CPPT 9010: Facility Design & Operation

CPPT 9010: Facility Design & Operation
4/14/2017 CPPT 9010: Facility Design & Operation D.I.T. DT275 Masters in Chemical and Pharmaceutical Process Technology 17th December 2009 Clement Farrar BA BAI MSc MIEI

Lecture Overview 1) General Support Utilities 2) Water 3) Clean Steam
4) Waste 5) CIP & SIP 6) Autoclaves 7) Washers 8) Solution Transfer

1) Support Utilities What are Support Utilities?
Why do we need Support Utilities?

Support Utilities Essential Utilities Clean Steam Generators
WFI Generators RO Skids Potable Water Process Air CIP Skids Other Utilities Glycol Instrument Air CO2 O2

Clean Steam (CS) Clean Steam is generated with Clean Steam Generators by the distillation of RO or WFI Clean Steam is used for sanitization

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 endotoxins Suitable to inject intravenously Uses include: Final rinse for CIP’s Clean Steam generation Product formulations Equipment washing

Gases Oxygen O2 Carbon Dioxide CO2
4/14/2017 Gases Oxygen O2 Oxygen 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 loop Carbon Dioxide CO2 Carbon Dioxide is used to maintain the desired level of oxygen It is sparged through the reactor vessels via the oxygen/ carbon dioxide distribution

Other Utilities Glycol Instrument Air
4/14/2017 Other Utilities Glycol Glycol is used as the coolant (through vessel jackets) Glycol is stored in a Process Glycol Surge Tank Glycol is distributed throughout the process via the Glycol Distribution Lines Instrument Air Instrument air is high pressure air which is used to operate actuator valves and does not contact process contact surfaces

HVAC (Heating, Ventilation & Air Conditioning)
HVAC System HVAC systems are located in the interstitial places between the building floors Its purpose is to maintain the heat, ventilation and air conditioning at the desired level Air Handling System Production Room With Defined Requirements Supply Air Outlet

Process Waste Treatment
Process Waste must be treated prior to discharging from site

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 WFI Steam 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

2) Water

Water Overview Utility Water Clean Water Softened Water System
RO (Reverse Osmosis) Water System WFI (Water for Injection)

Utility Water Plant Flow Chart
Utilities Water User 1 Utility Water Storage Tank Chlorine Analyser Softened Water Plant User 2 User 3 Chlorine Analyser Distribution Pumps User 4 Sodium Hypochlorite Storage Tank & Dosing Pumps User 5 Inlet from Local County Council

Utility Water Usage Uses of Utility Water
As utility water in all buildings (for cooling) Domestic Water Supply to all buildings Supply to the cooling towers Chilled Water Utility water feeds the softened water generation plant For generation of RO & WFI Boiler feed water

Why do we need ‘Clean Water’?
4/14/2017 Why do we need ‘Clean Water’? Water for Injection (WFI) is a raw material (excipient) Suitable to inject intravenously Needs to be ‘clean’ - stripped of any inorganics, organics, microorganisms and have low endotoxin Specification of WFI defined in various Pharmacopeia’s There 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 Castle Water for Injection Most widely used raw material at Grange Castle By its name, WFI is suitable to inject intravenously WFI 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.

How do we make ‘Clean Water’?
4/14/2017 How do we make ‘Clean Water’? Drinking water is supplied to the facility Drinking water undergoes a series of purification steps to turn it into WFI Examples of Purification steps include softening, deionisation, distillation Drinking 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, distillation In the next few slides, I will discuss the different purification steps used at Grange Castle in order to turn our drinking water into WFI.

