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Recent content by sundrop139

  1. sundrop139

    Compendial quality grade for water used in lab analytical testing

    I refer you to the USP for specific and general information on water quality for analytical testing. The USP has specs for various grades of water and each test usually lists the grade of water required for that test.
  2. sundrop139

    transport validation

    You need to supply more information if you want a meaningful reply. For example, what materials are involved and their end application, what mode of transporation, what are the conditions of the transportation: duration, temperature, rate, etc.
  3. sundrop139

    Residue on Soap-drawn Stainless steel

    Without knowing the specifics of the soap, cleaning recommendations are difficult. As I see it, you have three options: a) contact a company specializing in cleaning; b) contact your customer to provide guidance; or c) try to figure it out yourself. Generic cleaning methods available to you...
  4. sundrop139

    Change of HEPA filters

    Vendor / manufacturer can provide background information on the performance of their filters, but you are also responsible on your end as the manufacturer cannot know the effect of your particluates on their equipment. If you seek to only supply HEPA air to an area then your 10% rule may be...
  5. sundrop139

    Cabinets vs. disposable bags

    I am looking for a cheap, easy, and effective way to protect fill-off equipment from air contamination after cleaning (water boil-out). We are looking at cabinets vs. disposable plastic bags - is there something better? Products are non-active or sterile excipients in steel drums and pails...
  6. sundrop139

    Cleaning Validation

    You have not provided much background as to the nature of the residue or cleaning agent, and with no specfic question you cannot get specific answers. UV detection alone will result from all components of the residue unless first separated, by chromatography, for example. I use evaporative...
  7. sundrop139

    Cleaning Validation: Set residue limits for CIP-100 and active

    As background, I work at a bulk chemical manufacturer that sells bulk excipients. We make over 300 products, none of which are active or sterile. We set our product residue limit at 10 ppm (w/w) in the next batch. We are audited by small and large pharmaceutical companies and none have...

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