PharmaCab ® SP GMP Cabinet Washer
Technical Datasheet
Cleaning Confidence
(p) 800-356-3300 (f) 608-222-5348 sanimatic.com
Model Number Key
5 6 8 10 11 1213 1415 16171819 Example Model #: SP333-11R0E-GS0-AE-00000C 7 9 4
1
2
3
20 21 C
Chamber Model SP333 34" W x 34" D x 40" H SP443 48" W x 48" D x 40" H SP444 48" W x 52" D x 48" H
1–5
Door Configuration 1
6
Single Door (Standard)
2
Double Door
System Configuration 1
7
Right Handed (Standard)
2
Left Handed
Final Rinse Type R
8
Recirculated Final Rinse (Standard)
S
Single Pass Final Rinse
Dryer System 0
9
No Dryer System (Standard)
1
Dryer System - No Service Panels
2
Dryer System - Front Service Panels (Single Door)
3
Dryer System - Front & Back Service Panels (Double Door)
Recirculated Heating E
10
Electric (Standard)
S
Steam
Supply Pressure Monitoring G Pressure Gauge (Standard) T Pressure Transmitter
11
Supply Flow Monitoring S
12
Flow Switch (Standard)
M Flow Meter
Conductivity Monitoring 0
13
Wash & Rinse Conductivity Control (Standard)
Controls A Allen-Bradley ® Controls Package (Standard)
14
Reporting 0
15
No Reporting (Standard)
T
Report Ticket Printer
P
SaniTrend ® Cloud CR Insights+
Water Addition 0
16
Dual Water Ports (Standard)
1
Dual Water Ports with (1) Pneumatic Valve
2
Dual Water Ports with (2) Pneumatic Valves
Chemical Addition 0
17
Dual Chemical Ports (Standard)
1
Single Chemical Delivery
2
Dual Chemical Delivery
Drain Type 0
18
Gravity Drain (Standard)
1
Drain Pump
Drain Cooling 0
19
No Drain Cooling Valve (Standard)
1
Drain Cooling Valve
Sampling Method 0
20
No Sample Station (Standard)
1
Sample Station - Single Door
2
Sample Station - Unload Side (Double Door)
3
Sample Station - Load Side (Double Door)
sanimatic.com 2
Table of Contents
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2. Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3. Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 31CertificationsandClassifications . . . . . . . . . . . . . . . . . . . . . . . . . . 5 32StructuralFraming.................................. 5 33Hygienicc....................................... 6 34ServicePanels.....................................6 35ElectricalConduit ...................................6 36Pneumatics.......................................6 37InstrumentTags....................................6 4. Utility Requirements ................................... 7 5. Physical Size & Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6. Component Manufacturers ............................... 9 7. Equipment Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 71Chamber.........................................10 72CirculationSystem.................................. 11 73HeatingSystem ....................................11 74ControlSystem.................................... 11 741LowVoltageControlPanel.......................... 11 742Pneumatics................................... 12 743HighVoltageControlPanel. . . . . . . . . . . . . . . . . . . . . . . . . .12 744LoadSideOperatorInterface . . . . . . . . . . . . . . . . . . . . . . . . 12 8. Equipment Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 81SystemOperatingConditions............................12 82LoadingandUnloadingOperation . . . . . . . . . . . . . . . . . . . . . . . . . 12 83CleaningCycle.....................................13 84SystemAutomation................................. 13 85AutomationInterface................................ 13 9. Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10. Product Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 101DoorConfiguration ..................................14 102SystemConfiguration................................14 103FinalRinseType ...................................15 104DryerSystem .....................................15 105RecirculatedHeating................................ 16 106SupplyPressureMonitoring ............................17 107SupplyFlowMonitoring ...............................17 108Reporting .......................................17 109WaterAddition.................................... 19 1010ChemicalAddition..................................19
sanimatic.com 3
TD-0002.4
Table of Contents (continued)
1011DrainType...................................... 19 1012DrainCooling.....................................20 1013SamplingMethod ..................................20 11. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 111Racks.......................................... 21 1111Rack–LowLoadDensity(Budgetary) . . . . . . . . . . . . . . . . . . . . 21 11 1 2 Rack – Medium Load Density (Budgetary) . . . . . . . . . . . . . . . . . 21 1113Rack–HighLoadDensity(Budgetary) . . . . . . . . . . . . . . . . . . . 21 1114RiboflavinTest–Rack .............................21 1115Passivation–Rack...............................21 1116BorescopeInspectionVideo–Rack . . . . . . . . . . . . . . . . . . . . 21 1117TransferCart–SP333 .............................22 1118TransferCart–SP443.............................22 1119TransferCart–SP444.............................22 11 1 10 Part 3D Modeling – Design Cost (per Part) . . . . . . . . . . . . . . . . 22 11111Part3DModeling–Trip(Budgetary) . . . . . . . . . . . . . . . . . . . . 22 112SystemAdditions...................................23 1121Passivation–System............................. 23 1122HydrostaticTest ................................23 1123RiboflavinTest–Chamber . . . . . . . . . . . . . . . . . . . . . . . . . .23 1124RiboflavinTest–RinseTank . . . . . . . . . . . . . . . . . . . . . . . . . 23 11 2 5 Borescope Inspection Video - System . . . . . . . . . . . . . . . . . . . 23 11 2 6 Seismic Zone Anchorage Calculations . . . . . . . . . . . . . . . . . . . 