Gmp steam sterilizer for pharmaceutical applications

Ensure consistent sterilization and contamination control across your production line with advanced temperature management and automated operations, safeguarding the integrity of pharmaceutical products from pre-filled injections to textile equipment wraps.

Sterilizes and Filters Pharmaceutical Components

AUSTAR’s GMP Steam Sterilizer is engineered to meet the rigorous demands of pharmaceutical and biotech sterilization processes. Featuring a full jacket design constructed from AISI 316L stainless steel, this sterilizer ensures optimal chamber temperature distribution with a precision of ±0.5℃. Equipped with a reliable PLC control system from Allen-Bradley or Siemens, it provides automated cycle management with a user-friendly touch screen interface.

Designed to sterilize a wide array of components, including pre-filled injections, vials, ampoules, and pharmaceutical rubber stoppers, it is vital for maintaining sterility in production lines. With a range of models from 270L to 10m³+, it offers customizable solutions for various production scales. The system utilizes a 0.2μm hydrophobic air filter for high-pressure sterilization and cooling, ensuring contamination-free filtration.

This steam sterilizer is compatible with diverse operational processes, operating efficiently in batch modes with PID-controlled temperature adjustments. Compliant with GMP standards, it supports up to 20 adjustable sterilization procedures to cater to different sterilization requirements. Optional customization and engineering support are available, ensuring alignment with your specific production needs.

With built-in automatic diagnostics and cycle data integrity checks, the GMP Steam Sterilizer reduces operational downtime, maintaining continuous high-quality output in your pharmaceutical applications.

Benefits

  • Enhances contamination control with precise temperature and filtration management.
  • Reduces labor intensity and errors with automated, PLC-controlled operations.
  • Supports diverse sterilization needs with customizable procedure settings.
  • Ensures compliance with stringent industry standards, including GMP.
  • Minimizes operational downtime with robust diagnostics and maintenance features.

General


Applications
Biopharmaceuticals,Detergents,Liquid formulations,Pharmaceutical tablets
End products
Pharmaceutical rubber stoppers,Vials,Pre-filled injections,Ampoules,Textile wraps for equipment,Detergent bottles
Steps before
Cleaning,Preparation of items,Loading items into sterilizer
Steps after
Packing,Quality inspection,Storage
Input ingredients
filter covers,filters,equipment components,textiles,rubber plugs,bagged products,liquids in ventilated or sealed containers,pre-filled injections,vials,ampoules
Output ingredients
sterilized filter covers,sterilized filters,sterilized equipment components,sterilized textiles,sterilized rubber plugs,sterilized bagged products,sterilized liquids,sterilized pre-filled injections,sterilized vials,sterilized ampoules
Market info
Austar is known for specializing in the design and manufacture of engineered-to-order industrial equipment, particularly in the pharmaceutical and biotechnology sectors, offering solutions that focus on quality, innovation, and meeting specific customer requirements.

Technical Specifications


Chamber temperature distribution
±0.5℃
Chamber Structure
AISI 316L stainless steel with full jacket design
Control System
Allen-Bradley or SIMENS PLC
Air Filtration
0.2μm hydrophobic air filter
Drainage water cooling
60℃ or below
Temperature Control
PID controls with exchange rate adjustment on-off valve
User Access Levels
5 access level passwords
Procedures
20 adjustable procedures
Model Capacity Range
270L to 10m³+
Communication Interface
Standard,compatible with most PC peripherals
Automatic Diagnosis
Control program and cycle data integrity
Sterilization Capability
Filter covers,equipment components,textiles,etc.

Operating Characteristics


Temperature Control Accuracy
±0.5℃
Automation Level
PLC-controlled
Air Filtering System
0.2μm hydrophobic air filter
User Access Levels
5 user access level passwords
Program Adjustability
20 adjustable procedures
Temperature Control Method
PID controls
Model Range
270L to 10m3+
Water Cooling System
Drainage water cooling to 60℃ or below
Communication Interface
Standard communication interface compatible with most PC peripherals
Automatic Diagnosis
Yes

Material Compatibility


Corrosive resistance (e.g. acids)
AISI 316L stainless steel
Biological compatibility
Yes,suitable for sterilizing items in the pharmaceutical and bioprocess industries
Cleanability
Designed with full jacket structure for enhanced cleanability
Density/particle size
Compatible with items of various sizes and densities
Abrasion resistance
AISI 316L stainless steel provides abrasion resistance

Product type Characteristics


Sterilizable Items
Filter covers,textiles,liquids in containers

Physical Characteristics


Chamber temperature distribution
±0.5℃
Chamber structure
AISI 316L stainless steel with full jacket design
Model size range
270L to 10m³+

Custom Options


Control System
Allen-Bradley or SIMENS PLC control system
Chamber Size
270L to 10m3 + sterilization cabinets
User Access Level
5 user access level passwords
Sterilization Procedures
20 adjustable procedures
Communication Interface
Standard communication interface compatible with PC peripheral equipment
Air Filtration
0.2μm hydrophobic air filter
Control Panel
Color touch screen and printer
Temperature Control
PID controlled