Millipore Steritest™ Symbio Automated Microbial Limit Testing System

Overview

The Millipore Steritest™ Symbio Automated Microbial Limit Testing System is an engineered solution for sterility assurance and microbial enumeration in regulated pharmaceutical, biotechnology, and medical device manufacturing environments. Built upon the principle of membrane filtration followed by incubation and colony enumeration, the system automates the critical fluid-handling steps—filtration, rinsing, and sample transfer—while maintaining strict aseptic integrity throughout the process. Unlike manual or semi-automated systems, Steritest™ Symbio integrates dual-channel parallel filtration architecture, enabling concurrent processing of up to six samples per cycle without cross-contamination risk. Its compact footprint and low-profile pump design are specifically validated for seamless integration into laminar airflow cabinets (vertical and horizontal), isolators, and restricted access barrier systems (RABS), minimizing spatial constraints while maximizing operational efficiency in Grade A/B cleanroom settings.

Key Features

• Compact, low-height pump module optimized for placement inside laminar flow hoods and isolators—reducing ergonomic strain and increasing usable workspace.
• Automated pump head shroud ensures precise, repeatable installation of single-use filter cassettes (0.45 µm or 0.22 µm pore size), eliminating manual alignment errors and enhancing procedural consistency.
• High-accuracy volumetric control with ±1% repeatability across defined flow rates; programmable timing resolution down to 0.1 second for precise small-volume sampling (e.g., 10–100 mL).
• Two pressure-regulation modes—standard and gentle—allow dynamic pump speed reduction when resistance increases (e.g., viscous solutions or clogged filters), protecting sensitive microorganisms from shear stress and improving recovery rates.
• Sealed, particle-free enclosure with passive thermal management eliminates internal fans or moving parts that could generate airborne particulates—fully compliant with ISO 14644-1 Class 5 (Grade A) environmental requirements.
• Ergonomic front-panel layout with adjustable bottle holder height, tilt-adjustable display, tactile feedback buttons, and glove-compatible interface reduces operator fatigue and minimizes procedure interruption during extended shifts.

Sample Compatibility & Compliance

Steritest™ Symbio accommodates a broad range of pharmaceutical preparations—including aqueous solutions, oily suspensions, lyophilized reconstitutes, and low-viscosity biologics—via customizable filtration protocols. It supports standard 47 mm and 50 mm membrane filters (cellulose nitrate, mixed cellulose ester, PVDF) and integrates seamlessly with Millipore’s certified sterile filter cassettes. The system meets essential regulatory expectations for data integrity and process validation: built-in audit trail logs all user actions, method changes, and system events with timestamp and operator ID; electronic signatures comply with 21 CFR Part 11 and EU Annex 11 requirements; and software architecture adheres to GAMP 5 principles for computerized system validation. Routine operation satisfies ISO 13408-1 (sterility testing of medicinal products), USP , Ph. Eur. 2.6.1, and JP XVII sterility test guidelines.

Software & Data Management

The embedded firmware provides intuitive navigation via its 4.3″ color LCD with multi-language support (English, Simplified Chinese, French, German, Italian, Japanese, Portuguese, Spanish). Users can store up to 250 pre-defined test methods—including filtration volume, rinse volume, flow rate, and hold times—with step-by-step visual guidance displayed during execution. All test records—including raw sensor data, alarm logs, and operator inputs—are stored internally with optional export to USB drive in CSV or PDF format. For enterprise integration, optional Ethernet connectivity enables remote monitoring and centralized data aggregation within LIMS or MES platforms, supporting trend analysis, CAPA initiation, and periodic review per ICH Q5A and Q9 requirements.

Applications

• Sterility testing of final drug products, active pharmaceutical ingredients (APIs), and excipients under compendial methods (USP, EP, JP).
• Microbial limit testing (MLT) of non-sterile pharmaceuticals per USP and .
• Environmental monitoring sample processing in cleanrooms and isolators.
• Validation of sterilization processes, including filtration efficacy studies and extractables/leachables filtration support.
• Quality control release testing in contract manufacturing organizations (CMOs) and biologics facilities operating under FDA, EMA, or PMDA oversight.

FAQ

Is Steritest™ Symbio compliant with 21 CFR Part 11 for electronic records and signatures?
Yes—the system includes configurable user roles, password protection, full audit trail, and electronic signature capability aligned with FDA 21 CFR Part 11 and EU Annex 11 requirements.
Can the system be validated for use in GMP environments?
Yes—it is supplied with IQ/OQ documentation templates and supports PQ execution per GAMP 5; qualification packages are available upon request.
What types of single-use cassettes are compatible?
Millipore-certified Steritest™ cassettes (0.22 µm and 0.45 µm pore sizes, PES or MCE membranes) are fully supported; third-party cassettes may be used but require compatibility verification.
Does the system support integration with laboratory information management systems (LIMS)?
Yes—via optional Ethernet interface and standardized data export formats (CSV/PDF), enabling bidirectional communication with major LIMS platforms.
What maintenance is required for routine operation?
No scheduled mechanical maintenance is required; only periodic cleaning of external surfaces with approved disinfectants and annual calibration verification using traceable standards.