Publications, Pharmaceutical

Performance of ETFE-Coated Components for Container Closure Integrity

Maintaining container closure integrity is essential for injectable packaging to ensure drug safety, efficacy, shelf life, regulatory compliance, and quality. It is a critical aspect of pharmaceutical manufacturing that safeguards patient health and maintains the integrity of the drug throughout its lifecycle. With the rise of biologics and next-generation vaccines (mRNA, adenoviral vectors..), storage conditions can require deep-cold temperatures to maintain the long term stability of the drug. Such harsh storage conditions put the container closure solution under stress and packaging manufacturer must demonstrate their solutions perform as excepted down to -80°C.

For more information on ONdrugDelivery.

Download the Performance of ETFE-coated Components Publication Now
Author(s): Sébastien Cordier Dr Benjamin Brocco Estelle Verger Arnaud Clausse
5 Jun 2023

Container Closure Integrity (CCI) is crucial for injectable drugs for several reasons:

  1. Product Safety: Injectable drugs are administered directly into the body, making their safety of utmost importance. Container closure integrity ensures that the drug is protected from external contamination and maintains its sterility throughout its shelf life. Any breach in the container closure system could lead to microbial contamination or drug oxidation, which could cause infections or adverse reactions when injected to a patient.
  2. Efficacy: The integrity of the container closure system is vital to preserve the drug’s efficacy. Injectable drugs are formulated to be effective under specific conditions, and any loss or alteration of the drug due to a compromised container closure system may compromise its therapeutic effectiveness. For instance, exposition to oxygen or moisture can lead to degradation, resulting in decreased potency or altered chemical properties.
  3. Shelf Life and Stability: Injectable drugs often have a defined shelf life, which is determined by their stability over time. Container closure integrity plays a crucial role in maintaining the drug’s stability by preventing interactions with external factors such as air, moisture, or other external contaminants. A robust container closure system ensures that the drug remains stable and retains its desired characteristics throughout its designated shelf life.
  4. Regulatory Compliance: Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have stringent requirements for container closure integrity. Compliance with these regulations is essential for ensuring patient safety and obtaining approvals. Pharmaceutical companies must demonstrate the integrity of their container closure systems through appropriate testing methods and validation studies.
  5. Quality: CCI is an essential component of quality control in pharmaceutical manufacturing. Ensuring the integrity of the container closure system is part of a comprehensive quality assurance program that includes rigorous inspections, testing, and validation procedures. By maintaining CCI, pharmaceutical manufacturers can minimize the risk of product recalls, protect their brand reputation, and ensure consistent product quality.

In this article, Aptar Pharma discuss the importance of closure components for maintaining Container Closure Integrity (CCI) in deep-cold storage conditions. Enabling drug packaging in extreme conditions will support the development of increasingly sensitive drug products such as mRNA vaccines, complex biologics and biotech drugs. Using helium-leak and headspace laser analysis, Aptar Pharma has demonstrated the ability of PremiumCoat® vial stoppers to maintain Container Closure Integrity down to -80°C. This feature, combined with the ETFE film-coating that protects drugs from Extractable and Leachables, makes the PremiumCoat® platform an ideal solution for accelerating your sensitive drug development.

Learn more about Aptar Pharma Expertise
in Injectable Drug Delivery

Find Out More in Injectable Drug Delivery

This Might Also Be of Interest

22 Jul 2024

ETFE-Coated Syringe Plunger Machinability with Vented Insertion

Publications, Pharmaceutical, Market Insights, Product Solutions, Device Innovations

Read More
10 Jul 2024

The Art of CCIT: Deterministic Method Selection

Webinars, Pharmaceutical, Market Insights, Product Solutions

Read More
14 Jun 2024

Vial Stopper Compatibility: Criteria and Testing Methods

Publications, Pharmaceutical, Device Innovations, Market Insights, Product Solutions

Read More
7 Jun 2024

Derisking the Development of Sensitive Injectables

Webinars, Pharmaceutical, Market Insights, Product Solutions, Device Innovations

Read More
1 2 3 13
Back To Top