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  • 1.  Cleaning agent

    Posted 20-Mar-2017 23:12
    I am looking for recommendations for cleaning desinfectan . What  type of cleaning formula can be used to kill bacteria, fungi and spores in a controlled environment room? Can we mix two chemical agents? I want to create a cleaning procedure. 




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    Brenda Miller
    Quality Assurance Manager Combat Medical Systems
    Harrisburg, NC
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  • 2.  RE: Cleaning agent

    Posted 21-Mar-2017 06:29
    First you need to define what is to be cleaned.  Then whether the agents are permitted.  There are many to choose from.  Care must be exercised with quaternary ammonium compounds.

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    Robert Schiff PhD, FRAPS, RAC
    President and CEO
    Schiff & Company, Inc.
    West Caldwell NJ
    United States
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    Original Message


  • 3.  RE: Cleaning agent

    Posted 22-Mar-2017 07:46
    Hi Brenda

    I would  advise you to work with a microbiologist on this, whether internal or at a test lab. Also, be sure to do research on what agents are sold AND allowed in the regions you are planning to market your device in. If you validate and recommend the use of something like a dilute glutaraldehyde solution, you will find that may not be allowed in the UK for example, or in Ohio (closer to home, under OSHA concerns). The unfortunate part is that these vary in availability and regulatory status. 

    Are you working with a reputable teat lab? LexaMed and NAMSA are good starting points, but there are many.

    Good luck!

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    715-307-1850




    Original Message


  • 4.  RE: Cleaning agent

    Posted 21-Mar-2017 08:30
    Most of the Sporicidal agents are very similar in chemical makeup. Try Spor-Klenz for a start. Good old Sodium Hypochlorite has been used for years because it works. Germicidal products such as Sterisol work well. Decon Ahol (IPA) is your first entry point barrier.

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    Gregory Kleinert
    Biocoat, Inc.
    Warrington PA
    United States
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    Original Message


  • 5.  RE: Cleaning agent

    Posted 21-Mar-2017 15:23
    Thank you both.

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    Brenda Miller
    Quality Assurance Manager Combat Medical Systems
    Harrisburg, NC
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    Original Message


  • 6.  RE: Cleaning agent

    Posted 21-Mar-2017 23:36

    Brenda, a wide range of aqueous solutions – from alcohols, phenols, iodine, chlorine, bleach, hydrogen peroxide, acetic acid, etc. to the exotic and specific biocides - are in use for various applications.  As your query states ‘kill bacteria, fungi and spores’ I believe you are interested in biocidals that are effective across multiple species.  You will find a multitude of chemical agents with their lethal concentrations here:

    Antiseptics and Disinfectants: Activity, Action, and Resistance

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC88911/



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    Homi Dalal RAC
    Regulatory Affairs Leader
    Dynamic Controls
    Christchurch
    New Zealand
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    Original Message


  • 7.  RE: Cleaning agent

    Posted 24-Mar-2017 19:01
    Try to get in touch with sales person from Steris. 

    Decontamination, Surgical and Critical Care Services | STERIS

    They will advise you the best disinfectant based on your needs either bactericidal, fungicidal, sporocidal, etc. The products are labelled with the usage direction.

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    Gaurang Bhavsar
    Edison NJ
    United States
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    Original Message


  • 8.  RE: Cleaning agent

    Posted 24-Mar-2017 19:46
    Brenda,

    Cleaning and sterilization (killing bacteria, fungi or spores) should be distinguished for validation purposes.

    As for cleaning validation, it is worth reading FDA info on the issue at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124777.htm

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


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