Sterile
PROCESSING

ANSI/AAMI ST108 Compliance

Ensuring compliance with ANSI/AAMI ST108 requires accurate water testing and proactive system management. We provide comprehensive water testing services tailored to sterile processing needs.

Sterile Processing: Ensuring Compliance with ANSI/AAMI ST108

Water quality is a critical factor in the reprocessing of reusable medical devices. The Association for the Advancement of Medical Instrumentation (AAMI) has established ANSI/AAMI ST108:2023, a definitive standard that sets water quality requirements for medical device processing. Developed with input from nearly 120 experts, this standard replaces AAMI TIR34:2014/(R)2021 and provides clear guidelines to help healthcare facilities meet best practices.

Expert Water Testing & Customized Solutions

Ensuring compliance with ANSI/AAMI ST108 requires accurate water testing and proactive system management. We provide comprehensive water testing services tailored to sterile processing needs, delivering:

  • Detailed Water Quality Analysis – Testing for key parameters such as pH, microbial content, and conductivity.

  • Custom Troubleshooting Guides – Personalized recommendations based on test results to address water quality issues.

  • Targeted Solutions – Practical guidance to optimize water treatment systems, ensuring compliance and efficiency.

Key Aspects of ANSI/AAMI ST108

This standard defines essential water quality and steam purity benchmarks for effective medical device processing. It covers:

  • Defined Water Quality Levels: Specifies the appropriate water quality for each stage of sterile processing.

  • Risk Management & Accountability: Establishes responsibilities for processing facilities and incorporates risk assessment.

  • Quality Metrics: Provides measurable criteria for water properties, including pH, microbial content, and conductivity.

  • System Maintenance & Monitoring: Outlines procedures for maintaining and improving water treatment systems.

  • Emergency Protocols: Addresses how to respond to disruptions such as boil water advisories or other interruptions.

By integrating expert water testing and customized troubleshooting strategies, We help healthcare facilities navigate ANSI/AAMI ST108 requirements, enhance patient safety, and ensure long-term compliance.

What Are Endotoxins?

Endotoxins are toxic components found in the outer membrane of certain bacteria, especially gram-negative bacteria. When these bacteria break down or die, endotoxins are released into the water and can trigger strong immune responses in humans, particularly in sensitive environments like hospitals or pharmaceutical settings. Effective removal of endotoxins is crucial in maintaining high-purity water systems. ST108 is specifically designed to reduce endotoxin levels, helping facilities meet strict water quality standards.

What is Total Organic Carbon (TOC)?

Total Organic Carbon (TOC) is a key indicator of the amount of organic compounds present in water. These compounds can come from natural sources like plant material or from man-made sources such as pharmaceuticals, industrial waste, or disinfectants. TOC doesn’t measure individual contaminants—instead, it gives a general sense of how much organic matter is in the water. High TOC levels can impact water treatment processes, contribute to biofilm growth, and reduce system efficiency. Monitoring and controlling TOC is essential in high-purity water systems, especially in healthcare, pharmaceutical, and laboratory settings.

Bacterial Concerns vs. General Water Quality Issues: Understanding the Difference

Bacterial Issues – Immediate Action Required

If bacterial contamination is detected in the ST108 system, it requires immediate shutdown and corrective action. Bacteria, especially endotoxin-producing strains, pose serious health risks and can rapidly compromise water safety. Signs of bacterial issues may include:

  • Positive microbial test results

  • Increased endotoxin levels

  • Biofilm formation or visible slime

What to Do:

  1. Stop system use immediately to prevent exposure.

  2. Flush and disinfect the system per protocol.

  3. Investigate root causes, such as stagnant water, biofilm buildup, or a breach in system integrity.

  4. Retest after corrective actions before resuming operation.

Out-of-Range General Water Quality – Manage, but Continue Operation

Water quality parameters like TOC, conductivity, or minor discoloration may drift out of spec, but these are typically cosmetic or efficiency concerns rather than immediate health threats. While these issues should be corrected, they do not require stopping use of the system unless they indicate a developing bacterial problem.

Common General Water Quality Issues & Responses:

  • High TOC Levels – May encourage bacterial growth over time; check filtration and adjust pretreatment.

  • Slight Discoloration or Staining – Often caused by minerals; investigate source, but continued use is usually fine.

  • Elevated Conductivity – Could indicate scaling or system inefficiency; monitor and adjust accordingly.

Contact TCS Today

If you need expert help to develop a compliant and effective water management plan for your facility, contact us today.

    Service(s) Required:

      NY Compliance  Water Mgmt Plans  Domestic Water  HVAC/Process Systems

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    16 Wassell Lane
    Westport, CT 06880

    (203) 726-0716