Glossary Term
Seal Strength Testing
Definition
Seal strength testing refers to the process of evaluating the integrity and durability of the seals used in packaging, particularly for medical devices and pharmaceutical products. This testing measures the ability of a seal to maintain its function (e.g., preventing leakage, contamination, or degradation) under various conditions, such as stress, temperature, or pressure. Seal strength testing ensures that packaging materials (e.g., pouches, blister packs, and sterile barriers) meet the required standards for product safety and efficacy, preventing failures that could compromise the quality of the product or its sterility.
Relevance to the MedTech Industry
Seal strength testing ensures the reliability of packaging seals, which play a critical role in preserving the safety, sterility, and quality of medical devices and pharmaceuticals. This testing verifies that the packaging can withstand handling, storage, transportation, and environmental factors without compromising the product inside, thus ensuring that the product reaches the end user in the intended condition. For medical devices, proper seal strength is essential to avoid contamination or product failure, which could impact patient safety.
Additional Information & Related Terms
Key Methods for Seal Strength Testing
Peel Testing:Peel testing is one of the most common methods used to measure seal strength. It involves pulling the two sides of the packaging apart and measuring the force required to separate the seal. The results indicate the strength and consistency of the seal.
Tensile Testing:Tensile testing measures the force required to stretch or break a seal. This method provides data on the seal's durability and its resistance to physical stress during transportation and storage.
Burst Testing:Burst testing is used to assess the strength of seals under internal pressure. The seal is subjected to increased pressure until it breaks, which helps to determine the seal's ability to withstand internal stresses, such as gas or vacuum conditions.
Seal Integrity Testing:This testing evaluates the overall performance of a seal, including whether it is capable of maintaining sterility and protecting the contents from contamination. Techniques like dye penetration or vacuum decay testing may be used.
Related Terms
Sterilization Packaging: The packaging used to maintain the sterility of medical devices or pharmaceuticals, which must pass seal strength tests to prevent contamination.
ISO 11607: A standard that outlines the requirements for packaging of terminally sterilized medical devices, including seal integrity.
Peel Strength: A measure of the force required to separate the seal of a packaging material, often used to evaluate seal strength.
Good Manufacturing Practices (GMP): Regulatory guidelines that ensure the quality and integrity of medical device manufacturing, including packaging and seal strength.
Barrier Properties: The ability of packaging materials to prevent the ingress of contaminants such as bacteria, moisture, and gases, ensuring the integrity of the seal.