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    Elite Quality Enzymes

    Uploaded by

    Mohammad Zabeh

    Copyright:

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

    Elite Quality Enzymes

    Uploaded by

    Mohammad Zabeh
    2 views2 pages

    Original Title

    elite-quality-enzymes

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    © © All Rights Reserved

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    Copyright:

    © All Rights Reserved
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    Download as pdf or txt
    2 views2 pages

    Elite Quality Enzymes

    Uploaded by

    Mohammad Zabeh

    Copyright:

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

    QUALITY YOU CAN

    COUNT ON!

    Reduce your time to market with our new enhanced Added Value with Elite Enzymes
    Elite quality enzymes that are suitable for • Enhanced Change Control • Critical control parameter (CCP)

    manufacturing of diagnostic kits and reagents.


    Notification - 12 Weeks • QA batch review
    • Certificate of origin • Lot sample retained
    Enzyme Benefits: • Retest date • Vendor management

    • Supply chain transparency • ISO 9001 certification


    • Vendor assessment

    • Original manufacturer • OEM kit assembly


    • Custom quality control • Flexible packaging availability

    Cat. No. Pack Size Description Usage


    SRE0005 5 mL Proteinase K Tritirachium album for Proteinase K is a stable and highly reactive serine protease. Useful for the proteolytic
    15 mL molecular diagnostics inactivation of nucleases during the isolation of DNA and RNA.
    5 x 5 mL
    SRE0001 5g Pepsin from porcine gastric mucosa Used to produce F(ab')2 fragments of antibodies. Pepsin is a peptidase used to digest
    10 g proteins and is commonly used in the preparation of Fab fragments from antibodies.
    SRE0006 5 ku Thymidine Phosphorylase An enzyme that catalyzes the reversible conversion of thymidine to thymine.
    SRE0011 1g γ-globulins from bovine blood Bovine γ-globulin has been used as an immunological challenge in studies of
    10 g mechanisms of immunotolerance. Plasma protein fraction rich in antibodies.
    25 g
    100 g
    SRE0008 40 un Galactose-1-phosphate Uridyltransferase Used in clinical chemistry for diagnosis of galactose-1-phosphate uridyltransferase
    50 un from galactose-adapted yeast deficiency.
    SRE0018 100 ku Lyticase from Arthrobacter Luteus Used for cell lysing for DNA extraction.
    250 ku
    SRE0020 2 ku Butyrylcholinesterase from equine serum Used for diagnosing liver diseases, malignancies, and pulmonary tuberculosis.
    10 ku
    SRE0027 1 mu Heparin sodium salt from porcine mucosa Monitoring crude heparin for quality.
    100 ku
    250 ku
    500 ku

    Enyzmes Available For IVD Applications:


    • Clinical chemistry • Molecular diagnostics
    • Coagulation • Diabetes care
    • Histology • Point of care
    • Immunoassay • Microbiology
    • Hematology

    For more information visit


    sigma-aldrich.com/diagnostics

    | | | |
    SIGMA-ALDRICH QUALITY GUIDELINES
    Standard Premium Elite GMP/Compendia
    Attributes
    Quality Level Quality Level Quality Level Quality Level
    Research, Industrial and Research, Industrial and Upstream and Downstream API, BPE, IVD, Biopharma
    Product Use
    Chemical Specialities Chemical Specialities Biopharma Processing Applications
    Raw Material Regulatory Non-Regulated Non-Regulated
    Regulated Applications Regulated Applications
    Requirements Applications Applications
    ISO 9001 plus other ICH Q7, IPEC,
    Quality Systems Controls ISO 9001 ISO 9001
    Controlled Processes 21 CFR, 13485
    Discretionary Confidential Confidential Information Confidential Information
    Sourcing Information Proprietary
    Information Shared Under CDA Shared Under CDA Shared Under CDA
    Analytical Methods
    Certificate of Analysis
    CCN
    Product Specification
    Certificate of Origin
    Expiry or Retest Date
    Vendor Assessment
    Critical Control Parameter
    (CCP)
    QA Batch Review
    Lot Sample Retained
    Vendor Management
    Validation

    Elite Quality Level Details


    Recommended for upstream and downstream processing, registered starting materials and raw materials (material can be in regulatory
    Product Use filing). This level does not support the use of the product as an API or Excipient.
    • Quality Management System, including some elements of industry standards
    • Controlled Manufacturing process, not validated
    • Internally qualified analytical method. If compendial methods are used, they are validated by definition.
    • Certificate of Analysis (CofA) and MSDS available
    • Certificate of Origin (CofO) available
    • Expiry or Recommended Retest Date supplied – supported by Sigma-Aldrich data
    Features
    • Manufacturing and risk assessment. Residual solvents, melamine, and BSE TSE statements available.
    • Retained sample
    • Quality review of batch records
    • Manufactured by Sigma-Aldrich or by qualified supplier who commits to
    notification of changes and transparency
    • Sourcing information disclosed under confidentiality agreement
    Analytical release specifications and/or method, manufacturing site, packaging site, testing site, type of manufacture, significant manufacturing
    Change process changes.
    Notification*
    Notification timeline: 12 weeks

    Enabling Science to Order/Customer Service: sigma-aldrich.com/order World Headquarters


    Technical Service: sigma-aldrich.com/techservice 3050 Spruce St.
    Improve the Quality of Life St. Louis, MO 63103
    Development/Custom Manufacturing Inquiries: [email protected]
    (314) 771-5765
    Safety-related Information: sigma-aldrich.com/safetycenter sigma-aldrich.com

    ©2014 Sigma-Aldrich Co. LLC. All rights reserved. SIGMA, SAFC, SIGMA-ALDRICH, ALDRICH and SUPELCO are trademarks of Sigma-Aldrich Co. LLC, registered in the US and other countries. FLUKA is a trademark of
    QFP_DP
    Sigma-Aldrich GmbH, registered in the US and other countries. Sigma-Aldrich, Sigma, Aldrich, Supelco, Fluka and SAFC brand products are sold by affiliated Sigma-Aldrich distributors. Purchaser must determine
    81622
    the suitability of the product(s) for their particular use. Additional terms and conditions may apply. Please see product information on the Sigma-Aldrich website at www.sigmaaldrich.com and/or on the reverse
    1104
    side of the invoice or packing slip.

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