Scribd Logo
Upload

Welcome to Scribd!

  • 32 views

    09 II Final WEB

    Uploaded by

    Manoj Naruka

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    09 II Final WEB

    Uploaded by

    Manoj Naruka
    32 views2 pages

    Original Title

    09_II_final_WEB

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

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

    09 II Final WEB

    Uploaded by

    Manoj Naruka

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    INDUSTRY INSIGHT

    Comparing Terminal Sterilization and Aseptic Processing


    of Pharmaceutical Products

    The purpose of sterilization is to provide to the patient an Aseptic Processing


    efficient drug product that can be used with the highest
    Aseptic processing is a process performed maintaining the
    safety level. Terminal sterilization and aseptic processing
    sterility of a material that is assembled from components,
    are two approaches to obtain a sterile drug product;
    each of which has been previously sterilized. This is
    however, they are two fundamentally different methods.
    achieved by using adequate conditions and facilities
    For personnel within the pharmaceutical and medical
    designed to prevent microbial contamination. Aseptic
    device industries, this Industry Insight compares terminal
    processing relies on several independent factors for
    sterilization and aseptic processing.
    prevention of recontamination of previously sterilized
    components. Therefore, a SAL is not applicable as accidental
    While terminal sterilization and aseptic processing are two contamination caused by inadequate technique cannot be
    different methods to obtain a sterile drug product, regulatory reliably eliminated. Aseptic processing presents a higher risk
    bodies in the United States (US) and European Union (EU) of microbial contamination of the product than terminal
    agree that terminal sterilization is preferred and should be sterilization. Any manual or mechanical manipulation of
    considered first to minimize the risk of contamination and the sterilized drug, containers, or closures prior to or during
    its consequences. aseptic filling and assembly poses the risk of microbial
    contamination.

    “Wherever possible, a process in which the Decision Making


    product is sterilized in its final container The selection of the sterilization method follows a clearly
    (terminal sterilization) is chosen.” defined decision tree that starts with terminal sterilization.
    There are various terminal sterilization technologies.
    —European Pharmacopoeia Heat sterilization is the preferred technology. In case of
    temperature-sensitive products, the application of an
    alternative technology, ionizing radiation (Gamma or
    E-beam) is an alternative, followed by gas sterilization
    Terminal Sterilization (e.g., Peracetic Acid (PA), Nitrogen Dioxide (NO2), EO). Aseptic
    Terminal sterilization is achieved by exposure to a physical processing is the last possibility as stated in all major
    (e.g., temperature, radiation) or chemical sterilizing agent standards (European Medicines Agency (EMA), US Food and
    (e.g., Vaporized Hydrogen Peroxide (VHP), Vaporized Drug Administration (FDA)).
    Peracetic Acid (VPA), Ethylene Oxide (EO)) for a
    predetermined extent of treatment. The product is sterilized The justification for the chosen sterilization or aseptic process
    in its final packaging (or final assembled form), which highly should include an extensive and science-based benefit risk
    reduces subsequent sterility risk. The process is validated evaluation and it should be demonstrated that suitable
    to provide a Sterility Assurance Level (SAL) lower than 10-6, development efforts have been made to enable terminal
    which means a probability of less than one unsterile product sterilization (i.e., adapt formulation, container and more).
    on a one million population. Terminal sterilization provides a
    SAL that is possible to calculate, validate and control, and thus
    incorporates a safety margin.

    For more information or to contact a Sterigenics’ Expert Advisor


    visit sterigenics.com or call +1 (800) 472-4508 page 1 of 2
    INDUSTRY INSIGHT

    Summary - Eudralex Vol 4 Annex 1 Draft Manufacture of Sterile


    Medicinal Products
    Terminal sterilization is preferred to sterilization by aseptic
    processing for pharmaceutical products because it provides - Eudralex Vol 4 Annex 12 Use of ionising radiation in the
    a SAL that is possible to calculate, validate and control, and manufacture of medicinal products
    thus incorporates a safety margin. For aseptic processes, a - Guidance for Industry Sterile Drug Products produced by
    SAL is not applicable as accidental contamination caused by Aseptic processing - cGMP
    inadequate technique cannot be reliably eliminated.
    - Guidance for Industry Submission of Documentation for
    The manufacturer of sterile medicinal product must deploy sterilization Process Validation in Applications for Human
    all possible efforts during product development to use a and veterinary Drug Products
    terminal sterilization technology as it provides the highest - Guidance for Industry Submission of Documentation
    assurance of sterility and as a result the highest patient in Applications for Parametric release of human and
    safety level. veterinary Drug Products Terminally sterilized by Moist
    Heat Processes
    Reference - ICH M7 (R1) on assessment and control of DNA reactive
    - AAMI (Association for the Advancement of Medical (mutagenic) impurities in pharmaceuticals to limit
    Instrumentation) TIR (Technical Information Report) potential carcinogenic risk
    16:2013 Microbiological aspects of ethylene oxide
    sterilization - ICH Q11 Development and manufacture of drug substances

    - CPMP (Committee for Proprietary Medicinal Products)/ - ISO (International Standards Organization) 11135:2014
    QWP (Quality Working Party)/054/98 Decision Tree for Sterilization of healthcare products - Ethylene Oxide -
    the selection of sterilization methods Requirements for development, validation and routine
    control of a sterilization process for medical devices
    - CPMP/QWP/155/96 Note for guidance on development
    pharmaceutics - ISO 13408-2 Aseptic processing of health care products –
    Sterilizing filtration
    - CPMP/QWP/159/01 EMA (European Medicines Agency)/
    CVMP (Committee for Medicinal Products for Veterinary - ISO TS 19930:2017 Guidance on aspects of a risk-based
    Use)/271/01 Rev.1Note for guidance on limitations to the approach to assuring sterility of a terminally-sterilized,
    use of ethylene oxide in the manufacture of medicinal single use health care product unable to withstand
    products processing to achieve maximally a sterility assurance level
    of 10-6
    - EMA/CHMP (Committee for Medicinal Products for
    Human Use)/CVMP/QWP/128000/2014 Concept Paper - PDA (Parenteral Drug Association) (2017) Aseptic and
    on Guideline on the selection of sterilization processed Sterile Processing. Control compliance and future trends.
    Tim Sandle and Edward C. Tidswell
    - EMA/CHMP /CVMP/QWP/BWP/85074/2015 - Draft
    Guideline on the sterilization of the medicinal product, - PDA 2017 Aseptic Processing Survey, questions 5 and 6
    active substance, excipient and primary container
    - USP (U.S. Pharmacopeial Convention) 1229.4 STERILIZING
    - EMA/CHMP/ICH (International Council for Harmonisation FILTRATION OF LIQUIDS
    of Technical Requirements for Pharmaceuticals for
    Human Use)/167068/2004 Guideline on Pharmaceutical - WHO (World Health Organization) Annex 6 GMP for sterile
    development pharmaceutical products
    - EMA/CHMP/ICH/83812/2013”Assesment and control of
    DNA reactive (mutagenic) impurities in pharmaceuticals
    to limit potential carcinogenic risk

    Disclaimer: The information contained in this document is for general information purposes only. Sterigenics assumes no responsibility
    for errors or omissions in the contents. Sterigenics reserves the right to make additions, deletions or modification to the contents of this
    document at any time without prior notice.
    ©2019 Sterigenics. All rights reserved. Printed in the USA. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, without the
    express written permission of Sterigenics. AC105.Industry Insight 9 v1, November, 2019.

    For more information or to contact a Sterigenics’ Expert Advisor


    visit sterigenics.com or call +1 (800) 472-4508 page 2 of 2

    You might also like