Packaging Material Testing is a vital aspect of Quality Control, ensuring that product containers and packaging components — especially those used for pharmaceutical materials, medical devices, and food products — are suitable for their intended use, demonstrate no adverse interactions with the product, and prevent deterioration during storage throughout the product’s shelf life.
While package testing may involve determining physical properties, chemical testing may also be vital. Butterworth Laboratories can help with these important aspects of Quality Control. We have experience in the required testing using both qualitative and quantitative techniques.
Our Pharmaceutical Packaging Material and Container Testing Services support pharmaceutical manufacturers with packaging compliance, material analysis, container suitability and quality assurance testing.
Extractables & Leachables
Extractables and Leachables are materials that migrate from the container or packaging and may contaminate the product. Both the European and US pharmacopoeias provide monographs for glass and plastic additives used in containers and packaging systems. Our services include identification and physical properties, such as melting points, of polymers.
Ethylene Oxide Sterilisation Residues
Butterworth has assisted clients in controlling ethylene oxide and its hydrolysis residues in accordance with ISO 10993-7:2022 for an extensive range of medical devices and packaging materials, including process developments.
Residual Oxygen and Moisture in Modified Atmospheric Packaging (MAP) Systems
The presence of oxygen can cause product deterioration through oxidation. Butterworth has developed bespoke in-house sampling techniques for Modified Atmospheric Packaging (MAP) systems analysis across all commonly used packaging forms, such as plastic containers, blister packs and glass vials. Moisture can also interact with susceptible products, leading to degradation. Butterworth has also developed in-house procedures for determining residual moisture in packaging for our clients.
Pressurised Gas Containers
Butterworth has extensive experience in the identification and quantification of propellants in pressurised containers, such as aerosol cans. This includes both percentage and trace quantities of residual oxygen.
Why use Butterworth Laboratories Limited?
We have highly motivated staff and extensive experience, developed over many years, to demonstrate true expertise in all of the above QC testing requirements, across both the pharmaceutical and other industries, using published standards and in-house procedures. We can also offer advice on sampling and sample transport operations, which, especially for ethylene oxide determinations, are vital to achieving accurate results and regulatory approval.
Frequently Asked Questions
Packaging material testing evaluates whether containers, closures, blister packs, vials, medical device packaging, and other packaging systems are suitable for their intended use. Testing helps confirm product compatibility, stability, safety, and compliance with relevant pharmacopoeial and regulatory requirements.
Packaging materials can interact with the product over time, potentially affecting quality, safety, efficacy, or shelf life. Compatibility testing helps identify risks such as contamination, adsorption, oxidation, moisture ingress, or chemical migration from packaging components.
E&L testing identifies chemicals that could move from the packaging into the product. Extractables are compounds that can be pulled out under extreme conditions, while Leachables are what actually migrate into the product during normal storage
Manufacturers typically retest when there is a change in barrier materials, sterilisation processes, manufacturing locations, or even the product’s shipping configuration.
Packaging testing helps evaluate how packaging materials protect products during storage by assessing factors such as oxygen ingress, moisture content, chemical migration, and material compatibility throughout the product’s shelf life.
Explore some of the techniques we commonly use for the testing of packaging materials:
