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SED-2YX-R

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SED-2YX-R

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SED-2YX-R — Fully Automatic Rubber Stopper & Aluminum Cap Ultrasonic Washer

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SED-2YX-R Fully Automatic Rubber Stopper Ultrasonic Washer (4th generation). Pharmaceutical equipment for cleaning, sterilizing and drying rubber stoppers, lyophilized stoppers, aluminum caps, and composite caps used in

GMP (China 2010)EU cGMPUS FDA21 CFR Part 11 alignment (electronic signature + electronic record + 3-tier password)

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Fonctionnement

Stoppers/caps tumble in a slow-rotating wash drum (0.5–10 rpm VFD adjustable) inside a 135°C-rated wash tank (-0.1 to 0.25 MPa pressure). Process steps: (1) High-pressure spray + agitation pre-wash via central spray pipe + spiral guide vanes; (2) Gas-water mixed boiling rinse — bottom compressed-air injectors create bursting bubbles that micro-deform stoppers; (3) Ultrasonic + vacuum debubbling — bubbles in stopper crevices burst, allowing wash water in; (4) Self-circulating fine wash via Nanfang pump and inline filter; (5) Water sampling for QC; (6) WFI rinse; (7) Dry-heat sterilization (Fo ≥ 30 min adjustable) at 135°C with stainless heater coil + Class-100 HEPA hot-air circulation; (8) Cooling via Class-100 fresh air through 0.22 µm respirator until ≤ 50°C; (9) Reverse-rotation auto unloading through closed-system aseptic discharge port. Cantilever drum mounting (bearings outside tank) prevents wear-debris contamination. Inlet and outlet doors in different cleanroom grades with pneumatic interlock.

Processus de fonctionnement

1Stoppers/caps tumble in a slow-rotating wash drum (0.5–10 rpm VFD adjustable) inside a 135°C-rated wash tank (-0.1 to 0.25 MPa pressure).

2Process steps: (1) High-pressure spray + agitation pre-wash via central spray pipe + spiral guide vanes; (2) Gas-water mixed boiling rinse — bottom compressed-air injectors create bursting bubbles that micro-deform stoppers; (3) Ultrasonic + vacuum debubbling — bubbles in stopper crevices burst, allowing wash water in; (4) Self-circulating fine wash via Nanfang pump and inline filter; (5) Water sampling for QC; (6) WFI rinse; (7) Dry-heat sterilization (Fo ≥ 30 min adjustable) at 135°C with stainless heater coil + Class-100 HEPA hot-air circulation; (8) Cooling via Class-100 fresh air through 0.22 µm respirator until ≤ 50°C; (9) Reverse-rotation auto unloading through closed-system aseptic discharge port.

3Cantilever drum mounting (bearings outside tank) prevents wear-debris contamination.

4Inlet and outlet doors in different cleanroom grades with pneumatic interlock.

Caractéristiques techniques

Caractéristiques de la variante : SED-2YX-R

Caractéristiques

Modèle

SED-2YX-R

Tension

50Hz 380V 3-phase 5-wire

Fluides et énergie

Three-phase 380V 50Hz 5-wire 8.5 kW; purified water ≥ 0.25 MPa, 130 kg/cycle; WFI ≥ 0.25 MPa, 150 kg/cycle; clean compressed air; Class-100 fresh air ~80 m³/cycle; drains DN65 / DN80 (304); WFI inlet DN38; PW inlet DN38

Détails de conformité

Inlet and outlet doors located in different cleanroom grades with pneumatic interlock to prevent cross-contamination. Tank wetted surfaces all radius-transition, no dead corners, no residue, mirror-polished Ra ≤ 0.4 µm. Sanitary-grade pipes inside-and-outside polished; argon-protected automatic welding. Utility requirements per cycle: purified water 130 kg @ ≥ 0.25 MPa; WFI 150 kg @ ≥ 0.25 MPa; Class-100 fresh air 80 m³.

Puissance

8.5 kW

Dimensions

Longueur

1800 mm

Largeur

1500 mm

Hauteur

2000 mm

Poids

2000 kg

Emprise au sol

1800 × 1500 × 2000 mm (10,000-pc batch model). Larger batch sizes increase footprint.

