Water for Pharmaceutical Use Part 2: Water refinement designing Presented by Dr. Errol Allcoc 30 June 2005, Pret

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ObjectivesTo look at the essential innovation and prerequisites for:Water treatment systemsStorage requirementsSampling and testingDifferent sorts of water utilized as a part of pharmaceuticalsMicrobial breaking points, sterilization. Water framework configuration Pipes inclined so water does not pool and can deplete easilySanitary fittings

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Water for Pharmaceutical Use Part 2: Water cleansing building Presented by Dr. Errol Allcoc 30 June 2005, Pretoria, South Africa Errol.Allcock@microsep.co.za 083-459 6267 Supplementary Training Modules on Good Manufacturing Practice

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Objectives To look at the essential innovation and necessities for: Water treatment frameworks Storage prerequisites Sampling and t esting Different sorts of water utilized as a part of pharmaceuticals Microbial points of confinement, sanitization

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Water framework configuration Pipes inclined so water does not pool and can deplete effectively Sanitary fittings & associations Constructed of reasonable materials, for example, stainless steel Circulate the water Incorporate non-return valves (NRV)

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Further water treatment purging stages downstream of the pre-treatment framework Filtration Disinfection Reverse osmosis or de-ionization Distillation or ultra-filtration

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D Flow heading bolts on funnels are imperative Deadleg segment X <2D If D=25mm & remove X is more noteworthy than 50mm, we have a dead leg that is too long. Sterile Valve Water scours deadleg Water framework outline (1) There ought to be no dead legs

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Water framework plan (2) 1. Ball valves are unsatisfactory 2. Microbes can develop when the valve is shut 3. The water is defiled as it goes through the valve Stagnant water inside valve

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Water framework outline (3) Sanitary pumps Clamp s and O rings versus strung fittings Heat exchangers Side arm level measuring gadgets are unsatisfactory

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Typical de-ionizer schematic from water conditioner HCl NaOH 6 5 4 3 2 1 Water must be continued circling Anionic segment Cartridge channel 5 µm Cartridge channel 1 µm Cationic section UV light Eluates to balance plant Ozone generator Hygienic pump Return to de-ionizer Outlets or capacity. Deplete line Air break to sewer

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Up and Down Flow DOWNFLOW : No directing and better particle catch, however higher danger of UPFLOW : stopping up Channeling Used in yet bring down Polishing danger of obstructing Used in Pretreatment

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SEM of Ion-Exchange Resin Bead breadth: 300 to 1200 µm (0.3 to 1.2 mm) Beads pores: 1 to 100 nm (0.001 to 0.1 µm) Bead dry weight 40 to 60%

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Ion-Exchange Resin Bead demonstrate Fixed Anion Counter Cation Styrene Cross connecting Agent (DVB) Hydrating Water

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1 2 1 2 Reverse Osmosis Reverse Osmosis P Osmotic weight 1 2 Reverse osmosis layer (RO) Feed water Purified water

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Low weight High weight Feed water under weight Semi-penetrable film Purified water crude water Reject water Permeate water deplete or reuse Reverse osmosis (RO) hypothesis

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Reverse Osmosis Membrane Permeate Feed Water Reject

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Typical 2-organize RO schematic Water from conditioner or de-ionizer Second stage dismiss water backpedals to first stage cradle tank first stage cushion tank First stage RO cartridge Branch first stage dismiss focus First stage filtrate sustains second stage RO with abundance back to first stage support tank . Air break to sewer Second stage RO cartridge second stage cradle tank High weight pump Cartridge channel 1 µm Hygienic pump Second stage RO water meets Pharmacopeia measures Water comes back to first stage support tank Outlets or capacity

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Use of invert osmosis Advantages Disadvantages Many utilizations purged water encouraging of refining units or ultra-filtration units Water for Final Rinse Water for Injection s (if admissible)

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Ultra-filtration Can be utilized for WFI or for Water For Final Rinsing for parenteral assembling (if allowed) Removes natural contaminants ,, for example, endotoxins Operation at 80°C , and cleansing at 121 °C

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Ultrafiltration Ultrafilters are asymetric layers, here and there composite Under pressure,small estimate particles experience the membrane,whereas atoms bigger then the NMWL are held

