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    CoA TSA 1442400050 Lote 2702950

    Uploaded by

    Mike Sanchez
    This document provides a certificate of analysis for a lot of agar strips. It details specifications for the product including pH, growth promotion testing results, typical composition, manufacturing and quality controls. The lot was tested and released in compliance with standards.

    Copyright:

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

    CoA TSA 1442400050 Lote 2702950

    Uploaded by

    Mike Sanchez
    120 views1 page
    This document provides a certificate of analysis for a lot of agar strips. It details specifications for the product including pH, growth promotion testing results, typical composition, manufacturing and quality controls. The lot was tested and released in compliance with standards.

    Original Description:

    Certificado analitico

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    © © All Rights Reserved

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    This document provides a certificate of analysis for a lot of agar strips. It details specifications for the product including pH, growth promotion testing results, typical composition, manufacturing and quality controls. The lot was tested and released in compliance with standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    120 views1 page

    CoA TSA 1442400050 Lote 2702950

    Uploaded by

    Mike Sanchez
    This document provides a certificate of analysis for a lot of agar strips. It details specifications for the product including pH, growth promotion testing results, typical composition, manufacturing and quality controls. The lot was tested and released in compliance with standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    HYCON AGAR STRIPS

    Certificate of Analysis
    Catalogue Number : 1.44240.0050
    Medium Abbreviation : AGAR STRIPS TSM
    (941135)

    Lot Number
    Manufacturing Date
    Expiration Date
    Storage Conditions

    : 2702950
    : 09-FEB-2016
    : 08-AUG-2016
    : 2 25C

    ISO 14001 Environmental Management

    Lot Analysis

    This product was manufactured in a Millipore SAS facility


    whose Environmental Management program is approved by an
    accredited registering body to the appropriate ISO 14001
    Systems Standard.

    This product was designed and manufactured


    to meet the following specifications:
    Criteria
    pH

    Pharmacopoeia

    Specifications
    7.3 0.2

    Results Status
    7.2

    Conform

    No
    growth

    Conform

    We certify that the product described herein meets the


    following criteria:

    Quality Assurance Lot Release Criteria

    Growth Promotion Test

    Samples were found


    to be sterile after 7
    days at
    20-25C and 30-35C
    Recovery range :

    Product Description

    This manufacturing lot was sampled, tested and released


    according to the following specifications:

    Staphylococcus aureus
    ATCC 6538

    50 - 200% after 24 to
    48 hours at 30-35C

    76%

    Conform

    Escherichia coli
    ATCC 8739

    50 - 200% after 24 to
    48 hours at 30-35C

    106%

    Conform

    Aspergillus brasiliensis
    ATCC 16404

    50 - 200% after 72
    hours at 20-25C

    106%

    Conform

    Candida albicans
    ATCC 10231

    50 - 200% after 72
    hours at 20-25C

    83%

    Conform

    Pseudomonas
    aeruginosa
    ATCC 9027

    50 - 200% after 24 to
    48 hours at 30-35C

    96%

    Conform

    Bacillus subtilis
    ATCC 6633

    50 - 200% after 24 to
    48 hours at 30-35C

    131%

    Conform

    Agar strips are used with RCS Microbial Air Sampler.


    Modified Tryptic Soy Agar with neutralizers against
    disinfectants and growth supplements; for identification
    of the total count of fastidious and sublethally damaged
    microorganisms
    For further information, instructions and safety data
    refer to the package insert and the safety data sheet.

    Typical Composition of the Medium


    Formula per liter of purified water:
    Pancreatic Digest of Casein
    Soy Bean Peptone
    Sodium Chloride
    Agar
    Buffer System
    Supplements

    15.0 g
    5.0 g
    5.0 g
    15.0 g

    Formula can be adjusted and/or supplemented and


    sources of components are selected to meet the
    performance criteria required.

    Good Manufacturing Practices


    This product was manufactured in a Millipore SAS
    facility which adheres to Good Manufacturing Practices.

    ISO 9001 Quality Standard


    This product was manufactured in a Millipore SAS
    facility whose Quality Management System is
    approved by an accredited registering body to
    ISO 9001 Quality System Standard.

    Complies, where applicable, with


    Pharmacopoeia recommendations.

    European

    and

    US

    100 % Inspection
    Visual control of each agar strip.

    Statistical Controls
    Packaging integrity.
    Conformity of labelling and packaging.

    Biological Tests

    Sterility Assurance
    Level

    Sterility
    Representative samples were subjected to a sterility test by
    direct incubation of the agar strips.
    Growth Promotion
    Growth Promotion Tests were conducted by direct inoculation
    of the media. All the samples provided good growth and typical
    colony morphology.

    Batch Record

    According to the above results, the product complies with


    Millipore SASs acceptance criteria and is released.

    The lot of agar strips has complete documentation which


    includes product description, test protocol, test specification
    and results.
    LKI-TSMCOQ Version 2.0 10/15
    Hycon and RCS are Registered Trademarks of Merck KGaA
    ISO is a Registered Trademark of the International Organization for Standardization
    ATCC is a Registered Trademark of the American Type Culture Collection
    The M Mark is a trademark of Merck KGaA, Darmstadt, Germany.
    2012 Merck KGaA, Darmstadt, Germany. All rights reserved.

    Dborah Wild
    BioMonitoring Quality Manager

    00012888FM Version 3.0

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