1 CPPT 9010: Facility Design & Operation 4/14/2017CPPT 9010: Facility Design & OperationD.I.T. DT275Masters in Chemical and Pharmaceutical Process Technology17th December 2009Clement FarrarBA BAI MSc MIEI
2 Lecture Overview 1) General Support Utilities 2) Water 3) Clean Steam 4) Waste5) CIP & SIP6) Autoclaves7) Washers8) Solution Transfer
3 1) Support Utilities What are Support Utilities? Why do we need Support Utilities?
5 Clean Steam (CS)Clean Steam is generated with Clean Steam Generators by the distillation of RO or WFIClean Steam is used for sanitization
6 Water For Injection (WFI) Water for Injection (WFI) is a raw material (excipient)Needs to be ‘clean’ - stripped of any inorganics, organics, microorganisms and have low level of endotoxinsSuitable to inject intravenouslyUses include:Final rinse for CIP’sClean Steam generationProduct formulationsEquipment washing
7 Gases Oxygen O2 Carbon Dioxide CO2 4/14/2017GasesOxygen O2Oxygen is an essential requirement for the growth of cells (in the case of bio-processing)It is sparged through the bioreactor vessels via the oxygen/ carbon dioxide distribution loopCarbon Dioxide CO2Carbon Dioxide is used to maintain the desired level of oxygenIt is sparged through the reactor vessels via the oxygen/ carbon dioxide distribution
8 Other Utilities Glycol Instrument Air 4/14/2017Other UtilitiesGlycolGlycol is used as the coolant (through vessel jackets)Glycol is stored in a Process Glycol Surge TankGlycol is distributed throughout the process via the Glycol Distribution LinesInstrument AirInstrument air is high pressure air which is used to operate actuator valves and does not contact process contact surfaces
9 HVAC (Heating, Ventilation & Air Conditioning) HVAC SystemHVAC systems are located in the interstitial places between the building floorsIts purpose is to maintain the heat, ventilation and air conditioning at the desired levelAir HandlingSystemProduction RoomWithDefinedRequirementsSupplyAirOutlet
10 Process Waste Treatment Process Waste must be treated prior to discharging from site
11 Cleaning & Steaming Clean in Place (CIP) Steam in Place (SIP) Before process equipment can be used it must be Cleaned and Steamed (or Autoclaved)Clean in Place (CIP)Method of cleaning the process equipment and associated pipe-work using a variety of cleaning agents such as RO Water, Caustic, Acid and WFISteam in Place (SIP)Method of sanitizing the process equipment and associated pipe work by steaming at high temperatures (~121°C) until certain criteria are met and all micro-organisms are killed
13 Water Overview Utility Water Clean Water Softened Water System RO (Reverse Osmosis) Water SystemWFI (Water for Injection)
14 Utility Water Plant Flow Chart UtilitiesWaterUser 1Utility WaterStorage TankChlorine AnalyserSoftenedWaterPlantUser 2User 3Chlorine AnalyserDistribution PumpsUser 4SodiumHypochloriteStorage Tank&DosingPumpsUser 5Inlet from Local County Council
15 Utility Water Usage Uses of Utility Water As utility water in all buildings (for cooling)Domestic Water Supply to all buildingsSupply to the cooling towersChilled WaterUtility water feeds the softened water generation plantFor generation of RO & WFIBoiler feed water
16 Why do we need ‘Clean Water’? 4/14/2017Why do we need ‘Clean Water’?Water for Injection (WFI) is a raw material (excipient)Suitable to inject intravenouslyNeeds to be ‘clean’ - stripped of any inorganics, organics, microorganisms and have low endotoxinSpecification of WFI defined in various Pharmacopeia’sThere are various types of “clean water” that are used in pharmaceutical processes (e.g. purified water, utlra pure water, water for injection).For the purposes of this presentation will concentrate on WFI, which is the water type used in the manufacturing processes at Grange CastleWater for InjectionMost widely used raw material at Grange CastleBy its name, WFI is suitable to inject intravenouslyWFI therefore needs to be “clean”. By clean we mean that it is stripped of all the bare essentials, e.g. inorganics (salts), organics, micro-organisms and have low endotoxin.There are tight specifications for WFI that we need to demonstrate compliance with. At grange castle, we demonstrate that the WFI meets USP and EP specifications, will discuss the actual specifications later in the presentation.
