W9127822R0005 Section J - Exhibit 11.2.2 SOP-FAC 021 Sterilizer.pdf

STANDARD OPERATING PROCEDURE (SOP) – ANNUAL PREVENTIVE

MAINTENANCE ACTIVITIES FOR STERILIZERS IN NAMRU-6 LIMA AND

IQUITOS SITES

General Requirements for Lima and Iquitos

NAMRU-6 has the following sterilizers in Lima and Iquitos:

- Lima site:

o STERIS AMSCO 250LS, Small Steam Sterilizer, 20” x 20” x 38” o 120v, 1PH, 240v, 3PH (for integral electric steam generator – stainless steel) o Serial Number: 030051821

- Iquitos site:

o STERIS AMSCO 110LS, Small Steam Sterilizer, 16” x 16” x 26” o 120v, 1PH, 240v, 3PH (for integral electric steam generator – stainless steel) o Serial Number: 030051823

Contractor shall provide the names and certification of the technicians performing preventive maintenance tasks. Only qualified technicians trained in the operation and maintenance of STERIS or similar quality sterilizers shall perform preventive and corrective maintenance tasks.

If required to repair or replace parts of the sterilizers, Contractor shall provide original parts and shall coordinate procurement of those with STERIS factory.

Contractor shall perform annual preventive maintenance activities to sterilizers as specified in this document. It is the responsibility of the contractor to perform a full inspection of the systems and collect all required information to provide a quality preventive maintenance. In addition, contractor shall review operation manuals for the equipment of the systems under this contract and include any recommended preventive maintenance activities by the manufacturer not mentioned in this document.

Contractor shall include all materials, tools and personal protective equipment necessary to perform preventive and corrective maintenance work. Contractor must use the necessary and appropriate equipment to delimit the work area and not allow the pedestrian traffic. The contractor’s staff shall use the appropriate PPE for the activity to perform. NAMRU-6 will not provide any materials, tools nor PPE to the contractor to perform their work.

The contractor shall provide a weekly progress report to the NAMRU-6 facilities department, as well as a completion report when completing the maintenance work to include: activities performed with pictures, recommendations, conclusion and future needed corrective maintenance tasks. When a corrective maintenance work is required, the contractor shall submit a report detailing the problem encountered, with a quotation of the solution.

The preventive maintenance work will be coordinated between NAMRU-6 facilities staff and the staff assigned by the contractor.

Section J - Exhibit 11.2.2 SOP-FAC 021

Contractor shall perform operational testing of the systems at the completion of each preventive maintenance work. NAMRU-6 facilities department will assign a staff to participate in the operational testing and contractor shall prepare an operational testing form (checklist) to be signed by the facilities staff once testing is perform and accepted.

It is the responsibility of the contractor to dispose properly out of NAMRU-6 facilities all consumable materials and garbage generated by the contractor during the performance of the maintenance activities.

Applicable codes:

The following are applicable codes for the elaboration of the preventive maintenance plan, reports and activities mentioned in this document:

OEBGD (Overseas Environmental Baseline Guidance Document) International Plumbing Code International Mechanical Code BMBL 6th edition – Biosafety in Microbiological & Biomedical Laboratories RNE – Peruvian National construction code Local regulations and codes

Description of work required in Lima & Iquitos

STERILIZERS IN LIMA AND IQUITOS

The contractor shall perform the following preventive maintenance activities to sterilizers in Lima and Iquitos:

STERILIZERS – LIMA AND IQUITOS

Item Sub-system Task Frequency

1 General

Preliminary preparation for the preventive maintenance: Discuss with user/autoclave operator on the operation and/or issues found during the operation of the sterilizer.

Annual

2 General Print and review the issues/problem indicators from the sterilizer printer Annual

3 Sterilizer’s Door Verify that the proximity switch of door is working properly Annual

4 Sterilizer’s Door Check voltage of the power connector of the door Annual

5 Sterilizer’s Door Check door is working properly Annual

6 Steam and water supply valves

Check operation of each valve manually.

Verify valves are working in good conditions

Annual

7 Steam and water supply valves Check leak detection valves Annual

8 Manifold Piping Check all steam supply manifolds. Replace components if necessary

Annual

9 Manifold Piping Check all exhaust steam manifolds.

Replace components if necessary

Annual

10 Other piping Review pressure regulation valve. Replace if necessary

Annual

11 Other piping Check filter of jacket. Replace if necessary Annual 12 Other piping Check filter of steam supply Annual 13 Other piping Check filter of water supply Annual 14 Other piping Check correct operation of safety valve Annual

15 Other piping Check pressure chamber and gages of jacket

Annual

16 Other piping Check cartridge filters in the air inlet Annual 17 Other piping Check water valves. Replace if necessary Annual 18 Control Check fan operation. Replace if necessary Annual 19 Control Replace batteries Annual

20 Control Check operation of the flooding alarm control

Annual

21 Control Replace printer cartridges Annual 22 Electric Steam Generator Check set-up of daily purge of generator Annual

23 Electric Steam Generator Inspect all wiring and connections looking for damages or deterioration

Annual

24 Electric Steam Generator Check all control wiring Annual 25 Electric Steam Generator Check the heaters controls Annual

26 Electric Steam Generator Check all manual valves. Replace all if necessary.

Annual

27 Electric Steam Generator Check operation of each solenoid valve.

Perform a sterilization cycle and check operation of each one.