23 1127BarrierFlanges.................................23 1128SystemAutomation..............................24 113 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 1131FunctionalSpecification(FS) . . . . . . . . . . . . . . . . . . . . . . . . . 25 1132ConfigurationSpecification(CS) . . . . . . . . . . . . . . . . . . . . . . . 25 1133FactoryAcceptanceTest(FAT) . . . . . . . . . . . . . . . . . . . . . . . 25 1134SiteAcceptanceTest(SAT) . . . . . . . . . . . . . . . . . . . . . . . . . 25 1135 Installation Qualification / Operational Qualification (IQ/OQ) . . . . . . 25 1136InstrumentDataSheets ...........................25 1137TraceabilityMatrix...............................25 11 3 8 Additional Turn Over Package (TOP) - Hard Copy . . . . . . . . . . . . 25 114FieldService..................................... 26 11 4 1 Installation Assistance (Budgetary) . . . . . . . . . . . . . . . . . . . . . 26 1142Start-up&Training(Budgetary) . . . . . . . . . . . . . . . . . . . . . . . 26 1143SATAssistance(Budgetary) . . . . . . . . . . . . . . . . . . . . . . . . . 26 1144IQ/OQAssistance(Budgetary) . . . . . . . . . . . . . . . . . . . . . . . . 26 11 4 5 On-site Rack Assistance (Budgetary) . . . . . . . . . . . . . . . . . . . . 26 11 4 6 Preventive Maintenance (PM) Program (Budgetary) . . . . . . . . . . . 26 11 4 7 Recommended Spare Parts (RSP) Budget (Budgetary) . . . . . . . . . 26
sanimatic.com 4
TD-0002.4
1. Introduction
Technical information provided within this document is for Sani-Matic’s Configured Design Offering (CDO) of PharmaCab ® SP GMP cabinet washers This offering of cabinet washers meets cGMP standards and adheres to the latest ASME Bioprocessing Equipment (BPE) Cabinet Washer Standards Alternative Design Requests (ADR) for variations in construction, size, component manufacturers, options, orientation, or other technical requirements should be directed to the Sani-Matic sales group for custom quoting and engineering The system details described in Sections 2 through 9 apply to all three chamber models and their standard options, which are designat- ed with "(Standard)" in the model key The selectable product options within the model key are described in Section 10 Accessories such as racks, carts, field services, and other system additions are described in Section 11
2. Applications
The PharmaCab SP of GMP cabinet washers can be used for a variety of small to medium sized parts, including dedusters, tablet press parts, glassware, filter housings, scoops, hoses, laboratory equipment, fittings, clamps, gaskets, valves and more For the available usable space dimensions and volumes see Table 4: Usable Space Dimensions.
Scoops
Hoses
Dedusters / Tablet Press Parts
Filter Housings
Glassware
3. Construction
3.1 Certifications and Classifications • Electrical Area Classification: Non-hazardous • Electrical Certification: UL 508A
• Seismic Design: Seismic Zone Anchorage Calculations are available as a system accessory See Section 11.2.6 • Industry Standards: Current ASME BPE; FDA Good Manufacturing Practices (cGMP) CFR Title 21, Part 820; Good Automated Manufacturing Practices (GAMP 5) • System Certifications: None 3.2 Structural Framing • Material: 304ss square and rectangular tubing • Surface Finish: Bead blasted • All structural framing is contained within the system maintenance space • Fully welded, single-piece construction • Adjustable bolt pad feet for locating the equipment at a fixed location in the facility The adjustability allows the equipment to be leveled on uneven or sloped surfaces
sanimatic.com 5
TD-0002.4
3.3 Hygienic Piping
• Material: 316Lss hygienic tubing and fittings • Fittings: BPE certified (where applicable) • Surface Finish: 20 µin Ra ID (SF1) / 32 µin Ra OD
• Welding: Welds are completed using an orbital welder The welder interior is as-welded and argon gas purged All welds are borescope inspected for quality and accepted per current ASME BPE standards – see Section 9 Documentation for more information • Weld Finish: As-welded ID / color cleaned OD • Slope: 1 / 8 " per foot / 10% (GSD2) • Connections: Tri-clamp fittings with single hinged heavy-duty clamps with wing nuts • Gasket Material: EPDM (USP Class VI) • Valves: Diaphragm type with 316Lss body, PTFE faced / EPDM backed diaphragms, and pneumatic actuators 3.4 Service Panels • Description: Panels located on the load/unload side interface to provide access to interior maintenance space of the washer • Material: 304ss • Surface Finish: 32 µin Ra 3.5 Electrical Conduit • Material: Rigid conduit is schedule 40 galvanized pipe with PVC coating Flexible conduit to be non-metallic UL rated PVC with nylon fittings Connection to electrical devices operating at 50 volts and higher is installed with flexible conduit Connection to low voltage electrical devices is installed with flexible cord Calibrated instruments are provided with extra cord, allowing them to remain connected when moved to a calibration cart 3.6 Pneumatics • Location: Instrument air filters, pressure regulators and solenoids are mounted outside the control panel in the maintenance space • Material: Pneumatic equipment is connected to the skid mounted solenoid valves with polyethylene tubing 3.7 Instrument Tags • Description: Each valve, instrument, and equipment is provided with an identification tag containing the corresponding P&ID tag number • Material: 304ss • Weld Finish – Load/Unload Side: Ground and polished • Weld Finish – Maintenance Space: Color cleaned • Gasketing: EPDM foam
sanimatic.com 6
TD-0002.4
4. Utility Requirements
The following are the minimum required utilities for the proper operation of the equipment If these utilities are not available, an Alternative Design Request may be required
Table 1: Utility Requirements
Water - Supply
Drain
Instrument Air
Electrical
Chemical
Chamber Model
Working Volume (Gal)
Connection Size / Type (Chamber)
