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SED-KJTZ-L
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SED-KJTZ-L
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SED-KJTZ-L — Rubber Stopper Aseptic Closed-Barrel Transfer System

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

The SED-KJTZ-L is an aseptic closed-barrel transfer system for pharmaceutical rubber stoppers,comprising: (1) an open Restricted Access Barrier System oRABs (model GLG1400-GD/SED-KJTZ-L) installed at the discharge end of

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Fonctionnement

A sterilized transfer barrel is brought into the oRABs isolation cabinet (after self-purification for 10–15 min to achieve Class A). Via glove ports, the operator opens the barrel lid and aligns it with the washer discharge nozzle. The washer discharge cycle fills the barrel. The lid is sealed and locked via gloves. The barrel is moved sideways by rollers onto the flat transfer cart. The cart is pushed to the filling machine, its rollers lifted to the filling platform height. Via the filling line side door, the barrel is transferred to the filling line oRABs and stoppers are manually scooped into the buffer hopper for filling.

Processus de fonctionnement
1A sterilized transfer barrel is brought into the oRABs isolation cabinet (after self-purification for 10–15 min to achieve Class A).
2Via glove ports, the operator opens the barrel lid and aligns it with the washer discharge nozzle.
3The washer discharge cycle fills the barrel.
4The lid is sealed and locked via gloves.
5The barrel is moved sideways by rollers onto the flat transfer cart.
6The cart is pushed to the filling machine, its rollers lifted to the filling platform height.
7Via the filling line side door, the barrel is transferred to the filling line oRABs and stoppers are manually scooped into the buffer hopper for filling.

Caractéristiques techniques

Caractéristiques de la variante : GLG1400-GD (oRABs base model)

Caractéristiques

Modèle
SED-KJTZ-L
Tension
AC 220V 50Hz
Fluides et énergie
AC 220V 50Hz, 1 kW. Gloves and HEPA filter consumables; 2× Philips 8W UV-C lamps for sterilization; Dwyer differential pressure sensors.
Détails de conformité
Internal cabinet cleanliness: Class A / ISO 5 (Class 100). Operating environment: Class B background. HEPA H14 filter, 99.995% efficiency at 0.3 μm. Differential pressure 5–10 Pa to room. Air velocity 0.36–0.54 m/s. Total noise <70 dBA. PAO test port included. Surface finish Ra≤0.8.
Puissance
1 kW

Dimensions

Longueur
1400 mm
Largeur
650 mm
Hauteur
2550 mm
Poids
300 kg
Emprise au sol
oRABs dimensions: 1400 × 650 × 2550 mm; net weight 300 kg. Height from ground adjustable.

Matériaux

Matériaux en contact
316L stainless steel (closed wide-mouth barrels); SUS304 stainless steel + PTFE rollers; HYPALON gloves
Matériaux du bâti
SUS304 stainless steel frame (50×50 box tubing) and panels; 8mm transparent PC endurance board; 8mm tempered glass operating door; 6mm glass side door

Caractéristiques principales

Open RABs (oRABs) with Class A / ISO 5 internal environment
HEPA H14 filter at 99.995% efficiency on 0.3 μm particles; initial resistance ≤160 Pa, final 300 Pa
German EBM direct-drive radial fan (noise 49–53 dBA)
Two HYPALON glove ports (NORTH USA, Dia 250 mm × L 810 mm, δ 0.4 mm)
Two UV-C sterilization lamps (8W Philips)
Stainless-steel powerless roller conveyor (SUS304 + PTFE φ38) for friction-free bucket transfer
Electric lifting side door
Online Dwyer differential pressure monitoring (0–500 Pa HEPA both-ends; 0–60 Pa inside-outside)
Temperature and humidity monitoring (18–26°C; 45–65% RH)
PAO test port for HEPA validation
Two 316L closed wide-mouth barrels (φ400×500 mm) with snap-lock lids (included in system)
Siemens S7-200 Smart PLC + 7" Proface HMI
Adjustable overall floor height
Maintains aseptic Class A environment for stopper transfer between washer and filler
Eliminates manual exposure of sterilized stoppers to Class B environment
Premium components: Siemens PLC, Dwyer pressure sensors, German EBM blower, NORTH USA gloves, Philips UV/lighting
Adjustable floor height for matching different equipment platforms
Door interlock with open-door alarm for operator safety
Complete turnkey system: oRABs + 2 barrels included

Applications

Aseptic transfer of cleaned/sterilized rubber stoppers from washer to filling line
Buffer station between stopper washer and capping machine
Class A barrier for sterile component handling in injectable manufacturing

Secteurs

Sterile injectable manufacturing (powder injection, water injection)
Aseptic pharmaceutical filling lines
Vaccine and biologics filling

Marques des composants

Siemens S7-200 Smart-SR40 — PLC (Germany)
Siemens EM DR08, EM AM06, EM AE04 — I/O modules
Proface 7" — HMI (Japan)
EBM Germany — HEPA blower
Philips 14W — Fluorescent lamp (Netherlands)
Philips 8W × 2 — UV lamp (Netherlands)
NORTH USA — HYPALON gloves
Dwyer — Differential pressure sensors (USA)
CHNT/9A — Contactor (China)
Mean Well / MW 50W DC24V — Switching power supply
Klockner Moeller/P1-32 — Breaker
MRO/220V-50V — Transformer
SED
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Nettoyage et entretien

Self-purge for 10–15 minutes after startup; verify air velocity, particle count, floating and sedimentation bacteria (optional). Surfaces Ra≤0.8 are wipe-cleanable. SUS304+PTFE rollers prevent metal-on-metal friction debris. After each batch, rotate the washer discharge nozzle to cleaning/sterilization state and power off.

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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