Annual

28 Electric Steam Generator Replace all solenoid valves Annual 29 Electric Steam Generator Check operation of safety valve Annual 30 Electric Steam Generator Clean drain Annual 31 Electric Steam Generator Check level indicator. Replace if necessary Annual

32 Electric Steam Generator Check operation of each pressure control switch

Annual

33 Electric Steam Generator Check each pressure control switch is set-up correctly

Annual

34 Electric Steam Generator Check all pressure gages. Replace if necessary

Annual

35 Electric Steam Generator Check operation of water level control Annual

36 Electric Steam Generator Check boiler and heaters are free of dust and clean

Annual

37 Electric Steam Generator Check operation of safety valves Annual

38 Sterilizer Perform preventive maintenance recommended by manufacturer in O&M manual of equipment

Annual

39 Sterilizer Replace all components recommended by manufacturer on an annual basis

Annual

Contractor will also include requirements per O&M manuals and any additional requirements not mentioned in this document but required or recommended by manufacturer as preventive maintenance activities to perform quarterly or annually.

SPECIAL REQUIREMENTS

LIST OF SUPPLIES AND/OR SPARES

Contractor shall provide and install during annual preventive maintenance the minimum supplies and/or materials at each site shown in tables below:

LIMA SITE

Item Description Qty Equipment/System

1 Full Spare Parts Package for Lima 250LS Steris AMSCO Sterilizer

1 250LS STERIS

AMSCO Sterilizer at

Lima 2 Full Spare Parts Package for Lima 110LS Steris AMSCO

Sterilizer

1 110LS STERIS

AMSCO Sterilizer at Iquitos

ADDITIONAL INFORMATION

ANNEX 1: TECHNICAL DATA OF 110LS AND 250LS STERIS AMSCO STERILIZERS

ANNEX 1

AMSCO® 110LS AND AMSCO® 250LS

SMALL STERILIZERS – LIFE SCIENCES

(Typical - details may vary.)

APPLICATION

AMSCO 110LS and AMSCO 250LS Small Sterilizers are designed for use in laboratory and industrial applications.

Each is configured with pre-vacuum, liquid, and gravity cycles. A full list of standard and optional cycles begins on page 2.

DESCRIPTION

AMSCO 110LS and AMSCO 250LS Small Sterilizers for life science applications are the next advancement in the STERIS line of steam-jacketed sterilizers. Both sterilizers are equipped with the latest features in state of the art technology and ease of use.

Interior Chamber Dimensions

• AMSCO 110LS – 16 x 16 x 26" (406 x 406 x 660 mm)

• AMSCO 250LS – 20 x 20 x 38" (508 x 508 x 965 mm)

Allen-Bradley MicroLogix™ Control System with enhanced functionality and user-friendly Allen-Bradley PanelView Plus™ 6 600 interface screen.*

• Touch-sensitive screen with 18-bit color graphic display

• Display features 320 x 240 resolution color-active matrix

• Display is designed with emphasis on human factors and user recognizable symbols.

SD1026 (04/01/16)

Item ________________________ Location(s)___________________

MODEL/CHAMBER SIZE (W x H x L)

❑ AMSCO 110LS

16 x 16 x 26" (406 x 406 x 660 mm) ❑ Prevacuum (LV-110) ❑ Isothermal (LI-110)

❑ AMSCO 250LS

20 x 20 x 38" (508 x 508 x 965 mm) ❑ Prevacuum (LV-250) ❑ Isothermal (LI-250)

STEAM SOURCE

❑ Building Steam ❑ Stand Alone Electric Steam Generator

❑ STERIS Provided ❑ Customer Provided ❑ Integral Electric Steam Generator1

❑ Carbon Steel ❑ Stainless Steel Voltage Options

❑ 208 Volt, 60 Hz ❑ 240 Volt, 60 Hz ❑ 400 Volt, 50 Hz ❑ 480 Volt, 60 Hz ❑ 600 Volt, 60 Hz

❑ Integral Indirect Stainless-Steel Clean Steam Generator (SD589)

❑ SINGLE DOOR

❑ Cabinet Enclosed/Freestanding ❑ Recessed

❑ DOUBLE DOOR

❑ Recessed through One Wall

❑ Sterile side ❑ Non-sterile side ❑ Recessed through Two Walls2

OPTIONS

❑ Power Door(s) ❑ Liquid Air Cool (w/vacuum)

❑ Decontamination Cycle ❑ Pure Steam Piping to Chamber ❑ Air Detector System ❑ Reference Recorder ❑ Printer on Both Ends9

❑ Bioseal3, 4

❑ RTD Load Probe(s) and F0 Sterilization ❑ One Probe ❑ Two Probes (max. 2)

❑ Drain Line Reference Probe ❑ Air-Differential Seal (NOE) for Double Door Units ❑ Back Panel for Single Door Cabinet Enclosed Unit ❑ 1" Chamber Penetration, Qty. 1

