Water Filtration Contract - Attachment B - Testing Requirements.pdf

e) ineffective cleaning/disinfection due to water contaminants interfering with device processing chemicals.

6 Categories of water quality for medical device processing

6.1 Introduction

The water quality needed for the various stages of medical device processing is determined by the type of medical device and by the disinfection or sterilization process used. For example, the processing of stainless steel surgical instruments that are steam sterilizable has different water quality requirements than the processing of flexible endoscopes, which require high-level disinfection or low-temperature sterilization.

6.2 Three categories of water quality

Table 2 describes three categories of water quality in terms of the characteristics that are important for medical device processing and the level of treatment that may be needed:

a) Utility Water: water as it comes from the tap that can require further treatment at the facility to achieve water quality measurement values outlined in Table 2. This water is mainly used for flushing, washing, and intermediate rinsing (e.g., rinsing between cleaning and disinfection).

NOTE The decision regarding the need to treat incoming tap water to provide adequate water quality for medical device processing should be undertaken in every facility that processes medical devices.

b)- Critical Water: water that meets the water quality measurement values detailed in Table 2; to achieve these values, the water generally requires extensive treatment by a multi-step process that can include a pretreatment, does include primary treatment (e.g., RO and/or DI), storage, distribution, and can include final treatment to provide a level of assurance that microorganisms and inorganic and organic material are removed from the water. See section 8.3.2.2 for recommended treatment methods. This water is mainly used for the final rinse after high-level disinfection, for the final rinse for critical devices prior to sterilization and feedwater for process steam production.

NOTE Using Critical Water for all stages of medical device processing can be unnecessary, costly, and can cause damage to water system or processing equipment (see Annex D).

c) Steam: vaporized water that is produced by a centralized boiler or a generator/heat exchanger near the sterilizer. When the steam is tested as a condensate, it should meet the specified criteria as defined in Table 2.

NOTE See i Annex D for additional information.

Utility Water is predominantly used for medical device processing with the exception of final rinse, where Critical Water is recommended. At the point of production, Utility Water and Critical Water should meet the requirements as specified in Table 2. Tap water can require treatment to meet these requirements. The bacteria level for Critical Water in Table 2 (< 10 CFU/mL [< 10,000 CFU/L]) is consistent with the Clinical & Laboratory Standards Institute (CLSI) guidelines.

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© 2023 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST108;2023 17 cosgroveca Highlight cosgroveca Highlight cosgroveca Highlight

Table 2—Categories and performance qualification levels of water quality for medical device processing

Water Quality Measurement Units Utility Water Critical Water Steam* pH @ 25 °C: pH 6.5 - 9.5 5.0 - 7.5 5.0 — 9.2**

Total Alkalinity mg CaCO3/L <400 <8 <8

Bacteria CFU/mL <500*** <10 N/A

Endotoxin EU/mL N/A*** <10 N/A Total Organic Carbon

(TOC) mg/L (ppm) N/A <1.0 N/A

Color and Turbidity Visual Colorless, clear, without sediment

Colorless, clear, without sediment

Colorless, clear, without sediment

Ionic Contaminants

Aluminum mg/L <0.1 <0.1 <0.1

Chloride mg/L <250 <1 <1

Conductivity µS/cm <500 <10 <10

Copper mg/L <0.1 <0.1 <0.1

Iron mg/L <0.1 <0.1 <0.1

Manganese mg/L <0.1 <0.1 <0.1 , Nitrate mg/L <10 <1 <1

Phosphate mg/L <5 <1 <1

Sulfate mg/L <150 <1 <1

Silicate mg/L <50 <1 <1

Total Hardness mg CaCO3/L <150**** <1 <1

Zinc mg/L <0.1 _ <0.1 <0.1

* Steam parameters are for monitoring as steam condensate **See 6:3 a) for specifics. For local steam generation, the condensate pH should be 5.0 to 7.5. For boiler-treated steam, most boilers should be treated to maintain a condensate pH of 7.5 to 9.2 ***When Utility Water is used after chemical high-level disinfection as a final rinse, the bacteria should be <10 CFU/mL and endotoxin <10 EU/mL **** If hardness is greater than 150 mg/L a water softener is recommended unless used for washing where the cleaning chemistry is capable of handling higher levels of hardness

6.3 Rationale for Table 2 water quality parameters and other considerations:

a) pH: Water having extremes in pH can cause damage of device surfaces. In addition, an extreme pH can interfere with the efficacy of cleaning agents and disinfectants (see E.2.18). Utility water is expected to have a pH in the range of 6.5 to 9.5. The pH of the water will be dependent on the disinfection chemistry (e.g., chlorine, monochloramine) and water treatment strategy of the local municipality. Potable water is typically in the higher portion of this range. For Critical Water the specification is based upon typical values for the water produced. For boiler-treated steam that travels through an extensive distribution network that can be oxidized (e.g., black iron), acidic pH can result in corrosion of the piping and transfer of rust to the sterilizer load, therefore pH should be controlled to maintain a pH of 7.5 to 9.2. For steam produced by a dedicated generator the pH can be in the range of 5.0 to 7.5 (see EN 285).

