Inicio / Equipos / Lavadora de tapones de goma / SED-KJWZ-L Sterile Bag Discharge Transfer System (Double-Bag Single-Seal oRABS)
SED-KJWZ-L
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SED-KJWZ-L
SED · SED-KJWZ-L · Destacado
SED-KJWZ-L — SED-KJWZ-L Sterile Bag Discharge Transfer System
La descripción completa de este modelo aún se está traduciendo. Consulte los detalles en inglés o solicite información a nuestro equipo. English
The SED-KJWZ-L is a sterile bag (double-bag single-seal) discharge transfer system designed to mount on the discharge end of a rubber stopper / aluminum cap washer. It functions as an open Restricted Access Barrier Syste
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Funcionamiento
Sterile double bags are placed inside the chamber via the side door (after exterior decontamination). Operator engages pneumatic clamps front and rear to fix outer bag, then inner bag (front/rear with point-touch interlock for safety). Heat sealer is pushed forward to align with washer discharge spout. Left foot pedal arms the sealer; right foot pedal triggers stopper/cap discharge from the washer (filling time and quantity controlled by pedal release). After fill, sealer retracts; operator manually ties inner bag with cable tie; second left-pedal press auto-flattens and heat-seals the outer bag (160–170°C, 0.4 MPa, 0.8–1.2 s, ±0.2°C control). Side door 2 opens to discharge sealed bag via the platform exit area to a transport cart bound for the filling line. Internal H14 HEPA + German EBM VFD-controlled blower maintains downflow at 0.36–0.54 m/s; UV lamp + LED illuminate. Differential pressure gauges monitor HEPA loading and chamber pressure; glove door alarm triggers if opened in operation to protect chamber positive pressure.
Proceso de funcionamiento
1Sterile double bags are placed inside the chamber via the side door (after exterior decontamination).
2Operator engages pneumatic clamps front and rear to fix outer bag, then inner bag (front/rear with point-touch interlock for safety).
3Heat sealer is pushed forward to align with washer discharge spout.
4Left foot pedal arms the sealer; right foot pedal triggers stopper/cap discharge from the washer (filling time and quantity controlled by pedal release).
5After fill, sealer retracts; operator manually ties inner bag with cable tie; second left-pedal press auto-flattens and heat-seals the outer bag (160–170°C, 0.4 MPa, 0.8–1.2 s, ±0.2°C control).
6Side door 2 opens to discharge sealed bag via the platform exit area to a transport cart bound for the filling line.
7Internal H14 HEPA + German EBM VFD-controlled blower maintains downflow at 0.36–0.54 m/s; UV lamp + LED illuminate.
8Differential pressure gauges monitor HEPA loading and chamber pressure; glove door alarm triggers if opened in operation to protect chamber positive pressure.
Especificaciones técnicas
Especificaciones de la variante: GLG2000-PS: oRABS isolation cabinet
Especificaciones
Modelo
SED-KJWZ-L
Tensión
AC 220V, 50Hz
Suministros
AC 220V 50Hz electrical supply (1 kW oRABS + heat sealer); compressed air at 0.4 MPa via φ8 mm PU line for pneumatic clamps and heat seal; mounted at washer discharge end; environment must be Class B cleanroom
Detalles de conformidad
Class A / ISO 5 inside chamber per cGMP; designed for Class B cleanroom environment; particle limits: ≥0.5 μm ≤3520/m³, ≥5.0 μm ≤20/m³; differential pressure to surroundings 5–10 Pa positive; HEPA initial resistance ≤160 Pa, terminal 320 Pa; total noise <70 dBA; PAO integrity test port for HEPA validation
Potencia
1 kW
Presión de aire
0.4 MPa (sealing); φ8mm PU air line
Dimensiones
Longitud
2300 mm
Anchura
650 mm
Altura
2450 mm
Peso
430 kg
Superficie de instalación
2300 mm × 650 mm × 2450 mm (oRABS cabinet); 820 mm × 420 mm × 760 mm (heat sealer)
Materiales
Materiales en contacto
All product-contact and chamber-internal surfaces SUS304 stainless steel (frame, sealing plates, intake plates, heat sealer support and cover) with internal Ra≤0.8 surface finish; sterile bags and HYPALON gloves
