Sartorius Microsart™ e.motion Sterile Filter Membranes
| Brand | Sartorius |
|---|---|
| Origin | Germany |
| Model | Microsart™ e.motion |
| Membrane Material | Nitrocellulose (CN) |
| Pore Sizes | 0.2 µm, 0.45 µm, 0.8 µm |
| Diameters | 47 mm, 50 mm |
| Surface Finish | White/Black, Grey/White, Green/Dark Green, White/Green |
| Packaging | Individually sealed in proprietary folded pouches, sterile, no protective backing paper |
| Compatibility | Designed exclusively for Microsart™ e.motion filter dispenser and Sartorius adsorption pads |
Overview
The Sartorius Microsart™ e.motion sterile filter membranes are precision-engineered nitrocellulose (CN) membranes designed for quantitative microbial enumeration in regulated pharmaceutical, biotechnology, and clinical laboratory environments. These membranes operate within the context of membrane filtration—a standardized microbiological method defined by ISO 8559, USP , EP 2.6.12, and ASTM D4291—where liquid samples are drawn under vacuum through a defined-pore membrane, retaining viable microorganisms on the surface for subsequent incubation and colony enumeration. The e.motion membranes are not standalone instruments but critical consumables integral to the semi-automated Microsart™ e.motion filtration platform, ensuring reproducible sample retention, optimal colony morphology development, and compatibility with downstream staining and imaging workflows.
Key Features
- High-purity nitrocellulose matrix with consistent pore structure and low extractables—validated per USP and EP 3.2.1 for pharmaceutical use.
- Sterile, individually packaged in proprietary folded pouches—eliminates need for manual handling or removal of protective backing paper, reducing contamination risk and operator variability.
- Engineered flatness and dimensional stability (±0.1 mm tolerance) ensure seamless alignment and sealing within the e.motion filter dispenser’s precision-guided chamber.
- Optimized surface contrast options (e.g., white/black, grey/white, green/dark green) support high-contrast colony visualization under both ambient light and automated digital imaging systems.
- Validated performance across a range of sample matrices including aqueous buffers, isotonic saline, antibiotic solutions, and low-turbidity biologics formulations.
- Manufactured in Germany under ISO 13485-certified conditions and subject to full lot traceability, including certificate of analysis (CoA) with batch-specific sterility testing (ISO 11737-2) and endotoxin limits (<0.25 EU/mL).
Sample Compatibility & Compliance
The Microsart™ e.motion membranes demonstrate broad compatibility with pharmacopoeial test methods for total aerobic microbial count (TAMC), yeast and mold count (TYMC), and specified pathogen detection (e.g., E. coli, P. aeruginosa, S. aureus). Their hydrophilic CN surface enables rapid wetting without surfactants, minimizing filtration time and preserving viability of stress-sensitive organisms. Each membrane variant is pre-qualified for use with Sartorius adsorption pads and validated for adherence to ISO 11140-1 (sterilization indicators) and ISO 14644-1 (cleanroom particulate control) when deployed in Grade A/B environments. Full compliance documentation—including regulatory dossiers aligned with FDA 21 CFR Part 11 requirements for electronic records and audit trails—is available upon request for GMP and GLP audits.
Software & Data Management
While the membranes themselves are passive consumables, their integration into the Microsart™ e.motion ecosystem enables traceable, software-driven workflow management. When used with the e.motion platform’s integrated barcode reader and LIMS-compatible interface, each membrane lot number is automatically logged alongside sample ID, operator, date/time stamp, and vacuum pressure profile. This supports ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and facilitates automated report generation compliant with Annex 11 and ICH M7 guidelines. Raw colony count data can be exported in CSV or PDF format with embedded metadata for review and archival.
Applications
- Pharmaceutical final product release testing per USP and EP 5.1.4.
- Environmental monitoring of Grade A filling lines using low-volume rinse sampling.
- Bioburden assessment of raw materials, excipients, and process water (PW, WFI).
- Validation of sterilizing-grade filtration processes (e.g., 0.2 µm CN membranes for WFI testing).
- Microbial limit testing of herbal extracts, topical formulations, and ophthalmic preparations where colorimetric interference necessitates high-contrast membrane surfaces.
- Research applications requiring high-resolution colony isolation for MALDI-TOF MS identification or genomic sequencing library prep.
FAQ
Are Microsart™ e.motion membranes compatible with non-Sartorius filtration manifolds?
No. These membranes are dimensionally and functionally optimized for the Microsart™ e.motion dispenser’s vacuum seal geometry and auto-eject mechanism. Use with third-party systems may compromise sterility assurance and colony recovery rates.
What is the shelf life of unopened e.motion membrane pouches?
36 months from manufacture date when stored at 15–25°C and ≤60% RH. Lot-specific expiration dates are printed on each pouch and verified in the CoA.
Can the 0.2 µm membranes be used for mycoplasma detection?
Yes—0.2 µm nitrocellulose membranes meet ISO 11140-1 Annex C criteria for mycoplasma retention and are referenced in EP 2.6.7 for sterility testing of cell culture reagents.
Do these membranes require pre-rinsing before use?
No. They are supplied ready-to-use, pre-sterilized via gamma irradiation (25 kGy), and validated for immediate application without pre-wetting or rinsing steps.
How is membrane lot traceability maintained during routine QC testing?
Each pouch carries a unique 2D barcode linked to Sartorius’ ERP system; scanning during setup auto-populates LIMS fields with CoA reference, manufacturing date, and sterility test results.
