Pharmaceutical ultra pure water distribution system
Ensure stringent purity standards with a modular water distribution system designed to seamlessly integrate into aseptic processing, facilitating compliance with regulatory requirements while optimizing utility consumption.
The industrial freeze dryer from TRUKING TECHNOLOGY LIMITED is expertly designed for biopharmaceutical applications requiring precise moisture removal. This freeze dryer utilizes an advanced sublimation process, ideal for stabilizing sensitive products such as vaccines, insulin, and protein therapeutics. With its modular architecture, it seamlessly integrates into existing production lines, ensuring high throughput and efficiency. Its automation, powered by an industrial PC with 21 CFR Part 11 compliance, facilitates remote monitoring and control. Compliant with cGMP and FDA standards, the dryer guarantees product integrity and regulatory adherence. The inclusion of Clean-In-Place (CIP) features reduces downtime, ensuring swift, contamination-free maintenance. Available in various materials, including stainless steel, it offers excellent corrosion resistance, tailored to withstand rigorous pharmaceutical environments. Customizable options and engineering support ensure the equipment meets unique processing requirements, providing a reliable solution to biopharmaceutical moisture stabilization challenges.
Benefits
- Ensures product stability and potency with precise moisture control.
- Reduces labor costs with automated, remote monitoring capabilities.
- Minimizes downtime through efficient Clean-In-Place (CIP) systems.
- Offers customizable material options for enhanced corrosion resistance.
- Ensures regulatory compliance with cGMP and FDA standards.
- Applications
- Small volume parenterals (svp),Injectable formulations,Biopharmaceuticals,Traditional chinese medicine,Large volume parenterals (lvp),Bioengineering applications,Oral liquid formulations,Aseptic processing,Diagnostic reagents,Pharmaceuticals
- End products
- Fermentation broths,Antibiotic solutions,Vaccines,Tinctures and extracts from chinese herbs,Hematology reagents,Insulin,Sterile water for injections,Lyophilized powders,Oral suspension syrups,Ophthalmic solutions,Herbal extracts,Parenteral nutrition solutions,Protein therapeutics,Diagnostic elisa kits,Intravenous saline solutions
- Steps before
- Purification,Concentration,Extraction,Reaction,Crystallization
- Steps after
- Sterilization,Packing,Inspection,Leakage Testing,Tablet Pressing
- Input ingredients
- pharmaceutical raw materials,food industry raw materials,bulk water for processing
- Output ingredients
- ultra-pure water,pharmaceutical-grade water,food-grade water,purified water for aseptic processing
- Compliance
- cGMP,FDA,ISPE
- Automation
- Industrial PC control with Audit trail,data integrity
- Operation
- Online CIP and SIP from one touch HMI
- Water Quality
- Ultra pure water systems
- Distribution Skid
- Modular for PW,WFI
- Remote Access
- Compliant with 21 CFR Part 11
- Modular distribution skids
- PW,WFI
- Ease of operation
- High
- Ease of maintenance
- High
- Automation level
- Industrial PC control
- Audit trail
- Yes
- Data integrity
- Yes
- Graphical debugging
- Yes
- Remote access
- Compliant with 21 CFR Part 11
- CIP/SIP
- Online from one touch HMI
- Compliance
- cGMP,ISPE,FDA
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Control Panel Type
- Industrial PC control
- Compliance,Certifications
- cGMP,ISPE,FDA
- Integration Possibilities
- Audit trail,data integrity
- Remote Access
- 21 CFR Part 11 compliance
- HMI Type
- One-touch HMI
- Online CIP/SIP
- Yes
- 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.