(AMSCO 110LS only)5

❑ One Additional Chamber Penetration

(AMSCO 250LS)5

❑ Vacuum Pump6

❑ 120 V, 1-Ph / 208 / 240 Vac, 3-Ph ❑ 120 V, 1 Ph / 240 Vac 3-Ph ❑ 120 V, 1-Ph / 480 Vac, 3-Ph ❑ 120 V, 1-Ph / 600 Vac, 3-Ph ❑ 230 V, 1 Ph / 400 Vac, 3-Ph (International) ❑ Other - Specify ___________________

❑ Dry Contacts ❑ Backflow Preventer ❑ Auto Flush for Steam Generator ❑ 0.2 Micron Bacterial Retentive Filter ❑ Green Gravity Water Saver System ❑ STERI-GREEN® Water Conservation System ❑ STERI-GREEN PLUS® Water Conservation System

(Chilled water required)

ACCESSORIES (for AMSCO 110LS)7

❑ One Intermediate Shelf (16 x 16 x 26") ❑ Air Compressor, Portable, 115 Vac

ACCESSORIES (for AMSCO 250LS) ❑ One Intermediate Shelf (20 x 20 x 38") ❑ Seismic Tie-Down Kit8

❑ Air Compressor, Portable, 115 Vac ❑ Loading Rack and Two Shelves (20 x 20 x 38")

❑ Single Door ❑ Double Door ❑ Loading Car ❑ Transfer Carriage ❑ Chamber Track Assembly

❑ Single Door ❑ Double Door ❑ Loading Car, Transfer Carriage & Chamber Track

Assembly ❑ Single Door ❑ Double Door

❑ Multiprobe Sealing Gland (20 x 20 x 38") ❑ AMSCO™ Stand Alone Water Conservation System

Notes:

1. AMSCO 110LS double door sterilizers are not available with integral electric steam generator.

2. Available for AMSCO 250LS double door sterilizers only. Contact engineering if mounting through two walls is required for AMSCO 110LS.

3. Units with the bioseal option require UL/CSA field certification.

4. Available on AMSCO 250LS double manual door sterilizers only.

5. One chamber penetration is standard on

AMSCO 250LS.

6. 1-Ph is for control, 3-Ph is for pump motor

7. Loading rack & 2 shelves standard on

AMSCO 110LS.

8. Based on CA requirements.

9. Printer at operating end is standard. Option adds additional printer to non-operating end.

Selections Checked Below Apply To This Equipment

* Allen-Bradley MicroLogixTM and Allen-Bradley PanelView PlusTM are registered trademarks of Rockwell Automation, Inc.

Cycle Programming and Flash Memory

• 20 cycles may be individually selected and programmed

• Help screens for control operation

• SD memory card is used for storing cycle data

• Service reprogrammable flash ROM memory

• Program permanently stored in flash memory

• Variables permanently stored in flash memory

Vertical Sliding Door(s)

AMSCO LS configurations include choice of single or double door sterilizers and open or recessed mounting. The doors are manually operated. Door seals (1 per door) are non-lubricated, steam activated.

NOTE: Recess two wall mounting is not available for AMSCO 110LS double door sterilizers.

Modularized Vessel And Piping

Vessel and piping are designed for increased dependability and reduced service time.

• Reduced piping components increase reliability

• Vessel design allows higher operating temperature of 141°C (285°F)

• Non-clogging chamber drain line prevents media from plugging drain line

• Emergency manual exhaust valve

STANDARDS

Each sterilizer meets applicable requirements of the following listings and standards, and carries the appropriate symbols.

• ASME Code, Section VIII, Division 1 for unfired pressure vessels. The pressure vessel is so stamped; ASME Form U-1 is furnished. Shell and door are constructed to withstand working pressure of 50 psig (344.7 kPa).

• ASME Code, Section I, Part PMB for power boilers, if optional steam generator is supplied.

• Seismic Pre-Approval R-0272 (for AMSCO 110LS) Seismic Pre-Approval R-0275 (for AMSCO 250LS)

• Pressure Equipment Directive (PED): 97/23/EC.

• IEC 61326-1 Issued: 2012/07/10 Ed: 2 ELECTRICAL EQUIPMENT

FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC

REQUIREMENTS - PART 1: GENERAL REQUIREMENTS

• EU 2006/42/EC Issued: 2006/05/17 DIRECTIVE OF THE

EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MACHINERY

• CEN EN ISO 12100 Issue: 2010/11/15 SAFETY OF MACHINERY

- GENERAL PRINCIPLES FOR DESIGN - RISK ASSESSMENT AND RISK

REDUCTION

• IEC 61010-1 Issued:2010/06/10 Ed:3 SAFETY REQUIREMENTS

FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND

LABORATORY USE - PART 1:GENERAL REQUIREMENTS

• UL 61010-1 Issued: 2012/05/11 Ed:3 SAFETY REQUIREMENTS

FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND

LABORATORY USE - PART 1: GENERAL REQUIREMENTS

• IEC 61010-2-040 Issued: 2015 Ed:2 SAFETY REQUIREMENTS

FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND

LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR

STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL

MATERIALS

• CAN/CSA C22.2 # 61010-1 Issued: 2004/07/12 (R2009)

SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR

MEASUREMENT, CONTROL, AND LABORATORY USE PART

1:GENERAL REQUIREMENTS; GEN. INST. NO. 1: 2008

• CSA C22.2 #61010-2-040 Issued: 2007/12/01 Ed:1 SAFETY

REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT,

CONTROL AND LABORATORY USE PART 2-040: PARTICULAR

REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS

USED TO TREAT MEDICAL MATERIALS

• FCC 47CFR 15B clA Issued: 2011/04/21 Title 47 CFR PART

15 SUBPART B UNINTENTIONAL RADIATORS CLASS A VERIFICATION

CYCLE DESCRIPTIONS

Standard and optional cycles are as follows:

Gravity Cycle (standard) provided on prevacuum, and isothermal sterilizers, for sterilization of heat- and moisture-stable goods at 100°C to 141°C (212°F to 285°F), and decontamination of bagged non bio-hazardous laboratory wastes. Gravity cycle utilizes gravity air-displacement principle. However, the gravity cycle has a standard drying phase which uses a vacuum. The drying phase can be disabled.

Liquid Cycle (standard) provided on prevacuum, and isothermal sterilizers, for sterilization of liquids and media in vented borosilicate glass or metal containers at 100°C to 141°C (212°F to 285°F). Liquid cycle uses optimal solution cooling feature, during exhaust (cooling) phase, to control exhaust rate.

Prevacuum Cycle (standard) provided only on prevacuum sterilizer, for efficient, high-volume sterilization of porous, heat-and moisture-stable materials at 100°C to 141°C (212°F to 285°F). Prevacuum cycle utilizes a mechanical air-evacuation system.

USP 660 Cycle (standard) developed to assist meeting the requirements of USP 660 sterilization test cycle for glassware.

Continuous Cycle (standard) This cycle allows for up to 9,999 cycles to be run consecutively without the need of an operator.

Cycle parameters can be set, along with the amount of time to lapse in between cycles. For this cycle to function, a power door is required to facilitate automatic opening and closing.

Waste Bag Cycle (standard) This cycle has been preconfigured with cycle parameters shown to be effective when processing lab waste in autoclavable bags. Through air removal assistance and a controlled exhaust, the internal temperature is increased more effectively and faster, while minimizing boil over of any liquids present. Parameters may need to be adjusted based on specific loads. Bags should not be completely sealed.

Isothermal Cycle (optional) provided only on isothermal sterilizer, for processing of heat-sensitive and heat-coagulable solutions in vented borosilicate glass or metal containers at 78°C to 110°C (170°F to 230°F). Isothermal cycle utilizes steam to enhance temperature control and prevent layering of steam and air within the chamber. Process maintains positive pressure in chamber to inhibit media boiling.

NOTE: Temperature control spread is greater on Isothermal units ±6°C.

Liquid Air Cool (Optional) provides water to jacket, and air pressure to chamber to improve exhaust time for liquid loads, and to reduce boil-over.

Effluent Decontamination Cycle (Optional) is used for processing contaminated laboratory waste (BL-3 and BL-4). Condensate produced during processing cycle is decontaminated before discharge to floor drain. Steam is admitted through bottom of sterilizer chamber, and chamber is exhausted out top side of vessel. During purge and vacuum pulses, all purge and exhaust gases are vented through a

0.2 micron bacterial retentive filter. Filter housing is steam jacketed to prevent wetting of filter membrane. Available with fast exhaust or optimal solution cooling (slow exhaust) exhaust types. User is responsible for development of process parameters.

Leak Test Cycle, provided only on prevacuum sterilizer, for verification of door seal and piping system integrity. Cycle parameters are pre-programmed and fixed. Acceptable maximum leak rate is 1.0 mm Hg/minute over a 10-minute period following a fixed stabilization time.

Daily Air Removal Test (Dart) Cycle, provided only on prevacuum sterilizer, for verification of effective removal of residual air in chamber and load during testing. Test cycle determines if even and rapid steam penetration into test load occurred. Cycle parameters are preprogrammed and fixed.

Bowie-Dick Test is available for 121°C (250°F) and 132°C (270°F) prevacuum cycles.

ENVIRONMENTAL SUSTAINABILITY

Automatic Utilities Startup/Shutdown

This feature permits slow cooling of the entire vessel and load.

Shutdown may be programmed to activate at the end of any designated cycle or time of day. When activated, control system automatically shuts off all utility valves, conserving steam and water usage. Sterilizer utilities can be restarted either by programmed time or manual operation. A different shutdown and restart time can be programmed for each day.

Green Mode

The Green Mode is a standard feature on the control that will shut off the steam to the jacket after the unit has sat idle for a specified period of time. The specific time frame is determined by the user and entered into the control during set up; it can be changed at any time.

Green Gravity Water Saver System

The Green Gravity Water Saver System provides additional water savings by collecting steam effluent and holding it in a cooling tank, reducing the amount of water required to cool the effluent.

STERI-GREEN® Water Conservation System

This system significantly reduces the consumption of potable water. The STERI-GREEN system utilizes a mixing tank and an air-cooled heat exchanger to cool and recycle vacuum pump water and steam effluent. Water temperature is constantly monitored to minimize the need to add fresh cool water to the mixing tank. The end result is water savings in the range of 45 to 55% per sterilization cycle over the vacuum pump alone, or 70-80% over a water ejector. When ordered, system includes a vacuum pump (3-phase power required).

