Citrein 50 Hot Sterilant (Citric Acid 50%)

Citrein 50 Hot Sterilant (Citric Acid 50%)

1. Key Benefits

Citrein 50 is a liquid concentrate for the citric thermal disinfection, cleaning, and decalcification of hemodialysis machines, providing comprehensive machine maintenance in a single solution. The high-strength 50% citric acid concentration delivers powerful thermal disinfection and scale removal for hemodialysis equipment while being safe, efficient, and biodegradable. The solution effectively combines three critical functions: sterilization, cleaning, and decalcification, ensuring optimal machine performance and extending equipment lifespan.

2. Indications

Citrein 50 (Citric Acid 50%) Hot Sterilant is indicated for:

• Thermal disinfection of hemodialysis machine fluid pathways
• Cleaning and decalcification of dialysis equipment
• Heat sterilization protocols in renal care facilities
• Regular maintenance of Fresenius and other dialysis machines with hot sterilization provision
• Prevention of mineral buildup and biofilm formation
• Comprehensive disinfection cycles as part of infection control protocols

3. How it Works

Thermal Disinfection Mechanism: Citric acid works through thermal disinfection at elevated temperatures (83°C), where the combination of heat and acid creates a hostile environment for microorganisms. The solution achieves comprehensive microbial kill through protein denaturation and cellular disruption at high temperatures.

Decalcification Action: The citric acid chelates calcium and magnesium ions, effectively dissolving mineral deposits and scale buildup in machine fluid pathways, maintaining optimal flow rates and preventing equipment damage.

Multi-Modal Action: Working concentration of 3% Citric Acid 50% at 83°C with 15-minute exposure time provides bactericidal, fungicidal, tuberculocidal, and virucidal properties including effectiveness against HBV, HCV, and HIV.

4. Quality and Safety

Manufacturing Standards: Available from multiple manufacturers including B. Braun, Nipro, and other medical device companies, produced under strict pharmaceutical standards ensuring consistent quality and performance.

Regulatory Compliance: Meets European standards EN 13727/14561, EN 13624/14562, EN 14348/14563, and EN 14476, demonstrating comprehensive antimicrobial efficacy at specified conditions.

Environmental Safety: Biodegradable formulation that breaks down safely after use, reducing environmental impact while maintaining superior disinfection performance.

Quality Assurance: Each batch undergoes rigorous testing to ensure consistent concentration and antimicrobial effectiveness, with documented test reports verifying performance standards.

5. Important Considerations

Operating Parameters:

• Temperature: 83°C for optimal disinfection
• Exposure Time: 15 minutes minimum contact time
• Working Concentration: 3% dilution of Citric Acid 50%
• Packaging: Available in 6L and 10L canisters for facility convenience

Antimicrobial Spectrum:

• Bactericidal: Effective against vegetative bacteria
• Fungicidal: Active against fungal pathogens
• Tuberculocidal/Mycobacteriacidal: Kills mycobacteria including TB
• Virucidal: Inactivates enveloped and non-enveloped viruses including hepatitis viruses and HIV

Usage Protocol:

• Dilute concentrate to working concentration per manufacturer instructions
• Ensure adequate temperature (83°C) and contact time (15 minutes)
• Follow machine-specific protocols for thermal disinfection cycles
• Complete with appropriate rinsing procedures post-disinfection

Storage Requirements:

• Store concentrate in cool, dry environment
• Protect from extreme temperatures and direct sunlight
• Keep containers tightly closed when not in use
• Check expiration dates and rotate stock appropriately

Safety Precautions:

• Handle concentrate with appropriate personal protective equipment
• Ensure adequate ventilation during preparation and use
• Follow facility protocols for chemical handling and disposal
• Monitor temperature and timing parameters for effectiveness

Professional Considerations:

• Requires trained personnel familiar with thermal disinfection procedures
• Integration with overall machine maintenance and infection control programs
• Regular monitoring of solution concentration and temperature parameters
• Documentation of disinfection cycles for quality assurance

Professional Note: Citrein 50 Hot Sterilant represents a comprehensive solution for hemodialysis machine maintenance, combining powerful disinfection with essential cleaning and decalcification functions. Healthcare facilities should ensure proper training, monitoring, and documentation protocols to maximize effectiveness and maintain patient safety standards.

References

1. Citric Acid 50% Liquid Machine Disinfection – B. Braun Product Documentation
2. 50% Citric Acid Thermal Disinfection – B. Braun USA Technical Specifications
3. Voda Feelpure Dialysis Machine Disinfectant Citric Acid 50% Solution – Product Information
4. CA-50 50% Citric Acid Solution – Nipro Medical Corporation
5. Citrosil Hot Sterilization System – Surni Product Documentation
6. Citric Thermal Disinfection Standards – HemaSource Technical Data
7. European Standards EN 13727/14561, EN 13624/14562, EN 14348/14563, EN 14476