Matériaux

Matériaux en contact

316L stainless steel (drum) mirror-polished Ra ≤ 0.4 µm; 304 stainless steel (tank, central spray, gas wash, breather, discharge spirals); PTFE (sanitary soft seal); cemented carbide (mechanical seal); chlorine-free aluminum silicate insulation

Matériaux du bâti

304 stainless steel 1.5 mm shell; carbon steel channel frame; 304 stainless steel brushed exterior panels

Caractéristiques principales

4th generation, designed to 2010 GMP + EU cGMP + US FDA

Throughput 20,000 pcs/shift; 1–1.5 hour cycle

Handles rubber stoppers, lyo stoppers, aluminum caps and composite caps

Combined cleaning: high-pressure spray + air-water boiling rinse + ultrasonic + self-circulating fine wash + WFI rinse

Dry-heat sterilization Fo ≥ 30 min adjustable, 135°C tank design temperature

Hot-air assist drying via Class-100 HEPA + stainless heater coil at 120°C

Cooling via Class-100 fresh air through 0.22 µm respirator to ≤ 50°C

Reverse-rotation spiral discharge; sealed aseptic port option

Cantilever drum support — bearings outside tank prevent wear-debris contamination

Drum: 316L stainless steel, deburred punched holes, mirror-polished Ra ≤ 0.4 µm

Tank: design pressure -0.1 to 0.25 MPa; chlorine-free aluminum silicate insulation 50 mm

30–35% drum loading rate

All process valves changed from solenoid to pneumatic diaphragm (lower noise, longer life)

Inlet and outlet doors in different cleanrooms with pneumatic interlock (anti-cross-contamination)

Optional Class-100 isolator at outlet with FFU + glove ports + air-quality monitoring

Vacuum or manual feeding; spring-return self-aligning feed door (anti-spill)

PLC + colour LCD touchscreen with 3-tier password rights, electronic signature and electronic record (21 CFR Part 11 alignment)

Independent CIP/SIP — 4 swappable 360° wash balls inside tank

Cylinder dimensions Ø600 × 800 mm (drum); Ø870 × 1000 mm (tank)

Power 8.5 kW, 50 Hz 380V 3-phase 5-wire; weight ~2000 kg

Five-step cleaning + sterilize + dry + cool + discharge in one closed cycle

Cantilever drum design eliminates wear-particle contamination from bearings

Designed and built to GMP + cGMP + FDA — operating in 30 Chinese provinces and exported abroad

Optional Class-100 outlet isolator for true aseptic discharge

Siemens PLC + HMI with electronic-signature 21 CFR Part 11 alignment

All sanitary-grade polished pipes; argon-protected automatic welding throughout

Applications

Cleaning and sterilizing rubber stoppers and aluminum caps for powder injectables

Cleaning lyo stoppers for lyophilized injectables

Cleaning stoppers for water-injection ampoules, oral solution, and large-volume infusion bottles

Pharmaceutical primary-packaging component preparation under GMP

Secteurs

Pharmaceutical (injectable, lyophilized, oral solution, large-volume infusion)

Sterile primary packaging component cleaning

Marques des composants

PLC + colour LCD HMI: Siemens 6AV6 643-OCD01-1AX1 (Germany)

Programmable module: Siemens 6ES7 221-1BF22-0XA8 (Germany)

PLC expansion: Siemens 6ES7 222-1HF22-0XA8 (Germany)

Bus connector: Siemens 6ES7 972-0BA12-0XA0 (Germany)

Relay LY2NJ ×27: Siemens (Germany)

AC contactor 3TB4142 ×3: Schneider (France)

VFD: Delta (Taiwan)

Cycloidal reducer XWY5-87-0.75: Zibo Reducer Plant (China)

Booster water pump MHI40-4-1/E/3-400-50: Nanfang CNP (China)

Air triplet AFC3000: Taiwan

Steam trap CS19W sanitary: Sino-foreign Shanghai JV (China)

Mechanical seal — acid/alkali-resistant cemented carbide: Wenzhou Mechanical Seal (China)

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Conformité

GMP (China 2010)

EU cGMP

US FDA

21 CFR Part 11 alignment (electronic signature + electronic record + 3-tier password)