Packaging Testing & Evaluation
Packaging plays a vital role in maintaining the safety, stability, and quality of pharmaceutical and healthcare products. Proper packaging systems protect products from environmental factors, contamination, and degradation, ensuring medicines remain safe, effective, and compliant throughout their shelf life.
At Keysight Chemtech, we provide comprehensive packaging testing and evaluation services designed to verify the safety, compatibility, and regulatory compliance of packaging materials and container systems. Our scientific teams combine analytical expertise with advanced instrumentation to evaluate how packaging materials interact with pharmaceutical products. Through rigorous testing and scientifically validated methodologies, we help manufacturers identify potential risks, ensure product stability, and meet global regulatory requirements.
We partner closely with pharmaceutical companies, biotechnology organizations, and medical device manufacturers to support packaging development from early evaluation to regulatory submission and commercial-scale manufacturing.
Our Services
Extractables & Leachables Studies
We conduct in-depth E&L studies to identify chemical compounds that may migrate from packaging materials into drug products. These studies evaluate potential patient safety risks, guide material selection, and ensure compliance with global regulatory standards including FDA, USP, ISO, and EU MDR.
Migration Studies
Migration testing assesses the transfer of substances from packaging into pharmaceutical products under various storage, handling, and environmental conditions. This helps determine chemical stability, formulation compatibility, and patient safety, supporting both quality control and regulatory submissions.
Container Closure Integrity Testing(CCIT)
CCIT verifies that packaging systems provide an effective barrier against contamination, moisture, and external environmental stressors. Our testing ensures that containers maintain product sterility, stability, and potency throughout storage, transportation, and shelf life.
Material Interaction & Stability Assessment
We evaluate interactions between packaging materials and pharmaceutical formulations to determine compatibility, impact on product stability, potency, and shelf life. These studies ensure that packaging systems support safe and effective delivery of the drug product.
Toxicological & Environmental Risk Evaluation
Our toxicology experts assess potential health risks associated with chemicals originating from packaging materials, while also evaluating environmental impact. This ensures that packaging systems meet both safety and regulatory requirements, minimizing patient risk.
Regulatory Documentation & Reporting
Keysight Chemtech prepares submission-ready documentation, including analytical reports, risk assessments, and validation summaries. All reports are aligned with global regulatory expectations, supporting smooth regulatory approvals, audit readiness, and product commercialization.
Why Choose Keysight Chemtech for Packaging Testing?
- End-to-End Packaging Evaluation: From material selection to final container system testing.
- Regulatory Compliance: Adherence to FDA, USP, ISO, and EU standards.
- Advanced Analytical Infrastructure: State-of-the-art labs for accurate, reproducible, and reliable results.
- Risk Mitigation: Early identification of material or formulation issues reduces product recalls and regulatory delays.
- Client-Focused Reporting: Clear, audit-ready documentation for regulatory submissions and quality assurance.