PDA Technical Glossary

Ethnographic research method used to observe and analyze behaviors in actual end-use contexts (actual environments and use scenarios). (TR73)

A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.

Thermoplastic material formulation (that may or may not contain rubber/natural latex) derived from elastic polymer; often used interchangeably with the term “rubber.” (TR73)

A chemical component that is removed from a material by application of an artificial or exaggerated force (e.g., solvent, temperature, time). The term extractable is often erroneously used to describe a leachable. (TR14) (TR15) (TR26) (TR41) (TR45) Chemical substances that can be extracted from components of material process fluid contact surfaces by exertion of an exaggerated force (e.g., organic solvent, extreme elevated temperature, ionic strength, pH, contact time, etc.) Extractables may represent most but not all of the potential leachables that may be seen in process fluids. (TR66) Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. (TR54-4) Organic or inorganic chemical entity that is forced out of container closure system materials and components under laboratory experimental conditions. (TR73)

Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)

Amount of fluid remaining in the syringe when the plunger has reached the end of travel within the barrel. (TR73)

A science discipline that examines human psychological, social, physical, and biological characteristics to evaluate the design, operation, or use of products or systems for optimizing human performance, health, safety, and/or habitability. [Synonym: Ergonomics] (TR62)(TR80)

In the hands of the end user who can be the health professional or the patient. In-Use refers to the time period where product is in the custody of the end user or health care professional. (TR53)

A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)

A thin, hollow, metal tube commonly used with a syringe to inject substances into the body. (TR73)

Rigid or flexible polymeric substance used to seal and protect the needle. (TR73)

A safety feature or mechanism that effectively reduces the risk of an exposure incident (e.g., accidental needlestick). (TR73)

Rigid plastic support placed into a tub to keep syringes upright with sufficient separation to allow for easy manipulation by manual or automated fill-line systems. (TR73)