Sartorius Microsart® 168M3-MS Triple Stainless Steel Filtration Stand

Overview

The Sartorius Microsart® 168M3-MS Triple Stainless Steel Filtration Stand is an engineered solution for membrane filtration-based microbial enumeration in regulated pharmaceutical, biotechnology, and clinical laboratory environments. Designed in accordance with ISO 8573-7, USP /, EP 2.6.12, and ASTM D5928, the stand operates on the principle of vacuum-assisted sterile filtration—enabling quantitative recovery of viable microorganisms (bacteria, yeasts, and molds) from aqueous or low-viscosity liquid samples. Its compact, modular architecture eliminates reliance on traditional glassware assemblies (e.g., side-arm flasks, trap bottles, and inline pump protectors), thereby reducing contamination risk, operator variability, and spatial footprint by up to 70% compared to conventional setups. The unit serves as the central mechanical interface between sample filtration consumables and the Microsart® E-jet direct-discharge vacuum pump, forming a fully integrated, GLP-compliant membrane filtration system.

Key Features

• Triple-position stainless steel filtration base constructed from electropolished AISI 316L, ensuring corrosion resistance, cleanability, and full autoclavability (121 °C, 20 min, 15 psi).
• Integrated 3-way stainless steel valve per filtration position, enabling independent sterile venting post-filtration—preventing backflow contamination and maintaining membrane integrity during filter transfer.
• Push-to-connect quick-coupling interface compatible with Microsart® E-jet pumps and all Microsart®/Biosart® funnel types; assembly and disassembly completed in under 2 minutes without tools.
• Standardized lateral quick-connect ports allow daisy-chaining of multiple 168M3-MS stands for parallel processing of heterogeneous sample sets.
• No requirement for secondary containment vessels (e.g., filter flasks or hydrophobic pump protectors), reducing consumable cost and waste generation while improving workflow continuity.

Sample Compatibility & Compliance

The 168M3-MS stand supports all standard 47 mm diameter membrane filters used in pharmacopoeial microbial limit testing—including cellulose ester, nylon, PVDF, and mixed ester membranes—when paired with validated funnels. It accommodates both pre-sterilized ready-to-use formats (Microsart® @Filter, Biosart® 100/250) and reusable sterilizable components (stainless steel, borosilicate glass, and autoclavable polycarbonate funnels). All configurations comply with regulatory expectations for sterility assurance: the independent 3-way valve permits positive-pressure sterile air exchange after filtration without membrane exposure to ambient air, satisfying FDA guidance on aseptic technique in environmental and product testing. System validation documentation—including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) templates—is available upon request for GMP-aligned implementation.

Software & Data Management

While the 168M3-MS stand itself is a hardware-only platform with no embedded electronics or firmware, it is fully interoperable with Sartorius’ digital laboratory ecosystem. When used in conjunction with the Microsart® E-jet pump (which features optional RS-232/USB connectivity), filtration event timestamps, cycle counts, and pump runtime can be logged into LIMS or ELN systems via configurable ASCII output. The mechanical design supports 21 CFR Part 11–compliant audit trails when paired with validated electronic record systems—particularly where filtration parameters (e.g., vacuum level, duration, filter lot number) are manually entered or barcode-scanned at the point of use. Routine cleaning and sterilization logs may be maintained using Sartorius’ optional LabX® Connect module for traceable equipment maintenance history.

Applications

• Pharmaceutical water system monitoring (PW, WFI, purified water) per USP and EU Annex 1 requirements.
• Microbial limit testing of non-sterile drug products, excipients, and raw materials in accordance with USP , EP 2.6.12, and JP 4.07.
• Bioburden assessment of cell culture media, buffers, and process intermediates in biomanufacturing facilities.
• Environmental monitoring filter analysis in cleanrooms and isolators (ISO 14644-1 Class 5–8).
• Method transfer and validation studies requiring high reproducibility across multiple analysts and shifts.

FAQ

Is the 168M3-MS stand compatible with non-Sartorius filtration funnels?
Yes—provided the funnel has a standard 47 mm support ring and mates mechanically with the stand’s quick-connect collar (ISO 7206-1 compliant interface). However, full regulatory validation is only guaranteed when used with Sartorius-qualified consumables.
Can the stand be cleaned in a laboratory dishwasher?
Electropolished AISI 316L construction allows compatibility with alkaline enzymatic wash cycles; however, thermal shock from rapid temperature changes must be avoided. Autoclaving remains the recommended sterilization method.
Does the 3-way valve require calibration or periodic maintenance?
No. The valve is a passive, manually actuated stainless steel component with no moving seals or elastomers. It requires only routine visual inspection and cleaning between uses.
What vacuum pressure range is optimal when pairing with the Microsart® E-jet pump?
The system is designed for stable operation at –0.8 to –0.95 bar (absolute), which ensures efficient filtration without membrane collapse or bubble point compromise for standard 0.45 µm or 0.22 µm membranes.
Is the 168M3-MS suitable for viscous or particulate-laden samples?
It is intended for low-turbidity, low-viscosity aqueous solutions (e.g., injectables, buffers, purified water). For high-particulate or viscous matrices, pre-filtration through a coarse screen or centrifugation is advised prior to membrane filtration.