Connection Size / Type (Pump Casing)
Disconnect Size @ 460V AC (amps)
Connection Size / Type
Flow Rate (gpm)
Connection Size / Type
Volume (cfm)
Connection Size / Type
SP333 SP443 SP444
10" TC 10" TC 10" TC
22 25 25
15" TC 15" TC 15" TC
05" TC 05" TC 05" TC
≤ 40 ≤ 40 ≤ 40
05" FNPT 05" FNPT 05" FNPT
20 20 20
100 100 100
05" TC 05" TC 05" TC
NOTE: • Drain temperature is variable based on the cycle • Water Supply
− Total water volume required is dependent on cycle parameters − Varying water supply temperatures can be accommodated
• Two (2) chemical ports located in the chamber sump sidewall are provided for chemical addition If backflow prevention is required, it is provided by others See Section 10.10 Chemical Addition for options to add local chemical pump and container assemblies • Electrical service is 3PH / 60 Hz
sanimatic.com 7
TD-0002.4
5. Physical Size & Layout The following is the overall size of the equipment as represented in the image below The default system orientation is a right-handed configuration, with the door swing to the right and the HMI interface to the left when viewing the system from the load side The Dryer System is a common option selected and is the only option that changes the listed system dimensions
Table 2: System Size
System Dimensions
Max System Depth - D Max (in)
System Weight (lbs)
Dryer - Weight Addition (lbs)
Dryer - Height Addition (in)
Chamber Model
Door Swing (in)
W (in)
D (in)
H (in)
SP333 SP443 SP444
96 42 97 110 56 97 110 60 105
53 67
42
4,300 4,600 5,400
900 lbs
23 23 23
56 56
1,000 lbs 1,000 lbs
71
"DOOR SWING"
"D MAX"
"D"
"DOOR SWING"
"W"
"H DRYER"
"H"
NOTE: • System dimensions and system weight listed are for standard options • System operating weight is dependent on the construction of the loaded parts rack when inside of the chamber • The image above shows the addition of the optioned dryer system (see Section 10.4 Dryer System ) and a pass-through double door design (see Section 10.1 Door Configuration ) • Door swing of 105° is needed for transfer cart clearance and engagement
sanimatic.com 8
TD-0002.4
6. Component Manufacturers
Note that inclusion of certain components is dependent on the model options selected
Table 3: Component Manufacturers and Models
Component
Manufacturer
Model
Chamber
Sani-Matic
—
Chemical Pump
Watson Marlow Watson McDaniel Watson McDaniel
313FDM/D
Condensate – Trap
FTT
Condensate Bypass – Trap
WT1000
Conductivity Sensors / Transmitters
Rosemount
225 / 403 / 1056
Control Enclosure Diaphragm Valves
Hoffman
CSD 650 BFY
GEMÜ Tru-Flo
Dryer – Butterfly Valves
Dryer – Fan
Cincinnati Fan Tutco Farnum
PBS-10A
Dryer – Heater
FT600 007-W
Dryer – HEPA Filter
Flanders
Dryer – Hoses Electric Heater
Ace Sanitary Glo-Quartz
RSD
D6
Flow Meter Flow Switch
Hoffer
H03A
ifm efector
S16700
Human Machine Interface Unit(s)
Allen-Bradley ® Allen-Bradley
PanelView TM Plus 7 - 7" Operator Terminal
PLC
CompactLogix TM
Pressure Transmitter
ifm efector
PI2304 FMB50
Level Transmitter – Chamber
Endress + Hauser
Proximity Switches
ifm efector
IFT / MFS
Sample Valve
Top Line
SV26
Sanitary Pump / Motor
Fristam / WEG
FPR3522 / 215TC VL-3A / VessaLite ®
Sight Glass / Light Solenoid Valves Spray Assemblies
Sani-Matic
SMC
SY7000 / SV Series / VX Series
Sani-Matic
—
Steam & Condensate – Ball Valves
SVF
N8
Steam Coil
Sani-Matic Pyromation
—
Temperature Element / Transmitter
R5T185L483
sanimatic.com 9
TD-0002.4
7. Equipment Description
7.1 Chamber The chamber contains four (4) rotary spray assemblies mounted
to the top, sides, and bottom The spray assemblies provide repeatable spray coverage to the process parts’ exterior surfaces and the chamber’s interior during all phases of the cycle (pre-rinse, wash, final rinse) Each spray assembly includes strategically located spray orifices, along with removable static spray ball on the end of the arm for additional spray coverage The spray assemblies are constructed of 316Lss and have fluid-driven rotary unions with hubs and bushings composed of 316Lss and USP Class VI thermoplastic materials Each spray assembly includes a magnetic proximity switch to confirm rotation during all phases of the cleaning cycle • Chamber construction − Installation Type: Floor Mounted − Thickness: 12 ga
Side View
Top View
− Insulation: 2" thick chloride free insulation with 304ss sheathing on door(s) only 05" thick closed cell foam insulation on chamber and sump
− Door(s): Manually operated side-hinged door(s) with a laminated tempered glass viewing window, inflatable EPDM door gasket with low pressure switch to alarm, adjustable position door stop, and proximity switch
to confirm door closure − Design: Atmospheric
− Material: 316Lss wetted surfaces / 304ss non-wetted surfaces −Interior Finish: 20 µin Ra with welds ground and polished
−Exterior Finish – Load/Unload Sides: 32 µin Ra with welds ground and polished − Exterior Finish – Maintenance Space: Bead blasted and/or welds color cleaned • Chamber connections and components − Four (4) Rotary spray assemblies − One (1) Active rack connection – spring loaded PTFE coupler mates with parts rack to provide spray coverage
to the active rack piping, targeting the interior surfaces of process parts − Two (2) Rail assemblies for rack guidance with load side wheel stop − One (1) Sump outlet strainer ( 3 / 8 " perforated core with 40 mesh overlay) − One (1) Chamber LED light − One (1) Temperature transmitter with 0-100 °C range and 4-20 mA output − One (1) Toroidal conductivity sensor with 0-100 mS/cm range and 4-20 mA output − One (1) Contacting conductivity sensor with 0-10 µS/cm range and 4-20 mA output − One (1) Level transmitter (pressure type) with 0-12" range and 4-20 mA output