Soft Water Generation Utility Water supplied to Soft Water plant
Water is softened by removing hardness ions (Ca2+ and Mg2+) present in drinking water Softener resins replace the hardness ions with sodium ions (Na+) Soft Water plant also removes particulates from water using multi media filters Soft Water is dosed with chlorine to control microbial growth

Soft Water Plant - Sample Schematic
User 1 User 2 User 3 User 4 To Site Distribution User 5 User 6 Multi Media #3 Water Softener #1 Soft Water Storage Tank Bisulfite Addition Water Softener #2 Multi Media #2 Distribution Pumps Water Softener #3 Multi Media #1 Utility Water Inlet Hypochlorite Addition Hardness Analyser

Reverse Osmosis (RO) Generation
4/14/2017 Reverse Osmosis (RO) Generation RO membranes remove dissolved organics and inorganic contaminants from soft water High pressures drive water molecules to pass from higher to lower concentrated solution Opposite to osmosis Achieves good salt reduction (approx 95%) Requires constant removal of waste stream (concentrate) to optimise performance Requires routine sanitisation (heating) and cleaning (chemical) to ensure quality Next stage to the water purification process is Reverse Osmosis Reverse 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

Reverse Osmosis Water Generation - Sample Schematic
4/14/2017 Reverse Osmosis Water Generation - Sample Schematic RO STORAGE TANK RO LOOP RETURN RO DISTRIBUTION SOFT WATER BREAK TANK ACTIVATED CARBON FILTER 0.5 um FILTER RO MEMBRANES PUMP RE-CIRCULATION TO TANK SOFT WATER SOFT WATER BREAK TANK ACTIVATED CARBON FILTER 0.5 um FILTER RO MEMBRANES PUMP RE-CIRCULATION TO TANK SOFT WATER RO Generation Capacity 17 m3/ hr

Water for Injection (WFI) Generation
WFI generated through distillation Requires boiling RO feed water and condensing distillate Phase transfer Separates dissolved and undissolved impurities from the water

Water for Injection (WFI) Generation
Impurities need to be frequently removed (blowdown) to ensure quality Any microorganisms killed during phase transfer Endotoxins separated during phase transfer

WFI Generation Still

Storage and Distribution Systems
4/14/2017 Storage and Distribution Systems Not just generation of ‘Clean Water’ that is important Storage and distribution systems are equally (if not more) important than generation USP and EP WFI biological specifications are very high Bioburden <10 cfu/100ml Endotoxin <0.25 EU/ml Storage and distribution systems are designed to minimise microbial growth High distribution temperatures Pipework surface finish Continuous, turbulent flow Zero dead-leg valves Generation is only half of the battle to supplying manufacturing with clean water that meets WFI specification The way in which the clean water is distributed is equally, if not more, important

WFI System Use/ Maintenance
4/14/2017 WFI System Use/ Maintenance The manner in which the WFI distribution system is used/ maintained is also important WFI is easily contaminated (biologically and chemically) by people Care required with usage to ensure that WFI specifications are met Use of IPA Use of clean autoclaved hoses/ gaskets Flushing prior to use Management of the user points Good hose management Management of the user points with respect to contamination control

WFI Specifications and Sampling Considerations
4/14/2017 WFI Specifications and Sampling Considerations EP and USP define WFI biological and chemical specifications Extensive sampling is performed daily on WFI systems to ensure water quality Daily biological samples Continuous conductivity and TOC analysers Heavy metals, nitrates and description test performed weekly System performance continually monitored to ensure operating within validated range Investigations required for any out of specifications If system designed and operated in the correct way, it is usual not to find any out of specification results.

What is ‘Clean Water’ used for?
WFI can be the most widely used Raw Material at a Pharma Facility WFI Uses include: Final rinse for CIP’s Clean Steam generation Raw material used for media and buffers make up Product formulations Make up water for product contacting CIP’s Equipment washing Area Cleaning Sinks

3) Clean Steam

Clean Steam Overview What is Clean Steam? Where is it Used?
How is it Made? Pipe Work & Components Standards

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 qualified Routinely monitored and Quality tested. Have to demonstrate absence of microorganisms in a condensed steam sample Have chemical specifications that must be complied with Regulatory requirement to comply to biological and chemical specifications for these systems

