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HTY-ASL01/02

Sterility Test Pump

Used for sterility test of sterile preparations

The HTY-ASL01/02 Sterility Test Pump is designed to support membrane filtration-based sterility testing in pharmaceutical and microbiological laboratories.

Used together with sterility test canister systems, It provides controlled and stable fluid transfer during sterility testing procedures, helping reduce operator variability and improve test consistency in accordance with pharmacopoeial requirements.

The system is suitable for use in GMP-regulated QC environments where standardized and reproducible sterility testing workflows are required, including applications aligned with ChP, USP, EP, and JP.

Easy tube loading and an SOP operation mode for efficient use

With pressure monitoring protection for safe operation

Compatible with canisters from other brands

Features

Standardized Sterility Testing Workflow:
  • Tempered glass touch panel with an intuitive interface for routine sterility testing operations.
  • The system supports both SOP Mode and Normal Mode. Up to 300 test recipes can be stored in SOP Mode to help standardize testing procedures and improve workflow consistency across operators and batches.
  • Three pressure control modes: Pressure Alert, Pressure Regulation, and Normal Mode, support controlled operation under different sterility testing requirements.
Controlled Reliable Performance:
  • The system is equipped with a high-performance motor combined with digital current control technology to ensure stable and reliable pumping performance during membrane filtration procedures.
  • Controlled fluid transfer helps improve operational consistency and supports reproducible sterility testing workflows.
Protection & Safety:
  • The integrated safety hood design helps prevent glove pinching during operation and improves operator protection during routine laboratory use.
  • The system includes protection functions for overcurrent, overvoltage, overload, and tubing blockage to support stable operation and reduce the risk of process interruption.

Specifications

Power Supply: 95-260VAC/50-60Hz N.W: 20kg
Material: 316L Stainless steel Power: 120W
Bottle Holder Height: 43cm Screen: 4.3" Colorful LCD
Speed: 1-300rpm Dimensions: 22.5x40.0x13.5cm

Compliance

Suitable for sterility testing workflows performed in accordance with ChP 1101, USP <71>, EP 2.6.1 and JP 4.06 compendial methods.

Manufactured under ISO 9001 and ISO 14001 certified quality systems, each production batch undergoes sterility validation, bacterial challenge testing, and growth promotion verification to ensure reliable testing performance.

Applications

Pharmaceutical Sterility Testing

Widely used for membrane filtration-based sterility testing of sterile pharmaceutical products, including antibiotics, preparations containing bacteriostatic ingredients, sterile APIs, intravenous fluids, aqueous injections, sterilized medical devices, and Water for Injection (WFI).

GMP-Regulated QC Laboratories

Suitable for routine sterility testing workflows in pharmaceutical quality control laboratories where standardized and reproducible membrane filtration procedures are required.

Microbial Limit Testing

Can also be used for microbial limit testing of pharmaceuticals, food, beverages, and other products requiring membrane filtration-based microbiological analysis.

Tailin Bioengineering

Pharmaceuticals

Tailin Bioengineering

Food & Beverage

Tailin Bioengineering

Biotechnology

FAQ

The system includes stall and overload protection, which can detect abnormal resistance such as tubing blockage or improper installation. When this occurs, the pump will automatically stop and trigger an alarm to prevent damage to samples or equipment.

Yes. The pump supports adjustable speed control, allowing users to adapt flow rates based on test requirements (e.g., different sample volumes or filtration speeds). This flexibility is important in environments where multiple product types are tested.

Yes, it is designed for repeated and continuous operation in QC labs. However, in high-throughput environments, periodic rest cycles and routine checks are recommended to ensure long-term motor stability and tubing integrity.

It is primarily designed for membrane filtration-based sterility testing workflows, especially when paired with canister systems. For direct transfer methods, suitability depends on the overall experimental design, but it is not the primary intended application.

Daily Surface Sanitation: After every test, wipe the housing with sterile water to prevent microbial growth and “salt spots” (corrosion) caused by dried liquid spills. Ensure the drain tray is cleaned, sterilized, and dried before re-entering the cleanroom.

Quarterly Deep Cleaning: Regularly disassemble the pump head outside the cleanroom to remove tubing debris that can hinder roller rotation. This prevents mechanical wear and ensures the pump’s motor operates at peak efficiency.

Emergency Spill Response: If a liquid spill occurs during a test, immediately absorb the liquid to protect the power supply. Post-experiment, the device must be transferred out for a thorough internal cleaning and re-validation of flow accuracy.

Annual Performance Qualification (PQ): Conduct a formal performance check at least once a year. This includes verifying flow rate accuracy, distribution uniformity, and roller lubrication to meet GMP compliance and ensure consistent sterility assurance.

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