From Concept to Containment and Beyond: 5 Essential Elements of Packaging

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

Packaging for biopharmaceuticals is a multidimensional concept that addresses the critical need to protect and deliver complex and products safely and effectively. Given the sophisticated nature of biopharmaceuticals, packaging that comes in direct contact with a drug product must meet stringent criteria to maintain the integrity and efficacy of the product throughout its lifecycle.

What are the essential elements of packaging drug products?

In the context of container closure systems (CCS) for sterile injectable drugs, this is best understood through a systematic evaluation of their protection, compatibility, safety, and performance attributes. The FDA's regulatory guidance highlights the critical nature of these systems in ensuring drug product safety and efficacy. It specifically emphasizes that each component of a CCS—a stopper, a seal, and a vial —must be carefully selected and qualified for its intended use to comply with regulations, prevent contamination and preserve drug integrity.

5 Essential Elements of Packaging

1. Protection of Drug Product:
   • Ensure the packaging acts as an effective barrier against external contaminants like oxygen, moisture, and microbes, which could compromise the drug's sterility and stability
   • Evaluate container closure integrity (CCI), which must adhere to standards like the United States Pharmacopeia (USP) guidelines.
   • Mitigate risk of drug degradation, leakage, and microbial contamination with a well-sealed CCS


2. Compatibility with Drug Product:
   • Assess chemical interactions that might change the drug's pH or introduce impurities
   • Conduct tests to examine potential leachables and extractables from packaging materials
     • Leachables are chemicals that can migrate into the drug product from container materials
     • Extractables are compounds that can be extracted from a material under stress conditions
   • Select materials with minimal interaction with the drug product, to maintain intended formulation and efficacy over its shelf life


3. Safety of Packaging Components:
   • Verify that materials are biocompatible and do not pose any toxicological risks to patients
   • Avoid introducing harmful compounds into the drug product


4. Performance
   • Deliver the correct dose without compromising the drug's integrity
   • Evaluate the mechanical aspects:
     • penetrability and resealing ability of vial stoppers
     • force required to insert and retract needles
     • resistance to breakage
   • Ensure optimal performance with rigorous testing to confirm under expected storage and handling conditions


5. Selection, Qualification & Compliance:
   • Test for stability under various environmental conditions to verify that packaging can maintain the drug's intended quality, potency, and purity
   • Determine shelf life and associated quality specifications
   • Standards and guidelines comply with regulatory requirements set forth by agencies like FDA and EMA

Containment Solutions to Help Get Your Drug to Market

The selection of drug packaging is important for the success of your product launch and beyond. West can partner with you to get your product to market faster while mitigating risk. Consider where you are on the journey and collaborate with us to meet your next milestone. 

West Ready Pack® Containment Solution: Ready-to-Use Sterile Packaging

At West, our portfolio includes superior quality ready-to-use stoppers, seals, and vials that demonstrate CCI, giving you peace of mind that everything works as intended. Ready Pack® components can accelerate time to market and reduce risks associated with selecting individual components that may not work well together. Components in the Ready Pack® containment solution are available in small quantities, which are ideal for early-stage development or small-volume filling and are supplied by West, allowing you the convenience of easy ordering and quick delivery. 

West is a leading global manufacturer in the design and production of technologically advanced, high-quality, containment for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health. Whether it’s Ready Pack® or other components needed, contact us to determine your packaging needs and create a customized approach, keeping these 5 essential elements in mind.