17 How do we make ‘Clean Water’? 4/14/2017How do we make ‘Clean Water’?Drinking water is supplied to the facilityDrinking water undergoes a series of purification steps to turn it into WFIExamples of Purification steps include softening, deionisation, distillationDrinking water is supplied to site, same drinking water that is supplied to homes.In comparison to WFI, drinking water is much less pure.Drinking water undergoes a series of purification steps in order to turn it into WFI. Purification steps can include softening, deionisation, distillationIn the next few slides, I will discuss the different purification steps used at Grange Castle in order to turn our drinking water into WFI.
18 Soft Water Generation Utility Water supplied to Soft Water plant Water is softened by removing hardness ions (Ca2+ and Mg2+) present in drinking waterSoftener resins replace the hardness ions with sodium ions (Na+)Soft Water plant also removes particulates from water using multi media filtersSoft Water is dosed with chlorine to control microbial growth
19 Soft Water Plant - Sample Schematic User 1User 2User 3User 4To Site DistributionUser 5User 6Multi Media #3Water Softener #1Soft Water Storage TankBisulfite AdditionWater Softener #2Multi Media #2Distribution PumpsWater Softener #3Multi Media #1Utility Water InletHypochlorite AdditionHardness Analyser
20 Reverse Osmosis (RO) Generation 4/14/2017Reverse Osmosis (RO) GenerationRO membranes remove dissolved organics and inorganic contaminants from soft waterHigh pressures drive water molecules to pass from higher to lower concentrated solutionOpposite to osmosisAchieves good salt reduction (approx 95%)Requires constant removal of waste stream (concentrate) to optimise performanceRequires routine sanitisation (heating) and cleaning (chemical) to ensure qualityNext stage to the water purification process is Reverse OsmosisReverse Osmosis is used in both DS and DP for the generation of WFI, but also RO water is used as make up water for CIPs
21 Reverse Osmosis Water Generation - Sample Schematic 4/14/2017Reverse Osmosis Water Generation - Sample SchematicRO STORAGE TANKRO LOOP RETURNRO DISTRIBUTIONSOFT WATER BREAK TANKACTIVATED CARBON FILTER0.5 um FILTERRO MEMBRANESPUMPRE-CIRCULATION TO TANKSOFT WATERSOFT WATER BREAK TANKACTIVATED CARBON FILTER0.5 um FILTERRO MEMBRANESPUMPRE-CIRCULATION TO TANKSOFT WATERRO Generation Capacity 17 m3/ hr
22 Water for Injection (WFI) Generation WFI generated through distillationRequires boiling RO feed water and condensing distillatePhase transferSeparates dissolved and undissolved impurities from the water
23 Water for Injection (WFI) Generation Impurities need to be frequently removed (blowdown) to ensure qualityAny microorganisms killed during phase transferEndotoxins separated during phase transfer
25 Storage and Distribution Systems 4/14/2017Storage and Distribution SystemsNot just generation of ‘Clean Water’ that is importantStorage and distribution systems are equally (if not more) important than generationUSP and EP WFI biological specifications are very highBioburden <10 cfu/100mlEndotoxin <0.25 EU/mlStorage and distribution systems are designed to minimise microbial growthHigh distribution temperaturesPipework surface finishContinuous, turbulent flowZero dead-leg valvesGeneration is only half of the battle to supplying manufacturing with clean water that meets WFI specificationThe way in which the clean water is distributed is equally, if not more, important
26 WFI System Use/ Maintenance 4/14/2017WFI System Use/ MaintenanceThe manner in which the WFI distribution system is used/ maintained is also importantWFI is easily contaminated (biologically and chemically) by peopleCare required with usage to ensure that WFI specifications are metUse of IPAUse of clean autoclaved hoses/ gasketsFlushing prior to useManagement of the user pointsGood hose managementManagement of the user points with respect to contamination control
27 WFI Specifications and Sampling Considerations 4/14/2017WFI Specifications and Sampling ConsiderationsEP and USP define WFI biological and chemical specificationsExtensive sampling is performed daily on WFI systems to ensure water qualityDaily biological samplesContinuous conductivity and TOC analysersHeavy metals, nitrates and description test performed weeklySystem performance continually monitored to ensure operating within validated rangeInvestigations required for any out of specificationsIf system designed and operated in the correct way, it is usual not to find any out of specification results.
