Tailin HTY-30B Dedicated Microbial Detection Vacuum Pump

Overview

The Tailin HTY-30B Dedicated Microbial Detection Vacuum Pump is an engineered solution for membrane filtration-based microbial enumeration and limit testing in regulated pharmaceutical, biotechnology, and quality control laboratories. Designed specifically to interface with Tailin’s HTY-series filtration manifolds and sterile, single-use filter cups or culture chambers, the HTY-30B operates on a dry-running, maintenance-free diaphragm pump principle—eliminating oil contamination risks and ensuring consistent vacuum delivery across repeated filtration cycles. Its compact footprint (220 × 230 × 125 mm) and lightweight construction (5 kg) enable seamless integration into laminar flow hoods, biosafety cabinets, or shared QC benchtops without compromising sterility workflow integrity. The pump delivers a stable maximum flow rate of 5 L/min under operational load, enabling rapid filtration of low-viscosity aqueous samples—including purified water, Water for Injection (WFI), sterile saline, and clarified beverage matrices—while maintaining pressure stability critical for quantitative recovery of viable microorganisms per USP , EP 2.6.12, and ISO 8573-7.

Key Features

• Oil-free, corrosion-resistant diaphragm pump architecture ensures zero risk of hydrocarbon contamination and eliminates routine lubrication or oil changes.
• Direct discharge design—no intermediate vacuum flask required—reduces setup complexity, minimizes aerosol generation during filter transfer, and shortens total assay turnaround time.
• Integrated illuminated push-button switch with status indicator enables intuitive operation and real-time power confirmation under glovebox or hood lighting conditions.
• Acoustically optimized housing limits operational noise to ≤60 dB(A) at rated load—compliant with ISO 7779 and suitable for open-lab environments where auditory ergonomics impact technician fatigue.
• IP20-rated enclosure provides protection against solid ingress during standard cleanroom handling; compatible with alcohol-based surface disinfection protocols (e.g., 70% IPA wipes).
• CE-marked electrical safety compliance (EN 61000-6-3, EN 61000-6-4) and RoHS-conformant material composition support global deployment in GMP-regulated facilities.

Sample Compatibility & Compliance

The HTY-30B is validated for use with 47-mm and 50-mm diameter sterile membrane filters (e.g., mixed cellulose ester, polycarbonate, or PVDF) within Tailin HTY-20/HTY-40 filtration manifolds. It supports all pharmacopoeial microbial limit test methods requiring membrane filtration—particularly for non-sterile product testing per USP and EP 2.6.12. The pump’s consistent vacuum profile (–60 to –85 kPa typical operating range) ensures reproducible filter wetting and uniform microbial retention across sample volumes up to 1,000 mL. Device performance aligns with ISO/IEC 17025 method validation requirements when paired with calibrated manifolds and certified filters. No calibration certificate is supplied with the pump itself; however, its fixed-speed operation (no variable-speed controller) simplifies IQ/OQ documentation for regulated users.

Software & Data Management

As a standalone hardware component without embedded firmware or digital interfaces, the HTY-30B does not incorporate software, data logging, or connectivity features. This design prioritizes reliability, electromagnetic compatibility (EMC), and audit readiness in GLP/GMP environments where uncontrolled firmware updates or network exposure pose validation risks. All operational parameters—including runtime, maintenance intervals, and visual inspection records—are documented manually in laboratory notebooks or integrated into electronic lab notebook (ELN) systems via standardized SOP entries. For facilities requiring 21 CFR Part 11-compliant traceability, the pump is routinely referenced as a “fixed-parameter auxiliary device” in equipment qualification protocols alongside associated filtration assemblies.

Applications

• Routine microbial limit testing of purified water and WFI in pharmaceutical manufacturing and QC labs.
• Environmental monitoring sample processing (e.g., rinse waters, swab eluates) where low particulate load and high flow efficiency are required.
• Raw material and excipient screening per ICH Q5C and pharmacopoeial compendia.
• Pre-filtration clarification prior to ATP bioluminescence or qPCR-based microbial detection workflows.
• Educational microbiology laboratories requiring robust, low-maintenance vacuum sources for undergraduate and graduate teaching modules.

FAQ

Is the HTY-30B compatible with non-Tailin filtration manifolds?
Yes—provided the manifold uses standard 47-mm or 50-mm filter holders and operates within the pump’s vacuum and flow specifications. However, full system validation (e.g., microbial recovery studies) must be performed independently.
Does the pump require periodic calibration?
No. As a fixed-speed, analog vacuum source without adjustable output, it falls outside the scope of calibration per ISO/IEC 17025; routine verification of flow rate and noise level is recommended annually.
Can the HTY-30B be used for viscous or particulate-laden samples?
No. It is strictly intended for low-viscosity, particle-free liquids. Suspensions, emulsions, or solutions containing >10 µm particulates may cause premature diaphragm wear or clogging of internal valves.
What is the expected service life under continuous QC usage?
With proper ventilation and avoidance of condensate ingress, the pump demonstrates ≥10,000 hours of operational durability based on accelerated lifetime testing per IEC 60068-2-64.
Is a CE Declaration of Conformity available for regulatory submission?
Yes—Tailin provides a full EC DoC covering EMC, LVD, and RoHS directives upon request with proof of purchase.