Bio-Pharm
PharmaCab ® MP: High-Throughput Capacity GMP Washer Cleans Entire Suite in One Load.
The Sani-Matic PharmaCab ® MP is an automated hygienic cabinet washer engineered for critical cleaning. Its high-throughput capacity allows bio-pharm manufacturers to clean an entire manufacturing suite in one load. The PharmaCab MP Series meets cGMP and ASME BPE standards.
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The Sani-Matic PharmaCab MP Series is designed to ensure process parts such as filter housings, pill slats, encapsulation parts, drums and more, receive a validatable clean.
Applications
Advantages • Validation. Hygienic design to meet validation requirements. Extensive documentation and comprehensive process monitoring are provided. • Complete Clean. The PharmaCab MP Series provides full, documentable cleaning coverage with multiple rotating and oscillating sprays, proof of rotation sensors, radiused corners and custom-designed racks with an active coupler connection to distribute solution throughout the rack. • Easy to Use. The sprays contain non-threaded, ¼ turn spray nozzles for easy inspection and cleaning. The Rack Systems are easy to load and transport. Unload side sample station for quick testing is available. • Safety. Inflatable door gaskets maintain watertight barrier. Industry Standard Compliance • FDA Current Good Manufacturing Practices (cGMP), CFR Title 21, Part 820 • Underwriters Laboratory (UL): Controls, Standard 508 • ANSI / ISA-88 (S88) Batch Control and Recipe Management • ASME BPE Standards
Dedusters / Tablet Press Parts
Pill Slats
Filter Housings
Encapsulation Parts
Drums
Fittings
Documentation
Standard • O peration and maintenance manuals • R ecommended spare parts (RSP) list
Optional • F unctional Specifications (FS) • C onfiguration Specification (CS) • Factory Acceptance Test (FAT) • Site Acceptance Test (SAT) • Installation and Operation Qualification (IQ/OQ) • T raceability matrix • Instrument data sheets
• Mechanical Bill of Materials (BOM) • Instrumentation calibration records • M aterial Test Reports (MTRs) • W eld maps and weld logs (including qualification and inspection records) • Inspection test results, reports and certificates • C omponent vendor documentation • A s-built General Assembly (GA) drawings • A s-built Process and Instrumentation Diagrams (P&ID) • A s-built electrical drawings
• B orescope Inspection Video • H ydrostatic test certificate • C leaning and passivation certificate • R iboflavin spray coverage test
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SaniTrend ® Cloud Reporting Software
AUDIT TRAIL (CR INSIGHTS+)
CLEANING CYCLE REPORTS (CR INSIGHTS+)
Add SaniTrend ® Cloud Cleaning Reports (CR) software to your equipment to efficiently and automatically record and store critical data (e.g., temperature, conductivity). SaniTrend ® Cloud CR Insights+ records all critical data in easy- to-interpret cleaning records and additional insights like event logs, Overall Equipment Effectiveness (OEE) scoring, Preventive Maintenance (PM) Tracking, and more. The Insights+ edition also logs a full HMI Audit Trail and is 21 CFR Part 11 compliant for electronic records and signatures. Learn more at our website at sanimatic.com/sanitrendcloud/
OEE TRENDING (CR INSIGHTS+)
Standard Features
Chamber • W etted 316L stainless steel, 25 µin Ra Non-wetted 304 stainless steel, 32 µin Ra • Radiused corners for self-cleaning • W ash chamber LED light
Drying System • E xternal dryer system included for precise moisture control • H eated air is controlled to a set point temperature • S team heat Chemical Delivery • T wo pumps provide accurate dosage of chemicals • Ready access pump and containers for easy maintenance Process Monitoring for Repeatable Cleaning • PLC-controlled cycle times with adjustable recipe set points • P ressure is maintained at pump discharge • Solution flow verification • H eated air is controlled at the discharge of the dryer • Differential pressure is monitored on the HEPA filter • C onductivity probes control chemical concentrations and prove final rinse • S olution temperature is monitored in the CIP supply and return Maintenance Access • S ealed doors eliminate room air balance issues Manifolds • Diaphragm valves are used in all sanitary lines • Elastomers are USP Class VI approved Pumps • Sanitary centrifugal pump - casing drain allows for complete drainage • Liquid ring pump - casing drain allows for complete drainage Voltage • 4 80V, 3-Phase, 60 Hz Loading • P it-mounted design
Chamber Doors • Single door design • 316L stainless steel and tempered safety glass • Pneumatically inflated door gasket • Safety interlocks prevent inadvertent door operation Control System • A llen-Bradley CompactLogix with PanelView Plus HMI • F orty (40) user-defined recipes • R ecipes can be modified for function, cycle times, temperatures and other key cycle parameters • T hree password protected levels of access • U tility and maintenance screens on operator interface • Ethernet port for connection to facility network Chamber Spray System • T he rotating sprays provide maximum coverage of all load items and eliminate coverage dead spots • P roof of rotation sensors • Non-threaded, ¼ turn removable nozzles • S olution distribution connection for rack system Debris Screen • L arge, easy-to-clean stainless steel 1 / 8 " perforated screen is located in the wash chamber’s sump Solution Supply • E xternal CIP system is included to supply solution to washer Solution Heater • S team heat
Optional Features • D ouble door (pass-through) design • S eismic zone anchorage calculations • Barrier flanges • Drain cooling valve
• R emote chemical supply • 2 0 µin Ra finish • P assivation • S ample station • F loor-mounted design
BPB-0003.4
Rack Systems
• Designed for your process. Custom-engineered rack systems are designed by 3-D modeling individual process parts to provide defined part arrangement, ensuring optimum placement for validatable cleaning. • Active Rack Systems. A coupler connection allows solution to be distributed throughout the rack for a targeted spray. • On-Site Rack Service. Sani-Matic field service engineers are available to perform on-site riboflavin spray coverage testing and rack modifications if required. • Safety. Roll-in racks or racks with transfer carts assist operators with easy and safe process parts handling and transporting.
PharmaCab MP Series System Components
PharmaCab MP Series systems have three major components: the GMP washer, an external CIP system and an external dryer.
Cleaning Confidence. Repeatable results you can count on every time you clean your process parts and equipment. That’s Cleaning Confidence from Sani-Matic.
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Sani-Matic, Inc.
1915 S. Stoughton Rd., Madison, WI 53716
(p) 800-356-3300
(f) 608-222-5348
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