Pharmaceutical-grade Pw storage and distribution system
Ensure consistent purity and compliance in your pharmaceutical water production with a modular, customizable storage and distribution system tailored to meet stringent sterilization and documentation requirements.
Stores and Distributes Purified Water
The PW Storage and Distribution SKID System from AUSTAR is designed for the precise handling of purified water in biopharmaceutical and pharmaceutical settings. This modular and customizable system utilizes a professional modular 3D design, ensuring both efficiency and ease of integration within your existing clean utility infrastructure. It supports multiple sterilization modes, including hot water, ozone, pure steam, and 121℃ superheated water sterilizations, to meet diverse production needs. Engineered with components from reputable global brands, the system guarantees long-term stability and reliability. Its automation is optimized according to GAMP5 standards, adding layers of stability and traceability through a comprehensive documentation system. The PW SKID system is rigorously tested to align with FDA cGMP, EU GMP, WHO GMP, and SFDA GMP standards, ensuring compliance with stringent industry regulations. Furthermore, it includes robust cleaning and maintenance capabilities, facilitating user-friendly operation and minimal downtime through its sophisticated engineering support options.
Benefits
- Ensures regulatory compliance with GMP standards, supporting quality assurance and safety in production.
- Offers flexibility through customizable sterilization options, accommodating various production requirements.
- Enhances operational efficiency by maintaining continuous and reliable purified water supply.
- Minimizes maintenance time and costs with user-friendly design and high-quality components.
- Supports traceability and process validation with GAMP5-optimized automation and documentation.
- Applications
- Aseptic containment products,Pharmaceutical formulation technology,Clean utilities,Biopharmaceuticals,Pharmaceutical process contamination control
- End products
- Vaccines,Sterile injectables,Aseptic vials,Biopharmaceutical formulations,Monoclonal antibodies,Purified water for pharmaceutical use,Freeze-dried pharmaceuticals
- Steps before
- Water Purification,Component Selection,Modular 3D Design Customization,System Design with Sterilization Modes,Program Optimization
- Steps after
- Verification and Testing Activities,Sterilization,FDA cGMP Compliance,EU GMP Compliance,WHO GMP Compliance,SFDA GMP Compliance
- Input ingredients
- Output ingredients
- 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.
- Modular Design
- 3D Design
- Sterilization Mode
- Hot Water / Ozone / Pure Steam / 121℃ Superheated Water
- Compliance Standards
- GAMP5
- Verification,Testing
- RA/DQ/IQ/OQ
- GMP Compliance
- FDA / EU / WHO / SFDA
- Sterilization methods
- Hot water,ozone,pure steam,121℃ superheated water
- Modular design
- 3D design
- System traceability
- Complete documentation according to GAMP5
- Verification and testing
- Risk assessment,DQ,IQ,OQ
- Compliance
- FDA cGMP,EU GMP,WHO GMP,SFDA GMP
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Footprint
- Compact
- Structure
- Modular 3D Design
- Appearance
- Pleasant
- Tank shape
- Customizable
- Operator-friendliness
- High
- Daily maintenance
- Convenient
- Sterilization modes available
- Hot water,ozone,pure steam,121℃ superheated water
- Customization
- Available
- Material
- Components from well-known brands
- Design Compliance
- GAMP5
- Compliance,Certifications
- FDA cGMP,EU GMP,WHO GMP,SFDA GMP
- Customization Options
- Modular 3D design
- Sterilization Modes
- Hot water / Ozone / Pure steam / 121℃ superheated water
- Component Brand Selection
- Well-known global brands
- Operation System
- Optimized with GAMP5
- Documentation System
- Complete for traceability
- Verification and Testing Activities
- RA/DQ/IQ/OQ