USP Water Systems Built for cGMP Environments

SaniSpec — Sanitary Design, Cost-Effective Ownership

SaniSpec delivers USP-quality purified water in a sanitary, cGMP-aligned design built for reliability and ease of ownership. With configurable ASTM Type I/II/III polishing steps, 1–10 GPM performance, and integration options for modern facility controls, SaniSpec provides consistent water quality without the high cost or complexity of traditional pharma-grade systems.

Why SaniSpec?

Biotech and pharmaceutical teams need purified water that meets strict quality expectations without the cost or complexity of traditional pharma-grade systems.

TOC drift, inconsistent resistivity, and microbial concerns can slow method development and complicate audits.

SaniSpec applies sanitary, cGMP-aligned design principles to deliver stable, USP-quality water at 1–10 GPM—supporting clean runs, smooth qualifications, and predictable ownership costs.

  • USP Purified Water output with stable resistivity and low TOC

  • Sanitary, cGMP-aligned construction without the high pharma-grade price

  • Scalable 1–10 GPM production to support R&D, pilot operations, and QA/QC labs

STANDARD FEATURES

What’s Included in Every SaniSpec System

Every SaniSpec unit ships with a validated, hygienic purification train and monitoring package designed to meet USP Purified Water expectations. These core features provide dependable performance, predictable maintenance, and clean integration into regulated R&D, biotech, and QA/QC environments.

  • USP-Quality Water Output

    Delivers stable resistivity and low TOC with instrumentation aligned to USP <645> conductivity requirements.

  • Sanitary, Hygienic Construction

    Designed with cGMP-aligned principles—smooth flow paths, proper drainability, and sanitary connection options.

  • Configurable RO/DI Treatment Train

    Reverse osmosis with DI polishing as standard, with optional upstream or downstream steps based on your URS.

  • Microbial Control Strategy

    Hot-water or ozone sanitization options, plus available UV and sub-micron filtration where needed.

  • Integrated Monitoring & Alarms

    Conductivity/resistivity and temperature as standard; optional TOC analyzer and remote alarm visibility.

  • Distribution & Point-of-Use Support

    Supports recirculating loops or individual POU final filters for analytical or production workflows.

the SaniSpec advantage

Features that Matter

SaniSpec applies sanitary design principles and cGMP-aligned components to deliver dependable USP-quality water. Each feature is built for long-term performance, streamlined validation, and predictable cost of ownership.

  • Water Quality & Compliance

    • USP-quality output with stable resistivity/conductivity

    • Inline TOC, USP <645> conductivity options, microbial control strategies

    • Sanitary, hygienic layout with proper drainability

  • Throughput & footprint

    • 1–10 GPM range for R&D through pilot scale
    • Compact skid footprint for mechanical rooms and labs
    • Loop-ready system design
  • Reliability & Service

    • Duty/standby options for critical components

    • Remote alarming and status visibility

    • Service-friendly layout and clear maintenance intervals

  • Integration

    • BMS/SCADA connectivity using common protocols

    • Data-handling options supportive of 21 CFR Part 11 practices

    • Documentation packages for qualification activities (IQ/OQ)

ENGINEERED FOR COMPLIANCE. BUILT FOR SANITARY PERFORMANCE.

Technical Specifications

SaniSpec delivers USP Purified Water through a sanitary, cGMP-aligned design engineered for reliability in regulated environments. Typical configurations include RO, DI polishing, microbial control strategies, and monitoring options that support qualification activities and day-to-day lab operations.

Parameter
SaniSpec (Typical Range / Configurable Options)
Production Rate
1–10 GPM (3.8–38 L/min)
Product Water
USP Purified Water; ASTM Type II; optional Type I polish at point of use
Primary Treatment
Reverse osmosis with DI polishing (configurable)
Microbial Control
Hot-water or ozone sanitization; UV and sub-micron filtration options
Monitoring
Conductivity/resistivity, temperature; optional TOC analyzer
Distribution
Recirculating loop support; POU final filters
Materials
Hygienic, sanitary construction; materials per URS
Controls/HMI
PLC/HMI with alarm logging; BMS/SCADA integration options
Utilities
Electrical/feedwater/drain sized to selected flow; heat load varies by sanitization mode
Documentation
Turnover package; IQ/OQ support; FAT/SAT available
*Materials and finishes selected to meet your URS and site standards.

Talk with an engineer today

Discuss your purified water requirements with an engineer and get guidance on configuring SaniSpec for your lab, pilot space, or QA/QC environment.

Water Usage
8 hrs./GPD
Water
Quality
Loop
Size
Loop
Flow
750/2250
750/2250
RO
RO/DI
Type III
1"
1 1/4"
12 GPM
20 GPM

Frequently asked questions

Still Have Questions?

We’ve answered the most common ones below—but if there’s something else on your mind, we’re just a message away.

E-mail Sales & Support

SaniSpec produces USP Purified Water and supports ASTM Type II output. When needed, the system can include polishing steps to reach Type I quality at specific points of use.

SaniSpec supports both hot-water and ozone sanitization, allowing the system to be aligned with site utilities, materials, and microbial control plans.

Typical SaniSpec builds deliver 1–10 GPM purified water for R&D, biotech, and QA/QC environments. For flow rates above this range, the SkidSpec platform is the next step.

Yes. SaniSpec offers standard integration paths for BMS and SCADA, including alarming, status visibility, and data collection to support regulated workflows.

Yes. SaniSpec can be supplied with turnover documentation, IQ/OQ support, and FAT/SAT services to help teams complete commissioning and qualification activities smoothly.

Lead time is shaped by instrumentation choices, sanitization mode, material requirements, and the documentation package needed for your project.

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Let's talk solutions

Our team’s ready to help you find the right system, answer questions, or get your order started. Reach out today—we’ll get back to you quickly.

contact us

Let's talk solutions

Our team’s ready to help you find the right system, answer questions, or get your order started. Reach out today—we’ll get back to you quickly.

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