SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System

K190104 · Steris Corporations · MED · Mar 22, 2019 · General Hospital

Device Facts

• Record ID: K190104
• Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
• Applicant: Steris Corporations
• Product Code: MED · General Hospital
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended Use

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: 1. Pre-filtration through two pre-filters: - Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. - Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. 2. UV Irradiation: - During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water. 3. 0.1 micron filtration: - The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

Device Story

Automated liquid chemical sterilization system for heat-sensitive medical devices; uses S40 Sterilant Concentrate (peracetic acid) to process loads in 6 minutes at 45.5-60°C. System includes processor, interchangeable trays/containers, and Quick Connects for internal channel access. Processor dilutes sterilant, monitors temperature/contact time, and performs automated rinse cycles using UV-treated, filtered water. Used in healthcare facilities; operated by staff. Provides printed cycle documentation; alarms for out-of-spec parameters (temperature, pressure, conductivity, UV intensity, filter integrity). Ensures sterilization efficacy; reduces sterilant residuals to safe levels via automated rinsing. Benefits patient by providing sterile critical/semi-critical devices.

Clinical Evidence

Bench testing only. Efficacy validated via AOAC Official Methods (966.04, 955.17, 955.14, 955.15, 964.02) and quantitative suspension tests demonstrating sporicidal, fungicidal, bactericidal, virucidal, and tuberculocidal activity. Simulated-use testing showed >6-log reduction of Geobacillus stearothermophilus spores. Biocompatibility and stability testing confirmed non-cytotoxicity and shelf-life compliance for the modified sterilant component.

Technological Characteristics

Microprocessor-controlled liquid chemical sterilizer. Uses peracetic acid (S40 Sterilant Concentrate). Features automated dilution, temperature control (45.5-60°C), and rinse cycles with UV-irradiated, 0.1-0.2 micron filtered water. Includes interchangeable processing trays/containers and Quick Connects. System monitors cycle parameters (time, temperature, pressure, conductivity, UV intensity, filter integrity) and provides printed documentation.

Indications for Use

Indicated for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices and accessories in healthcare facilities.

Regulatory Classification

Identification

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

Special Controls

*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

Predicate Devices

• SYSTEM 1E Liquid Chemical Sterilant Processing System (K180342)
• SYSTEM 1 endo Liquid Chemical Sterilant Processing System (K173256)

Reference Devices

• SYSTEM 1 endo Liquid Chemical Sterilant Processing System (Model 6900) (K182827)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 22, 2019

Steris Corporations Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K190104

Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: Class II Product Code: MED Dated: March 5, 2019 Received: March 6, 2019

Dear Jennifer Nalepka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190104

Device Name

SYSTEM 1E Liquid Chemical Sterilant Processing System

Indications for Use (Describe)

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

* The extensive treatment of EPA potable water consists of:

- 1. Pre-filtration through two pre-filters:
- · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
- · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.

## 2. UV Irradiation:

- During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
- 3. 0.1 micron filtration:
- · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

IX Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Indications for Use

510(k) Number (if known) K190104

### Device Name

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

### Indications for Use (Describe)

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a serif font in black. Below the word is a graphic of several horizontal wavy lines in blue. The registered trademark symbol is in the upper right corner of the logo.

# 510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist Tel: [phone] Fax: [phone]

Summary Date: March 5, 2019

Premarket Notification Number: K190104

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 1. Device Name

| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant<br>Processing System |
|------------------------|-------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical<br>Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |

#### Predicate Device 2.

SYSTEM 1E Liquid Chemical Sterilant Processing System, K180342

#### 3. Description of Device

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate.

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

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S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

#### Indications for Use 4.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semicritical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

- 米 The extensive treatment of EPA potable water consists of:
- 1. Pre-filtration through two pre-filters:
- Pre-filter A is a gross depth filter that removes approximately 2.5 . micron or larger particles/contaminants.
- Pre-filter B is a surface filter that removes particles/contaminants > . 0.1 micron.
- 2. UV Irradiation:
- During transit through the UV water treatment chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
- 3. 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered . through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

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#### 5. Technological Characteristic Comparison Table

The SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device; the specific modification described in this submission is for an alternate supplier for a component of S40 Sterilant Concentrate. The differences between the proposed and predicate devices are limited to the addition of an alternate supplier for a proprietary component of S40 Sterilant Concentrate.

There were no changes to the SYSTEM 1E Processor.

| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor<br>(K180432) | Comparison | | | | | | | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------|
| Indications<br>for Use | The SYSTEM 1E Liquid<br>Chemical Sterilant Processing<br>System is intended for liquid<br>chemical sterilization of<br>cleaned, immersible, and<br>reusable critical and semi-<br>critical heat-sensitive medical<br>devices in healthcare<br>facilities.<br><br>The SYSTEM 1E Processor<br>dilutes the S40 Sterilant<br>Concentrate to its use dilution<br>(>1820 mg/L peracetic acid),<br>liquid chemically sterilizes<br>the load during a controlled<br>6-minute exposure at 45.5 to<br>60°C, and rinses the load with<br>extensively treated* potable<br>water. After completion of a<br>cycle, critical devices should<br>be used immediately; semi-<br>critical devices should be<br>used immediately or may be<br>handled and stored in a<br>manner similar to that of high<br>level disinfected endoscopes.<br>Critical devices not used<br>immediately should be<br>processed again before use.<br><br>The SYSTEM 1E Processor<br>uses only S40 Sterilant | The SYSTEM 1E Liquid<br>Chemical Sterilant Processing<br>System is intended for liquid<br>chemical sterilization of<br>cleaned, immersible, and<br>reusable critical and semi-<br>critical heat-sensitive medical<br>devices in healthcare<br>facilities.<br><br>The SYSTEM 1E Processor<br>dilutes the S40 Sterilant<br>Concentrate to its use dilution<br>(>1820 mg/L peracetic acid),<br>liquid chemically sterilizes<br>the load during a controlled<br>6-minute exposure at 45.5 to<br>60°C, and rinses the load with<br>extensively treated* potable<br>water. After completion of a<br>cycle, critical devices should<br>be used immediately; semi-<br>critical devices should be<br>used immediately or may be<br>handled and stored in a<br>manner similar to that of high<br>level disinfected endoscopes.<br>Critical devices not used<br>immediately should be<br>processed again before use.<br><br>The SYSTEM 1E Processor<br>uses only S40 Sterilant | Identical | | | | | | | |
| | Concentrate to liquid<br>chemically sterilize medical | Concentrate to liquid<br>chemically sterilize medical | | | | | | | | |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor<br>(K180432) | Comparison | | | | | | | |
| | devices. | devices. | | | | | | | | |
| | * The extensive treatment of<br>EPA potable water consists<br>of:<br>1. Pre-filtration through<br>two pre-filters:<br>• Pre-filter A is a gross<br>depth filter that<br>removes<br>approximately 2.5<br>micron or larger<br>particles/contaminants.<br>• Pre-filter B is a surface<br>filter that removes<br>particles/contaminants<br>> 0.1 micron.<br>2. UV Irradiation:<br>• During transit through<br>the UV water<br>treatment chamber, a<br>UV dose sufficient to<br>achieve a ≥ 6-log<br>reduction of MS2 virus | * The extensive treatment of<br>EPA potable water consists<br>of:<br>1. Pre-filtration through<br>two pre-filters:<br>• Pre-filter A is a gross<br>depth filter that<br>removes<br>approximately 2.5<br>micron or larger<br>particles/contaminants.<br>• Pre-filter B is a surface<br>filter that removes<br>particles/contaminants<br>> 0.1 micron.<br>2. UV Irradiation:<br>• During transit through<br>the UV water<br>treatment chamber, a<br>UV dose sufficient to<br>achieve a ≥ 6-log<br>reduction of MS2 virus | | | | | | | | |
| | is delivered to the | is delivered to the | | | | | | | | |
| | water. | water. | | | | | | | | |
| | 3.<br>0.1-micron | 3.<br>0.1-micron | | | | | | | | |
| | filtration: | filtration: | | | | | | | | |
| | • The water prepared by | • The water prepared by | | | | | | | | |
| | pre-filtration and UV<br>irradiation is filtered | pre-filtration and UV<br>irradiation is filtered | | | | | | | | |
| | through redundant, | through redundant, | | | | | | | | |
| | 0.1-micron (absolute | 0.1-micron (absolute | | | | | | | | |
| | rated) membranes to | rated) membranes to | | | | | | | | |
| | remove bacteria, fungi | remove bacteria, fungi | | | | | | | | |
| | and protozoa > 0.1 | and protozoa > 0.1 | | | | | | | | |
| | micron. | micron. | | | | | | | | |
| Feature | Proposed Device<br>SYSTEM 1E Processor | Predicate Device<br>SYSTEM 1E Processor<br>(K180432) | Comparison | | | | | | | |
| Operating<br>Principles/<br>Technology | A microprocessor controlled<br>unit with interchangeable<br>processing trays/containers.<br>The processor lid opens to<br>reveal the processing<br>chamber in which the load is<br>placed. Devices with internal<br>lumens are interfaced with the<br>processor using connectors.<br>Sterilant Concentrate is<br>placed in a specialized<br>compartment and when the<br>processor fills with water, it<br>creates the sterilant use<br>dilution from the single use<br>sterilant cup. The processor<br>monitors and controls the use<br>dilution temperature and<br>contact time. The processor<br>automatically rinses the load<br>with extensively treated water<br>to remove sterilant residuals. | A microprocessor controlled<br>unit with interchangeable<br>processing trays/containers.<br>The processor lid opens to<br>reveal the processing<br>chamber in which the load is<br>placed. Devices with internal<br>lumens are interfaced with the<br>processor using connectors.<br>Sterilant Concentrate is<br>placed in a specialized<br>compartment and when the<br>processor fills with water, it<br>creates the sterilant use<br>dilution from the single use<br>sterilant cup. The processor<br>monitors and controls the use<br>dilution temperature and<br>contact time. The processor<br>automatically rinses the load<br>with extensively treated water<br>to remove sterilant residuals. | Identical | | | | | | | |
| Process<br>Parameters | Standardized cycle<br>parameters cannot be altered<br>by operator. The critical<br>process parameters are:<br>• Contact Time<br>• Use Dilution<br>• Temperature<br>• Peracetic acid<br>concentration<br>• Bacterial retentive water<br>filter integrity<br>• UV irradiation | Standardized cycle<br>parameters cannot be altered<br>by operator. The critical<br>process parameters are:<br>• Contact Time<br>• Use Dilution<br>• Temperature<br>• Peracetic acid<br>concentration<br>• Bacterial retentive water<br>filter integrity<br>• UV irradiation | Identical | | | | | | | |
| Process<br>Monitors | • Cycle Printout<br>documents successful<br>cycle completion or<br>identifies fault if cycle<br>aborts<br>• Alarms if thermocouples<br>indicate temperature out<br>of specification<br>• Alarms if pressure<br>switch indicates that<br>high pressure pump is<br>not operating…