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    15 Agreement Between Manufacturer and Sterilizer

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    Cao Minh Trí
    The document outlines the key elements that should be included in a written agreement between a product manufacturer and a contract sterilizer. These elements include: delineating the sterilization process parameters; specifying responsibilities for validation, biological indicators, and documentation; outlining procedures for batch review and product release; and defining how changes, deviations and damaged products will be handled. The purpose of the written agreement is to ensure sterilization consistency, regulatory compliance, and prevent misunderstandings between the parties.

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    15 Agreement Between Manufacturer and Sterilizer

    Uploaded by

    Cao Minh Trí
    139 views2 pages
    The document outlines the key elements that should be included in a written agreement between a product manufacturer and a contract sterilizer. These elements include: delineating the sterilization process parameters; specifying responsibilities for validation, biological indicators, and documentation; outlining procedures for batch review and product release; and defining how changes, deviations and damaged products will be handled. The purpose of the written agreement is to ensure sterilization consistency, regulatory compliance, and prevent misunderstandings between the parties.

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    The document outlines the key elements that should be included in a written agreement between a product manufacturer and a contract sterilizer. These elements include: delineating the sterilization process parameters; specifying responsibilities for validation, biological indicators, and documentation; outlining procedures for batch review and product release; and defining how changes, deviations and damaged products will be handled. The purpose of the written agreement is to ensure sterilization consistency, regulatory compliance, and prevent misunderstandings between the parties.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    139 views2 pages

    15 Agreement Between Manufacturer and Sterilizer

    Uploaded by

    Cao Minh Trí
    The document outlines the key elements that should be included in a written agreement between a product manufacturer and a contract sterilizer. These elements include: delineating the sterilization process parameters; specifying responsibilities for validation, biological indicators, and documentation; outlining procedures for batch review and product release; and defining how changes, deviations and damaged products will be handled. The purpose of the written agreement is to ensure sterilization consistency, regulatory compliance, and prevent misunderstandings between the parties.

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    © All Rights Reserved
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    WRITTEN AGREEMENT BETWEEN PRODUCT

    MANUFACTURER AND CONTRACT STERILIZER


    TECHNICAL TIP #15
    The Association for the Advancement for Medical Instrumentation
    (AAMI) provides several guidance documents to augment ANSI/
    AAMI/ISO 111351, Validation and routine control of ethylene
    oxide sterilization. One such document is AAMI TIR No. 14 20092, Contract Sterilization Using Ethylene Oxide. Within this
    document, much attention is given to the written agreement
    established between a product manufacturer and a contract
    sterilization supplier. The following is a summary of the
    information presented in the TIR.
    Before starting contract sterilization processing, a written
    agreement that outlines the services to be provided by both
    parties should be developed and approved. Requirements for the
    agreement between two parties are found in 21 Code of Federal
    Regulation 801.150(e)3. This section of the regulations requires a
    written contract when interstate shipping is involved. For
    intrastate services, a contract is recommended to ensure
    compliance with the GMP requirements for device master
    records (21 CFR 820.181)4. The regulation specifies the contents
    of the agreement, including a requirement for a detailed
    delineation of the sterilization process. It is necessary to examine
    the contract sterilizers compliance with this regulation. In
    addition to the requirements of 21 CFR 801.150, good business
    practices may require other inclusions in the written agreement to
    clarify the division of responsibilities.

    Process Validation
    The written agreement should specify all parameters to be
    qualified by the contractor and the criteria for re-qualification.
    Loading Configuration
    The agreement should specify the pallet patterns, vessel loading
    configuration, packaging, and whether the load is pre-wrapped or
    shrink-wrapped for each product or product family.
    Biological Indicators and Product Test Samples
    The agreement should specify responsibility for placement,
    retrieval, handling, processing, and maximum time intervals
    before shipment of BIs and product test samples. It should
    include instructions for packaging and shipment of BIs and
    product test samples to test laboratories for analysis.
    Cycle Parameters and Process Control
    The agreement should specify the process parameters and the
    allowable limits that should be achieved for sterilization once the
    sterilization process has been validated.
    Post-sterilization Handling
    The agreement should specify procedures for post-sterilization
    quarantine of the product before release for distribution.

    The written agreement may be in the form of a formal business


    contract or in the form of internal Standard Operating Procedures
    (SOPs) that are signed by both parties. The written agreement
    shall, directly or by reference to existing documents, indicate the
    responsibilities of each party for assuring the completion of all
    GMP requirements related to the sterilization process. For
    ethylene oxide sterilization, the written agreement should contain
    or reference the following:

    Batch Records and Review

    Information Transfer

    Audits

    The agreement should specify the individuals at each facility


    responsible for coordinating the flow of information between
    establishments and for approving procedural changes.

    The agreement should specify the scope of audits, corrective


    actions, documentation or audit, and confidentiality.

    Documentation
    The agreement should specify all required documentation (for
    example: procedures, processing records) to be used and
    maintained. Both parties should agree on the manner in which
    documentation changes are to be made.

    The agreement should specify procedures and responsibility for


    approving sterilization batch records prior to release.
    Finished Product Release
    The agreement should specify product release procedures and
    identify the individuals who are responsible for approving release
    for distribution.

    Control of Changes, Process Deviations, and Product


    Damage
    The agreement should specify the individuals to be notified of
    any changes or deviations in the manufacturing or sterilization
    process. It should also specify the individual at the manufacturer
    or manufacturing facility that should be contacted when product
    is damaged to determine how the product should be handled at
    the contract sterilizer.

    Reprocessing of Loads

    References

    The agreement shall specify how reprocessing procedures are


    established, implemented, and controlled to assure that the
    reprocessing steps and product meet the validation and routine
    processing specification criteria.

    1. ANSI/AAMI/ISO 11135, 2007 Medical devices Validation


    and routine control of ethylene oxide sterilization

    Material Handling and Documentation


    Adherence to Title 21, CFR, Part 801.150 is required for label
    control. The agreement should specify how adherence is to be
    controlled/conducted.
    Contract Agreement Criteria
    The written agreement shall specify all shipping arrangements
    including labeling for shipping and should identify laboratories to
    be used for sample testing.
    The contract is a valuable tool to assure sterilization consistency
    and regulatory compliance, and to help prevent
    misunderstandings between the parties. It binds both parties to
    the procedures and agreements which control all aspects of the
    sterilization process.

    For more information, please contact:


    STERIS Isomedix Services, Inc.
    5960 Heisley Road
    Mentor, Ohio 44060
    877.783.7479
    www.isomedix.com
    TechTip 15: 11/09, Rev 2

    2. AAMI TIR No. 14 - 20092, Contract Sterilization Using


    Ethylene Oxide
    3. 21 CFR Part 801.150(e): Medical devices, processing,
    labeling, or re-packing 1996
    4. 21 CFR Part 820 Medical Devices; Current Good
    Manufacturing Practice (CGMP) 1996

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