− Two (2) Water inlet connections (10" tri-clamp) − Two (2) Chemical inlet connections (05" tri-clamp) − One (1) Exhaust connection (60" flange for SP333, 80" flange for SP443/SP444 - See Table 7: Dryer Utilities ) Usable space dimensions vary by model size, as shown in Table 4: Usable Space Dimensions The usable space dimensions identify the maximum parts loading dimensions, when taking rack design into consideration
Table 4: Usable Space Dimensions
Usable Space Volume (ft 3 )
Usable Space Dimensions
Chamber Model
W"
D"
H"
SP333 SP443 SP444
34 48 48
29 43
38 38 46
21
45
47
60
Usable Space Dimensions
sanimatic.com 10
TD-0002.4
7.2 Circulation System The circulation system draws solution from the chamber sump and distributes it to the chamber rotary sprays or active rack It is self-contained within the system’s maintenance space • Circulation system components − One (1) 15" pneumatic two-way diaphragm valve - system drain − One (1) Centrifugal supply pump ◊ 140 gpm at 40 psi ◊ 316Lss wetted materials with EPDM elastomers ◊ Silicon carbide vs silicon carbide internal mechanical seal
◊ 3500 rpm, 10 HP, washdown motor ◊ 05" tri-clamp casing drain connection − One (1) 05" pneumatic two-way diaphragm valve – supply pump casing drain − One (1) Heater outlet temperature transmitter with 0-100 °C range and 4-20 mA output − One (1) Flow switch with discrete output − One (1) Pressure gauge with 0-60 psi range − One (1) 20" x 20" pneumatic diaphragm horizontal sterile access two-valve assembly for distributing solution to either the rotary sprays or the rack's active coupler − Hygienic piping manifold
7.3 Heating System
• One (1) 60" hygienic heater housing assembly • One (1) In-line electric immersion heater − Material: 316Lss (wetted) − Connections: 60" Tri-clamp (process) − Size: 30 kW − Protection: High temperature thermocouple − Duty: See Table 5: Electric Heater Data
Table 5: Electric Heater Data
Electric Heater Sizing
Chamber Model
Approx. Heatup Time 20 °C to 80 °C (min)
kW
SP333 SP443 SP444
30 30 30
15
20 20
NOTE: • Electric immersion heater may have surface finishes that do not meet the listed hygienic piping surface finish Ra value
7.4 Control System 7.4.1 Low Voltage Control Panel • One (1) UL Listed enclosure, NEMA 4X, 304ss construction with painted carbon steel back plate • One (1) Allen-Bradley CompactLogix, 1 MB Memory
− Four (4) 8-point discrete input modules − Two (2) 8-point discrete output modules
− Two (2) 8-point 4-20 mA analog input modules − One (1) 4-point 4-20 mA analog output module • One (1) Ethernet hub • Two (2) Low air pressure alarm switches
sanimatic.com 11
TD-0002.4
7.4.2 Pneumatics
• One (1) Instrument air filter • Two (2) Air pressure regulators with gauges • One (1) Eight-station pneumatic solenoid bank
• One (1) Two-station pneumatic solenoid 7.4.3 High Voltage Control Panel • One (1) Fan-cooled UL Listed enclosure, 304ss construction with painted carbon steel backplate • One (1) Circuit breaker rated for 100 Amps • One (1) 24V DC, 20 Amp power supply 7.4.4 Load Side Operator Interface All components are mounted through the washer's service panel and are not enclosed (NEMA 1) • One (1) Allen-Bradley PanelView Plus 7, 7" color touchscreen
• One (1) Conductivity analyzer - dual channel • One (1) Illuminated emergency stop switch • One (1) Alarm horn • One (1) Disconnect switch
• One (1) Data communication port • One (1) Illuminated reset button
8. Equipment Operation
8.1 System Operating Conditions • Maximum System Operating Temperature: 90 °C (Rinse & Wash Phases) • Approximate System Noise Levels: 80 dBA (Rinse & Wash Phases), 70 dBA (Dryer Phases) 8.2 Loading and Unloading Operation • Loading − Dirty process parts are loaded onto a parts rack, which sits on a transfer cart − The operator opens the load door − The transfer cart with parts rack is positioned in front of the load door and is pushed into the rail assembly inside the washer for engagement and locking − The parts rack is pushed from the transfer cart into the chamber and engages with the active coupler − The operator disengages the empty transfer cart from the rail assembly, pulls the transfer cart away from the chamber, and closes the door − The operator selects the appropriate cleaning cycle from the HMI • Unloading − The operator opens the unload door at the completion of the cleaning cycle, which is indicated on the HMI − An empty transfer cart is positioned in front of the unload door and is pushed into the rail assembly inside the washer for engagement and locking − The parts rack is pulled from the chamber onto the transfer cart − The operator disengages the transfer cart from the rail assembly, pulls the transfer cart away from the chamber, and closes the door − The transfer cart is taken to the appropriate area and clean process parts are unloaded
sanimatic.com 12
TD-0002.4
8.3 Cleaning Cycle The following is an example of a typical cleaning cycle Drain steps are performed after each rinse or wash phase The final rinse and subsequent drain steps can be repeated until desired final rinse conductivity levels are met • Rinse • Chemical #1 Wash • Rinse • Chemical #2 Wash • Rinse • Final Rinse • Heated Drying (Requires Dryer System option) • Cooling (Requires Dryer System option) All steps are setup as individual operation codes (Opcodes) enabling full customization of cleaning cycles Cycle times are dependent upon many factors such as part type, soil load, available utilities, and drying requirements 8.4 System Automation Sani-Matic provides all programming of the HMI and PLC, enabling automation of the provided system For additional custom system automation (eg, Custom HMI Screens, Additional Security Levels, External System Communications), see the System Automation options • Cleaning sequences will be automatically controlled using wash cycle recipes • Up to (40) different recipes can be stored in the PLC • Each recipe has its own