Clean Steam - What is it ? Clean steam is simply steam that contains very little impurities when condensed back to water It is generated and distributed in a way that reduces potential impurities (biological or chemical) from reaching use points

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 sanitisation Other uses include: Used in agitator seals in Bioreactors for sterile boundary. Used to supply HVAC humidification (instead of dedicated hum steam generator)

Clean Steam - How is it made?
These are the 1850Kg/Hr & 2800Kg/hr clean steam generators

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

Clean Steam Trapping Example of Steam Trap: balanced pressure type from Spirax Sarco - there are different sizes and different condensate capacities available

Clean Steam - Pipe-Work & Components
Steam separators (to help improve steam dryness). Trap Set Arrangement Clean Steam Separator Typical Pressure Reduction Set

Clean Steam Specifications
CS Condensate requirements: Clean steam condensate = WFI quality Currently no section dedicated to clean steam so clean steam is required to meet current pharmacopia requirements for WFI

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 1:100 Steam lines should be sized to give a max velocity of 25M/sec - this is again to ensure trapping is not negated

Construction Guidelines / Best Practices (e.g. ISPE Guidelines)
Clean steam traps - vertically mounted, steam off takes from top of pipes etc The material of gaskets used on ASME BPE clamps and valves on clean steam distributions are an important consideration

4) Waste Neutralisation

Waste Neutralisation - Overview
Consists of Waste Neutralisation Tank and ancillary equipment Its function is to treat the Process Waste prior to discharging to the Local Authority Sewer

Waste Neutralisation Functionality
Waste Neutralisation Tank - Critical Parameters pH Temperature Availability of Oxygen Flow to Sewer

pH Waste can have a too high or too low pH pH corrected using H2SO4 for high pH pH corrected using NaOH for low pH pH of the effluent is continually adjusted between 6 - 8 Temperature Generally 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

Availability of Oxygen It is critical to keep the neutralisation tank oxygenated to avoid the proliferation of Anaerobic bacteria There are generally air blowers attached to an air jet system located at the bottom of the tank Oxygen is monitored in the tank and sustained at a level that will restrict Anaerobic zones where anaerobes may grow Flow to Drain When the discharge limit is reached the Sewer Valve can be interlocked to maximise the usage of the capacity of the tank on occasions

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!

Potential IPCL Issues Too Much Water Being Generated on Site.
Intermittent Elevated Suspended Solids The waste tank is a great home for Bugs as there can be a constant source of food and ambient temperatures there Intermittent Elevated Sulphate Concentrations Dosing 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

Waste Neutralization Plant Review
Waste Neutralisation System IPCL Operational Issues Suspended Solids Volumetric Flow Mech & Civil Repairs Required SPOF Design Verification Tank Maintenance

5) CIP/ COP

CIP/ COP CIP (Clean In Place) COP (Clean Out of Place)
4/14/2017 CIP/ COP CIP (Clean In Place) Automated chemical cleaning system Fixed vessels and transfer lines Validated process and procedures Equipment is cleaned by combination of heat, force and chemical exposure COP (Clean Out of Place) (Generally for smaller equipment) Portable Vessels Small Components (e.g. Manual Valves, Probes) Miscellaneous Equipment Discuss CIP/COP, working through each bullet point. Explain the concept around Validated, Automated systems and the reasons why.

CIP Cycle Used on Lines & Vessels
4/14/2017 CIP Cycle Used on Lines & Vessels Lines are generally quick as they are small in comparison with vessels CIP cycles use hot chemical solutions CIP 100 solution (KOH, base or caustic) CIP 220 solution (HCl, Acid) Blow down steps RO & HWFI rinses There 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 media Buffer Cycle – abbreviated WFI wash. Buffer solutions only contain salts which can not alone support contamination

CIP Cycle Steps in the Cycle are typically:
4/14/2017 CIP Cycle Steps in the Cycle are typically: Step 1: Reverse Osmosis (RO) water rinse Step 2: Blow down Step 3: Caustic solution rinse Step 4: Blow down Step 5: RO rinse Step 6: Blow down Step 7: Acid solution rinse Step 8: Blow down Step 9: Hot Water for Injection (HWFI) rinse Step 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.