28 What is ‘Clean Water’ used for? WFI can be the most widely used Raw Material at a Pharma FacilityWFI Uses include:Final rinse for CIP’sClean Steam generationRaw material used for media and buffers make upProduct formulationsMake up water for product contacting CIP’sEquipment washingArea CleaningSinks
30 Clean Steam Overview What is Clean Steam? Where is it Used? How is it Made?Pipe Work & ComponentsStandards
31 Clean Steam - What is it ?Pharmaceutical Clean Steam is a pure heat source used in pharmaceutical sanitisations (mostly)Clean Steam is generally any steam system that is qualifiedRoutinely monitored and Quality tested.Have to demonstrate absence of microorganisms in a condensed steam sampleHave chemical specifications that must be complied withRegulatory requirement to comply to biological and chemical specifications for these systems
32 Clean Steam - What is it ?Clean steam is simply steam that contains very little impurities when condensed back to waterIt is generated and distributed in a way that reduces potential impurities (biological or chemical) from reaching use points
33 Clean Steam - Where is it used? cGMP Autoclaves (decontamination autoclaves may use Plant Steam)Manufacturing Process (SIP’s) - throughout all manufacturing areas & processes clean steam is used for sanitisationOther uses include:Used in agitator seals in Bioreactors for sterile boundary.Used to supply HVAC humidification (instead of dedicated hum steam generator)
34 Clean Steam - How is it made? These are the 1850Kg/Hr & 2800Kg/hr clean steam generators
35 Clean steam - Pipework & Components Clean systems generation & distribution systems are made up of 316L s/s electropolished high purity piping components.Condensate build up in clean steam systems is to be avoided – it can affect clean steam dryness quality and if left accumulate on distribution systems can present bioburden issues.‘Trapping’ – the removal of condensate
36 Clean Steam TrappingExample of Steam Trap: balanced pressure type from Spirax Sarco - there are different sizes and different condensate capacities available
37 Clean Steam - Pipe-Work & Components Steam separators (to help improve steam dryness).Trap SetArrangementClean SteamSeparatorTypical PressureReduction Set
38 Clean Steam Specifications CS Condensate requirements: Clean steam condensate = WFI qualityCurrently no section dedicated to clean steam so clean steam is required to meet current pharmacopia requirements for WFI
39 Construction Guidelines / Best Practices (e.g. ISPE Guidelines) Clean steam systems are sloped to assist with condensate removal usually in the direction of steam flow - is as per WFI sloped pipework 1:100Steam lines should be sized to give a max velocity of 25M/sec - this is again to ensure trapping is not negated
40 Construction Guidelines / Best Practices (e.g. ISPE Guidelines) Clean steam traps - vertically mounted, steam off takes from top of pipes etcThe material of gaskets used on ASME BPE clamps and valves on clean steam distributions are an important consideration
42 Waste Neutralisation - Overview Consists of Waste Neutralisation Tank and ancillary equipmentIts function is to treat the Process Waste prior to discharging to the Local Authority Sewer
43 Waste Neutralisation Functionality Waste Neutralisation Tank - Critical ParameterspHTemperatureAvailability of OxygenFlow to Sewer