setpoint values (eg, time, temperature, conductivity) which are adjustable • Up to (96) individual steps per recipe • Each step in the recipe is composed of Operation Codes (Opcodes) which define the phase of the wash cycle (eg, caustic wash, final rinse) Opcodes can be arranged, omitted, or duplicated within the recipe as needed • Up to (96) unique Opcodes • Measured process variables have alarms with adjustable high/low setpoint values • Up to (96) different setpoint values (eg, time, temperature, conductivity) • The operator will have the ability to initiate, monitor and edit (with correct security level) the wash cycle, recipes, and setpoint values via the HMI • (3) HMI security levels are included • HMI User security is setup for local users If desired, Active Directory User Authentication can be setup by the facility in which the system is installed 8.5 Automation Interfaces The standard system allows for two (2) 24V DC digital output signals for water fill, as well as two (2) 24V DC digital output signals for chemical addition The signals are used to activate external equipment (eg, zero-static block valve) for water fill and chemical addition cycle steps The cabinet washer system monitors and alarms these incoming utilities as required
sanimatic.com 13
TD-0002.4
9. Documentation One (1) hard copy and one (1) electronic copy of the documentation package is provided as standard The documentation is provided in the English language and is designed to meet the applicable cGMP and GAMP 5 standards and testing The following lists the standard documentation – see Section 11.3 Accessory Category - Documentation for additional optioned documents • Operation and maintenance manuals • Recommended Spare Parts (RSP) list • Mechanical Bill of Materials (BOM) - serial numbers, model numbers, certifications, ranges and additional information • Instrumentation calibration records - as provided with vendor documentation
• Chamber drainability report • Material Test Reports (MTRs) • Weld Maps and Weld Logs including qualification and inspection records • Inspection test results, reports and certificates • Component vendor documentation • As-built General Assembly (GA) drawings • As-built Process and Instrumentation Diagram (P&ID) • As-built electrical drawings
10. Product Options
10.1 Door Configuration The Double Door option adds a second door to the cabinet washer system for a pass-through configuration where load (dirty) side and unload (clean) side operations are physically separated by the cabinet washer system In addition to the operator interface described in Section 7.4.4 Load Side Operator Interface , this option adds additional unload side interfaces as well as the necessary controls: • Unload side operator interface components − One (1) Allen-Bradley PanelView TM Plus 7, 7" color touchscreen HMI − One (1) Illuminated e-stop − One (1) Alarm horn • One (1) Pneumatic solenoid valve • One (1) Pressure regulator • One (1) Low pressure switch The required service panels are installed on the unload side of the system Controls interlocks are established to prevent both doors being open simultaneously 10.2 System Configuration The Left Handed option can be chosen for a left handed opening of the door with HMI and operator interfaces on the right side of the system when facing the load side This layout is a mirror image of what is shown in Section 5 Physical Size & Layout
sanimatic.com 14
TD-0002.4
10.3 Final Rinse Type The Single Pass Final Rinse option adds a final rinse tank and associated controls and piping to the system to allow for a final rinse phase that is not recirculated within the washer chamber • Rinse tank: − Working Volume, Dimensions and Access: See Table 6: Rinse Tank Data
Table 6: Rinse Tank Data
Rinse Tank
Chamber Model
Volume (gal)
Tank Ø (in)
Tank Sidewall (in)
Access
Split tank body (12" tri-clamp)
SP333
20
12
41
SP443 SP444
40 50
18 18
38 46
6" tri-clamp hand hole 6" tri-clamp hand hole
− Tank Heads: Flanged and dished − Thickness: 12 ga − Insulation: 05" thick closed cell foam insulation (sidewall only) − Design: Atmospheric
− Material: 316Lss wetted surfaces / 304ss non-wetted surfaces − Interior Finish: 20 µin Ra with welds ground and polished − Exterior Finish: 32 µin Ra with welds color cleaned • Rinse tank components: − One (1) Hygienic spray assembly with directionally drilled static spray ball and supply tube − One (1) Vent filter assembly consisting of an in-line housing with 02 micron hydrophobic filter element and two (2) hygienic check valves − One (1) Rupture disk with +15 psi/full vacuum rating, burst alert sensor, and downtube piping − Two (2) Level switches (tuning fork) • Additional circulation system components: − One (1) 20" pneumatic two-way diaphragm valve for rinse tank block to pump suction − The standard two-way piping drain valve is replaced with one (1) 20" x 15" pneumatic diaphragm horizontal sterile access two-valve assembly for distributing chamber solution to either the pump suction (recirculation phase) or to drain (final rinse phase) 10.4 Dryer System The addition of any dryer system option allows for heated drying and cooling phases to be included in the cleaning cycle These phases reduce the amount of final rinse water on the process parts and rack within the chamber prior to unloading Air is pulled from the surrounding area of the maintenance space where the supply fan is installed and is discharged from the washer chamber at the exhaust flange connection The following components and controls are added to the system when selecting a dryer system: • Dryer Supply System − One (1) Pre-filter, paper, 999% filtration to 10 micron − One (1) Centrifugal fan ◊ 400 cfm at 6" wc ◊ Direct Drive ◊ 1 HP washdown duty motor ◊ 304ss construction − One (1) In-line electric heater ◊ 24 kW
