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Automated 10 m³ Ethylene Oxide (ETO) sterilizer chamber for heat-sensitive medical devices, syringes, catheters, and blistered surgical kits.
Chamber Capacity: 10 m³ (Approx. 4 standard EUR pallets)
The ET-100 ETO Gas Sterilizer provides low-temperature (37°C to 55°C) gas sterilization for heat-sensitive plastics, electronic medical sensors, and pre-packaged surgical devices. The system manages pre-conditioning humidification, ETO gas injection, dwell sterilization, and multi-cycle vacuum degassing aeration within a single ATEX-compliant pressure vessel.
| Chamber Volume | 10,000 Liters (10 m³)Source: SAMPLE datasheet — replace with approved datasheet |
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| Gas Mixture | 100% ETO or 90/10 CO2 BlendSource: SAMPLE datasheet — replace with approved datasheet |
| Working Temp | 37°C to 55°CSource: SAMPLE datasheet — replace with approved datasheet |
| Wash stations | Recirculated water, fresh water, WFI, compressed airSource: SAMPLE datasheet — replace with approved datasheet |
| Product-contact parts | AISI 316L stainless steelSource: SAMPLE datasheet — replace with approved datasheet |
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| Contact surface finish | ≤ 0.8, mechanically polished 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 |
| Process water | WFI final rinse at 2-3 bar and 60-80 °C; PW for pre-rinseSource: 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) | 6,500 × 1,900 × 2,300 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
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| Net weight (approx.) | 4,800 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.
EU directive and international certification scheme for equipment intended for use in potentially explosive atmospheres, including solvent vapour and combustible dust zones.
All configurations
Confirms that the ET-100 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: endotoxin challenge and heat penetration studies over three consecutive qualified cycles.
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 | StandardET-100 Standard | ET-100 Aseptic |
|---|---|---|
| Output | Chamber Capacity: 10 m³ (Approx. 4 standard EUR pallets) | Chamber Capacity: 10 m³ (Approx. 4 standard EUR pallets) |
| GMP mode | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with SCADA, zone pressure monitoring and batch report |
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| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
|---|---|---|---|---|---|
| Spray nozzle set | GP-WM-NOZL-ET100-01 | Wear part | 1 set | 12 months | 3 weeks |
| Terminal HEPA filter | GP-WM-HEPA-ET100-02 | Consumable | 1 per zone | On failed integrity test | 4 weeks |
| Conveyor mesh belt | GP-WM-BELT-ET100-03 | Wear part | 1 no | 24 months | 8 weeks |
| Door inflatable gasket | GP-WM-DGSK-ET100-04 | Wear part | 2 nos | 12 months | 3 weeks |
| Heater bank element | GP-WM-HEAT-ET100-05 | Electrical | 2 nos | On failure | 3 weeks |
| Format change part set | GP-WM-FRMT-ET100-06 | Change part | 1 per container size | Per format change | 6 weeks |
| Recirculation pump seal kit | GP-WM-PMPS-ET100-07 | Service kit | 1 kit | 12 months | 2 weeks |
Models, typical specification, utilities and materials of construction for the washing & sterilising 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 washing & sterilising 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.
Vial washing, depyrogenation, filling, stoppering and capping systems for sterile liquid lines. Sample content for staging; replace with the approved controlled document before go-live.
Common questions about our pharmaceutical machinery.
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