b) Alkalinity: Total alkalinity is the measure of dissolved solids which are alkaline in nature such as bicarbonate, carbonate, and hydroxide. High alkalinity levels increase the tendency of hard water salts to form scale. High alkalinity in the final rinse water increases potential for concentration of alkaline dissolved solids onto the device during drying. This dried alkaline residue can then be reactivated under the high temperature and humidity conditions of a steam sterilizer causing devices to become stained or corroded. The performance of

18 © 2023 Association for the Advancement of Medical Instrumentation • ANSI/AAMI ST108:2023 birrieltorresgj processing department, infection prevention and control) and integrated into the overall quality process in the health care facility. Variables in the system may be controlled to achieve assurance of product quality and process efficacy.

Monitoring frequency will vary, depending on the quality improvement goals, the health care facility policies and procedures for the handling of unfavorable or unplanned events, and the type of process variable.

An investigation should be conducted for any problem relating to any aspect of water quality. Problems and updates should be reported to those involved with medical device processing.

There should be a planned, systematic, and ongoing process for verifying compliance with procedures. Quality processes can be enhanced by audits that are conducted on a regular basis. The information from these activities should be summarized and made available to individuals, groups, or teams as needed.

Table 5 and Table 6 describe the water quality monitoring that shall be performed as part of a quality improvement process within their area. Continuous quality improvement involves conducting risk analyses (see Clause 5).

Table 5—Frequency for water quality monitoring at water generation system

Water quality measurement Type of testing

Routine monitoring sampling site

Minimum frequency of testing*

Utility Water Critical Water pH pH meter** or Colorimetric dipsticks (sample tested within 15 minutes)

After the last treatment step

Quarterly Monthly

Conductivity Conductivity meter (in line or by measurement of a collected sample)

After the last treatment step, Storage tanks (if used)

Quarterly Daily

Total Alkalinity Colorimetric dipsticks Alkalinity test kit**

After the last treatment step, storage tanks (if used)

Quarterly Monthly

Total Hardness

Determination of ppm as CaCO3 by Calorimetric dipsticks, Titration kit**, or Handheld meter**

After the last treatment step

Quarterly Monthly

Bacteria Heterotrophic plate count (see Annex H)

Loop out and loop return points

N/A Monthly

Endotoxin LAL test (see Annex H) Loop out and loop return points

N/A Monthly

*NOTE 1 The recommendations for frequency of testing in this table are the recommended minimum frequency. If problems or issues arise with the water quality, it may be necessary to increase the frequency until they are resolved.

*"NOTE 2 When using these tests, the user should carefully follow the manufacturer's written IFU for accurate results. When measuring Critical Water levels, the water sample must be filled to the brim for these test kits, sealed and, if the sample is hot, allowed to cool to room temperature before testing. Testing within 15 minutes of sample collection prevents carbon dioxide absorption that can result in'an inaccurate pH.

34 © 2023 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST108:2023 cosgroveca

Table 6—Frequency for water quality monitoring at point-of-water-use

Water quality measurement Type of testing

Routine monitoring sampling site

Minimum frequency of testing*

Utility Water

Critical Water

Steam pH_ pH meter** or Colorimetric dipsticks (sample tested within 15 minutes)

At the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Conductivity Conductivity meter** or Colorimetric dipsticks

At the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Total Alkalinity Colorimetric dipsticks or Alkalinity test kit**

At the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Total hardness

Determination of ppm as CaCO3 by Calorimetric dipsticks, Titration kit** ,or Handheld meter**

At the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Bacteria Heterotrophic plate count (see Annex H)

Each location of point-of-use in department

Quarterly Monthly N/A

Endotoxin LAL test (see Annex H) Each location of point-of-use in department

N/A Monthly N/A

Visual Inspection

Visual Inspection of inside of equipment - Look for residue, staining, scaling, and discoloration (Annex I)

Spray Arms/Inside Chamber Walls/Inside Interior of Machine

Daily Daily Daily

*NOTE 1 The recommendations for frequency of testing in this table are the recommended minimum frequency. If problems or issues arise with the water quality, it may be necessary to increase the frequency until they are resolved.

**NOTE 2 Test type needed to measure Critical Water and Steam levels. Steam condensate must be filled to the brim, sealed, and allowed to cool before testing to prevent carbon dioxide absorption.

The minimum frequency of testing aligns with established water monitoring programs performed during medical device manufacturing. Device processing is an extension of the medical device supply chain, so a continuation of the water quality requirements is necessary for continued patient safety. The testing frequency described in Table 5 and Table 6 are recommended minimum frequencies to demonstrate the water system remains in a state of control. The risk assessment performed by the multidisciplinary team may identify sampling points that will require an increase in testing frequency (e.g., less frequently used point-of-use, portion of circulation loop containing a dead-leg).

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