PharmaCabTM SP Series GMP Cabinet Washer - Sani-Matic,

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Bio-PharmPharmaCab SP SeriesGMP Cabinet WasherTMTechnical DatasheetCleaning Confidence1915 S. Stoughton Rd., Madison, WI 53716(o) 800-356-3300(f ) 608-222-5348sanimatic.com

Model Number KeyExample Model #: 1819 2021C1–5678910111213Chamber ModelSP33334" W x 34" D x 40" HSP44348" W x 48" D x 40" HSP44448" W x 52" D x 48" HDoor Configuration1Single Door (Standard)2Double DoorSystem Configuration1Right Handed (Standard)2Left HandedFinal Rinse TypeRRecirculated Final Rinse (Standard)SSingle Pass Final RinseDryer System0No Dryer System (Standard)1Dryer System - No Service Panels2Dryer System - Front Service Panels (Single Door)3Dryer System - Front & Back Service Panels (Double Door)Recirculated HeatingEElectric (Standard)SSteamSupply Pressure MonitoringGPressure Gauge (Standard)TPressure TransmitterSupply Flow MonitoringSFlow Switch (Standard)MFlow MeterConductivity Monitoring014A151617181920Wash & Rinse Conductivity Control (Standard)ControlsAllen-Bradley Controls Package (Standard)ReportingEElectronic Data (Standard)PReport Ticket PrinterWater Addition0Dual Water Ports (Standard)1Dual Water Ports with (1) Pneumatic Valve2Dual Water Ports with (2) Pneumatic ValvesChemical Addition0Dual Chemical Ports (Standard)1Single Chemical Delivery2Dual Chemical DeliveryDrain Type0Gravity Drain (Standard)1Drain PumpDrain Cooling0No Drain Cooling Valve (Standard)1Drain Cooling ValveSampling Method0No Sample Station (Standard)1Sample Station - Single Door2Sample Station - Unload Side (Double Door)3Sample Station - Load Side (Double Door)sanimatic.com 2

Table of Contents1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52. Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53. Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53.1 Certifications and Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . 53.2 Structural Framing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53.3 Hygienic Piping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53.4 Service Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63.5 Electrical Conduit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63.6 Pneumatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63.7 Instrument Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64. Utility Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65. Physical Size & Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76. Component Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87. Equipment Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97.1 Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97.2 Circulation System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107.3 Heating System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107.4 Control System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107.4.1 Low Voltage Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . .107.4.2 Pneumatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117.4.3 High Voltage Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 117.4.4 Load Side Operator Interface . . . . . . . . . . . . . . . . . . . . . . . .118. Equipment Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118.1 Loading and Unloading Operation . . . . . . . . . . . . . . . . . . . . . . . . . 118.2 Cleaning Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118.3 Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128.4 Automation Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128.5 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129. Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1210. Product Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1310.1 Door Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1310.2 System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1310.3 Final Rinse Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1310.4 Dryer System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1410.5 Recirculated Heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1510.6 Supply Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1510.7 Supply Flow Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1610.8 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1610.9 Water Addition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .TD-0002.116sanimatic.com3

Table of Contents (continued)10.10 Chemical Addition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1610.11 Drain Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1610.12 Drain Cooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1610.13 Sampling Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1711. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1711.1 Accessory Category – Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . .1711.1.1 Rack – Low Load Density (Budgetary) . . . . . . . . . . . . . . . . . . . . 1811.1.2 Rack – Medium Load Density (Budgetary) . . . . . . . . . . . . . . . . . 1811.1.3 Rack – High Load Density (Budgetary) . . . . . . . . . . . . . . . . . . . 1811.1.4 Riboflavin Test – Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1811.1.5 Passivation – Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1811.1.6 Borescope Inspection Video – Rack . . . . . . . . . . . . . . . . . . . .1811.1.7 Transfer Cart – SP333 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1911.1.8 Transfer Cart – SP443 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1911.1.9 Transfer Cart – SP444 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1911.1.10 Part 3D Modeling – Design Cost (per Part) . . . . . . . . . . . . . . . .1911.1.11 Part 3D Modeling – Trip (Budgetary) . . . . . . . . . . . . . . . . . . . .1911.2 Accessory Category – System Additions . . . . . . . . . . . . . . . . . . . . . 2011.2.1 Passivation – System . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2011.2.2 Hydrostatic Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011.2.3 Riboflavin Test – Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . 2011.2.4 Riboflavin Test – Rinse Tank . . . . . . . . . . . . . . . . . . . . . . . . . 2011.2.5 Borescope Inspection Video - System . . . . . . . . . . . . . . . . . . . 2011.2.6 Seismic Zone Anchorage Calculations . . . . . . . . . . . . . . . . . . . 2011.2.7 Barrier Flanges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2011.3. Accessory Category – Documentation . . . . . . . . . . . . . . . . . . . . . . 2111.3.1 Functional Specification (FS) . . . . . . . . . . . . . . . . . . . . . . . . . 2111.3.2 Configuration Specification (CS) . . . . . . . . . . . . . . . . . . . . . . . 2111.3.3 Factory Acceptance Test (FAT) . . . . . . . . . . . . . . . . . . . . . . . 2111.3.4 Site Acceptance Test (SAT) . . . . . . . . . . . . . . . . . . . . . . . . .2111.3.5 Installation Qualification / Operational Qualification (IQ/OQ) . . . . . .2111.3.6 Instrument Data Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . 2111.3.7 Traceability Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2111.4. Accessory Category – Field Service . . . . . . . . . . . . . . . . . . . . . . .2211.4.1 Installation Assistance (Budgetary) . . . . . . . . . . . . . . . . . . . . . 2211.4.2 Start-up & Training (Budgetary) . . . . . . . . . . . . . . . . . . . . . . . 2211.4.3 SAT Assistance (Budgetary) . . . . . . . . . . . . . . . . . . . . . . . . . 2211.4.4 IQ/OQ Assistance (Budgetary) . . . . . . . . . . . . . . . . . . . . . . . . 2211.4.5 On-site Rack Assistance (Budgetary) . . . . . . . . . . . . . . . . . . . . 2211.4.6 Preventative Maintenance (PM) Program (Budgetary) . . . . . . . . . . 2311.4.7 Recommended Spare Parts (RSP) Budget (Budgetary) . . . . . . . . . 23TD-0002.1sanimatic.com4

1. IntroductionTechnical information provided within this document is for Sani-Matic’s Configured Design Offering (CDO) of PharmaCab SP Series GMPcabinet washers. This offering of cabinet washers meets cGMP standards and adheres to the latest ASME Bioprocessing Equipment (BPE) CabinetWasher standards.Alternative Design Requests (ADR) for variations in construction, size, component manufacturers, options, orientation, or other technicalrequirements should be directed to the Sani-Matic sales group for custom quoting and engineering.2. ApplicationsThe PharmaCab SP Series 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 chamber and usable space dimensions and volumes see Table 4: Chamber and Usable Space Dimensions.Dedusters / TabletPress PartsGlasswareFilter HousingsScoopsHoses3. Construction3.1 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), ANSI / ISA-88 (S88) Batch Control and Recipe Management System Certifications: None3.2 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 theequipment to be leveled on uneven or sloped surfaces.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 9Documentation for more information. Weld Finish: As-welded ID / color cleaned OD Slope: 1/8" per foot / 1.0% (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, TeflonTM faced / EPDM backed diaphragms, and pneumatic actuatorsTD-0002.1sanimatic.com5

3.4 Service Panels Description: Panels located on the load/