STERI-GREEN PLUS® Water Conservation System

The STERI-GREEN PLUS system utilizes facility chilled water supply. The system utilizes a mixing tank and a series of heat exchangers, integrated with the a chilled water loop, to cool and recycle vacuum pump water and effluent. Water temperature is constantly monitored to minimize the need to add fresh cool water to the mixing tank. This system provides up to 99% water savings over water ejector or vacuum pump upgrade alone. When ordered, system includes a vacuum pump (3-phase power required).

STANDARD FEATURES

Hinged front cabinet panel opens for convenient access to sterilizer piping and control system.

Resistance Temperature Detectors (RTDs) are installed for sterilizer temperature control. The chamber drain line RTD senses and controls temperature variations within the sterilizer chamber. A jacket RTD provides temperature control within the jacket space. These RTD signals, converted into electrical impulses, provide accurate control inputs and readouts throughout entire cycle.

Software calibration is provided for all temperature and pressure inputs. Calibration is performed in the service mode, accessible through the touch screen displays, and accomplished using external or internal temperature and pressure sources. Control system provides a printed record of all calibration data for verification to current readings.

Cycle Data Records, recorded on the printer tape, are saved to an SD card and can be retrieved for on-screen review or sent via email. Network connection required.

Optimal solution cooling is designed to safely cool various liquids in vented, borosilicate glass containers with minimum liquid loss due to boil-over, and to keep normal evaporation loss below 5%. Optimal solution cooling is an integral part of the factory-programmed liquid cycle. During the exhaust (cooling) phase, the control utilizes this feature to optimize the exhaust rate regardless of load size or container fill volume, up to one liter. During cooling, the initial rate, initial rate transition point, as well as the second rate and final vacuum level are adjustable.

Steam purge feature is provided to assist in air removal and preheat the load.

Automatic steam shutoff to jacket is provided for isothermal and liquid cycles. When activated for isothermal cycles, the jacket control conducts a timed jacket drain, automatically allowing for the operation of cycles at lower temperatures.

When activated for liquid cycles, steam supply to the jacket is turned off during exhaust phase, allowing load to cool more efficiently.

Insulation, one-inch thick, asbestos-free spin-glass (rated at 1000 °F [538 °C] continuous) encompasses the exterior of the sterilizer vessel and is sealed in an oil and water resistant outer jacket.

Lighted DIN connectors are installed on all steam, water, and exhaust valves for reliability and ease of maintenance.

Air Backup to seals is provided on all double door sterilizers, with either bioseal or air differential seals.

Visible Gauges are standard. Chamber and jacket pressure gauges are standard on the operating end; in addition, on double-door units the chamber gauge is standard for the non-operating end.

CONTROL SYSTEM

Design Features

Together, the Allen-Bradley MicroLogix™ PLC control and PanelView Plus™ 6 600 display, monitor and control all sterilizer operations and functions. Control system is factory-programmed with standard sterilizing cycles, each adjustable to meet specific processing requirements. All control configuring is performed through touch screen displays.

Cycle values and operating features may be adjusted and verified prior to cycle operation. Once cycle is started, cycles and cycle values cannot be changed until cycle is complete.

On completion of cycle, timers reset to the previously selected values, eliminating the need to reset values between repeated cycles. If chamber temperature drops below the under temperature setting during the exposure phase, timer can be set to stop and automatically reset or resume once normal operating temperature is reached.

Critical control system components are housed within a sealed compartment to protect components from moisture and heat generated during sterilization process.

Operator interface control panel, consisting of touch screen and impact printer, is located on operating (load or nonsterile) end of sterilizer. If the sterilizer is equipped with double doors, an additional touch screen is provided on the non-operating (unload or sterile) end.

• Touch-Sensitive Screen features a color active matrix 18-bit graphics display. All sterilizer functions, including cycle initiation and cycle configuration, are operated by pressing the touch-sensitive areas on the display, referred to as buttons. Display indicates appropriate control buttons, operator prompts and status messages necessary to assist in sterilizer operation. All displayed messages are complete phrases with no codes to be cross-referenced. Display also indicates any abnormal conditions that may exist either in or out of a cycle.

• Ink-On-Paper Impact Printer, located above touch screen, provides an easy-to-read printed record of all pertinent cycle data on 2-1/4" wide paper. Data is automatically printed at the beginning and end of each cycle and at transition points during the cycle. A duplicate print can be obtained of the last cycle run.

Printer take-up spool stores an entire roll of paper, providing cycle records which can be saved for future reference. Three paper tape rolls are furnished with each unit.

• Non-operating end (NOE) control panel (equipped on double-door sterilizers only) includes a touch-sensitive screen similar to the operating end screen. Preprogrammed cycles can be started from the NOE control panel. Display concurrently shows the same information as the operating end screen display.

• Cycle configuration is performed by accessing the change values menu on either end of a double door sterilizer. Utility shutdown parameters can only be changed on the OE display. In addition to adjustment of cycle values, the following operating parameters can also be changed through the change values menu:

» Time Display and Printout Units in standard AM/PM or 24-hour military (MIL) time.

» Selectable Cycle Name permits user to name each cycle with any combination of letters, numbers, blank spaces, and underscores, up to eight characters long.

