Tailin Biotech HTY-ACB03 Aerosol Collection Instrument

Overview

The Tailin Biotech HTY-ACB03 Aerosol Collection Instrument is a purpose-built, manually operated device engineered to support pharmacopeial-compliant sampling of pressurized aerosol products for sterility testing (ChP 2020 General Chapter 1101) and microbial enumeration (ChP 2020 General Chapter 1105). It operates on a controlled mechanical displacement principle: by applying calibrated downward force via a stainless-steel plunger rod, the instrument depresses the actuator valve of an aerosol container held in a vertically oriented, adjustable cradle—thereby enabling quantitative release of product contents into a sterile, closed-circuit filtration system. Unlike open-air sampling methods, the HTY-ACB03 ensures full containment throughout the transfer process, eliminating risks of propellant dispersion, sample loss, or environmental contamination. Its design prioritizes operator safety, regulatory traceability, and reproducibility in pharmaceutical quality control laboratories performing routine batch release testing of metered-dose inhalers (MDIs), nasal sprays, topical aerosols, and other pressurized dosage forms.

Key Features

• Hermetic collection architecture: Fully enclosed pathway from aerosol valve to sterile filter membrane prevents propellant escape, cross-contamination, and exposure to ambient microbiota.
• Adjustable cradle mechanism: Precision-machined stainless-steel slot accommodates cylindrical aerosol containers ranging from 30 mm to 80 mm in diameter and up to 150 mm in height—ensuring stable vertical alignment during actuation.
• 316L stainless-steel construction: Corrosion-resistant, non-reactive, and compatible with standard autoclaving cycles (121 °C, 30 min, saturated steam), supporting GLP/GMP-compliant cleaning and sterilization protocols.
• Modular needle assembly: Removable, Luer-lock–compatible sampling needle (included) allows rapid replacement and validation of sterility integrity prior to each test run.
• Ergonomic plunger interface: 27 cm lever arm provides mechanical advantage for consistent, low-effort actuation—reducing operator fatigue during high-throughput testing.
• Dimensionally validated footprint: Compact form factor (22.5 × 40.0 × 11.2 cm base; 43 cm total suspension height) integrates seamlessly into ISO Class 5 laminar flow hoods and biosafety cabinets without compromising workspace efficiency.

Sample Compatibility & Compliance

The HTY-ACB03 is validated for use with aluminum, coated aluminum, and stainless-steel aerosol containers containing hydrocarbon, HFA-134a, HFA-227ea, or compressed gas propellants. It supports both single-actuation and multi-actuation sampling strategies as required by ChP 1101 Annex I and USP . Device operation conforms to principles outlined in ISO 14644-1 (cleanroom classification), ISO 14698-1 (biocontamination control), and EU GMP Annex 1 (sterile product manufacturing). While not certified to ASTM D1641 or USP , its mechanical performance and material specifications align with industry expectations for Class II medical device accessories used in pharmaceutical microbiology workflows.

Software & Data Management

The HTY-ACB03 is a standalone mechanical instrument with no embedded electronics or firmware. As such, it does not require software integration, firmware updates, or cybersecurity controls. All operational parameters—including container dimensions, actuation count, sterilization cycle logs, and operator identification—are documented manually in laboratory notebooks or electronic quality management systems (eQMS) per 21 CFR Part 11 requirements. Laboratories may pair the instrument with digital pressure transducers or gravimetric analyzers (not included) to record real-time mass loss or flow rate data, provided such add-ons undergo separate IQ/OQ/PQ validation.

Applications

• Sterility testing of preservative-free ophthalmic, nasal, and respiratory aerosols per ChP 1101 and USP .
• Microbial enumeration of non-sterile topical and oral aerosols per ChP 1105 and USP .
• Recovery validation studies assessing aerosol delivery efficiency into membrane filters under controlled pressure differentials.
• Process consistency monitoring during formulation development and stability testing of new MDI products.
• Training platform for aseptic technique in academic and contract testing laboratories accredited to CNAS CL01 (ISO/IEC 17025).

FAQ

Is the HTY-ACB03 compatible with ISO-certified isolators or restricted access barrier systems (RABS)?
Yes—the device’s compact footprint and absence of electrical components allow safe integration into Grade A environments when assembled and sterilized under validated conditions.
Can the plunger force be quantified or calibrated?
No—force application is operator-dependent and not instrument-measured. Users are advised to follow standardized training protocols and document actuation technique as part of method validation.
Does Tailin Biotech provide installation qualification (IQ) documentation?
Yes—upon request, Tailin supplies a configurable IQ template aligned with ISO 9001 and GMP Annex 15 requirements, including dimensional verification, material certification (EN 10204 3.1), and sterilization compatibility statements.
What maintenance intervals are recommended?
Visual inspection and functional check before each use; full disassembly, ultrasonic cleaning, and re-sterilization after every 10 uses or at shift change in continuous operation.
Is the HTY-ACB03 suitable for use with radiolabeled or cytotoxic aerosols?
Only when deployed within appropriately engineered containment (e.g., gloveboxes with negative pressure cascades) and supported by institutional radiation safety or hazardous drug handling SOPs.