USP <382>
United States Pharmacopeia 382 focuses on the functional suitability of packaging and delivery systems’ functional suitability requirements for parenteral dosage forms. These dosage forms include injections and implanted drug products and contain primary packaging components made of elastomeric material. Elastomeric components are designed to protect and contain the system’s contents while allowing safe and effective product access at the time of use.
The tests for functional suitability described in this chapter are intended to evaluate the fitness of an elastomeric component as part of a specific, final, parenteral product packaging and delivery system. These system-specific tests are designed to supplement an overall drug product packaging and delivery system development program. The tests provided in this chapter are not exhaustive, and additional tests may be required to adequately assess the functional suitability of a given packaging and delivery system for a particular product. Reevaluation of the functional suitability of a commercialized product’s packaging and delivery system may be required over the product’s life cycle when changes in components, processes, or the product itself occur.
Advanced Assurance: USP 382 Compliant Solutions
The function performed by an elastomeric component type depends on the packaging and delivery system, and it may cover more than one functional parameter. In all cases, the elastomeric component acts as a seal, protecting the drug product from product loss and contamination by microorganisms and other environmental contaminants. In dual-chamber packaging and delivery systems, an elastomeric component keeps drug product components separate and limits excessive migration of solvents or gases between chambers.
The Gold Standard in Drug Delivery Systems
Additional functional requirements depend on the intended use of the individual packaging and delivery system. In all plunger-based packaging and delivery systems, such as cartridge and syringe systems, the elastomeric component (i.e., the plunger) must move to empty the container upon demand. Tests are provided to evaluate these systems, including the Plunger Break-Loose and Extrusion Forces and Plunger Seal Integrity tests. Some elastomeric components are designed to be singly pierced by a spike or needle, sometimes repeatedly. In this scenario, penetrability, fragmentation, and self-sealing capacity assessments are relevant.
Offering The Precision Your Drug Delivery Systems Require
The proper selection and design of functional suitability assessment studies are based on sound scientific principles that are consistent with the packaging and delivery system design and mechanics, the nature of the pharmaceutical dosage form contained and delivered by the packaging and delivery system, the physical environment to which the finished drug product will be exposed during the product life cycle, the clinical setting and how the product dosage form is to be administered, and the assessed safety risks to those using and/or exposed to the contents of the packaging and delivery system during patient administration.
About Elastomeric Components
The function performed by an elastomeric component type depends on the packaging and delivery system, and it may cover more than one functional parameter. In all cases, the elastomeric component acts as a seal, protecting the drug product from product loss and contamination by microorganisms and other environmental contaminants. In dual-chamber packaging and delivery systems, an elastomeric component keeps drug product components separate and limits excessive migration of solvents or gases between chambers.
Gateway Analytical: Advance with Assurance
Our team is well-versed in the requirements for elastomeric components in pharmaceutical packaging, helping you ensure that your products are both safe for use and compliant with regulatory standards.
Functional Suitability Testing Made Easy
The proper selection and design of functional suitability assessment studies are based on sound scientific principles that are consistent with the packaging and delivery system design and mechanics, the nature of the pharmaceutical dosage form contained and delivered by the packaging and delivery system, the physical environment to which the finished drug product will be exposed during the product life cycle, the clinical setting and how the product dosage form is to be administered, and the assessed safety risks to those using and/or exposed to the contents of the packaging and delivery system during patient administration.
USP 382 Compliant Solutions
Additional functional requirements depend on the intended use of the individual packaging and delivery system. In all plunger-based packaging and delivery systems, such as cartridge and syringe systems, the elastomeric component (i.e., the plunger) must move to empty the container upon demand. Tests are provided to evaluate these systems, including the Plunger Break-Loose and Extrusion Forces and Plunger Seal Integrity tests. Some elastomeric components are designed to be singly pierced by a spike or needle, sometimes repeatedly. Penetrability, fragmentation, and self-sealing capacity assessments are relevant in this scenario. Tailor your elastomeric components for maximum protection and functionality in drug delivery systems. Explore our testing services for cartridge and syringe systems today .
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
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