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SED-1YX-Z
Sur devis
SED-1YX-Z
SED · SED-1YX-Z · En vedette

SED-1YX-Z — Rubber Stopper Washing / Sterilizing / Drying 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

Rubber stopper washing/sterilizing/drying machine. Features pure-steam sterilization, vacuum degassing, vacuum drying, and hot-air drying — all in a closed chamber. Designed for the new GMP (China) requirement of feeding

GMP (new version, China)Compliant with new-version GMP cleaning process requirements
Délai de livraison
Sur devis
Cadence
10000 pcs/batch

Fonctionnement

Process: feeding → coarse wash (powerful spray + stirring) → air-water mixed boiling rinse → vacuum degassing rinse → fine wash (self-circulating) → rinse with sampling → pure-steam sterilization (121°C, F0 value time-controllable) → vacuum drying → hot-air drying → vacuum cooling → discharge. Combines slow drum tumbling with high-pressure compressed air and boiling water; vacuum degassing forces water into stopper crevices; saturated pure steam penetrates and sterilizes; vacuum + hot air dries; pulsed vacuum cools to ≤60°C before reverse-spiral discharge.

Processus de fonctionnement
1Process: feeding → coarse wash (powerful spray + stirring) → air-water mixed boiling rinse → vacuum degassing rinse → fine wash (self-circulating) → rinse with sampling → pure-steam sterilization (121°C, F0 value time-controllable) → vacuum drying → hot-air drying → vacuum cooling → discharge.
2Combines slow drum tumbling with high-pressure compressed air and boiling water; vacuum degassing forces water into stopper crevices; saturated pure steam penetrates and sterilizes; vacuum + hot air dries; pulsed vacuum cools to ≤60°C before reverse-spiral discharge.

Caractéristiques techniques

Caractéristiques de la variante : SED-1YX-Z

Caractéristiques

Modèle
SED-1YX-Z
Cadence
10000 pcs/batch
Tension
380V
Fluides et énergie
380V power (40 kW); purified water 1500 kg; water for injection 700 kg; pure steam 0.25 MPa ~90 kg; compressed air 0.6-0.8 MPa 1.2 m3; vacuum <-0.095 MPa
Puissance
40 kW
Pression d’air
0.6-0.8MPa, 1.2m³

Dimensions

Longueur
2700 mm
Largeur
1850 mm
Hauteur
2500 mm
Poids
3000 kg

Matériaux

Matériaux en contact
316 stainless steel (cleaning tank); 316L stainless steel (cleaning drum); PTFE; medical-grade silicone rubber; chlorine-free aluminum silicate insulation
Matériaux du bâti
High-quality carbon steel welded frame; SS304 brushed plate (housing/insulation cover); 50mm chlorine-free aluminum silicate rock wool insulation

Caractéristiques principales

Compliant with new GMP requirements
Novel center water-curtain spray technology (laser-cut narrow water-curtain slots)
Self-developed visible aseptic discharge system with sight glass
Closed discharge system with CIP and SIP capability
Fixed elephant-trunk discharge — no rotational friction particles
Cleaning drum external drive — drive system outside chamber to avoid metal-particle contamination
Drum and rear cover slide out together on built-in rails for cleaning/maintenance
Self-circulating water with 2-stage filter, level switch, low/high alarms
Double-seal: high-precision mechanical seal + sanitary soft flexible seal
Active condensate / low-temp steam auto-discharge (replaces steam trap) — temperature fluctuation ≤±0.5°C
Dual temperature probe + new pressure transmitter at coldest point (drain)
F0 value calculated every 6 seconds (vs. legacy 60s)
All actuators carry physical position feedback signal
Touchscreen discharge control on Class A side
Variable frequency drum 0.5-8 rpm; different rpm per stage (wash/sterilize/dry/cool)
Drum loading rate 30-35%
Tank design pressure -0.1 to 0.25MPa, design temperature ≥150°C
Empty heat distribution ≤±1°C; full-load heat penetration ≤±1°C
0.22µm SIP-rated air filter on breather
Pneumatic interlock between feed and discharge doors (different cleanliness zones)
Inlet/outlet doors physically interlocked — never open simultaneously
Safety valve opens at 0.16MPa over-pressure
Spring-return auto inlet door — prevents stoppers falling into tank
Inflatable seal ring auto-sealing on discharge port
4 retractable spray balls for 360° in-line cleaning
Three-level password authority (operator / process supervisor / system admin)
PDF report export per batch
Up to 50 recipe storage with parameter export/import
Real-time and historical alarm querying
Process aligns with new GMP cleaning requirements (vacuum degassing + air-water boiling + stopper transposition)
Coldest-point temperature sensor at drain ensures accurate F0 calculation
Online cleaning (CIP) and online sterilization (SIP)
Discharge port standard-designed for aseptic transport docking
Optional Class A protective isolator with FFU + glove ports at discharge
Air cooling option for vessels >160k stoppers
Saves water through self-circulation

Applications

Pharmaceutical rubber stopper cleaning
Aluminum cap cleaning
Antibiotic powder & water injection production
Sterilization of injectable components

Secteurs

Pharmaceutical injectable manufacturing
Aseptic processing

Marques des composants

PLC and HMI touchscreen
Siemens
Pneumatic triplet, fittings, tee, piping
Taiwan-made (AirTAC equivalent)
Compressed air filter
Millipore
Valves
Hebron
Water pump (fine wash)
Imported German pump
Vacuum pump
Liquid ring vacuum pump (premium)
Cleaning tank
316 stainless steel
Cleaning drum
316L stainless steel
Mechanical seal
Acid/alkali-resistant alloy + PTFE
SED
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Conformité

GMP (new version, China)
Compliant with new-version GMP cleaning process requirements

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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