4/14/2017 Question 1) 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

GMP Expectations 21 CFR 211.67 21 CFR 211.182 21 CFR 211.68
4/14/2017 GMP Expectations 21 CFR Thorough 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 CFR Logs of equipment use and cleaning must be maintained. 21 CFR Automation 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

4/14/2017 GMP Expectations FDA 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.

Advantages of Automated CIP
4/14/2017 Advantages of Automated CIP Equipment 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 monitored As 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.

4/14/2017 CIP Hazards You have to break into lines and certain vessels to begin a CIP circuit This 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 operating Temperatures are in excess of 70oC Heated chemical solutions at high pressure (HCl & KOH). Always a danger when you break into a line or a system. Note 1 bar = 15psi Need 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

COP (Clean Out of Place)
4/14/2017 COP (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 station The equipment is cleaned by a combination of heat, force and chemical exposure.

4/14/2017 COP - Small Vessel This could be used to hold Acetic acid for example Most are on wheels..

4/14/2017 COP - Bath

4/14/2017 COP - Spool Piece Also known as flexible hose?

Question Why not manually wash small parts?

COP - Hazards Hazards are the same as for CIP but also include;
4/14/2017 COP - Hazards Hazards are the same as for CIP but also include; The need to hook up flexi hoses to the portable vessels to begin circuit This can potentially lead to incorrect fittings and loose connections The 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 solutions Manual handling of small vessels Chemical and physical hazards are the same as CIP but there are some situations unique to COP Techs are actually outside the COP station when the system is switched on.

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 121oC SIP 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

SIP Overview Automated steaming system Kills microorganisms and spores
4/14/2017 SIP Overview Automated steaming system Kills microorganisms and spores Releases massive energy when the saturated steam comes into contact with the microorganisms 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 121oC SIP 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

4/14/2017 SIP Operation One temperature probe (at the coldest point of the system) controls the sterilisation time - CONTROLLING TEMPERATURE PROBE Other temperature indicators (TI’s) are monitored to ensure uniform sterilisation. These TI’s are ‘trapped’ to ensure adequate condensate removal 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 121oC We 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 oC f0 is the length of time required to kill certain bacteria Not 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

4/14/2017 SIP Parameters STEAM - must be saturated (in equilibrium with it’s condensate) Saturated steam at a minimum temperature of 121.1ºC Temperatures above 127 oC can affect probe performance and damage gaskets PRESSURE 15 psig TIME Validated for different pieces of equipment using biological indicators ( BI’s ) There are (3) KEY SIP parameters that must be met for a successful Steaming: STEAM PRESSURE 15psig, means psi at the gauge. TIME If 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 growth Saturated 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.

SIP Key Functions Air Removal Condensate Removal 4/14/2017
If these are not removed then you don’t get saturated steam

4/14/2017 Air Removal Steam/ air mix will result in unsaturated steam (saturated steam required to kill microorganisms) Performed by bleeds at high points Bleed points remove air to ensure temp is kept at 121oC

4/14/2017 Condensate Removal Condensate also creates an unsaturated steam condition Condensate will cause cool spots Removed by low point Traps This also reduces temp and is drained off. Cold spots are possible places were bacteria can grow

Typical SIP Cycle Set up system per SOP Assure adequate signage
4/14/2017 Typical SIP Cycle Set up system per SOP Assure adequate signage Vent air up to 100o C then close exhaust Heat up system to temp [>121.10C] Hold system at validated temperature Cool down system slowly - maintain positive pressure by adding sterile air to avoid vacuum formation Maintain system closed and sterile under positive pressure

SIP Hazards High temperatures
4/14/2017 SIP Hazards High temperatures Pressurised steam - can blow off loose connections Unlagged plant in high risk areas

SOP (Steam Out of Place)
4/14/2017 SOP (Steam Out of Place) Used on small portable vessels Cycle parameters are the same as for SIP Carried out in designated SOP station Key functions (e.g. air removal) are the same as for SIP Ensure 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.

