USP Pre Filled Syringe Leachables Testing

USP Pre Filled Syringe Leachables Testing

USP Pre Filled Syringe Leachables Testing

The USP Pre Filled Syringe Leachables Testing is a critical component of pharmaceutical testing, particularly for injectable and parenteral products. This service ensures that leachable substances from the syringe do not adversely affect the product or patient safety. The process involves a series of meticulous steps to assess the potential contaminants that may leach into the solution within the pre-filled syringe.

The USP (United States Pharmacopeial Convention) guidelines provide stringent criteria for testing, ensuring that the materials used in pharmaceutical packaging and containers are safe and do not interact with the product in a harmful way. Leachables can include various compounds such as plasticizers, antioxidants, stabilizers, and other substances from the container or stopper.

The testing process begins with the selection of appropriate leachable standards and solvents based on the composition of the pre-filled syringe. Common solvents used in this testing are water, aqueous phosphate buffer (PB), 0.1 M sodium hydroxide (NaOH) solution, 0.1 M acetic acid (CH3COOH) solution, methanol, and ethanol.

The sample preparation involves disintegration of the syringe under controlled conditions to simulate real-world use scenarios. The extractant is then applied to the disintegrated material for a specified duration before it is filtered and analyzed using high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), or inductively coupled plasma mass spectrometry (ICP-MS).

The analytical techniques employed ensure accurate quantification of leachable substances, providing data that can be compared against the USP monographs for safety and compatibility. This service is particularly important for ensuring regulatory compliance with various standards including USP General Chapter 3.

The results of the testing are detailed in a comprehensive report, which includes the identification and quantification of leachable compounds. This information is vital for manufacturers to make informed decisions about raw material selection and packaging design.

Applied StandardsDescription
USP General Chapter Leachables and ExtractablesProvides guidelines for the identification, quantification, and control of leachable substances from pharmaceutical containers.
ISO 10993-18:2017Describes biological evaluation methods for medical devices.

Applied Standards

Applied StandardsDescription
USP General Chapter Leachables and ExtractablesThis chapter outlines the methodologies for determining leachable substances from containers, closures, and other contact materials used in drug products.
ASTM D2369-07(2015)Describes a test method for determining extractables from plastic materials using various solvents.

Eurolab Advantages

EuroLab offers unparalleled expertise and state-of-the-art facilities dedicated to pharmaceutical testing. Our team of experienced scientists and engineers is committed to delivering accurate, reliable, and compliant results that exceed your expectations.

  • Comprehensive understanding of USP guidelines for leachables and extractables testing
  • Use of advanced analytical techniques including HPLC, GC-MS, and ICP-MS
  • Experience in handling a wide range of pharmaceutical products
  • Dedicated resources for method development and validation
  • Compliance with international standards and regulatory requirements

We provide not only the testing service but also consultative support to help you navigate complex regulatory landscapes. Our commitment to quality ensures that your products meet the highest safety and efficacy standards.

International Acceptance and Recognition

  • The USP General Chapter Leachables and Extractables is internationally recognized, including by the European Medicines Agency (EMA) and the World Health Organization (WHO).
  • ASTM D2369-07(2015) is widely accepted in the pharmaceutical industry for extractable testing.
  • The results of USP leachables testing are often used as a basis for international regulatory submissions, enhancing your product’s global acceptance.

EuroLab ensures that all our testing aligns with these internationally recognized standards, providing you with data that is accepted worldwide.

Frequently Asked Questions

What are leachables in the context of pre-filled syringes?
Leachables refer to substances that may migrate from the container or closure system into the solution within a pre-filled syringe. These can include plasticizers, antioxidants, stabilizers, and other materials.
Why is USP leachables testing important for injectable products?
It ensures that the packaging does not interact with or contaminate the drug product, maintaining its integrity and safety. This testing is crucial for compliance with regulatory standards.
What methods are used in USP leachables testing?
The process involves disintegration of the syringe, application of extractant solvents, filtration, and analysis using HPLC, GC-MS, or ICP-MS.
How long does it take to complete USP pre-filled syringe leachables testing?
The duration can vary depending on the complexity of the product and the number of tests required. Typically, this process takes several weeks from sample receipt to final report issuance.
What is the role of international standards in USP leachables testing?
International standards like USP General Chapter and ASTM D2369-07(2015) provide a framework for consistent and reliable testing, ensuring compliance with global regulatory requirements.
How do I know if my product needs USP leachables testing?
Any pharmaceutical product that uses pre-filled syringes or other containers should undergo this testing to ensure safety and compliance with regulatory standards.
What is the cost of USP pre-filled syringe leachables testing?
The cost varies based on the complexity of the product, the number of tests required, and the turnaround time. We provide detailed quotes upon request.
How do I submit a sample for USP leachables testing?
You can submit your sample through our online submission portal or by contacting our customer service team directly. Our experts will guide you through the process.

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