Washing machine for pharmaceutical stoppers and caps

Streamline your aseptic processing with precise washing, sterilization, and siliconization of stoppers and caps, designed to maintain critical sterility and ensure seamless integration into your pharmaceutical production lines.

Processes and Sterilizes Pharmaceutical Stoppers

The Stopper Processing Machine from TRUKING stands out for its comprehensive washing, sterilization, and siliconization capabilities tailored for pharmaceutical applications. It incorporates automated vacuum-assisted loading and unloading systems, enhancing operational efficiency in high-speed production environments. This machine caters specifically to applications like injectable and pre-filled syringe production, ensuring precision in the siliconization process for uniform stopper coverage.

Capable of processing various end-products such as vaccines, biologics, and saline solutions, it ensures that each stopper meets strict aseptic criteria. The machine is compliant with GAMP, cGMP, and FDA standards, underscoring its suitability for stringent pharmaceutical and biotech manufacturing environments. Its design includes a liquid ring pump for noise reduction and a unique chamber door sealing device that preserves internal pressure during power failures, guaranteeing operational reliability.

Featuring real-time monitoring of crucial parameters like temperature and pressure and industry-standard 21 CFR Part 11 compliance for data integrity, the machine ensures transparent operations. Constructed with high-quality TIG welding and a polished chamber, it’s engineered to resist corrosion and maintain hygienic conditions. Further customization options are available to fit specific production requirements, supported by TRUKING’s engineering expertise.

Benefits

  • Enhances product safety by ensuring aseptic processing of stoppers.
  • Minimizes downtime with automated loading and unloading systems.
  • Improves operational efficiency through precise siliconization techniques.
  • Ensures compliance with GAMP, cGMP, and FDA standards.
  • Maintains data integrity and security with 21 CFR Part 11 compliant systems.

General


Applications
Injectable,Diagnostic reagent filling system,Softbag production,Lyophilization production,Traditional chinese medicine,Bfs production,Pre-filled syringe production,Ampoule production,Oral preparation
End products
Biologics,Vaccines,Insulin,Antibiotics,Saline solutions,Traditional herbal capsules,Oncology drugs,Herbal tinctures,Herbal extracts,Eye drops,Liquid antibiotics,Nasal sprays,Diagnostic kits,Electrolyte solutions,Vitamin infusions,Essential oils
Steps before
Washing,Purification,Preparation
Steps after
Sterilization,Siliconization,Packing,Inspection
Input ingredients
rubber stoppers,siliconization material,caps,liquid for washing,sterile filter
Output ingredients
sterilized rubber stoppers,processed stoppers,siliconized stoppers,washed caps
Market info
Truking is known for manufacturing engineered-to-order pharmaceutical equipment, specializing in liquid and solid preparation systems. They have a strong reputation for innovation and quality in the pharmaceutical machinery sector.

Technical Specifications


Compliance
GAMP,cGMP,FDA
Siliconization Technique
Smart Siliconization
Loading Method
Automatic vacuum assisted
Chamber Surface Finish
Ra ≦0.4µm
Welding Quality
High quality TIG welding
Pump Type
Liquid ring pump with cavity design
Sealing Device
Unique chamber door sealing device
Sterile Filter Testing
Online sterilization and integrity testing
Monitoring
Real-time temperature and pressure monitoring
Control System
Industrial PC control
Compliance Features
Audit trail,data integrity
Access Features
Remote access,21 CFR Part 11 compliance

Operating Characteristics


Automation level
PLC / Industrial PC
Batch vs. continuous operation
Batch
CIP/SIP
CIP
Smart Siliconization technique
Ensures even layer
Automatic vacuum assisted loading
Automatic
Online sterilization
Yes
Integrity testing of sterile filter
Real-time monitoring
Real-time monitoring
Temperature and pressure parameters

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Machine footprint
Customized based on cycle requirements
Chamber type
High quality TIG welded,mirror polished chamber
Control panel type
Industrial PC control
Discharge method
Automatic vacuum assisted out feed system

Custom Options


Control panel type
Industrial PC control
Audit trail feature
Compliant with 21 CFR Part 11
Remote access
Available