44 Waste Neutralisation Functionality pHWaste can have a too high or too low pHpH corrected using H2SO4 for high pHpH corrected using NaOH for low pHpH of the effluent is continually adjusted between 6 - 8TemperatureGenerally if the temperature rises above 37 Deg C, the cooling supply to the re-circulation line heat exchanger is activated and the effluent is cooled
45 Waste Neutralisation Functionality Availability of OxygenIt is critical to keep the neutralisation tank oxygenated to avoid the proliferation of Anaerobic bacteriaThere are generally air blowers attached to an air jet system located at the bottom of the tankOxygen is monitored in the tank and sustained at a level that will restrict Anaerobic zones where anaerobes may growFlow to DrainWhen the discharge limit is reached the Sewer Valve can be interlocked to maximise the usage of the capacity of the tank on occasions
46 Why Waste Must be Treated The EPA (Environmental Protection Agency) and Local County Council issue a License called an Integrated Pollution Control (IPC) License to every facility to allow the site to go into operation.Each facility is responsible for continuing to operate within the limits/ requirements outlined in the license.Each facility should have a monitoring program that includes daily, weekly, monthly, quarterly and annual monitoring events.Most importantly each site must restrict the effluent discharged from site on a daily basis to the specified limit!
47 Potential IPCL Issues Too Much Water Being Generated on Site. Intermittent Elevated Suspended SolidsThe waste tank is a great home for Bugs as there can be a constant source of food and ambient temperatures thereIntermittent Elevated Sulphate ConcentrationsDosing Large Volumes of Sulphuric Acid Due to the Alkali Nature of Waste from CIP activities (Caustic Cleans)Breaches of the effluent discharge limit are defined as pollution events.Consequence of continual license excursions would lead to fines and even a site shutdown
50 CIP/ COP CIP (Clean In Place) COP (Clean Out of Place) 4/14/2017CIP/ COPCIP (Clean In Place)Automated chemical cleaning systemFixed vessels and transfer linesValidated process and proceduresEquipment is cleaned by combination of heat, force and chemical exposureCOP (Clean Out of Place)(Generally for smaller equipment)Portable VesselsSmall Components (e.g. Manual Valves, Probes)Miscellaneous EquipmentDiscuss CIP/COP, working through each bullet point.Explain the concept around Validated, Automated systems and the reasons why.
51 CIP Cycle Used on Lines & Vessels 4/14/2017CIP CycleUsed on Lines & VesselsLines are generally quick as they are small in comparison with vesselsCIP cycles use hot chemical solutionsCIP 100 solution (KOH, base or caustic)CIP 220 solution (HCl, Acid)Blow down stepsRO & HWFI rinsesThere are (3) CIP Cycles a Technician can run:Line Cycle – full CIP ( transfer lines and valve rings (manifolds) )Vessel Cycle – full CIP for a reactor of a vessel used to store mediaBuffer Cycle – abbreviated WFI wash. Buffer solutions only contain salts which can not alone support contamination
52 CIP Cycle Steps in the Cycle are typically: 4/14/2017CIP CycleSteps in the Cycle are typically:Step 1: Reverse Osmosis (RO) water rinseStep 2: Blow downStep 3: Caustic solution rinseStep 4: Blow downStep 5: RO rinseStep 6: Blow downStep 7: Acid solution rinseStep 8: Blow downStep 9: Hot Water for Injection (HWFI) rinseStep 10: Blow down.This is used on tanks that have contained media,Notice the pattern that emerges, with the blow down in between each step.Each of you will become very familiar with the cycles and individual steps associated with the equipment in your areas.
