Interscience Stomacher® 400 Circulator Paddle Blender
| Origin | France |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Import Status | Imported |
| Model | Stomacher® 400 Circulator |
| Instrument Type | Laboratory Paddle Blender |
| Compliance | ISO 6887-1, EN ISO 6887-1, AOAC 990.12, USP <61>, FDA Bacteriological Analytical Manual (BAM) |
Overview
The Interscience Stomacher® 400 Circulator is a precision-engineered laboratory paddle blender designed for standardized, reproducible homogenization of microbiological samples in food, pharmaceutical, cosmetic, and environmental testing laboratories. Operating on the principle of controlled mechanical agitation—where a sterile, single-use stomacher bag is subjected to reciprocating paddle motion within a temperature-regulated water-jacketed chamber—the instrument ensures gentle yet effective release of microorganisms from solid or semi-solid matrices without thermal stress or cellular lysis. Unlike high-shear grinders or bead mills, the Stomacher® 400 preserves microbial viability and colony-forming unit (CFU) integrity, making it the reference method for quantitative recovery in regulatory-compliant enumeration protocols.
Key Features
- Integrated water-circulating temperature control system (±0.5 °C stability) to maintain sample integrity during homogenization—critical for thermolabile pathogens such as Listeria monocytogenes or Campylobacter jejuni
- Programmable blending cycles: 30–300 seconds, adjustable in 1-second increments; speed range: 0–230 rpm with real-time digital feedback
- Self-calibrating torque sensor ensures consistent mechanical energy delivery across batches, minimizing inter-run variability
- CE-marked, IP22-rated enclosure with safety interlock preventing operation when lid is open or bag is improperly seated
- Stainless-steel chamber and corrosion-resistant internal components compliant with ISO 13485 cleanability requirements
- Optional barcode reader integration for GLP/GMP traceability and audit-ready batch logging
Sample Compatibility & Compliance
The Stomacher® 400 Circulator accepts standard 40 mL and 200 mL sterile stomacher bags (including Interscience’s patented FilterBag® series with integrated 100 µm mesh). It accommodates heterogeneous matrices including raw meat, dairy products, leafy greens, powdered pharmaceuticals, and environmental swab eluates. The instrument meets the mechanical performance criteria outlined in ISO 6887-1:2017 (“Microbiology of the food chain — Preparation of test samples”), EN ISO 6887-1, AOAC Official Method 990.12, and USP “Microbiological Examination of Nonsterile Products”. Its validated homogenization profile supports FDA BAM Chapter 3 (Aerobic Plate Count) and Chapter 4 (Coliforms), and is routinely cited in EU Regulation (EC) No 2073/2005 for food safety monitoring.
Software & Data Management
When paired with Interscience’s LabStar™ LIMS-integrated software (v4.2+), the Stomacher® 400 enables full electronic recordkeeping per 21 CFR Part 11 requirements—including user authentication, audit trail with timestamped event logs, electronic signatures, and immutable data export in CSV or PDF/A-2 format. All blending parameters (duration, speed, temperature, operator ID, sample ID) are automatically captured and linked to downstream colony counting results from compatible Interscience Scan® series automated colony counters. Data synchronization supports seamless integration with enterprise-level QMS platforms used in GMP environments.
Applications
- Quantitative recovery of aerobic mesophiles, Enterobacteriaceae, E. coli, Salmonella, and Staphylococcus aureus from food challenge studies
- Preparation of uniform suspensions for membrane filtration, MPN assays, and MALDI-TOF MS sample loading
- Homogenization of lyophilized reference materials and proficiency testing panels under ISO/IEC 17043 guidelines
- Environmental monitoring of cleanroom surfaces, HVAC filters, and pharmaceutical manufacturing equipment swabs
- Supporting ISO 11133:2014 culture media performance qualification through standardized inoculum preparation
FAQ
Is the Stomacher® 400 Circulator suitable for use with hazardous or biocontainment samples?
Yes—when operated inside a certified Class II biosafety cabinet and using sealed, leak-tested FilterBag® variants, it complies with WHO Laboratory Biosafety Manual (4th ed.) Level 2 containment requirements.
Can blending parameters be locked to prevent unauthorized modification?
Yes—LabStar™ software supports role-based access control (RBAC), allowing administrators to restrict parameter editing to designated QC supervisors.
Does Interscience provide validation documentation for IQ/OQ/PQ protocols?
Yes—factory-issued Installation Qualification (IQ) and Operational Qualification (OQ) templates, plus PQ support packages aligned with ISO/IEC 17025, are available upon request.
What maintenance intervals are recommended for routine compliance?
Daily visual inspection of seals and paddles; quarterly calibration of temperature and speed sensors by an Interscience-certified service engineer; annual full performance verification per ISO/IEC 17025 Clause 6.4.3.