» Print Interval permits adjustment of the time period between cycle-status printouts generated during the sterilize phase.

» Security access code is required to enter the operating mode (running cycles), supervisor mode (changing val-ues), and service mode. Operating the sterilizer or accessing change values menu causes display to request the entry of an access code. If access code is not properly entered, display returns to the standby screen, denying user access to the sterilizer or program-ming. Access to the sterilizer can be limited to 12 operators, each with a different access code.

» Buzzer pulses on and off during alarm conditions.

Buzzer pulses at a different rate for one minute at cycle completion.

» Temperature Display and Printout Units in Celsius (°C) or Fahrenheit (°F). Temperature is set, displayed, controlled, and printed to the nearest 0.1°. Recalibration is not required when changing temperature units from °C to °F and vice versa.

» Pressure/Vacuum Display and Printout Units in psi/In/Hg, Bar (Gauge and Absolute). Recalibration is not required when changing pressure units.

• Compact flash port is provided for downloading cycle information to a Customer-furnished Excel spreadsheet file1. Approximately eight (one hour) cycles can be stored on the flash card before card has to be downloaded to PC.

• Flash memory permanently backs up all cycle memory. If a power failure occurs during a cycle, proper cycle completion occurs once power is restored. When power is lost, the cycle is held in phase until power is restored, exceeding the minimum government specification of one minute. Once power returns, the event is recorded on the printout and the cycle automatically resumes or restarts, depending on what phase the cycle was in at the time of power loss. If necessary, the operator can manually abort the cycle.

Typical Cycle Menu Display

Mobile and PC Messaging (Standard)

This is a standard feature on the control that allows the user to receive text messages or emails alerts regarding the status of the autoclave. The operator can choose from a list of # possible alerts from which to be notified.

SCADA Ready Control Interface (Standard)

If requested, STERIS can provide the user the information to allow communication between the autoclave and the Building Management System.

Printer Data Storage (Standard)

All printer data is saved internally and can be retrieved and viewed on the display screen and emailed to the user.

SAFETY FEATURES

Control lockout switch (equipped on chamber door) senses when door seal is energized and tight against the door. Control prevents cycle from starting until the limit switch signal is received. If control loses appropriate signal during cycle, alarm activates, cycle aborts, and chamber safely vents with a controlled exhaust.

Chamber float switch activates alarm, aborts cycle, and safely vents chamber with a controlled exhaust if excessive condensate is detected in the vessel chamber.

Door interlocks (double door units only) allow only one door to be opened at a time and, during processing, prevent the non-operating end (NOE) door from being opened until a satisfactory cycle is complete. If a cycle is aborted, the NOE door cannot be opened. (Compressed air utility required).

Pressure relief valve limits the amount of pressure buildup so that the rated pressure in the vessel is not exceeded.

Emergency stop button (located on front of the sterilizer) is included on all sterilizers manufactured with a power door. For units marked with CE label, a key is required to release the emergency stop (once pushed) before the unit can return to normal operation.

CONSTRUCTION

Shell Assembly

Two fabricated Type 316L stainless-steel shells, welded one within the other, form the sterilizer vessel. Type 316L stainless-steel end frame(s) is welded to door end. On single door units, back of chamber is fitted with welded, 316L stainless-steel formed head.

Sterilizer vessel is ASME rated at 50 psig (3.2 Bar) and insulated. The Vessel (for AMSCO 250LS only) includes one 1.0" (25 mm) NPT welded chamber bushing for Customer use.

Steam-supply opening inside the chamber is shielded by a Type 316L stainless-steel baffle.

Chamber Door(s)

Door is constructed of a single formed piece of Type 316L stainless steel. Door is insulated to reduce the surface temperature of the stainless-steel door cover.

During cycle operation, door is sealed by a steam-activated door seal. Door seal is constructed of a special long-life rubber compound. When sterilizer cycle is complete, the seal retracts under vacuum into a machined groove in sterilizer end frame.

Door seal can be manually retracted to open the door and remove critical load in an emergency situation (if loss of vacuum or loss of power occurs).

A handle is used to manually open (by lowering) and manually close (by raising) the door which is suspended by cables attached to a counterweight.

A long-life proximity switch is used, by the control, to determine if the door is closed. An additional seal pressure switch prevents inadvertent cycle initiation if door is not sealed.

The door assembly is equipped with a mechanical locking mechanism that ensures the door cannot be opened, as long as the seal is intact and energized, and more than 2.0 psi pressure is in the chamber. Door interlocks on double door sterilizers can be programmed to prevent inadvertent opening of door(s). Access code is required to override door interlocks.

NOTE: Bio-Seal option is available for AMSCO 250LS, double manual door sterilizers, as discussed on page 5.

Chamber Drain System

Drain system is designed to prevent pollutants from entering into the water-supply system and sterilizer. An optional backflow preventer is available. Water supply shutoff valve is located behind the front cabinet service panel under the chamber.

Automatic Drain Effluent Cooling

The piping system to the drain provides automatic condensing of chamber steam and disposal of condensate to waste.

Cooling water is added to ensure discharge temperature is discharged at or below 60°C (140°F). A separate resistance temperature detector (RTD) is included to limit the volume of water to only the amount required to achieve target temperature, thus conserving water.