53 4/14/2017Question1) Do we need to CIP a vessel if we are going to transfer the EXACT same solution in it again?2) Why?Discuss: Ask the group what they think
54 GMP Expectations 21 CFR 211.67 21 CFR 211.182 21 CFR 211.68 4/14/2017GMP Expectations21 CFRThorough and reproducible cleaning of equipment and transfer lines is required to prevent malfunction or contamination that would alter the quality and purity of the drug product beyond the established requirements.21 CFRLogs of equipment use and cleaning must be maintained.21 CFRAutomation of the equipment is permitted, but must be subject to routine calibrations, preventative maintenance and inspections.CFR = Code Federal Regulations is a US FDA regulation code
55 4/14/2017GMP ExpectationsFDA expects companies to have written procedures (SOP’s) detailing the cleaning process used for equipment.The cleaning cycle will remove product residue as well as cleaning solution from surfaces coming into contact with the product.Companies must validate each cleaning cycle for all pieces of equipment.Companies must have written procedures detailing the validation process of cleaning cycles.
56 Advantages of Automated CIP 4/14/2017Advantages of Automated CIPEquipment that has been CIP’d receives less wear and tear than items which are cleaned manually.CIP is more efficient than manual cleaning because the vessel has uniform and consistent cleaning.CIP means improved safety for personnel since they have no contact with heated chemical solutions.Labour required for cleaning is reduced.Production may be increased through reduction of down time.Automated technology allows documentation of the cleaning performance which can be monitoredAs per bullets.Techs more efficient at start of shift, these kinds of variations mean manual cleaning is less effective.Improved safety, but there are hazards associated with CIP.
57 4/14/2017CIP HazardsYou have to break into lines and certain vessels to begin a CIP circuitThis can lead to incorrect fittings and loose connections (e.g. transfer panels, spool pieces, filter housings).Pressurised air blow (2 bar).Pumps produce (5 bar) when operatingTemperatures are in excess of 70oCHeated chemical solutions at high pressure(HCl & KOH).Always a danger when you break into a line or a system.Note 1 bar = 15psiNeed pictures of a transfer panel, spool pieces etc to be placed in before or after tis slide alan and lauraine to provide.70 degrees will not cause burns, but will make you jump.Very rare that accidents occur with CIP, due to the good procedures in place, but it’s good to be aware…Pumps are used to deliver solutions and send back water to hold tanks, scavenger pumps
58 COP (Clean Out of Place) 4/14/2017COP (Clean Out of Place)Used on small portable vessels and small pieces such as filter housings and spool pieces (COP Bath)Carried out in designated COP stationThe equipment is cleaned by a combination of heat, force and chemical exposure.
59 4/14/2017COP - Small VesselThis could be used to hold Acetic acid for exampleMost are on wheels..
63 COP - Hazards Hazards are the same as for CIP but also include; 4/14/2017COP - HazardsHazards are the same as for CIP but also include;The need to hook up flexi hoses to the portable vessels to begin circuitThis can potentially lead to incorrect fittings and loose connectionsThe vessels and their connections may be hot after cleaning (PPE must be worn)Disconnecting hoses and the emptying of vessels may expose technicians to small volumes of hot cleaning solutionsManual handling of small vesselsChemical and physical hazards are the same as CIP but there are some situations unique to COPTechs are actually outside the COP station when the system is switched on.