Materiales del cuerpo
SUS304 50×50 mm rectangular tube frame and plate cladding (external Ra≤0.8); 8 mm tempered glass operation doors (4 outward-opening); 6 mm glass side doors (manual synchronous belt lift); nylon side door rails; SUS304 stainless steel support feet; flame-retardant moisture-resistant fiberglass HEPA media
Características principales
Double-bag single-seal design — inner cable-tied + outer heat-sealed
Heat sealer slides fore/aft to clear washer discharge during sealing
ISO 5 / Class A cleanliness inside unit, operated from Class B room
H14 HEPA filter @ 99.995% efficiency on 0.3 μm particles
German EBM direct-drive radial blower with VFD speed control
Two pairs of US NORTH HYPALON sterile gloves (8" or 10" elliptical mounts)
UV sterilization lamp + LED lighting
3 differential pressure gauges + 1 temperature/humidity gauge
PAO test port for HEPA integrity validation
Foot-pedal-controlled stopper discharge (operator hands stay at clamps)
Glove-door interlock alarm protects chamber positive pressure
Adjustable height-from-floor for washer alignment
Heat seal: 160–170°C, ±0.2°C, 0.4 MPa, 0.8–1.2 s on 550×4 mm seal face
Eliminates manual bagging exposure of sterile stoppers/caps after washing
Pre-fixed double-bag avoids re-bagging large filled bag (operator ergonomic)
Inner-bag tie + outer-bag heat seal prevents heat-seal residue contamination of stoppers
Sliding sealer keeps heat away from washer discharge port — protects washed stoppers
Sub-70 dBA noise inside Class B suite
Top-tier: Siemens PLC, EBM blower, NORTH gloves, Dwyer pressure sensors, Philips lamps
Aplicaciones
Sterile transfer of washed rubber stoppers from washer to filling line
Sterile transfer of washed aluminum overcaps to capping line
Bagged sterile transfer for vial filling and lyo loading lines
B-grade cleanroom operations requiring local A-grade environment
Sectores
Sterile injectable pharmaceuticals
Antibiotic powder and liquid injection manufacturing
Vaccine and biologics filling
Lyophilized product manufacturing
Marcas de componentes
Siemens (S7-200Smart-SR40 PLC, EM DR08/AM06/AE04 modules)
proface (7" touchscreen HMI)
EBM Germany (direct-drive HEPA blower)
NORTH USA (HYPALON sterile gloves)
Philips (UV lamp 8W, LED light 14W)
Dwyer (differential pressure sensors)
Suzhou Sujing (laminar flow membrane)
Chint (contactors)
Klockner Moeller / Eaton (circuit breakers)
MW Mean Well (DC24V switching power supply)
SED
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Documentación
Ficha técnica (PDF)
Resumen del equipo, especificaciones y dimensiones · Documento original (inglés)
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Manual del operador
Instalación, funcionamiento y diagnóstico · Documento original (inglés)
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Ficha comparativa (Estándar y Económica)
Comparación de configuraciones · Documento original (inglés)
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Protocolos IQ / OQ / PQ
Documentación de validación para conformidad GMP · Documento original (inglés)
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Protocolos FAT / SAT
Pruebas de aceptación en fábrica y en sitio · Documento original (inglés)
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Planos CAD (STEP / IGES / DWG)
Planos de ingeniería para la instalación · Documento original (inglés)
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Certificados de calibración
Nivel sonoro, resistencia de tierra, rigidez dieléctrica y rugosidad · Documento original (inglés)
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DQ (cualificación del diseño)
Protocolo completo de cualificación del diseño · Documento original (inglés)
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Certificados de materiales
Composición del acero inoxidable 316L · Documento original (inglés)
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