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Continuous Purified Water generation plant combining dual-pass RO, continuous Electro-Deionization (EDI), and automated 85°C hot water sanitization.
2,000 Liters/hour of Purified Water (Conductivity < 0.5 µS/cm @ 20°C)
The PW-2000 Purified Water Generation System produces high-purity Purified Water (PW) conforming to USP, EP, and IP pharmacopoeias. Incorporating a sanitary dual-pass Reverse Osmosis membrane array coupled with continuous Electro-Deionization (EDI) polishing modules, the plant operates without hazardous chemical regenerants.
| Purified Water Capacity | 2,000 L/hr @ 20°CSource: SAMPLE datasheet — replace with approved datasheet |
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| Conductivity Output | < 0.5 µS/cm @ 20°CSource: SAMPLE datasheet — replace with approved datasheet |
| Total Organic Carbon | < 100 ppbSource: SAMPLE datasheet — replace with approved datasheet |
| Working pressure | 3-6 bar(g)Source: SAMPLE datasheet — replace with approved datasheet |
| Product-contact parts | AISI 316L, orbital-welded, drainableSource: SAMPLE datasheet — replace with approved datasheet |
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| Contact surface finish | ≤ 0.4, electropolished µm RaSource: SAMPLE datasheet — replace with approved datasheet |
| Non-contact structure | AISI 304, bead-blasted satin finishSource: SAMPLE datasheet — replace with approved datasheet |
| Elastomers | Silicone / EPDM to FDA 21 CFR 177.2600 and USP Class VISource: SAMPLE datasheet — replace with approved datasheet |
| Plant steam | 6-7 bar(g) saturated, drySource: SAMPLE datasheet — replace with approved datasheet |
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| Supply voltage | 415 V ±10%, 3-phase + N + PE, 50 Hz (60 Hz option)Source: SAMPLE datasheet — replace with approved datasheet |
| Compressed air | 6 bar, dry and oil-free to ISO 8573-1 Class 2:4:1Source: SAMPLE datasheet — replace with approved datasheet |
| Control system | PLC with 10-inch colour HMI, recipe management and audit trailSource: SAMPLE datasheet — replace with approved datasheet |
| Overall dimensions (L × W × H) | 3,500 × 1,800 × 3,200 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
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| Net weight (approx.) | 3,400 kgSource: SAMPLE datasheet — replace with approved datasheet |
| Service clearance | 1,000 mm on operator and maintenance sidesSource: SAMPLE datasheet — replace with approved datasheet |
| Noise level | < 78 dB(A) at 1 mSource: SAMPLE datasheet — replace with approved datasheet |
* Specifications may vary by model. Contact us for exact configuration.
Third-party certification of the quality management system under which every machine in the range is designed, built and tested. It certifies the process, not the performance of an individual machine.
Evidence: ISO 9001:2015 Quality Management System Certificate (PDF · 2 KB)World Health Organization guidance on good manufacturing practice, widely used as the reference for export markets and WHO prequalification.
US regulation setting the controls under which electronic records and signatures are considered trustworthy and equivalent to paper records.
Evidence: Computerised System Validation & 21 CFR Part 11 Assessment Template (on request)Industry guidance for a risk-based approach to validating GxP computerised systems, used to scope the CSV deliverables supplied with the machine.
Standard for the design, materials, fabrication and surface finish of equipment used in bioprocessing and high-purity pharmaceutical service.
Monograph limits for conductivity, total organic carbon and endotoxin that pharmaceutical water and pure steam condensate must meet.
All configurations
Confirms that the PW-2000 design, as specified, meets the user requirement specification before manufacture begins.
GMP configurations
Documents that the machine is installed to drawing, connected to the specified utilities and calibrated.
GMP configurations
Challenges the machine across its operating ranges, alarms and interlocks to show it performs as specified.
Customer-executed; product-specific acceptance criteria
Executed by the customer with our support: a three-phase sampling programme over twelve months demonstrating consistent output quality.
All configurations; customer witnessing optional
Witnessed at our works before dispatch, so defects are corrected where the parts, tools and engineers are.
All configurations
Repeats the critical FAT checks at the customer site after installation and utility connection.
Machines with the PLC/HMI control package
Validation of the PLC/HMI control system to GAMP 5, including the 21 CFR Part 11 controls for electronic records.
| Model | StandardPW-2000 Standard | PW-2000 Pharma+ | PW-2000 Duplex |
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| Output | 2,000 Liters/hour of Purified Water (Conductivity < 0.5 µS/cm @ 20°C) | 2,000 Liters/hour of Purified Water (Conductivity < 0.5 µS/cm @ 20°C) | 2,000 Liters/hour of Purified Water (Conductivity < 0.5 µS/cm @ 20°C) from each of two duty/standby trains |
| GMP mode | GMP | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with SCADA, online TOC and 21 CFR Part 11 data logging | PLC with duty/standby changeover and remote monitoring |
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| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
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| Cartridge pre-filter, 5 µm | GP-UT-PFLT-PW2000-01 | Consumable | 1 set | 3 months or ΔP limit | 1 week |
| RO membrane element | GP-UT-ROMB-PW2000-02 | Wear part | 1 set | 24-36 months | 4 weeks |
| Sanitary pump mechanical seal | GP-UT-MSEL-PW2000-03 | Wear part | 2 nos | 12 months | 3 weeks |
| Conductivity sensor | GP-UT-COND-PW2000-04 | Electrical | 1 no | On failure | 3 weeks |
| Tri-clamp gasket kit, EPDM | GP-UT-GSKT-PW2000-05 | Consumable | 1 kit | 12 months | 1 week |
| Sterile vent filter, 0.2 µm | GP-UT-VFLT-PW2000-06 | Consumable | 1 no | 12 months or failed integrity test | 2 weeks |
| Steam trap service kit | GP-UT-STRP-PW2000-07 | Service kit | 1 kit | 12 months | 2 weeks |
| Diaphragm valve diaphragm | GP-UT-DIAV-PW2000-08 | Wear part | 4 nos | 12 months | 2 weeks |
Models, typical specification, utilities and materials of construction for the pharmaceutical utilities range. Sample content for staging; replace with the approved controlled document before go-live.
Front elevation and plan view with overall dimensions, service clearances and the utility connection schedule. Sample content for staging; replace with the approved controlled document before go-live.
Safety, installation, operation, cleaning, preventive maintenance and troubleshooting for the pharmaceutical utilities range. Sample content for staging; replace with the approved controlled document before go-live.
Protocol structure, prerequisites, test case tables and acceptance criteria for installation and operational qualification. Sample content for staging; replace with the approved controlled document before go-live.
Document review, mechanical, electrical, functional and performance checks witnessed at our works before dispatch. Sample content for staging; replace with the approved controlled document before go-live.
Installation verification, utility connection, re-test of critical FAT items and production trial at the customer site. Sample content for staging; replace with the approved controlled document before go-live.
GAMP 5 categorisation, 21 CFR Part 11 controls checklist, audit trail review and user access matrix for PLC/HMI control systems. Sample content for staging; replace with the approved controlled document before go-live.
Overview of the full range: capsule filling, tablet compression, blister packing, granulation, coating, washing, liquid filling and utilities. Sample content for staging; replace with the approved controlled document before go-live.
Guide to electronic records, electronic signatures, audit trails and access control on machine control systems. Sample content for staging; replace with the approved controlled document before go-live.
Common questions about our pharmaceutical machinery.
Get a custom quote, technical specifications, and delivery timeline from our experts.
