Tailin Biotech HTY-APL05/06 ISO Integrated Isolator Bacterial Collection System

Overview

The Tailin Biotech HTY-APL05/06 ISO Integrated Isolator Bacterial Collection System is a purpose-engineered peristaltic filtration instrument designed for seamless integration into Grade A sterile isolators used in pharmaceutical aseptic processing environments. It operates on the principle of positive-displacement peristaltic pumping to transfer liquid samples—typically membrane-filtered broth or suspension media—through sterile, single-use tubing sets onto 0.45 µm or 0.22 µm pore-size filter membranes. Unlike standalone microbial collection devices, this system is physically and functionally embedded within the isolator chamber wall, eliminating manual intervention, reducing glove-port usage, and minimizing contamination risk during membrane transfer and incubation steps. Its mechanical architecture supports ISO 14644-1 Class 5 (ISO Class 5) environmental integrity and complies with core design expectations outlined in EU GMP Annex 1 (2022), USP , and PDA Technical Report No. 75 on isolator qualification.

Key Features

• Linear tube-loading configuration enables rapid, repeatable installation of sterile peristaltic pump tubing without twisting or kinking—critical for maintaining flow consistency across validation batches.
• Automated tube clamping mechanism engages prior to pump activation and releases only after pressure stabilization, preventing accidental backflow or sample loss during system priming or interruption.
• Digital pulse rotary knob interface provides tactile feedback and precise speed selection; combined with non-volatile speed memory, it ensures reproducible rotational settings across multiple operators and shifts.
• Real-time pressure monitoring circuitry continuously evaluates backpressure at the pump head and triggers immediate shutdown if thresholds exceed pre-defined limits—protecting both filter integrity and operator safety during viscous or particulate-laden sample filtration.
• Tempered glass touch panel meets IP65-rated ingress protection requirements and resists chemical degradation from common isolator decontamination agents (e.g., vaporized hydrogen peroxide, alcohol-based sporicides).
• Comprehensive electrical safety architecture includes overcurrent, overvoltage, overload, and stall detection—each logged with timestamps in internal event history for audit readiness.

Sample Compatibility & Compliance

The HTY-APL05/06 ISO accommodates standard 0.45 µm and 0.22 µm sterile filtration assemblies compliant with ASTM F838-22 (bacterial retention testing). It supports a broad range of pharmacopeial sample types including injectables, ophthalmic solutions, lyophilized reconstituted products, and cell culture media. All wetted components—including pump housing, tubing retainers, and clamp actuators—are constructed from 316L stainless steel and medical-grade polymers validated for compatibility with sterilization cycles (SIP at 121 °C, 15 min) and VHP decontamination (≥1000 ppm, 2 hr exposure). The system’s mechanical design aligns with ISO 13485:2016 for medical device manufacturing and supports full traceability under FDA 21 CFR Part 11-compliant software extensions when paired with Tailin’s optional data acquisition module.

Software & Data Management

While the base HTY-APL05/06 ISO operates as a stand-alone hardware unit with local parameter control, its embedded RS-485 and optional Ethernet interfaces enable integration into centralized isolator monitoring platforms. When deployed with Tailin’s certified firmware version 3.2+, the system logs operational events—including start/stop timestamps, speed setpoints, pressure excursions, and fault codes—with millisecond resolution. Audit trails are encrypted, append-only, and exportable in CSV format for inclusion in regulatory submissions (e.g., ANDA, MA, BLA). The architecture supports electronic signature workflows aligned with ALCOA+ principles and facilitates periodic review per ICH E6(R3) and EU GMP Annex 11 requirements.

Applications

• Routine sterility testing of final drug products in compliance with USP , Ph. Eur. 2.6.1, and JP 4.07.
• Environmental monitoring sample concentration (e.g., isolator air/surface rinse fluids) where low-biomass recovery demands high-flow stability.
• Process validation support for aseptic fill-finish lines, including filter integrity challenge studies using defined microorganisms (B. diminuta, P. diminuta).
• QC release testing of biologics and advanced therapy medicinal products (ATMPs), where membrane clogging resistance and low shear stress are critical for preserving viability of sensitive analytes.

FAQ

Can the HTY-APL05/06 ISO be retrofitted into existing isolators?

Yes—provided the isolator manufacturer provides structural mounting specifications and electrical feedthrough clearance (minimum Ø60 mm conduit opening); Tailin supplies custom flange kits and isolation gaskets meeting ISO 10648-2 leakage class requirements.
Is tubing set qualification required for each new lot?

Per EU GMP Annex 15, tubing sets must undergo installation qualification (IQ) and operational qualification (OQ) upon first use; requalification is triggered only by material change or dimensional deviation exceeding ±0.05 mm tolerance.
Does the system support 21 CFR Part 11 compliance out-of-the-box?

No—the base unit lacks user authentication and electronic signature capability; however, it serves as a validated peripheral when connected to Tailin’s Part 11-enabled LIMS-integrated control station (HTY-CMS v4.1+).
What maintenance intervals are recommended for pump head calibration?

Pump head torque verification and rotational speed calibration must be performed semiannually using NIST-traceable tachometers and load cells, documented per ISO/IEC 17025 accredited procedures.