64 6) SIP (Steam In Place) 4/14/2017 F0 refers to the lethality of an autoclave process. Thus in an autoclaving process if the F0 = 8 it means that it has the same lethal effect on the microorganism as autoclaving at 121 0C for 8 mins.The traps we use are thermodynamic – they rely on a continuous passage of steam to the atmosphere to keep condensate removal channels open and ENSURE the temp remains at a minimum of 121oCSIP is sanitisation but ca be refered to as sterilisation as well. We don’t claim sterility, so we must be carefull how we phrase it.Saturated steam is pure stem, that has no air or condensate, meaning it has a constant temp. 121 degrees kills all bacteria
65 SIP Overview Automated steaming system Kills microorganisms and spores 4/14/2017SIP OverviewAutomated steaming systemKills microorganisms and sporesReleases massive energy when the saturated steam comes into contact with the microorganismsF0 refers to the lethality of an autoclave process. Thus in an autoclaving process if the F0 = 8 it means that it has the same lethal effect on the microorganism as autoclaving at 121 0C for 8 mins.The traps we use are thermodynamic – they rely on a continuous passage of steam to the atmosphere to keep condensate removal channels open and ENSURE the temp remains at a minimum of 121oCSIP is sanitisation but ca be refered to as sterilisation as well. We don’t claim sterility, so we must be carefull how we phrase it.Saturated steam is pure stem, that has no air or condensate, meaning it has a constant temp. 121 degrees kills all bacteria
66 4/14/2017SIP OperationOne temperature probe (at the coldest point of the system) controls the sterilisation time - CONTROLLING TEMPERATURE PROBEOther temperature indicators (TI’s) are monitored to ensure uniform sterilisation. These TI’s are ‘trapped’ to ensure adequate condensate removalThe traps we use are thermodynamic – they rely on a continuous passage of steam to the atmosphere to keep condensate removal channels open and ENSURE the temp remains at a minimum of 121oCWe have to ensure the temp is constant to be in line with the validated protocol.Temp probe at base of vessel which determines the length of the cycle.Validated at oCf0 is the length of time required to kill certain bacteriaNot only is TI located at base of vessel, but they are also dotted around the vessel to ensure maximum monitoring of temp throughout vessel. They have traps fitted to allow condensate to be drained off
67 4/14/2017SIP ParametersSTEAM - must be saturated (in equilibrium with it’s condensate)Saturated steam at a minimum temperature of 121.1ºCTemperatures above 127 oC can affect probe performance and damage gasketsPRESSURE15 psigTIMEValidated for different pieces of equipment using biological indicators ( BI’s )There are (3) KEY SIP parameters that must be met for a successful Steaming:STEAMPRESSURE 15psig, means psi at the gauge.TIMEIf ANY ONE of these parameters are not met then the system FAILS.Point out that there are different parameters for Vessels & Product Lines vs. Buffer lines.Validation uses spore strips as Biological Indicators to collect swab type samples to grow and check for spore growthSaturated steam is a steam/condensate equilibrium state……..if no condensate is present the steam does not kill as effectively.We use Fo calculations to decide when SIP is complete. The computer calculates these. It looks at the time the batch temperature was above 110’ and estimates kill time at 121’ on this basis.
68 SIP Key Functions Air Removal Condensate Removal 4/14/2017 If these are not removed then you don’t get saturated steam
69 4/14/2017Air RemovalSteam/ air mix will result in unsaturated steam (saturated steam required to kill microorganisms)Performed by bleeds at high pointsBleed points remove air to ensure temp is kept at 121oC
70 4/14/2017Condensate RemovalCondensate also creates an unsaturated steam conditionCondensate will cause cool spotsRemoved by low point TrapsThis also reduces temp and is drained off.Cold spots are possible places were bacteria can grow
71 Typical SIP Cycle Set up system per SOP Assure adequate signage 4/14/2017Typical SIP CycleSet up system per SOPAssure adequate signageVent air up to 100o C then close exhaustHeat up system to temp [>121.10C]Hold system at validated temperatureCool down system slowly - maintain positive pressure by adding sterile air to avoid vacuum formationMaintain system closed and sterile under positive pressure
72 SIP Hazards High temperatures 4/14/2017SIP HazardsHigh temperaturesPressurised steam - can blow off loose connectionsUnlagged plant in high risk areas
73 SOP (Steam Out of Place) 4/14/2017SOP (Steam Out of Place)Used on small portable vesselsCycle parameters are the same as for SIPCarried out in designated SOP stationKey functions (e.g. air removal) are the same as for SIPEnsure that steam out of place is not confused with Standard Operating Procedures.Exactly the same as SIP, out carried out in an enclosed SoP station.Higher potential for human error.
