ISMATEC Flowmaster™ ISM1022A Peristaltic Pump

Overview

The ISMATEC Flowmaster™ ISM1022A is a high-performance, stainless-steel-bodied peristaltic pump engineered for precise, contamination-free fluid handling in regulated industrial and laboratory environments. Operating on the principle of positive displacement via roller compression—where three rollers sequentially compress flexible tubing against a curved housing—the ISM1022A delivers repeatable volumetric flow without contact between the pump mechanism and the fluid path. This design eliminates the risk of cross-contamination, seal leakage, or particle generation, making it suitable for applications requiring strict adherence to hygienic process standards. Its robust architecture supports continuous operation under variable load conditions, with inherent self-priming capability and dry-run tolerance. Designed for integration into bioprocessing skids, clean-in-place (CIP) systems, and automated analytical workflows, the ISM1022A meets the mechanical and electrical safety requirements outlined in IEC 61000-6-2 (immunity) and IEC 61000-6-4 (emissions), and carries CE marking per the Low Voltage Directive 2014/35/EU and EMC Directive 2014/30/EU.

Key Features

• Stainless-steel enclosure rated IP65 for protection against dust ingress and low-pressure water jets—enabling safe deployment in wet or washdown-intensive areas such as pharmaceutical manufacturing suites and food processing lines.
• Tool-free, rapid tube change system allowing full pump head disassembly and tubing replacement in under 10 seconds—minimizing downtime during routine maintenance or product changeovers.
• Interchangeable 3-roller pump head compatible with tubing inner diameters from 6.4 mm to 16.0 mm and wall thicknesses of 1.6 mm or 3.2 mm—supporting a wide range of chemical resistance profiles and pressure ratings across silicone, Viton®, and Pharmapure® tubing materials.
• Analog control interface accepting standard industrial signals (0–5 VDC, 0–10 VDC, 1–20 mA, 4–20 mA) for seamless integration with PLCs, SCADA systems, or centralized process controllers.
• Multi-layer electronic protection including thermal shutdown, current-limiting circuitry, and stall detection—ensuring operational reliability during transient overloads or occlusion events.
• Integrated status signaling via analog outputs and discrete relay contacts for real-time monitoring of motor state, fault conditions, and rotational speed feedback.

Sample Compatibility & Compliance

The ISM1022A is validated for use with single-use and reusable tubing sets compliant with USP Class VI, FDA 21 CFR Part 11 (when paired with audit-trail-capable control software), and ISO 10993-5 cytotoxicity requirements. Its hygienic construction—free of crevices, threaded fasteners exposed to fluid paths, or elastomeric seals in contact with process media—aligns with ASME BPE-2022 surface finish specifications (Ra ≤ 0.8 µm for wetted stainless steel). The pump satisfies key regulatory expectations for equipment used in GMP environments, including traceability of calibration records, documented risk assessments per ISO 14971, and compatibility with validation protocols (IQ/OQ/PQ) required by EMA Annex 15 and FDA Guidance for Industry: Process Validation.

Software & Data Management

While the ISM1022A operates as a stand-alone analog-controlled device, it is fully interoperable with third-party supervisory control platforms supporting Modbus RTU or analog I/O mapping. When integrated into a validated data acquisition environment—such as LabArchives ELN, DeltaV DCS, or Siemens Desigo CC—the pump’s speed setpoint, actual RPM, and alarm states can be logged with time-stamped, user-attributed entries meeting ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Optional external controllers (e.g., ISMATEC IPC-100) provide USB/RS-232 connectivity, password-protected parameter locking, and configurable ramp profiles—facilitating compliance with 21 CFR Part 11 when deployed with electronic signature functionality and audit trail generation.

Applications

• Continuous feeding of cell culture media, buffers, and harvest streams in upstream bioprocessing trains.
• Accurate metering of cleaning agents and sanitants during CIP/SIP cycles in stainless-steel piping networks.
• Controlled reagent delivery in automated titration systems, HPLC solvent management, and inline pH adjustment loops.
• Low-shear transfer of shear-sensitive biologics—including monoclonal antibodies, viral vectors, and mRNA-LNPs—where maintaining structural integrity is critical.
• Hygienic dosing of flavorings, colorants, and preservatives in beverage blending and dairy production lines.

FAQ

What tubing sizes are supported by the ISM1022A pump head?
The standard 3-roller pump head accommodates tubing with inner diameters from 6.4 mm to 16.0 mm and wall thicknesses of either 1.6 mm or 3.2 mm.
Does the ISM1022A support digital communication protocols?
The base unit features analog I/O only; digital connectivity (Modbus RTU, RS-232) requires an optional external controller such as the ISMATEC IPC-100.
Is the pump suitable for sterile applications?
Yes—when used with gamma-irradiated, USP Class VI-certified single-use tubing and installed in accordance with ASME BPE hygienic practices, the ISM1022A supports aseptic fluid transfer up to 1.5 bar operating pressure.
Can the ISM1022A be validated under GMP guidelines?
Yes—the pump’s mechanical consistency, CE compliance, and compatibility with IQ/OQ documentation templates enable full qualification within pharmaceutical manufacturing quality systems.
What is the maximum allowable backpressure for continuous operation?
Maximum recommended backpressure is 1.5 bar at 500 rpm with 16 mm ID tubing; derating is advised above 1.0 bar when using smaller-diameter or higher-durometer tubing.