Vacuum System

Chamber pressure is reduced during the conditioning phase and drying phase through the means of either a standard water ejector or an optional vacuum pump upgrade. Subsequent to the drying phase, the chamber is returned to atmospheric pressure by admitting air through a bacteria-retentive filter.

Steam Source

Sterilizers are piped valved, and trapped to receive building-supplied steam delivered at 50 to 80 psig (344.7 to 551.6 kPa) dynamic. If building steam source is not available, an electric carbon-steel steam generator or electric stainless-steel steam generator may be provided to supply steam to the sterilizer.

Steam piping is constructed of brass and includes a shutoff valve, steam strainer and a brass pressure regulator.

Optional stainless-steel indirect-type steam generator can be installed as a pure steam source. Pure steam reduces the probability of contamination which could adversely affect research, such as tissue culture and trace metals studies.

Steam feeds from the jacket to the chamber. A check valve is added between the jacket and chamber on sterilizers with decontamination cycle option.

Piping

All piping connections terminate within the confines of the sterilizer and are accessible from the front and side of sterilizer.

• Solenoid Valves in manifold with DIN connectors simplify sterilizer piping and can be serviced individually.

• Manual Shutoff Valves are pressure rated at 125 psig (862 kPa) for saturated steam. Valve handles are low-heat conducting.

MOUNTING ARRANGEMENT

Sterilizers are arranged for either freestanding or recessed installation, as specified. Each sterilizer is equipped with a height-adjustable, steel floor stand. Sterilizer subframe is equipped with a synthetic rubber gasket to ensure tight fit between the cabinet panels on freestanding units or between the front cabinet panel and wall partition on recessed units.

On freestanding units, stainless-steel side panels enclose the sterilizer body and piping.

Each AMSCO 110LS and AMSCO 250LS sterilizer has a lockable front service panel.

OPTIONS

Stainless-steel piping to chamber delivers steam generated from Customer purified water source to the chamber and its contents. All steam-to-chamber piping components are constructed of 300 series stainless steel. Option can be provided with or without Pressure Reducing Valve.

Integral indirect stainless-steel clean steam generator automatically produces clean steam using Customer-supplied steam and purified water. Generator is integrally connected to the clean steam-to-chamber piping system.

30 kW carbon-steel electric steam generator typically fed by a potable water source with hardness not to exceed 171 mg/L.

The generator is available for both single and double door sterilizers. The generator is mounted underneath both single and double door units. The generator option is not available for AMSCO 110LS double door units.

30 kW electric stainless-steel steam generator is electrically powered, automatically filled with water having 1 M·cm resistivity, and operates whenever the sterilizer power is on.

Generator is integrally connected to the clean steam-to-chamber piping system. The generator option is not available for AMSCO 110LS double door units.

Auto Flush for Steam Generator provides automatic flush of steam generator upon startup of sterilizer. Can be by-passed by pressing Cancel. Not required for SS generators.

RTD load probes and F0 sterilization (maximum of 2) automatically sense the load temperature during cycle operation. A single thermal load probe is sealed through the sterilizer vessel and manually placed in the product container within the chamber prior to cycle operation.

In conjunction with the load probe option, individual cycles can be set to start exposure phase according to chamber drain temperature or according to load temperature. Also, F0 set points are available for each cycle, allowing for exposure phase termination based on the calculated F0 value.

Bioseal (for AMSCO 250LS double manual door units only) is a 1/4” steel plate which is welded to the chamber and a 1/4” thick silicone gasket that extends between the plate and a carbon steel wall frame which is welded to wall imbeds.The bioseal is provided on the non-operating end of the sterilizer, prevents passage of airborne microorganisms from the space between the vessel body and the structural wall opening.Steam is the primary source of pressure behind the door seal. All sterilizers with bioseals have air back-up to maintain seal pressure when out of cycle or if the steam source is not available.

Air-differential seal (double door units only), provided on the non-operating end of the sterilizer, minimizes airflow between the dirty and clean sides of the barrier.

Back cabinet panel is provided on single door, freestanding units where the unit is accessible on all sides.

Air detector (integral factory piping option) is used to determine whether any air or non-condensible gas present in the chamber is sufficient to impair the sterilizing process.

Backflow preventer option can be installed on sterilizer piping to prevent the unwanted reverse flow of water or other substances into the potable water supply.

Power door provides automatic opening and closing by depressing a foot pedal. (Not available for sterilizers with Bio-Seal option).

Vacuum Pump Upgrade: Water ejector is replaced with a water ring vacuum pump.

Drain line reference probe automatically senses the drain line temperature during cycle operation. Individual cycles can be set to start the exposure phase according to chamber drain temperature, or according to load temperature. This option replaces the standard drain RTD probe with a dual element RTD probe, in the same sheathing.

0.2 micron bacterial retentive filter provides sterile air during airbreak at end of cycle.

Reference recorder: An optional independent recorder is provided to record chamber drainline temperature and chamber pressure. The recorder is integrally mounted to the sterilizer fascia paneling.

Additional chamber penetration: One 1" NPT capped chamber penetration port is located at the side of the vessel so as not interfere with other piping. The port provides for up to twelve (12) owner provided thermocouple probes or other test instrumentation.

One port is provided as standard on AMSCO 250LS.

