Product Introduction
Regulated pharmaceutical quality control laboratories with high daily sample volumes face a triple operational challenge: maintaining data integrity through operator-independent test execution, achieving sufficient throughput to process all samples within standard working hours, and controlling the escalating consumable costs associated with high-frequency disposable filter cup usage. Each of these challenges individually impacts laboratory efficiency and compliance, but together they create a compounding effect — larger sample volumes demand more operator attention, increasing the risk of manual timing errors; higher throughput requirements accelerate disposable cup consumption, inflating the consumables budget; and the combination of both strains laboratory staffing and resources.
The HM-WX6G+ addresses all three challenges in a single integrated platform. Its 5-inch touchscreen provides programmable filtration timers for each of the six channels, ensuring that filtration durations are executed with instrument-controlled precision regardless of which technician operates the system — directly supporting the data integrity principles emphasized in modern GMP inspections. The on-screen display of active timer settings and channel status provides visual documentation of test conditions, supplementing the laboratory's standard documentation practices with objective instrument-generated records.
The six filtration positions double the per-batch processing capacity compared to triple-channel systems, enabling pharmaceutical facilities with 20–50 daily water samples to complete their testing programs in fewer batch cycles. For a facility processing 30 samples per day, the HM-WX6G+ reduces the number of required filtration batches from ten to five, cutting active filtration time by approximately half and freeing QC staff for other analytical responsibilities.
Each filtration position is equipped with an autoclavable Ø47mm/Ø50mm stainless steel filter cup rated for repeated 121°C high-pressure steam sterilization. The annual cost of disposable cups for a high-volume pharmaceutical facility is substantial — the HM-WX6G+ eliminates this expense entirely. Over the instrument's service life, cumulative disposable cup savings substantially exceed the initial purchase price, while also eliminating supply chain risk and biohazard waste volume. The dual diaphragm pumps, direct discharge design, L304 stainless steel housing, anti-backflow protection, and flame-sterilizable filter heads complete a filtration platform that comprehensively addresses the operational, compliance, and economic requirements of regulated pharmaceutical quality control laboratories.
Applications
- Multi-line pharmaceutical water system testing. Simultaneous PW and WFI microbiological examination across multiple production areas, water distribution loops, and sampling points with instrument-controlled timers for data integrity and autoclavable cups for consumable cost elimination.
- Regulatory inspection-ready pharmaceutical QC. Touchscreen timer settings provide visual documentation of filtration parameters, supporting GMP inspection audit trail requirements without manual stopwatch log entries.
- Contract testing laboratory services. Maximum samples-per-instrument throughput with documented test conditions and zero per-sample consumable cost for competitive turnaround time and profit margin optimization.
- Medical device manufacturing water monitoring. Batch microbiological assessment of process water from multiple manufacturing lines with autoclavable cups for validated GMP compliance and economical high-frequency testing.
- Food and beverage production quality assurance. High-throughput microbiological screening across multiple product lines with touchscreen-controlled filtration for inter-batch consistency and quality certification.
- Large-scale CDC and environmental water surveillance. Processing dozens of drinking water and environmental samples per day with instrument-controlled timing for inter-laboratory comparability in public health monitoring networks.
Key Features & Advantages
- 5-inch touchscreen with programmable per-channel timers. Instrument-controlled filtration durations eliminate operator-dependent timing variability, directly supporting GMP data integrity requirements for test reproducibility and objective documentation.
- Six-channel high-throughput parallel processing. Doubles per-batch sample capacity versus triple-channel systems, enabling pharmaceutical facilities to process daily sample volumes within standard working hours.
- Digital operation visibility. On-screen display of active channel timers, countdown values, and filtration parameters provides immediate visual documentation for supervisory review and regulatory audit support.
- Autoclavable stainless steel filter cups. Ø47mm/Ø50mm, 100 mL cups withstand repeated 121°C autoclave cycles — validated sterility assurance without disposable cup procurement, inventory, or biohazard waste disposal costs.
- Comprehensive consumable cost elimination. Substantial annual disposable cup savings at high sample volumes, with cumulative lifetime savings far exceeding the initial instrument investment.
- Dual diaphragm pump system with direct discharge. Eliminates external vacuum flask requirements and associated cleaning validation, simplifying setup and reducing compliance documentation burden.
- Independent touchscreen channel control. Each of six channels operates with individual on-screen start/stop and timer programming for maximum workflow flexibility.
- Flame sterilization compatible. Filter heads support rapid thermal decontamination between consecutive samples for high-frequency testing sessions without full autoclave cycles.
- Anti-backflow protection across all channels. Check valves prevent reverse flow in each channel, ensuring sample integrity is maintained during simultaneous six-channel operation.
- L304 stainless steel enclosure. Brushed corrosion-resistant finish withstands routine pharmaceutical laboratory disinfection and maintains professional appearance throughout service life.
- Direct discharge design. Eliminates intermediate waste collection for six channels, significantly reducing contamination points and post-batch cleanup time.
- High flow rate performance. >1000 ml/min no-load and >450 ml/min full-load per filter head ensures efficient processing within standard protocol timeframes across all channels.
