In an industry defined by innovation, one essential element quietly shapes the success of every injectable therapy: parenteral packaging. Parenteral packaging may sound technical, but its purpose is straightforward - it is the primary container system that holds, protects, and delivers sterile drug products to patients.
“Parenteral” refers to drug products administered by injection, bypassing the gastrointestinal tract. Depending on therapeutic requirements, these injections are delivered through several main routes, each chosen to optimize onset, duration, and patient experience (see illustration and table below).

The global pharmaceutical landscape is experiencing a major shift with the rapid rise of Glucagon-like peptide-1(GLP-1) drugs. Market projections estimate the value of this sector will reach $150 billion by 2030¹, underscoring the scale and significance of this innovation in medical care.

In December of 2025, United Stated Pharmacopoeia will make official the final version of USP <382> “Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems”, focusing on the functional testing of container closure systems. The tests in this chapter go beyond the current functional testing regimen in USP <381>, which is specific to the elastomeric component, the stopper, in a vial drug system. USP <382> broadens the scope of functional tests from only a stopper and vial to nearly all drug delivery systems. Additionally, drug manufacturers will typically need to perform the testing to show the functional suitability of the system, as the final configuration and use case will need to be known and established.

Welcome back to our continued deep dive into packaging components. In Part 1, we explored key regulatory frameworks that shape packaging components in pharmaceuticals, such as USP <382> (effective from 01 Dec 2025), EU GMP Annex 1, and EU Medical Device Regulation (MDR) 2017/745. These guidelines underscore the importance of ensuring packaging components maintain drug integrity and safety, focusing on aspects like functional suitability, aseptic processing, and comprehensive compliance documentation.

The primary packaging of injectable drug products plays a critical role in ensuring the safety, efficacy, and quality of the drug products. In this blog, we will explore the key considerations and methodologies involved in selecting the optimal primary packaging components for injectable drug products to ensure patient safety. 

Are you making the best packaging decisions? Learn about the 5 essential elements to consider - your drug depends on it.