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    Medical Devices - Quick Guide - Original - 28971

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    Medical Devices - Quick Guide - Original - 28971

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    Putri Dozan
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    Qu

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    Medical Devices – Quick Guide_Original_28971

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    86 views2 pages

    Medical Devices - Quick Guide - Original - 28971

    Uploaded by

    Putri Dozan
    Qu

    Copyright:

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

    Pharma&Biotech

    Medical Devices – Quick Guide

    Step 1 Step 2
    Select at random not more than 10 devices for testing. Ensure that the sample is in its final configuration and
    The number of devices tested is dependent on several packaging, including all component parts that make up
    This is a step-by-step guide factors including lot size, level of control, statistical
    considerations and past performance.
    the final medical device.

    detailing how to test medical Note: Suitability testing for each product or product family is required.
    Medical devices coming from cellulose-based components may contain
    devices for endotoxin. glucans. If glucan interference is observed, the use of a glucan-blocking
    reagent, such as β-G-Blocker, may be needed.

    Step 3 Step 4 Step 5


    Soak or immerse the device(s) or flush the fluid pathway Calculate the Endotoxin Release Limit (ERL). Test the extract.
    with LAL Reagent Water (LRW) that has been heated to
    37 ±1° C, keeping the LRW in contact with the surface(s) The endotoxin release limit for the extraction solution The extract should be tested with a positive product control,
    not less than 1 hour. This can be done in a depyro- can be calculated using the following equation: both in duplicate. In the event that there is interference
    genated glass or stainless steel container. Materials may evident, it is possible to dilute the extract further up to the
    be rendered endotoxin-free by heating at 250° C for K×N Maximum Valid Dilution (MVD). The MVD can be calculated
    30 minutes using a validated process. Adjust the volume V where: using the following equation:
    for rinsing or extraction according to the size and
    configuration of the device. K = allowable endotoxin per device ERL
    20.0 EU / device λ where:
    2.15 EU / device (for cerebrospinal contact)
    N = number of devices tested ERL = calculated in step 4
    V = total volume of extraction solution λ = the value of the lowest standard used in a
    quantitative assay or the labeled sensitivity
    Example: of the gel clot lysate used
    10 devices extracted in 1,000 mL of LRW
    Example:
    ERL = 20 EU / device x 10 devices = 0.2 EU / mL Extraction solution from example in step 4 tested
    1,000 mL with the kinetic chromogenic assay where the lowest
    standard is 0.005 EU/mL

    Hip Implant MVD = 0.2 EU / mL = 1:40


    0.005 EU /mL

    Surgical Plate

    Syringe

    Medical Tube
    Pacemaker

    Stent Knee Replacement Urinary Catheter Orthopedic Implant Screws


    www.lonza.com/pharmabiotech For more technical
    www.lonza.com/lal guidance register to our
    QC Insider™ Toolbox
    www.lonza.com/qcinsider

    Materials, Equipment & Documents Needed


    Reagents
    – Endotoxin detection kit (a variety of kits is available. Please
    contact your local sales representative for additional information.)
    – LAL Reagent Water (LRW) (# W50-640, W50-100, W50-500,
    W50-1000)

    Accessories
    – Glass dilution tubes (# N207)
    – Glass reaction tubes (# N201, N205), for use with the PYROGENT™
    Gel Clot Assays
    – Individually wrapped serological pipettes (optional)
    – Tips
    – 96-well plates (# 25-340), if using a plate-based method North America
    – Reagent reservoirs (# 00190035), if using a plate-based method Customer Service: 800 638 8174 (toll free)
    – β-G-Blocker (# N190), optional order.us@lonza.com
    Scientific Support: 800 521 0390 (toll free)
    Use pyrogen-free accessories that have been qualified for endotoxin testing. scientific.support@lonza.com

    Equipment and Software Europe


    – Pipettors Customer Service: +32 87 321 611
    – Timer order.europe@lonza.com
    – Vortex mixer Scientific Support: +32 87 321 611
    – Test tube rack scientific.support.eu@lonza.com
    – For use with the PYROGENT™ Gel Clot Assay: heating block or
    non-circulating hot water bath International
    – For use with the QCL-1000™ Endpoint Chromogenic Assay: Contact your local Lonza distributor
    heating block with adapter (# 25-038A) and spectro- or Customer Service: +1 301 898 7025
    filterphotometer with 405-410 nm filter or microplate reader Fax: +1 301 845 8291
    – For use with the Kinetic-QCL™ or PYROGENT™-5000 Kinetic scientific.support@lonza.com
    LAL Assays: incubating absorbance microplate reader
    – For use with the PyroGene™ rFC Assay: incubating fluorescence
    microplate reader Lonza Walkersville, Inc. – Walkersville, MD 21793

    All trademarks belong to Lonza or its affiliates or to their respective


    Supporting Documents third party owners. The information contained herein is believed
    – Certificate of Analysis (CoA) to be correct and corresponds to the latest state of scientific and
    technical knowledge. However, no warranty is made, either expres-
    – Endotoxin Detection Kit Package Insert sed or implied, regarding its accuracy or the results to be obtained
    – Endotoxin Detection Assay Procedure Quick Guide from the use of such information and no warranty is expressed
    or implied concerning the use of these products. The buyer as-
    – Endotoxin Assay Selection Guide sumes all risks of use and/or handling. Any user must make his
    – United States Pharmacopeial Convention. General Chapter <161> own determination and satisfy himself that the products supplied
    by Lonza Group Ltd or its affiliates and the information and re-
    Medical Devices – Bacterial Endotoxin and Pyrogen Tests
    commendations given by Lonza Group Ltd or its affiliates are (i)
    – United States Pharmacopeial Convention. General Chapter <85> suitable for intended process or purpose, (ii) in compliance with
    Bacterial Endotoxins Test environmental, health and safety regulations, and (iii) will not
    infringe any third party’s intellectual property rights.
    – European Pharmacopoeia (EP). European Directorate for the Quality
    of Medicines. Chapter 2.6.14 Bacterial Endotoxins ©2016 Lonza. All rights reserved.
    RT-DS024 03/16

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