- Modular detachable filter assemblies. Quick-release design for all six cup assemblies enables rapid autoclave loading and reinstallation, minimizing instrument downtime between test batches.
- Bench-top form factor. 648 × 238 × 202 mm at 11.3 kg integrates high-throughput capability into existing laboratory infrastructure without floor-mounted installation.
Technical Specifications
| Parameter | Specification |
|---|
| Model | HM-WX6G+ |
| Power supply | 220V / 50Hz |
| Power consumption | 48W |
| Number of filter heads | 6 |
| Built-in pumps | 2 diaphragm pumps |
| Discharge method | Direct discharge |
| Control type | 5-inch touchscreen |
| Applicable filter cup | Ø47mm/Ø50mm stainless steel 100 mL (autoclavable, reusable) |
| Single filter head flow rate (no load) | >1000 ml/min |
| Single filter head flow rate (full load) | >450 ml/min |
| Housing material | L304 stainless steel |
| Dimensions | 648 × 238 × 202 mm |
| Weight | 11.3 kg |
FAQ
Q1: How does the HM-WX6G+ address the three main challenges of pharmaceutical QC water testing?The HM-WX6G+ integrates solutions for data integrity, throughput, and cost in one platform. Data integrity is addressed through programmable per-channel touchscreen timers that execute filtration durations with instrument-controlled precision, eliminating the operator-dependent variability inherent in manual stopwatch timing. Throughput is addressed by six parallel filtration channels that double per-batch capacity versus triple-channel systems, reducing the number of daily batch cycles. Cost is addressed by autoclavable stainless steel filter cups that eliminate disposable cup purchases entirely — at high sample volumes, the substantial annual savings in disposable cups combined with the time savings from fewer batch cycles deliver a compelling return on investment that typically recovers the instrument cost within the first two years.
Q2: Can different timer durations be set for each of the six channels simultaneously?Yes. The 5-inch touchscreen allows independent timer programming for each of the six filtration channels. This is critical when processing samples with different characteristics simultaneously — for example, a low-viscosity purified water sample may require a shorter filtration duration than a more viscous liquid pharmaceutical product, and both can be running in parallel on different channels with their own programmed timers. The touchscreen displays all six timer countdowns simultaneously, allowing the operator to monitor the complete test at a glance.
Q3: How does the touchscreen interface support GMP inspection requirements?The touchscreen displays the active timer settings, channel status, and operational parameters for each test run, providing visual documentation of the conditions applied to each sample. During GMP inspections, inspectors frequently ask how filtration durations are controlled and whether the method is operator-dependent — the HM-WX6G+ provides an objective, instrument-controlled answer. The on-screen timer display can be photographed or recorded as part of the batch record, demonstrating that filtration conditions were applied consistently and reproducibly. This directly addresses data integrity concerns related to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
Q4: What is the total cost of ownership comparison with disposable cup systems?For a pharmaceutical facility processing 30 samples per day, five days per week, the annual disposable cup cost is substantial depending on cup pricing. Over five years, cumulative disposable cup costs can reach many times the initial instrument investment. The HM-WX6G+ stainless steel cups are purchased once and autoclaved after each test session, eliminating this recurring expense entirely. When combined with the labor time savings from reduced batch cycles (half the batches compared to triple-channel systems) and eliminated vacuum flask cleaning validation, the total cost of ownership advantage over the instrument's service life is substantial — often exceeding the initial purchase price multiple times over.
Q5: How does the dual pump system support six simultaneous filtration channels?The two diaphragm pumps distribute vacuum through an integrated manifold to all six filtration channels. The manifold design ensures even pressure distribution regardless of the number of active channels, and the direct discharge design means each channel's filtered liquid drains independently without cross-talk. The pump system is rated to maintain stable flow rates exceeding 450 ml/min per filter head even under full six-channel simultaneous operation, ensuring that adding more channels does not compromise individual channel performance.
Q6: Is the HM-WX6G+ suitable for 21 CFR Part 11 electronic records compliance?The HM-WX6G+ touchscreen provides on-screen display of timer settings and operational parameters, but does not generate electronic records in the 21 CFR Part 11 sense — it does not store data electronically or produce digital output files. For Part 11 compliance, laboratories typically supplement the instrument's visual display with their established documentation practices, such as photographing the screen at test start and completion or recording the displayed parameters in electronic batch records. The key compliance value of the touchscreen is that it provides instrument-controlled, objective filtration timing that eliminates operator-dependent variability — a data integrity requirement that underpins all record-keeping systems, whether paper or electronic.
Q7: What validation approach is recommended for the autoclavable cup system?The autoclavable cup validation follows the same principles used for other re-usable stainless steel pharmaceutical equipment. First, validate the autoclave sterilization cycle (121°C, 15–20 minutes) using biological indicators per standard sterilization validation protocols. Second, demonstrate that the stainless cups maintain dimensional stability and surface integrity across multiple autoclave cycles — this is typically confirmed by visual inspection and functional testing after a defined number of cycles. Third, document the cup re-sterilization procedure in the standard operating procedure, including the autoclave cycle parameters and the maximum number of re-use cycles before replacement. This validation approach is well-established in pharmaceutical manufacturing for stainless steel process equipment and follows the same regulatory expectations.
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