For biotech companies, selecting the right drug container is especially challenging since in-house capabilities are focused primarily on R&D rather than selecting the optimal drug container. However, it is crucial to evaluate different primary packaging solutions early on in the drug development phase.
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
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
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
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
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
ZX VIAL SUPPLIES Solution: Ready-to-Use Sterile Packaging
At ZX VIAL, 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 ZX VIAL SUPPLIES, allowing you the convenience of easy ordering and quick delivery.
ZX VIAL SUPPLIES 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.