74 SOP - Hazards High temperatures 4/14/2017SOP - HazardsHigh temperaturesPressurised steam - can blow off loose connectionsPotential for technicians to be exposed to pressurised steam
75 4/14/2017SOP RecommendationsIt’s essential to have someone check the set-up PRIOR to starting a SOP cycleInform co-workers PRIOR to starting a cycleWatch for leaks at the beginning of the cycle - this is when most leaks start
78 Autoclave OverviewDesigned for steam sterilisation of dry goods (e.g. filter housings, hoses, machine parts)Steam sterilisation takes place in autoclave under vacuum for a length of time governed by F0 calculationsF0 calculations give the time taken to achieve desired lethality rate of bacterial spores at a given temperature of steam
79 Autoclave Process Description Pre-cyclePre-conditioningHeatingExposurePost-conditioningEqualisation
80 Process Description Pre-cycle Pre-conditioning Heating Leak test Vacuum Level & Hold and Pressure Level & Hold or Forced Air RemovalHeatingHeating Up 1 & 2Filter heat up
81 Process Description Cont. ExposureSterilisationPost-conditioningVacuum Level & Hold and Pressure Level & Hold orSlow ExhaustEqualisation
83 Washer FunctionDesigned to insure adequate cleaning, rinsing and drying of product contact surfaces (e.g. Media/ Buffer/ Filling Line Parts)
84 Washer Process Overview WFI passes through a heat exchanger before entering the washer sumpThe heated WFI is pumped through spray jets on loop headers designed to cover all areas of items to be washedAddition of detergent via diaphragm pumpSteam coils installed in the sump heat the wash solution.Tank mounted on the side of washer stores hot WFI for once-through final rinseFiltered, heated air is circulated through cabinet during drying cycle
86 Washer Process Description PrewashCirculated Detergent Wash2 x Circulated RinseNon-circulated WFI RinseDrying
87 Washer Process Description - Prewash WFI from supply passes through heat exchanger before being pumped into washer sump.Hot WFI is circulated through spray jets on loop headers for specified length of time.Pneumatic ball valve directs water to drain. Cold water is added to drain solution to prevent damage to drain
88 Washer Process Description - Circulated Detergent Wash Hot WFI Sump fillDetergent is dispensed to the washer for specified amount of time (Must reach specified conductivity)CirculationDrain
89 Washer Process Description - 2 x Circulated Rinse As per PrewashTemperature & Time setpoints variable
90 Washer Process Description - Non-Circulated WFI Rinse Hot WFI Storage tank is filled and maintains its fill during the wash cycleSteam coils maintain heat in tankA separate header system is used for final WFI rinse to provide isolation from the circulated water
91 Washer Process Description - Drying Dryer air flows through steam heating coil and HEPA filter before circulationHigh volume blower circulates the hot air over items to be dried
93 4/14/2017Transfer of SolutionsHaving made up various solutions/ ingredients….. How do you get a solution made in Tank A into Tank B?Discuss: Ask the group, How do we get solutions from one tank to another?
94 Transfer of Solutions Lines Pumps Pressure Transfer panels 4/14/2017Transfer of SolutionsLinesPumpsPressureTransfer panelsLet’s look at transfer panels in more depthAll these items are involved in solution transfer.
95 What is a Transfer Panel? 4/14/2017What is a Transfer Panel?( sometimes called flow plates )
96 4/14/2017Transfer PanelsA Transfer panel has a number of ports with hard piping behind them connected to various vessels/ utilitiesPorts are connected using U-shaped pipes called ‘Jumpers’The jumpers create a closed loop connecting tanks/ utilities which can stretch across different areas
99 Question - Transfer Panel Hazards 4/14/2017Question - Transfer Panel HazardsWhat types of hazards can you think of that are associated with transfer panels?Discuss: Ask the group to discuss hazards that are associated with transfer panels.Write their responses on the white-board or on a flip chart.
100 Question - Transfer Panel Hazards When transferring solutions, hazards can include:Incorrect connectionsLoose jumper connectionsBreaking/ making connectionsPressurised tanks and linesTank Contents (acids, caustic)Again, the MSDS will contain all info necessary for providing first aid / spillage control