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  1. dtreacy

    FDA Guidelines for Inspection

    This is quite a difficult one to answer without additional information as to the exact application, environment, materials and risk to the product. In general a good reference document is the ISPE Baseline Vol 1. Guideline for new facilities, Bulk Pharmaceutical Chemicals. See www.ispe.org for...
  2. dtreacy

    Passivation

    Ultimately they will be welded into the loop, if they were passivated offline there would be a requirement for a final passivation once they were welded in place. Regards Daragh
  3. dtreacy

    Passivation

    Many thanks. The pipes will be capped and purged when in situ. The environmental conditions are indoor in dry hot service voids any from aggressive / corrosive vapours. Regards Daragh
  4. dtreacy

    Passivation

    I am extending the purified water loop on a site. My plan is to fabricate up the various spools in-situ and tie them into the loop at a later date. My question is this. Is it acceptable to fabricate these spools now and leave them sit for a couple of months without passivation. What are the...
  5. dtreacy

    Websites or books on pharmaceutical engineering

    The following 2 websites are quite good. www.picscheme.org www.ipse.org PS Joining the IPSE will also include access to "Pharmaceutical Engineering" magazine. Good Luck Daragh
  6. dtreacy

    UV Intensity Meter Calibration

    Your right, I believe that this is an extremely difficult problem. I have spent the past number of weeks contacting suppliers about calibrating these sensors and have received no definitive answer. Therefore I am putting forward the following logic argument for not calibrating the UV sensors and...
  7. dtreacy

    FAT procedure for hygienic vessels

    This thread seens to have died off. However to answer the last question. Riboflavin is relatively easy to find as it is Vitamin B2. Observed under UV light it glows Green Florescent
  8. dtreacy

    Rupture Disc for Hot WFI storage tank

    Hi, All the above replies sound good. I can only add the following Fit a heat tracing mechanism onto the vent filter housing to stop condensation blocking the filter and causing a loss of filter integrity during periods of vacuum / high differential pressures. Have a mechanism in place to...
  9. dtreacy

    BPE-2002 vs 3-A

    I personally have used the 2 sets of standards within my work. I find that that the BPE is most applicable for welding, piping, tank design and pumps. While the 3A standards are excellent for gasket and seal specification, heat exchangers etc. Hope this helps.
  10. dtreacy

    UV Intensity Meter Calibration

    We operate a 4 lamp UV disinfection unit on our purified water distribution loop. During a 3rd party audit we were requested to calibrate the UV intensity meter and duty hour totaliser on the unit. I have a number of questions regarding this: 1) Does anybody currently calibrate their duty hour...
  11. dtreacy

    ZDT, ZDL Valve P&ID Symbols

    Thanks Sounds Logical.
  12. dtreacy

    Plate and Frame Heat Exchanger for Purified Water

    HI all It’s a difficult one alright, the opinion seems to divided USA (Shell & Tube) / Europe (Plate & Frame). Anyway I've gone ahead and purchased a double walled plate & frame H/X. It will be used on a purified water loop, providing normal operations temperature control and thermal...
  13. dtreacy

    ZDT, ZDL Valve P&ID Symbols

    Hello All, Quick question. Does anyone know if there are specific P&ID symbols for Zero Dead Leg valves or does the normal diaphragm valve symbol suffice? Regards Daragh
  14. dtreacy

    Design of overflow drainer for deionized water tank

    Hi all, I agree, a U bend overflow poses too many problems in terms of contamination. We have a similar set up to the one described by PauloRibeiro. The only additional comments that I can state are as follows: 1)A level transmitter could be used instead of level switches it is less intrusive...
  15. dtreacy

    Feed to 2 purified water storage tanks.

    Hi PauloRibeiro The 1st tank will feed USP grade purified water to production and the laboratories. The 2nd tank feeds a WFI still and 2 PSGs. Since these are purification systems in their own right they do not have to be feed with USP grade water. For this water I can generate my own in-house...
  16. dtreacy

    Feed to 2 purified water storage tanks.

    PauloRibeiro, The 2 tanks are distribution tanks one tank each tank has its own distribution loop associated pumps and lamps. These loops are outside the scope of the problem. The issue is how to feed the 2 tanks with purified water from the generation system. I have called this the “feed...
  17. dtreacy

    Feed to 2 purified water storage tanks.

    Not necessarily, My problem is confined purely to the loop feeding 2 tanks (A & B) with purified water from a single generation skid, the loop starts at the EDI has the 2 tanks as use points and returns to the RO Break Tank (Pre RO Unit). Tank filling will be controlled on tank levels. Each...
  18. dtreacy

    How to caculate air flowrate required for prevent from vacuum forming?

    The best option is the 0.2 micron absolute hydrophobic vent filter as previously stated by quark. If sterilisation is critical ensure that the vent filter can be integirty tested in-situ to ensure that it provides full protection. Also heat tracing on the vent filter is essential as condensation...
  19. dtreacy

    Feed to 2 purified water storage tanks.

    Only one problem with this, is that all EDI product must be available on demand. ie. When a tank opens all water must be feed the tank, thus draining the recirculation line post feed valve. This is due to the fact that we require all the purified water produced. Is a bit of a difficult problem...
  20. dtreacy

    Design of overflow drainer for deionized water tank

    A problem with an overflow line, is that it is a potential area for bio-fouling. If the tank comes under a negative pressure it could pull back all the stagnant water in the U pipe and contaminate the tank and system. An alternative to this is to install a sanitary rupture disc on the tank that...

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