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SED-2JLM-J
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SED-2JLM-J
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SED-2JLM-J — Ampoule Leak-Detection Sterilization Cabinet

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SED-2JLM-J Ampoule leak-detection sterilization cabinet. Horizontal double-wall steam sterilizer with double motorized doors, designed and built to GMP. Used for autoclave steam sterilization, cooling, leak detection (va

GMPGB150.1/2/3/4-2011 (steel pressure vessel)
Délai de livraison
Sur devis
Cadence
70 kg

Fonctionnement

Horizontal double-wall cabinet: first pre-vacuum to remove residual cold air, then saturated steam raises temperature to 139 °C, held at 0.25 MPa for the sterilization period with F0 + time/temperature dual control. After sterilization, steam is vented and the load cooled. Leak detection is performed via vacuum + dye-water (or vacuum only), followed by a rinse cycle. The entire process is automatically controlled by Siemens S7-1200 PLC and can be safely switched to manual mode at any point.

Processus de fonctionnement
1Horizontal double-wall cabinet: first pre-vacuum to remove residual cold air, then saturated steam raises temperature to 139 °C, held at 0.25 MPa for the sterilization period with F0 + time/temperature dual control.
2After sterilization, steam is vented and the load cooled.
3Leak detection is performed via vacuum + dye-water (or vacuum only), followed by a rinse cycle.
4The entire process is automatically controlled by Siemens S7-1200 PLC and can be safely switched to manual mode at any point.

Caractéristiques techniques

Caractéristiques de la variante : SED-2JLM-J

Caractéristiques

Modèle
SED-2JLM-J
Cadence
70 kg
Tension
380V/220V, 50Hz, 3-phase 5-wire
Fluides et énergie
Drinking water 0.1–0.3 MPa; pure water 0.1–0.3 MPa; steam 0.3–0.5 MPa; compressed air 0.5–0.7 MPa; power supply 380V/220V 4.5 kW; steam consumption approx. 70 kg; water consumption approx. 1,300 kg
Puissance
4.5 kW
Pression d’air
0.5-0.7 MPa

Dimensions

Longueur
2730 mm
Largeur
1480 mm
Hauteur
2000 mm
Poids
2300 kg

Matériaux

Matériaux en contact
316L SS inner chamber (6 mm, 304 SS reinforcing ribs); 316L SS door panels; 304 SS sanitary pipework; 316L SS sterilization cart; 304 SS transport cart; 316L SS sterilization trays; medical-grade silicone rubber door seal
Matériaux du bâti
δ=1.2 mm 304 SS oil-polished brushed-finish outer cladding; 80 mm silica-alumina (/rock wool) insulation layer

Caractéristiques principales

Hermetic seal, double-door, motorized doors
Double-door interlock + pressure safety interlock (no steam if door not sealed; no door opening under pressure)
316L stainless steel inner chamber (6 mm), 304 SS reinforcing ribs
δ=1.2 mm 304 SS oil-polished brushed-finish outer cladding
80 mm premium silica-alumina (/rock wool) insulation layer
Medical-grade silicone rubber door seal, compressed-air automatic sealing
Design pressure 0.3 MPa, working pressure 0.25 MPa
Design temperature 144 °C, working temperature 139 °C
Thermal uniformity ≤±1 °C
Ultimate vacuum −0.095 MPa
F0 value + time/temperature dual control
Vacuum + dye-water leak detection (100% defect detection rate)
Process I (steam sterilization + vacuum + dye-water leak detection) and Process II (steam sterilization + vacuum leak detection)
Siemens S7-1200 PLC + touchscreen + micro-printer control
Yokogawa 6-channel paper-chart recorder
Real-time sterilization report output + temperature trend chart
Pt100 Class A temperature probe (accuracy ≤0.15 °C)
ASCO angle-seat pneumatic valve, 4 million operation lifespan
Water-ring vacuum pump: low noise, high vacuum
Spiral spray nozzles for uniform rinsing
Quick-release clamp pipe connections
Electronic signature, administrator access control
X-ray flaw inspection, compliant with GB150.1/2/3/4-2011
GMP-compliant design with full quality documentation
100% defect detection rate (vacuum + dye-water leak detection)
Double-door interlock for effective separation of clean and dirty zones
PLC MTBF 50,000 hours
Fully archivable sterilization records for every batch

Applications

Ampoule autoclave steam sterilization
Vial autoclave steam sterilization
Tubular bottle autoclave steam sterilization
Injectables sterilization + leak detection + washing
Oral liquid sterilization + leak detection + washing

Secteurs

Pharmaceuticals
Injectable manufacturing
Oral liquid manufacturing

Marques des composants

Angle-seat pneumatic valve
ASCO
Water-ring vacuum pump
Shanghai Yulong
Air filter (0.22 μm)
Santong Jingong
Heat exchanger
Huisituo
Circulating water pump
WILO
Solenoid valve
Airtac
Pressure gauge
Brady
Safety valve (0.1–0.3 MPa)
Guangyi
PLC S7-1200
Siemens
Touchscreen
Siemens
Micro printer (EPSON chip)
Weihuang
Paper chart recorder (6-channel)
Yokogawa
Pressure transmitter
HUBA
Temperature probe Pt100 Class A
Airisi
SED
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Conformité

GMP
GB150.1/2/3/4-2011 (steel pressure vessel)

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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