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Single-impact refining straightforward refining, single impact vapor pressure, thermo pressure Multi impact refining numerous impact stills Clean steam generators utilized where steam can come into contact with item contact surfaces, e.g. sanitization set up (SIP)

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Typical water stockpiling and conveyance schematic Hydrophobic air channel & burst circle Feed Water from DI or RO Cartridge channel 1 µm Spray ball Water must be continued coursing Optional in-line channel 0,2 µm UV light Outlets Heat Exchanger Air break to deplete Ozone Generator Hygienic pump

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Disinfection (1) Heat One of the most solid strategies for cleansing of water frameworks Ozone Produced effectively Leaves no buildup

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Disinfection (2) UV does not "disinfect" Flow rate basic Post-illumination recontamination might be an issue Lamps have limited life Other chemicals XO 2 Halogen Formaldehyde

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UV Technology : Electromagnetic Spectrum Gamma rays X Rays U.V. Visible Infrared 10 - 10 - 7 10 - 6 10 - 4 10 - 3 Wavelength(m) Ultraviolet radiation Ultra short Short Medium Long wave UV-C UV-B UV-A 315 100 400 200 280 Wavelength (nm)

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U. V. Innovation Relative power Wavelength (nm) 185 254 313 Emission of a low weight mercury light.

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Germicidal Action 100% 80% 254nm 60% 40% 20% 0% 300 320 240 260 280

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Conversion of hints of natural contaminants to charged species and at last CO2 (185 + 254) Limited obliteration of miniaturized scale life forms and infections (254) Limited vitality utilize Easy to work Polishing method just: might be overpowered if organics fixation in nourish water is excessively high. Organics are changed over, not expelled. Constrained impact on different contaminants Good outline required for ideal execution. UV Technology (185 + 254 nm)

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Contaminants Removal CONTAMINANT STILL MF DI RO UF AC IONS ORGANICS PARTICLES COLLOIDS BACTERIA VIRUSES Gasses UV : changes over natural atoms to CO2 or charged atoms

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Sampling (1) There must be an examining methodology Sample honesty must be guaranteed Sampler preparing Sample point Sample estimate

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Sampling (2) Sample holder Sample mark Sample stockpiling and transport Arrival at the research center Start of test

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Testing - setting details for purged water or WFI - (1) Ph. Eur. JP USP Int. Ph. pH 5 . 0-7 . 0 5 . 0-7 . 0 5 . 0-7 . 0 breeze through test C l < 0 . 5 breeze through test - finish test SO 4 finish test breeze through test - breeze through test NH 4 < 0 . 2 < 0 . 05 - breeze through test Ca/Mg pass test - - finish test Nitrates < 0,2 finish test - breeze through test Nitrites - finish test - -

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Testing - setting details for filtered water or WFI (2) Ph. Eur. JP USP Int. Ph Conductivity (µS/cm) - - < 1.3 - Oxidizable subs. pass test breeze through test - pass test Solids (ppm) < 10 < 10 - nmt (*) 10 TOC (ppm) - < 0.5 < 0.5 - Heavy metals - - - pass test CO 2 - - - pass test

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Testing Method check Chemical testing Microbiological testing test technique sorts of media utilized hatching time and temperature frightful and pointer life forms maker must set particulars

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Water for Injections International pharmacopeia prerequisites for WFI are those for purged water in addition to it should be free from pyrogens Usually arranged by refining Storage t ime ought to be under 24 hours Microbial breaking points must be indicated

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Water for Final Rinse Water for definite flush should be of an indistinguishable quality from the water required for pharmaceutical readiness

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Pyrogens and endotoxins Any compound infused into warm blooded animals which offers ascend to fever is a "Pyrogen" Endotoxins are pyrogenic, originated from Gram negative b acterial cell divider pieces D etect endotoxins utilizing a test for lipopolysaccharides (LPS) rabbit test identifies pyrogens LAL test distinguishes endotoxins U ltrafiltration , refining, & RO may expel pyrogens

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Sampling area Target Alert Action Raw water 200 300 500 Post sight and sound channel 100 300 500 Post conditioner 100 300 500 Post initiated carbon channel 50 300 500 Feed to RO 20 200 500 RO saturate 10 50 100 Points of Use 1 10 100 Suggested bacterial cutoff points (CFU/mL)