◊ 460V AC, 3PH, 60 Hz ◊ 304ss construction ◊ High temperature cutout thermocouple − One (1) HEPA filter, 9999% filtration to 03 micron − Supply ducting downstream of HEPA filter constructed of 316Lss − One (1) Differential pressure transmitter with 0-5" wc range and 4-20 mA output
sanimatic.com 15
TD-0002.4
• Electrical Components − One (1) 1 HP motor starter for the dryer supply fan − One (1) Controller for dryer electric heater
Adding service panels to the dryer system provides separation of the dryer maintenance space to the surrounding room interfaces The Dryer System – Front Service Panels (Single Door) includes service panels on the front load/unload side of the system The Dryer System – Front and Back Service Panels (Double Door) option includes service panels on both the front load side and back unload side of the system
Table 7: Dryer Utilities
Dryer - Air Supply
Dryer Air - Exhaust
Chamber Model
Connection Size / Type
Volume (CFM)
Temperature (°C)
Humidity (%RH)
Connection Size / Type 60" Flange 80" Flange
Volume (CFM)
Temperature (°C)
Humidity (% RH)
SP333 SP443 SP444
N/A N/A N/A
400 400 400
20 20 20
70 70 70
400 400 400
82 82 82
100 100 100
80" Flange
NOTE: • All dryer system options add 23" height to the overall system dimensions (see Table 2: System Size ) • All dryer system options add 900 lbs for model SP333 and 1,000 lbs for the SP443 and SP444 models to the system weight (see Table 2: System Size ) • If selecting a dryer system option with service panels, the appropriate option should be chosen based on the selected door configuration • Air supply for the dryer is drawn through the pre-filter from surrounding maintenance space air
10.5 Recirculated Heating The Steam option removes the electric heater from the base system and replaces it with a steam coil system for heating of the circulation system The following components are added: • One (1) Steam coil with the following specifications: − Duty: See Table 8: Steam Heating Data − Material: 316Lss − Insulation: None − Design: In-line coil − Rating: Non-ASME − Connections: 60" Tri-clamp (process), 05" tube - compression fittings (utility) • One (1) 60" Hygienic steam coil housing assembly • One (1) Steam supply piping manifold constructed of SCH80 carbon steel socket weld pipe and fittings − One (1) Y-Strainer with blow-off valve − One (1) Pressure gauge with manual ball valve for isolation − One (1) Modulating control v-ball valve with pneumatic actuator and positioner − One (1) Steam pressure relief valve (set at 125 psi) piped to the floor − One (1) Vacuum breaker with brass construction • One (1) Condensate return manifold constructed of SCH80 carbon steel socket weld pipe and fittings − One (1) Manual ball valve for condensate drain − One (1) Float and thermostatic steam trap − One (1) Check valve for condensate return isolation • One (1) Condensate bypass manifold constructed of SCH80 carbon steel socket weld pipe and fittings
− One (1) Balanced pressure thermostatic steam trap − One (1) Check valve for condensate return isolation
sanimatic.com 16
TD-0002.4
Table 8: Steam Heating Data
Approx. Heatup Time 20 ° C to 80 ° C (min)
Chamber Model
Connection Size / Type (Steam Supply)
Connection Size / Type (Condensate Return)
Load (lbs / hr)
SP333 SP443 SP444
10 10 10
075" Flange 075" Flange 075" Flange
05" Flange 05" Flange 05" Flange
120
180 180
NOTE: • The standard design is sized for applications with 50 psi steam Installations where the plant supplied steam is in excess of 50 psi may require a pressure reducing valve (PRV) Unless otherwise specified, it is assumed that the PRV is customer supplied and/or installed by others
10.6 Supply Pressure Monitoring The Pressure Transmitter option replaces the pressure gauge in the circulation system with a diaphragm type pressure transmitter The pressure transmitter has 0-60 psi range and 4-20 mA output This option adds system monitoring and alarming capabilities for the supply pressure 10.7 Supply Flow Monitoring The Flow Meter option replaces the flow switch in the circulation system with a turbine flow meter The flow meter has 0-200 gpm range and 4-20 mA output This option adds system monitoring and alarming capabilities for the supply flow 10.8 Reporting The Report Ticket Printer option adds a thermal serial printer to the system The printer enables the system to provide a printed report containing the wash parameters of the cleaning cycle All report data is stored in a buffer that is flushed upon starting the next cleaning cycle The printer is mounted through the washer’s unload side service panel Additional controls include a 120V power transformer in the HV electrical enclosure and a 120V power receptacle mounted behind the service panel SaniTrend® Cloud Cleaning
Records (CR) Insights+ is an online data software that provides auto- mated, secure data acquisition and reporting of critical cleaning cycle information, along with system opera- tional efficiency insights Users, having
OEE Reports
Cleaning Cycle Report
a facility user login account, access SaniTrend Cloud via a web browser The Insights+ edition of SaniTrend Cloud is 21 CFR Part 11 compliant for electronic records and signatures and includes the following: • (1) Industrial PC / Edge Device to buffer and transmit data to the cloud portal • Connectivity software installed on the industrial PC / edge device to allow it to connect to the PLC • SaniTrend Cloud online portal access • Product features:
SaniTrend Cloud's information on cleaning cycles and system performance; accessed anywhere by anyone from your team
− Store and Forward Capabilities − Cloud Documentation Storage − Live Dashboard Views − Email & SMS (Text) Notifications − Cloud Access to Data (Phone, Tablet, Mobile) − Unlimited Users
sanimatic.com 17
