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SED-1YX-K
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SED-1YX-K
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SED-1YX-K — Rubber Stopper Washing Machine

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

Fully automatic rubber stopper washing and drying machine (4th generation). Designed per China GMP, EU cGMP, and US FDA standards. Washing, rinsing, drying, and cooling all completed in a single closed chamber, eliminati

GMP (China)cGMP (EU)FDA (US) standard reference
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Fonctionnement

Rubber stoppers are loaded via the inlet into the rotating cleaning drum. Stages proceed automatically: feeding → water inlet → coarse wash (high-pressure spray + drum rotation/stirring) → drainage → ultrasonic + spray rinse (self-circulating fine wash saves water) → siliconization → drainage → spin-dry → hot-air drying (circulating clean air heated through a 100-grade filter; dryer temperature 70–150°C) → cooling (≤40°C) → discharge. Entire process controlled by PLC; parameters preset via touchscreen. Three modes: automatic, semi-automatic, and manual.

Processus de fonctionnement
1Rubber stoppers are loaded via the inlet into the rotating cleaning drum.
2Stages proceed automatically: feeding → water inlet → coarse wash (high-pressure spray + drum rotation/stirring) → drainage → ultrasonic + spray rinse (self-circulating fine wash saves water) → siliconization → drainage → spin-dry → hot-air drying (circulating clean air heated through a 100-grade filter; dryer temperature 70–150°C) → cooling (≤40°C) → discharge.
3Entire process controlled by PLC; parameters preset via touchscreen.
4Three modes: automatic, semi-automatic, and manual.

Caractéristiques techniques

Caractéristiques de la variante : SED-1YX-K

Caractéristiques

Modèle
SED-1YX-K
Tension
AC 50Hz, 380V
Fluides et énergie
Pure water: pressure ≥ 0.25 MPa, approx. 400 kg/batch; WFI: pressure ≥ 0.25 MPa, approx. 400 kg/batch; compressed air: 0.6–0.8 MPa, 2.0 m³; electricity: AC 50 Hz, 380 V, total power approx. 28 kW. Piping: main inlet DN=25 mm, secondary inlet DN=25 mm, upper discharge DN=100 mm, drain DN=50 mm.
Détails de conformité
Designed and manufactured per China GMP standard; materials,surface finish,rounded transitions,process piping welds,and installation fully comply with GMP. Cross-referenced against EU cGMP and US FDA standards. Equipment establishes complete production and quality control records,traceable and auditable. Supports electronic signature and three-level password management.
Puissance
28 kW
Pression d’air
0.6-0.8MPa/2.0m³

Dimensions

Longueur
1800 mm
Largeur
1600 mm
Hauteur
1800 mm
Poids
1800 kg
Emprise au sol
Overall dimensions: 1,800 × 1,600 × 1,800 mm. Requires: pure water ≥ 0.25 MPa / 400 kg; water for injection ≥ 0.25 MPa / 400 kg; compressed air 0.6–0.8 MPa / 2.0 m³; AC 50 Hz, 380 V power.

Matériaux

Matériaux en contact
316L stainless steel (cleaning drum); 304 stainless steel (cleaning tank, feed/discharge hopper, piping); PTFE (Teflon) gaskets and seals; medical silicone rubber seals; PDFE/PVDF as needed
Matériaux du bâti
Carbon steel frame; 304 stainless steel brushed plate (housing,thermal insulation cover); chlorine-free aluminum silicate rock wool insulation

Caractéristiques principales

Washing, rinsing, drying, and cooling in a single closed chamber
Eliminates cross-contamination
PLC + color LCD touchscreen control; full Chinese/English switchable interface
Three-level password authorization management (operator / process engineer / manager)
Electronic signature and electronic records (USB print supported)
Capacity: 10,000 Φ20 rubber stoppers per batch
Drum rotational speed: 0.5–10 rpm (variable frequency, stepless)
Advanced ultrasonic cleaning with vacuum degassing
Self-circulating fine wash (water-saving)
Hot-air drying: 70–150°C
Interior surface finish: Ra ≤ 0.4 µm
316L stainless steel cleaning drum with spiral guide plates for auto-discharge
External drum drive (bearing outside cleaning tank) — prevents contamination
212B-65 acid/alkali-resistant hard alloy + PTFE double mechanical seal
Insulation: chlorine-free aluminum silicate rock wool; outer cover 304 SS brushed plate
Compliant with China GMP, EU cGMP, US FDA standards
4th-generation product — proven over 10+ years, deployed in 30+ provinces nationwide and exported internationally
Fully closed single-pass process eliminates cross-contamination
Self-circulating fine wash significantly reduces water consumption
Online monitoring, detection, and control; traceable electronic records
Compliant with China GMP, EU cGMP, and US FDA standards
Capacity 10,000 stoppers/batch; drum speed 0.5–10 rpm (VFD stepless)

Applications

Rubber stopper cleaning and drying
Aluminum cap cleaning
Pharmaceutical injectable component cleaning

Secteurs

Pharmaceutical injectable manufacturing
Antibiotic powder injection
Water for injection (WFI) production

Marques des composants

Siemens — PLC and color LCD touchscreen
Schneider — AC contactor (LC1N0610), thermal overload relay (CDG3-DA), relay (RXM2ABABD), power supply, rotary switch, signal lights and buttons
Delta — inverter/frequency converter
Wolken — external mechanical seal (212B-65,acid/alkali-resistant hard alloy + PTFE)
Jiangsu Changzhou — cycloidal pin-wheel reducer (BWD131-289, motor 1.1 kW)
Qingdao — blower fan (DE-160, 380V/1.1 kW)
Nanfang Pump Industry (Hangzhou joint venture) — cleaning water pump (8-30)
Wenzhou suppliers — sanitary thin-wall stainless steel piping (304 SS), quick-release clamps, silicone gaskets, fittings
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Conformité

GMP (China)
cGMP (EU)
FDA (US) standard reference

Nettoyage et entretien

All process steps (washing, rinsing, drying, cooling) complete automatically in sequence. The cleaning drum interior and spiral guides have Ra ≤ 0.4 µm mirror finish; tank interior Ra ≤ 0.4 µm. Self-circulating fine wash uses pump + filtration to recirculate cleaning water through center spray. After each batch, drainage via electromagnetic valve; drum reverse-rotation for automatic discharge. Maintenance access via side and rear doors; large-diameter discharge opening doubles as manhole for internal cleaning.

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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