Glossary Term
Shelf Life
Definition
Shelf life refers to the length of time that a product, particularly a medical device, pharmaceutical product, or consumable, can be stored and remain effective, safe, and stable for use. It is the period during which a product maintains its intended quality, performance, and safety when stored under specified conditions. Shelf life is determined by factors such as the product’s composition, packaging, storage conditions, and the stability of its active ingredients or materials. Once the shelf life expires, the product may lose its effectiveness, become unsafe, or degrade beyond the acceptable standards.
Relevance to the MedTech Industry
Shelf life is a critical consideration because it ensures that products such as medical devices, pharmaceuticals, and biologics maintain their safety, efficacy, and performance until they are used. Shelf life is particularly important for products that are used to treat or diagnose patients, as compromised product quality can directly affect patient outcomes. Ensuring that medical devices and drugs remain safe and effective for their entire shelf life also plays a key role in regulatory compliance, inventory management, and product recall strategies. Manufacturers need to determine shelf life early in the development process and ensure proper storage and handling throughout the product’s life cycle.
Additional Information & Related Terms
Key Factors Affecting Shelf Life
Product Composition:The ingredients or materials used in a product, whether it’s a pharmaceutical drug, a medical device, or a consumable item, can significantly impact its shelf life. The stability of these components determines how long the product can retain its effectiveness.
Packaging:The packaging of a product plays a significant role in protecting it from environmental factors like moisture, oxygen, and light, which can degrade the product. Appropriate sealing, protective barriers, and tamper-evident features are essential for extending shelf life.
Storage Conditions:Temperature, humidity, and light exposure during storage can all influence the shelf life of a product. Manufacturers specify storage conditions to ensure that products maintain their quality throughout their shelf life.
Microbial Stability (for pharmaceuticals or biologics):For biologics, drugs, and other sterile products, microbial stability is a critical factor. The presence of contaminants can degrade the product more rapidly, reducing its shelf life.
Related Terms
Expiration Date: The date after which a product is no longer guaranteed to maintain its safety, efficacy, or stability. Often linked to shelf life.
Stability Testing: The process of testing a product under various conditions to determine its shelf life and ensure it maintains its quality over time.
Good Manufacturing Practices (GMP): Guidelines ensuring products are consistently produced and controlled according to quality standards, including shelf life considerations.
Storage Conditions: The temperature, humidity, and environmental factors under which a product must be stored to maintain its shelf life.
Regulatory Approval: The process by which a product, including its shelf life, is reviewed and authorized by regulatory bodies like the FDA to be marketed and sold.