TD-0002.4
− Analog & Digital Data Trending − Cleaning Cycle Reports: ◊ Unique Cycle ID ◊ Recipe Name ◊ Analog Values and Setpoints (eg, temperature, conductivity) ◊ Start Date/Time & Stop Date/Time ◊ Run time (actual) ◊ Downloadable Reports (Print/PDF) ◊ Commenting Feature ◊ Approval Feature − Additional Cleaning Cycle Report Insights ◊ Recipe Step Information & Duration ◊ Cleaning Cycle Events (Alarms, Messages, Holds) ◊ Run time (programmed) ◊ User ID − Event Log − Overall Equipment Effectiveness (OEE) Scores & Trending
− Preventive Maintenance (PM) Tracking − HMI Audit Trail (21 CFR Part 11 Compliance)
SaniTrend ® Cloud – Cleaning Cycle Reports (CR Insights+)
SaniTrend ® Cloud – OEE Trending (CR Insights+)
sanimatic.com 18
TD-0002.4
SaniTrend® Cloud – Audit Trail (CR Insights+)
NOTE: • Requires that the equipment be connected to the Internet (by others) • Find more information and tier comparisons on our SaniTrend ® Cloud website page
10.9 Water Addition The water addition options ( Dual Water Ports with (1) Pneumatic Valve and Dual Water Ports with (2) Pneumatic Valves ) add one (1) or two (2) 10" tri-clamp standard two-way diaphragm valves to the chamber water inlet ports for automatic water feed control 10.10 Chemical Addition The Single Chemical Delivery option is fully contained within the washer's structural framework and dispenses chemical into the chamber The assembly includes: • One (1) 05" tri-clamp standard two-way diaphragm valve • One (1) 05" check valve • One (1) Peristaltic pump with Bioprene tubing • One (1) 5-gallon chemical container with low level feedback switch, dip tube, and pressure relief/bypass assembly • Required piping, mounting hardware, and controls The Dual Chemical Delivery option adds a second chemical addition assembly as described above 10.11 Drain Type The Drain Pump option allows for sending all drain solutions to an external location and is used when no local drain is available The drain pump is fully contained within the washer's structural framework The following components are added to the main drain line: • One (1) Hygienic manifold combining chamber and drain pump drain connections • One (1) Air operated diaphragm pump, 10 gpm @ 59 psi • Two (2) 075" tri-clamp ball valves for downstream system drain and drain pump isolation • One (1) Point level switch for pump activation • One (1) Discharge check valve • Fittings and process piping This option adds one (1) solenoid valve and one (1) pressure regulator to operate and automate the above components during system drain steps Dual Delivery
NOTE: • This option also changes the drain utility connection from 15" to 10"
sanimatic.com 19
TD-0002.4
10.12 Drain Cooling The Drain Cooling Valve option adds a butterfly valve to the drain piping that allows the effluent to cool prior to being sent to drain The following components are included: • One (1) 10" Pneumatic actuated butterfly valve for cold water cooling • One (1) 10" Flow orifice • One (1) Temperature transmitter with 0-100 °C range and 4-20 mA output to monitor drain discharge • Fittings and process piping This option requires a cold water utility supply at 15 gpm, 40 psi, and 10 °C 10.13 Sampling Method
The sample station options [ Sample Station - Single Door, Sample Station - Unload Side (Double Door) and Sample Station - Load Side (Double Door) ] allow for an operator to sample the solution within the chamber sump Each option includes the following components: • One (1) Stainless steel enclosure with hinged clear plastic door, mounted through the service panel • One (1) 05" tri-clamp port added to the chamber sump with
pneumatic diaphragm valve to eliminate a dead leg • One (1) 05" manual sample valve for operator sampling
Sampling occurs by using a recipe step that pauses the system cleaning cycle, opening the pneumatic sample valve An operator then opens the manual valve to take the sample The operator advances the cleaning cycle to the next step through a start key at the HMI
NOTE: • The appropriate sampling method option should be chosen based on the desired sample station location and the selected door configuration
11. Accessories
11.1 Racks The Racks category of accessories contains information regarding Sani-Matic custom-designed racks Three levels of budgetary rack categories are highlighted below in Sections 11.1.1–11.1.3. Transfer carts required to load and unload the racks from the washer and move parts through the installed facility are detailed in Sections 11.1.7–11.1.9 The rack design process typically begins with a preliminary parts load list, which is defined by mutual Sani-Matic and owner/user efforts Two different 3D modeling service options are provided for developing 3D models of the load lists’ process parts After the process parts are 3D modeled, a preliminary rack configuration is developed and sent for review and approval Finalized rack design is completed and detailed General Assembly (GA) drawings are sent for review and approval The cost difference between budgetary and final design is adjusted during the project All racks are designed to fit the usable space shown in Table 4: Usable Space Dimensions Rack designs incorporate an active coupler that ties into the cabinet washer’s circulation manifold, which supplies the necessary flow and pressure through the active rack’s manifold to the active sprays and/or active part connections (eg, valves, hoses, small fittings) Support framework is manufactured of 316Lss and has a 20 μin Ra finish with welds ground and polished An option to change the rack finish to 20 µin Ra with welds color cleaned is also available Delicate parts such as glassware can be held by thermoplastic supports to eliminate or minimize part contact with stainless Other frame surface finishes and/or weld finishes can be accommodated if required The racks are manually rolled be- tween the transfer carts and the cabinet chamber on four (4) PTFE roller wheels Typical part loading height on the racks is between 40-72" for the SP333 and SP443, and between 40-80" for the SP444
