Stainless Steel Basket

Overview

The Stainless Steel Basket is a precision-engineered laboratory and industrial handling accessory designed for robust, corrosion-resistant sample containment, filtration, and thermal processing applications. Constructed from high-grade 304 or 316 stainless steel—depending on configuration—the basket leverages the material’s inherent resistance to oxidation, chlorides, and acidic environments, ensuring long-term structural integrity under repeated sterilization, autoclaving, or high-temperature drying cycles. Unlike polymer or coated alternatives, this basket operates without leaching, outgassing, or dimensional drift, making it suitable for GMP-compliant cleanrooms, pharmaceutical dissolution testing (per USP ), and materials science workflows requiring trace-metal-free contact surfaces. Its open-weave geometry facilitates uniform fluid dynamics, efficient heat transfer, and minimal sample retention—critical parameters in dissolution apparatus calibration, catalyst recovery, and particulate washing protocols.

Key Features

• Material: Seamless deep-drawn or welded construction from certified ASTM A240 304 or 316 stainless steel, with full mill test reports (MTRs) available upon request
• Surface Finish: Electropolished to Ra ≤ 0.4 µm (standard) or mechanically polished (optional), supporting ISO 13485 and FDA 21 CFR Part 211 surface cleanliness requirements
• Dimensional Stability: Tolerances held to ±0.15 mm across critical diameters and depths; validated for repeated thermal cycling from –20 °C to +500 °C
• Mechanical Integrity: Reinforced rim and base geometry engineered to withstand ≥50,000 cycles of mechanical loading in automated dissolution systems (e.g., Hanson SR8-Plus, Distek 2500)
• Traceability: Laser-etched alphanumeric ID (e.g., “SSB-UK-2024-XXXX”) compliant with ISO/IEC 17025 internal audit requirements

Sample Compatibility & Compliance

This basket accommodates solid dosage forms—including tablets, capsules, and granules—without deformation or edge abrasion during agitation. Its mesh aperture (standard 0.8 mm, optional 0.4 mm or 1.2 mm) meets USP specifications for basket method dissolution testing. It is compatible with all major USP Apparatus 1 systems and has been verified for use in ISO 10993-12 extractables studies. The absence of adhesives, coatings, or weld splatter ensures compliance with ICH Q5C stability guidelines for protein-based therapeutics. All units are supplied non-sterile but fully autoclavable (121 °C, 20 min, saturated steam), and may be pre-sterilized via gamma irradiation (25 kGy) under contract manufacturing agreements.

Software & Data Management

While the Stainless Steel Basket is a passive hardware component, its integration into regulated workflows requires documentation alignment with electronic quality management systems (eQMS). Each unit’s laser-etched ID links directly to LIMS or TrackWise records for lifecycle tracking—from receipt inspection through calibration history and retirement logs. For dissolution system qualification (IQ/OQ/PQ), the basket’s dimensional and mass verification data (per ASTM E2500) can be imported into Ansys Granta MI or Veeva Vault QMS using standardized CSV templates. Audit trails generated during routine calibration checks satisfy FDA 21 CFR Part 11 requirements when executed within validated software environments.

Applications

• USP Apparatus 1 dissolution testing for immediate-release and modified-release oral solid dosage forms
• Catalyst recovery and reuse in heterogeneous reaction monitoring (e.g., Pd/C, Raney Ni)
• Thermal gravimetric analysis (TGA) sample pans for volatile content determination
• Autoclave load carriers for sterile instrument trays and glassware racks
• Filtration support in hot filtration setups for recrystallization and API isolation
• Cell culture scaffold holders in bioreactor perfusion systems requiring non-pyrogenic metal contact

FAQ

Is this basket certified to any international material standards?
Yes—each batch is accompanied by a Certificate of Conformance referencing ASTM A240 and EN 10088-1, with optional third-party certification from SGS or Bureau Veritas.
Can the basket be customized for non-standard dimensions or mesh sizes?
Yes—custom configurations including tapered profiles, integrated handles, and laser-cut apertures are available under NDA with lead times of 6–8 weeks.
Does the basket require periodic recalibration or certification?
No—it is a passive mechanical component; however, dimensional verification per USP must be performed at installation and annually thereafter as part of equipment qualification.
What documentation is provided with shipment?
Standard delivery includes a CoC, MTR, dimensional inspection report, and cleaning validation summary (non-sterile grade). Sterilized units include a sterility certificate per ISO 11137.