TD-0002_PharmaCab® SP_Technical Datasheet_Rev4.0

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

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TD-0002.4

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