reactivity Tests, in Vitro
• EP 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and For Freeze-Dried Powders
• EP 2.6.1 Sterility Tests
• JP 7.03 Tests for Rubber Closure for Aqueous Infusion Systems
• JP 4.06 Sterility Tests
• JP 6.07 Insoluble Matter Test for Injections
• Eurofins General Platform Methods
• Client Supplied Analytical Standards/Test Procedures

Technique Highlights

• Functionality Testing
• Penetrability
• Self-Sealing Capability
• Identification Testing

Glass Materials

Eurofins Medical Device Testing provides information on the suitability of the glass used in packaging systems in addition to the surface and inner glass compositions supporting the packaging system’s durability or elemental composition.

Sample Types

• Tubes
• Vials
• Bottles
• Delivery Systems

Test Methods and Procedures

• USP <660> Glass Containers
• EP 3.2.1 Glass Containers for Pharmaceutical Use
• JP 7.01 Test for Glass Containers for Injection
• Eurofins General Platform Methods
• Client Supplied Analytical Standards/Test Procedures

Desiccants and Pharmaceutical Coils

Eurofins Medical Device Testing provides a complete evaluation of auxiliary packaging components, which include materials such as desiccant and pharmaceutical coils that are used as a supporting material in packaging system.

Pharmaceutical Coils Sample Types

• Cotton Coil
• Rayon Coil
• Polyester Coil

Desiccant Sample Types

• Bentonite
• Calcium Chloride
• Calcium Oxide
• Molecular Sieve
• Silica Gel

Test Methods and Procedures

• USP <670> Auxiliary Packaging Components
• Eurofins General Platform Methods
• Client Supplied Analytical Standards/Test Procedures

Technique Highlights

• Moisture Adsorption Capacity Studies