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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