Tailin Biotech Sterile Water Sampling Bags SWS Series

Overview

The Tailin Biotech Sterile Water Sampling Bags SWS Series are single-use, gamma-irradiated sterile containers engineered specifically for the aseptic collection and transport of water samples intended for microbiological analysis. Designed to replace traditional glass or reusable plastic sampling vessels requiring autoclaving, washing, and drying, the SWS bags eliminate process variability associated with cleaning validation and thermal sterilization cycles. Each bag is terminally sterilized using validated gamma irradiation (25–35 kGy) under ISO 11137-compliant conditions and sealed in individual peel-open sterile pouches to maintain bioburden-free integrity until point-of-use. The device operates on a passive containment principle—no active filtration or processing occurs—but ensures sample integrity through material compatibility, sterility assurance level (SAL) of 10⁻⁶, and chemical inertness toward target analytes including heterotrophic plate count (HPC), total coliforms, E. coli, and Pseudomonas spp.

Key Features

• Triple-layer laminated film construction (PET/AL/PE) provides superior puncture resistance, barrier performance against moisture vapor transmission (MVTR < 0.5 g/m²·24h), and mechanical stability during field handling, drop testing (1.2 m height onto concrete per ASTM D880), and centrifugation (up to 3,000 × g).
• Large-diameter sampling port (Ø28 mm) facilitates rapid, splash-free filling—even from low-flow sources or narrow-necked taps—while minimizing operator-induced contamination risk.
• Three calibrated volume options (100 mL, 250 mL, 500 mL) feature molded-in, non-fading graduation marks aligned to ISO 4787 volumetric accuracy Class B tolerances (±2% at nominal volume).
• Integrated snap-lock closure system eliminates need for secondary caps or tape; achieves >99.9% seal retention after 72-hour static pressure test (0.5 bar internal pressure).
• Optional pre-loaded sodium thiosulfate (1.8 mg per bag) enables immediate neutralization of free chlorine and chloramine residuals per EPA Method 1603 and Standard Methods 9060B—eliminating manual reagent addition and associated pipetting error.
• Flat-bottomed, self-standing geometry allows stable placement on laboratory benches, incubators, or automated colony counters without external support.

Sample Compatibility & Compliance

The SWS Series is validated for use with potable water, surface water, groundwater, wastewater effluent, and recreational water matrices. It complies with ISO 19458:2006 requirements for sterile sampling containers—including sterility verification (ISO 11737-1), extractables profiling (USP ), and endotoxin limits (<0.25 EU/mL). All batches undergo routine bioburden testing (ISO 11737-2) and sterility confirmation per USP . The polymeric composition demonstrates no detectable leachables affecting microbial recovery in accordance with AOAC 991.14 and APHA Standard Methods 9222B. Documentation packages include Certificate of Conformance, Sterilization Validation Report, and Extractables Summary—fully traceable to manufacturing lot number.

Software & Data Management

As a passive sampling device, the SWS Series does not incorporate embedded electronics or firmware. However, it integrates seamlessly into digital laboratory workflows via LIMS-compatible labeling: each sterile pouch carries a GS1-128 barcode containing unique lot ID, expiration date (24 months from sterilization), volume specification, and sodium thiosulfate status (Y/N). Optional custom label printing supports 2D DataMatrix encoding for automated sample tracking in GLP/GMP environments compliant with FDA 21 CFR Part 11 audit trail requirements. Batch records and sterilization logs are retained for ≥10 years per ISO 9001:2015 and ISO 13485:2016 retention policies.

Applications

• Routine compliance monitoring of drinking water distribution systems per WHO Guidelines for Drinking-water Quality and national standards (e.g., GB 5749-2022).
• Environmental surveillance of rivers, lakes, and coastal waters under national water quality assessment programs (e.g., China’s “River Chief System” or EU WFD monitoring protocols).
• Validation of point-of-use (POU) water purification systems in pharmaceutical cleanrooms (ISO 14644-1 Class 5–8) and hospital central sterile supply departments (CSSD).
• Field-based enumeration of indicator organisms (coliforms, E. coli, Enterococci) using membrane filtration (ISO 9308-1), IDEXX Colilert®, or chromogenic agar methods.
• Microbial stability studies of purified water (PW) and water-for-injection (WFI) in biopharmaceutical manufacturing per USP .

FAQ

Are the SWS bags certified for use in regulated pharmaceutical environments?
Yes—they meet USP , ISO 19458, and EP 2.6.12 requirements for sterile water sampling and are supplied with full traceability documentation suitable for GMP audits.
What is the shelf life and recommended storage condition?
24 months from date of gamma sterilization when stored unopened at 15–30°C, relative humidity ≤65%, and protected from direct UV exposure.
Can the bags be used for metals or organic contaminant analysis?
No—the SWS series is designed exclusively for microbiological testing; for chemical analysis, refer to Tailin’s certified trace-metal-free HDPE bottles (catalog #T-MET-HP) or borosilicate glass vials.
Is sodium thiosulfate concentration sufficient for high-chlorine municipal supplies?
Yes—1.8 mg per bag neutralizes up to 4.0 mg/L free chlorine or 8.0 mg/L monochloramine, covering typical distribution system residuals per EPA guidance.
Do the bags require any pre-use preparation?
None—each bag is ready for immediate use upon opening the sterile pouch; no rinsing, flaming, or additional sterilization is necessary.