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Accueil / Équipements / Armoire de stérilisation à bain d’eau / 13 m³ Double-Door Water-Shower Sterilizer (Autoclave)
SED-13SM-Q
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SED-13SM-Q
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SED-13SM-Q — 13 m³ Double-Door Water-Shower Sterilizer

La description complète de ce modèle est encore en cours de traduction. Consultez les détails en anglais ou demandez des informations à notre équipe. English

SED-13SM-Q 13 m³ Double Horizontal Sliding Door Water-Shower Sterilizer (Autoclave). Uses high-temperature circulating water as sterilizing medium delivered via spray. Closed circulating system controlled by external col

GMP inspection interface (supports IQ/OQ/PQ inspection programs)Pressure vessel quality certificate per autoclave industry criteria
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Délai de livraison
Sur devis
Cadence
1008 soft bags/chamber/cycle

Fonctionnement

Auto-inspection (energy and equipment status) → water inlet → spray water and pure-water chamber circulation (chamber bottom → circulation pump → heat exchanger → upper spray system) → temperature rising (steam admitted to heat-exchanger channel) → sterilizing (dual temperature + F0 monitoring to setpoint) → cooling (cold water admitted to heat-exchanger channel) → water outlet (programmed) → finish.

Processus de fonctionnement
1Auto-inspection (energy and equipment status) → water inlet → spray water and pure-water chamber circulation (chamber bottom → circulation pump → heat exchanger → upper spray system) → temperature rising (steam admitted to heat-exchanger channel) → sterilizing (dual temperature + F0 monitoring to setpoint) → cooling (cold water admitted to heat-exchanger channel) → water outlet (programmed) → finish.

Caractéristiques techniques

Caractéristiques de la variante : SED-13SM-Q 13 m³ double horizontal sliding-door water-shower sterilizer

Caractéristiques

Modèle
SED-13SM-Q
Cadence
1008 soft bags/chamber/cycle
Fluides et énergie
Steam supply (heat-exchanger heating side); cold water supply (cooling side); pure water for spray circulation (reused from chamber bottom reservoir); electrical for pumps, valves, PLC, and HMI; compressed air for pneumatic valves.
Détails de conformité
Comprehensive safety interlocks per pharmaceutical autoclave safety standards. GMP-compliant IQ/OQ/PQ inspection programs including empty/full heat distribution (3 repeats each), heat penetration (3 repeats), and bio-indicator challenge.

Dimensions

Longueur
4950 mm
Largeur
4000 mm
Hauteur
2500 mm
Emprise au sol
Chamber 2000 × Ø4350 mm. Overall machine envelope 4950 (L) × 4000 (W) × 2500 (H) mm. 13 m³ working volume.

Matériaux

Matériaux en contact
Chamber, plate-heat-exchanger sheets, spray system, and loading carts in 316L stainless steel; door seal in medical silicone rubber; flange in SS304.
Matériaux du bâti
Chamber: 316L stainless steel (X-ray inspected); flange and external plates: SS304; whole stainless steel wire-drawn external skin.

Caractéristiques principales

Horizontal cylindrical 316L stainless steel chamber for stability under repeated heat/cool cycles
Double horizontal sliding doors, cylinder-driven, with safety interlocks (no pressure with door open; door cannot open under pressure; door locked during cycle)
Efficient spiral spray / spray-board system for even heat distribution with no dead corners
Plate heat exchanger with 316 stainless steel plates
Cylinder bottom reservoir reuses pure chamber water — no separate water box
Calcium silicate insulation deck; whole stainless steel wire-drawn external plates
Standard GMP inspection interface (IQ/OQ/PQ programs)
Upper-machine + lower-machine control: PC monitors + Siemens PLC executes (MTBF >50,000 h)
Authority-tiered software: separate roles for operation, data query, parameter modification, program modification
Real-time pressure, temperature, time, F0 display; data and curve printout with backup
Remote computer monitoring
Designed pressure 0.35 MPa, temp 139°C; working 80–126°C
Heat distribution ≤±2°C, control precision ≤0.5°C
Sterilization time 70–99 min, programmable
13 m³ chamber capacity — loads up to 1008 soft IV bags per cycle
316L cylindrical body CO2-welded — long service life vs. rectangular vessels
Critical components imported (Danfoss pressure transmitter, JUMO Pt100 sensor, ASCO angle-seat valves, French circulation pump)
Comprehensive safety interlocks meet pharma autoclave safety standards
Built-in F0 management for terminal sterilization validation
GMP inspection interface supports IQ/OQ/PQ heat distribution and bio-indicator challenges
Suitable for soft IV bags, glass vials, ampoules, plastic bottles, beverage and food cans

Applications

Terminal sterilization of soft IV (LVP) bags
Liquid sterilization in glass vials and ampoules
Plastic-bottle liquid sterilization
Beverage bottle and food can sterilization
Pharmaceutical solution and suspension sterilization

Secteurs

Pharmaceutical manufacturing (LVP / parenteral / oral liquids)
Food and beverage processing
Health products / nutraceuticals

Marques des composants

Chamber: VSUN, 316L stainless steel (X-ray inspected)
Flange and external sheet: VSUN, SS304
Door sealing: VSUN medical-grade silicone rubber
PLC: Siemens (MTBF >50,000 h)
HMI touchscreen: Siemens
Pressure transmitter: Danfoss
Temperature sensor: JUMO Pt100 (≤0.15°C equilibrium accuracy)
Computer: Lenovo (backstage monitoring + report storage)
Printer: HP (sterilization report output)
Angle pneumatic valves: ASCO (double sealing, 4 million-cycle life)
Plate heat exchanger: 316 stainless steel plates
Vacuum pump: D-STRING (high-temp, stainless pump head)
Spraying system: VSUN, 316L stainless steel
Safety valve: Guangyi (high sensitivity)
Solenoid / air reversing valves: E.MC
Loading cart: VSUN, 316L stainless steel
Circulation pump: French imported hot-water pump
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Conformité

GMP inspection interface (supports IQ/OQ/PQ inspection programs)
Pressure vessel quality certificate per autoclave industry criteria

Documentation

Fiche technique (PDF)
Aperçu de l’équipement, caractéristiques et dimensions · Document d’origine (anglais)
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Manuel opérateur
Installation, fonctionnement et dépannage · Document d’origine (anglais)
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Fiche comparative (Standard et Économique)
Comparaison des configurations · Document d’origine (anglais)
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Protocoles IQ / OQ / PQ
Documentation de validation pour la conformité GMP · Document d’origine (anglais)
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Protocoles FAT / SAT
Essais de réception en usine et sur site · Document d’origine (anglais)
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Plans CAD (STEP / IGES / DWG)
Plans d’ingénierie pour l’implantation · Document d’origine (anglais)
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Certificats d’étalonnage
Niveau sonore, résistance de terre, rigidité diélectrique et rugosité · Document d’origine (anglais)
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DQ (qualification de la conception)
Protocole complet de qualification de la conception · Document d’origine (anglais)
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Certificats matières
Composition de l’acier inoxydable 316L · Document d’origine (anglais)
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