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HengAo HMP-01 Automated Culture Medium Preparation System

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Brand Tianjin HengAo
Origin Tianjin, China
Manufacturer Type Direct Manufacturer
Country of Origin China
Model HMP-01
Temperature Range RT to 80 °C
Temperature Uniformity ±0.5 °C
Humidity Range 20–95% RH
Chamber Capacity 10 L

Overview

The HengAo HMP-01 Automated Culture Medium Preparation System is an integrated benchtop platform engineered for precise, repeatable, and contamination-controlled preparation of microbiological and cell culture media. Unlike conventional manual or semi-automated workflows, the HMP-01 unifies sterilization, heating, mixing, cooling, and humidity-regulated holding into a single programmable sequence—minimizing operator intervention and eliminating inter-step transfer risks. Its core sterilization mechanism leverages saturated steam under controlled vacuum-assisted pressure conditions, elevating the boiling point of water to enable effective microbial inactivation at temperatures above 100 °C without requiring external autoclave integration. This principle aligns with established thermal sterilization theory described in ISO 11134 and USP , where lethality (F0) is directly governed by temperature-time profiles under saturated steam conditions. Designed for compliance-critical environments—including QC microbiology labs, bioprocess development units, and GLP-certified facilities—the system operates within a sealed 10 L stainless-steel chamber featuring double-wall insulation and PID-controlled thermal management.

Key Features

  • Integrated process automation: Sequential execution of dissolution, homogenization, sterilization (vacuum-enhanced saturated steam), temperature equilibration, and post-sterilization humidified holding—all programmable via intuitive touchscreen interface.
  • Precision thermal control: Dual-sensor feedback loop maintains chamber setpoint stability across the full operating range (RT to 80 °C) with uniformity ≤ ±0.5 °C (measured per ASTM E2234 at 9 spatial points).
  • Humidity-regulated environment: Built-in humidification and condensation management system sustains relative humidity between 20% and 95% RH during cooling and storage phases—critical for preventing agar solidification or powder caking prior to dispensing.
  • Stainless-steel fluid path: All wetted components—including impeller, jacketed vessel, steam inlet manifold, and drain valve—are constructed from electropolished 316L stainless steel, compliant with FDA CFR 21 Part 11 material requirements for pharmaceutical contact surfaces.
  • Process traceability architecture: Internal event logger records timestamped entries for all critical parameters (temperature, pressure, humidity, stir speed, cycle phase), supporting audit-ready documentation per GMP Annex 11 and ISO/IEC 17025 clause 7.9.

Sample Compatibility & Compliance

The HMP-01 accommodates standard liquid and powder-based media formulations—including nutrient broths (e.g., TSB, LB), selective agars (e.g., MacConkey, Sabouraud), and defined synthetic media—across volumes from 500 mL to 8 L per batch. Vessel geometry and variable-speed magnetic stirring (0–300 rpm) ensure homogeneous dissolution of heat-sensitive components (e.g., antibiotics, growth factors) without shear-induced degradation. The system meets mechanical safety requirements per IEC 61010-1 and electromagnetic compatibility standards EN 61326-1. Sterilization cycles are validated using biological indicators (BIs) per ISO 11140-1, and routine performance qualification follows protocols aligned with EU GMP Annex 15 and USP .

Software & Data Management

The embedded control software supports up to 99 customizable method templates, each storing complete parameter sets (target temperature ramp rates, dwell times, agitation profiles, humidity targets). All methods are password-protected and subject to role-based access control (administrator/operator). Raw data exports as CSV files include full time-series sensor logs, alarm history, and cycle completion certificates. Optional Ethernet connectivity enables remote monitoring via secure HTTPS interface and integration with LIMS or MES platforms through OPC UA protocol—facilitating electronic record retention compliant with 21 CFR Part 11 §11.10(a) and Annex 11 §5.3.

Applications

  • Routine preparation of sterile media for environmental monitoring in cleanrooms and isolators.
  • Batch-scale media conditioning for pharmaceutical sterility testing (USP ) and antimicrobial effectiveness testing (USP ).
  • Preparation of temperature- and humidity-sensitive formulations used in anaerobic culture systems and microaerophilic incubation workflows.
  • Supporting ISO 13485-certified medical device manufacturers in maintaining documented evidence of media integrity throughout production lots.
  • Enabling reproducible media conditioning for academic and industrial cell line expansion protocols where lot-to-lot variability must be minimized.

FAQ

Does the HMP-01 require connection to an external steam generator?

No—the system includes an integrated electric steam generator with deionized water reservoir and automatic level control.
Can the unit be validated for use in regulated pharmaceutical manufacturing?

Yes—DQ/IQ/OQ documentation packages are available, and the system supports installation in classified environments (ISO 5–8) when configured with HEPA-filtered air intake and pass-through ports.
What maintenance intervals are recommended for long-term reliability?

Quarterly calibration verification of temperature/humidity sensors and annual inspection of steam trap functionality and seal integrity are advised per manufacturer’s PQ protocol.
Is remote firmware update capability supported?

Firmware updates are performed via USB drive with cryptographic signature verification to ensure integrity and prevent unauthorized modification.

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