Steritailin® S1000 Closed-System Bacterial Collection & Culture Device

Overview

The Steritailin® S1000 is a single-use, sterile, closed-system bacterial collection and culture device engineered for pharmaceutical aseptic testing in compliance with pharmacopoeial requirements—including USP , Ph. Eur. 2.6.1, and ChP 1101. It operates as the consumable core component of Tailin Biotech’s HTY-series microbial recovery systems, enabling seamless integration with peristaltic pump-driven filtration units to perform membrane filtration-based sterility testing under fully enclosed conditions. Its design follows the fundamental principle of physical barrier isolation: by eliminating manual transfer steps between filtration and incubation, it prevents extrinsic microbial contamination during sample processing—a critical requirement for injectables, ophthalmic solutions, and other high-risk sterile drug products. The device functions as a dual-chamber, integrated filter-culture unit, where the test sample is vacuum- or pressure-assisted through a 0.45 µm or 0.22 µm sterilizing-grade membrane into a pre-sterilized growth chamber containing validated liquid culture media (e.g., Fluid Thioglycollate Medium or Soybean–Casein Digest Medium). This architecture supports both aerobic and anaerobic microbial recovery without system breach.

Key Features

• Dual-layer breathable packaging: Outer and inner pouches constructed from medical-grade polyolefin-based microporous membranes—engineered for high mechanical tensile strength (>30 N/cm), optimal gas permeability (O₂ transmission rate ≥1,200 mL/m²·24h·atm), and bacterial retention efficiency >99.9999% (Bacillus atrophaeus challenge, ISO 11140-1).
• Integrated air-filter cap with auto-release hanging loop: Patented polypropylene cap features a spring-loaded pressure-relief mechanism that opens automatically at ≥0.3 bar overpressure, preventing membrane rupture and ensuring operator safety during high-flow filtration; the molded hanging loop enables secure, tool-free attachment to laminar flow hood rails or biosafety cabinet brackets.
• Color-matched soft-grip tubing clamps: Ergonomically contoured silicone-elastomer clamps replace rigid metal clips—each clamp pair shares identical Pantone-coded coloration (e.g., blue-blue, green-green) for unambiguous line identification during multi-sample workflows; validated for ≥10,000 open/close cycles without loss of sealing force.
• Ultrasonic seam welding: All fluid-path welds performed using 20 kHz ultrasonic energy with real-time amplitude control and thermal monitoring, achieving hermetic seal integrity per ASTM F2476 (leak rate <1×10⁻⁶ mbar·L/s He).
• High-performance peristaltic tubing: Proprietary thermoplastic elastomer (TPE) pump tubing—rated for continuous operation at 120 rpm, with elongation at break >550%, Shore A hardness 65 ± 3, and compatibility with EO, hydrogen peroxide vapor (HPV), and gamma irradiation (25–40 kGy).

Sample Compatibility & Compliance

The Steritailin® S1000 accommodates diverse pharmaceutical formulations including aqueous injections, lipid emulsions, suspensions, lyophilized reconstitutes, and low-volume ophthalmic preparations. Its hydrophilic PVDF or mixed-cellulose ester (MCE) membranes exhibit low protein binding (<5 ng/cm²) and minimal extractables per USP . Device manufacturing adheres to ISO 13485:2016 quality management standards, with full traceability of raw materials, process parameters, and sterilization cycles. Each production lot undergoes bioburden reduction validation per ISO 11135 (EO), ISO 11137 (irradiation), and ISO 22441 (HPV), supported by sterility assurance level (SAL) verification of 10⁻⁶. Final product release includes endotoxin testing (<0.25 EU/mL), particulate matter analysis (USP ), and simulated-use integrity testing per ASTM F838.

Software & Data Management

As a passive consumable, the Steritailin® S1000 does not incorporate embedded electronics or firmware. However, its use is fully compatible with HTY-series instruments equipped with FDA 21 CFR Part 11-compliant software (v3.2+), supporting electronic batch records, audit trails, user access controls, and digital signature capture. Integration enables automatic logging of filtration time, volume processed, pump speed, and alarm events—ensuring alignment with GLP and GMP documentation requirements. All sterilization certificates, biocompatibility reports (ISO 10993-5/-10), and material safety data sheets (MSDS) are available via Tailin’s secure customer portal with version-controlled revision history.

Applications

• Sterility testing of final drug products per USP , EP 2.6.1, JP 4.07
• Environmental monitoring support for Grade A/B cleanroom isolators
• Validation of depyrogenation and sterilization processes
• Microbial limit testing for non-sterile APIs and excipients
• Bioburden assessment of container-closure systems prior to terminal sterilization

FAQ

Is the Steritailin® S1000 compatible with non-Tailin filtration instruments?
Yes—mechanical and dimensional specifications conform to ISO 8536-4:2021 for infusion set connectors and ASTM D3948 for fluid pathway interfaces; compatibility testing with major third-party peristaltic pumps (e.g., Masterflex L/S, Watson-Marlow 520S) is documented in Application Note AN-S1000-04.
What sterilization methods are qualified for this device?
EO (ethylene oxide), gamma irradiation (25–40 kGy), and hydrogen peroxide vapor (HPV) sterilization are fully validated; each method includes parametric release based on cycle mapping, biological indicator challenge (Geobacillus stearothermophilus ATCC 7953), and sterility testing per ISO 11737-2.
Can the device be used for anaerobic organism recovery?
Yes—when paired with pre-reduced, oxygen-scavenging media (e.g., FTGM supplemented with sodium thioglycollate and cysteine), the sealed chamber maintains anaerobic conditions for ≥14 days post-inoculation, verified via resazurin redox indicator and anaerobe growth controls.
Does the dual-layer packaging require removal before autoclaving?
No—the packaging is not intended for autoclaving; Steritailin® devices are supplied terminally sterilized and must be used directly from the intact pouch following aseptic opening per ISO 14644-1 Class 5 protocols.
How is lot-to-lot consistency ensured?
Every production lot undergoes 100% visual inspection (ASTM E2923), dimensional metrology (CMM-certified), and functional leak testing; statistical process control (SPC) charts monitor key parameters including weld seam thickness (±0.02 mm), membrane pore size distribution (SEM + bubble point), and clamp actuation force (±0.15 N).