NOTE: • All racks listed below are priced as budgetary and are to be used as budget placeholders until the rack design is finalized and approved • The quantities for parts, active sprays, and active part connections below are general guidelines only for budgetary estimating
sanimatic.com 20
TD-0002.4
11.1.1 Rack – Low Load Density (Budgetary) • Typical design may include: − Up to 50 parts − Up to 5 active sprays − Up to 5 active part connections 11.1.2 Rack – Medium Load Density (Budgetary) • Typical design may include: − 50-100 parts − Up to 10 active sprays − Up to 10 active part connections 11.1.3 Rack – High Load Density (Budgetary) • Typical design may include: − 100-150 parts − Up to 15 active sprays − Up to 15 active part connections
Parts
Active Part Connection (Hoses)
11.1.1
Active Coupler
11.1.4 Riboflavin Test – Rack This accessory provides a customer witnessed spray coverage testing using riboflavin for each rack Sani-Matic follows internal procedures that are developed using the ASME BPE Nonmandatory Appendix for Spray Device Coverage Testing A test report (SMI-LOG-004) is provided, documenting the system flow parameters as well as the rack part loading
11.1.2
Active Spray
11.1.3
NOTE: • This item is for riboflavin testing at Sani-Matic facilities The PharmaCab SP system, fabricated rack, and applicable customer parts must all be at Sani-Matic for execution • On-site riboflavin testing can be performed by Sani-Matic field service technicians; contact Sani-Matic for details
11.1.5 Passivation – Rack Sani-Matic will provide passivation of all rack surfaces A certificate of passivation is provided upon completion 11.1.6 Borescope Inspection Video – Rack Hygienic welds on the rack’s process piping are borescope inspected A DVD video record is provided
Riboflavin test
NOTE: • This item is only applicable to racks with active coupler connections and process piping within the rack
Borescope inspection view
sanimatic.com 21
TD-0002.4
11.1.7 Transfer Cart – SP333 Transfer carts are used to move the racks throughout the facility Transfer carts are designed to hold one rack A tray with a detachable collection bottle is provided to catch process soils and/or liquid during the transport through the facility The transfer carts are manufactured of 304ss and have a 32 µin Ra finish with welds color cleaned Carts are supported by two (2) straight and two (2) locking swivel casters of nylacron material The footprint of the SP333 transfer cart is 37" W x 51" D and the loading rail height is 36" 11.1.8 Transfer Cart – SP443 Transfer carts are used to move the racks throughout the facility Transfer carts are designed to hold one rack A tray with a detachable collection bottle is provided to catch process soils and/or liquid during the transport through the facility The transfer carts are manufactured of 304ss and have a 32 µin Ra finish with welds color cleaned Carts are supported by two (2) straight and two (2) locking swivel casters of nylacron material The footprint of the SP443 transfer cart is 51" W x 65" D and the loading rail height is 36" 11.1.9 Transfer Cart – SP444 Transfer carts are used to move the racks throughout the facility Transfer carts are designed to hold one rack A tray with a detachable collection bottle is provided to catch process soils and/or liquid during the transport through the facility The transfer carts are manufactured of 304ss and have a 32 µin Ra finish with welds color cleaned Carts are supported by two (2) straight and two (2) locking swivel casters of nylacron material The footprint of the SP444 transfer cart is 51" W x 69" D and the loading rail height is 36" 11.1.10 Part 3D Modeling – Design Cost (per Part)
A design engineer will 3D model each unique process component to be incorporated into the wash rack design The modeling will allow specific design elements to be incorporated into the rack and allow for repeatable component placement on the rack The modeling will take place at Sani-Matic’s facility via customer-provided drawings or process components shipped to Sani-Matic for modeling Shipping of the process components to and from Sani-Matic will be at the customer’s expense Sani-Matic retains ownership of the part models for sole use in rack design
NOTE: • Parts need to be shipped to Sani-Matic’s facility for this option
11.1.11 Part 3D Modeling – Trip (Budgetary) A design engineer will 3D model each unique process component so that they can be incorporated into the wash rack design The modeling will allow specific design elements to be incorporated into the rack and allow for repeatable component placement on the rack The modeling will take place at the customer’s facility reducing the amount of time that the process components are unavailable Generally, three components can be modeled per hour The number of components that can be modeled in the allotted time varies dependent on their complexity and their availability to the design engineerThis option is a budgetary value based on the provision of one (1) Sani-Matic technician for two (2) days, sixteen (16) hours of travel, and four (4) days of expenses Sani-Matic retains ownership of the part models for sole use in rack design
NOTE: • If selecting this accessory, the per part cost described in Section 11.1.10 Part 3D Modeling – Design Cost (per Part) does not apply • The final invoice is based on the actual hours worked and expenses invoiced at cost
sanimatic.com 22
TD-0002.4
Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26Powered by FlippingBook