SOP - Hazards High temperatures
4/14/2017 SOP - Hazards High temperatures Pressurised steam - can blow off loose connections Potential for technicians to be exposed to pressurised steam

4/14/2017 SOP Recommendations It’s essential to have someone check the set-up PRIOR to starting a SOP cycle Inform co-workers PRIOR to starting a cycle Watch for leaks at the beginning of the cycle - this is when most leaks start

6) Autoclaves

Autoclave

Autoclave Overview Designed 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 calculations F0 calculations give the time taken to achieve desired lethality rate of bacterial spores at a given temperature of steam

Autoclave Process Description
Pre-cycle Pre-conditioning Heating Exposure Post-conditioning Equalisation

Process Description Pre-cycle Pre-conditioning Heating Leak test
Vacuum Level & Hold and Pressure Level & Hold or Forced Air Removal Heating Heating Up 1 & 2 Filter heat up

Process Description Cont.
Exposure Sterilisation Post-conditioning Vacuum Level & Hold and Pressure Level & Hold or Slow Exhaust Equalisation

7) (Parts) Washers

Washer Function Designed to insure adequate cleaning, rinsing and drying of product contact surfaces (e.g. Media/ Buffer/ Filling Line Parts)

Washer Process Overview
WFI passes through a heat exchanger before entering the washer sump The heated WFI is pumped through spray jets on loop headers designed to cover all areas of items to be washed Addition of detergent via diaphragm pump Steam coils installed in the sump heat the wash solution. Tank mounted on the side of washer stores hot WFI for once-through final rinse Filtered, heated air is circulated through cabinet during drying cycle

Washer Cycle

Washer Process Description
Prewash Circulated Detergent Wash 2 x Circulated Rinse Non-circulated WFI Rinse Drying

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

Washer Process Description - Circulated Detergent Wash
Hot WFI Sump fill Detergent is dispensed to the washer for specified amount of time (Must reach specified conductivity) Circulation Drain

Washer Process Description - 2 x Circulated Rinse
As per Prewash Temperature & Time setpoints variable

Washer Process Description - Non-Circulated WFI Rinse
Hot WFI Storage tank is filled and maintains its fill during the wash cycle Steam coils maintain heat in tank A separate header system is used for final WFI rinse to provide isolation from the circulated water

Washer Process Description - Drying
Dryer air flows through steam heating coil and HEPA filter before circulation High volume blower circulates the hot air over items to be dried

8) Solution Transfer

4/14/2017 Transfer of Solutions Having 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?

Transfer of Solutions Lines Pumps Pressure Transfer panels
4/14/2017 Transfer of Solutions Lines Pumps Pressure Transfer panels Let’s look at transfer panels in more depth All these items are involved in solution transfer.

What is a Transfer Panel?
4/14/2017 What is a Transfer Panel? ( sometimes called flow plates )

4/14/2017 Transfer Panels A Transfer panel has a number of ports with hard piping behind them connected to various vessels/ utilities Ports are connected using U-shaped pipes called ‘Jumpers’ The jumpers create a closed loop connecting tanks/ utilities which can stretch across different areas

Transfer Panel & Jumpers

4/14/2017 Jumpers

Question - Transfer Panel Hazards
4/14/2017 Question - Transfer Panel Hazards What 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.

Question - Transfer Panel Hazards
When transferring solutions, hazards can include: Incorrect connections Loose jumper connections Breaking/ making connections Pressurised tanks and lines Tank Contents (acids, caustic) Again, the MSDS will contain all info necessary for providing first aid / spillage control

QUESTIONS???

CPPT 9010: Facility Design & Operation

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