Printer on both ends. An additional printer is provided on the non-operating end of the sterilizer.

Dry Contacts provide four (4) relays to communicate the following equipment status: door open, door closed, alarm, and unit on.

ACCESSORIES

Multiprobe sealing gland (for AMSCO 250LS units only) permits insertion of temperature probes, such as thermocouples or resistance temperature detectors (RTD), into the chamber. The assembly includes a stainless steel threaded gland, seal, and seat to accept a maximum of 12 Customer-supplied probes. Note that probe wire is 3/32 inch diameter.

Air Compressor, Portable, 115 Vac. This accessory is intended for pneumatic valves on sterilizers when an air utility is not provided by the facility. It may also be used for back-up pressure source for the door seal in bioseal applications.

This is a portable 1.5 Gallon compressor tank that delivers

59.5 LPM @ 345 KPa (1.7CFM @ 100 PSI). Refer to STERIS

drawing no. 755718-038 for complete specifications.

AMSCO Stand Alone Water Conservation System recirculates and cools sterilizer process water to reduce water consumption. The system includes a collection tank, a heat exchanger with integral cooling fan, recirculation pump and temperature and pressure switches.

When the system is operating, sterilizer water effluent passes through a fan-cooled heat exchanger. The fan cools the water before it returns to the collection tank. Additional cooling water is added only when a maximum temperature set-point is reached. Refer to tech data sheet SD929 for more details.

Seismic tie-down kit conforms to current California Code of Regulations.

PREVENTIVE MAINTENANCE

A global network of skilled service specialists can provide periodic inspections and adjustments to help ensure low-cost, peak performance. STERIS representatives can provide information regarding annual maintenance agreements.

NOTES

1. The sterilizer is not supplied with a vacuum breaker or backflow preventer and, where required by local codes, installation of such a device in water line is not provided by

STERIS.

2. Pipe sizes shown indicate terminal outlets only. Building service lines, not provided by STERIS, must supply the specified pressures and flow rates.

3. Disconnect switches (with OFF position lockout only; not provided by STERIS) should be installed in electric supply lines near the equipment.

4. Access to the recessing area from the control end of the sterilizer is recommended.

5. Clearances shown are minimal for installing and servicing the equipment.

6. If loading car and carriage are to be used with a AMSCO 250LS sterilizer, front clearance should equal twice the length of the sterilizer. This will permit complete withdrawal of the loading car from the chamber and allow convenient maneuverability of the transfer assembly to and from the sterilizer.

7. Floor drain should be provided within confines of sterilizer framework.

UTILITY REQUIREMENTS

Refer to Equipment Drawing for complete information.

Sterilizer Using Facility Steam1

Steam

1/2" NPT, 50 to 80 psig (344.7 to 551.6 kPa) dynamic, 97 to 100% vapor quality

Drain

1-1/2" ODT drain terminal. (Floor drain capacity must handle peak water consumption; refer to engineering data.)

Electrical - Controls

120 Volt, 50/60 Hz, 1-phase, 3.0 Amp

International:

230 Volt, 50/60 Hz, 1-Ph, 1.5 Amp

Sterilizer Feed Water

1.0" NPT, 30 to 50 psig (206.8 to 344.7 kPa) dynamic. Water is used for ejectors, vacuum pumps, exhaust condensers, and trap cooling. Refer to Table 1 for recommended water quality. Use of feed water within the nominal conditions will optimize equipment performance and reduce maintenance.

NOTE: Backflow prevention is not standard on the unit, but a backflow preventer option can be ordered.

Sterilizer Equipped With Integral Carbon Steel Steam Generator

Drain

1-1/2" ODT drain terminal. (Floor drain capacity must handle peak water consumption; refer to engineering data.)

Generator Drain

1/2" ODT

Electrical - Controls

120 Volt, 50/60 Hz, 1-phase, 9.5 Amp

International:

230 Volt, 50/60 Hz, 1-Ph, 1.5 Amp

Electrical - Generator

208 Volt, 50/60 Hz, 3-phase

240 Volt, 50/60 Hz, 3-phase

480 Volt, 50/60 Hz, 3-phase

600 Volt, 60 Hz, 3-phase

International:

380/415 Volt, 50/60 Hz, 3-Ph, (Prevacuum Units)

Sterilizer Feed Water

1.0" NPT, 30 to 50 psig (206.8 to 344.7 kPa) dynamic.

Refer to Table 1 for water specification guidelines.

Steam Generator Feed Water

1/2" NPT, 20 to 50 psig (137.9 to 344.7 kPa) dynamic. Refer to Table 2 for required water quality. Use of feed water within the nominal conditions will optimize equipment performance and reduce maintenance.

NOTE: Backflow prevention is not standard on the unit, but a backflow preventer option can be ordered.

Sterilizer Equipped With Integral Stainless-steel Steam Generator

Sterilizer Feed Water

1.0" NPT, 30 to 50 psig (206.8 to 344.7 kPa) dynamic.

Refer to Table 1 for required water quality.

Steam Generator Feed Water

1/2" NPT, 20 to 50 psig (137.9 to 344.7 kPa) Refer to Table 3 for required water quality.

Drain

1-1/2" ODT generator drain terminal. (Floor drain capacity must handle peak water consumption; refer to engineering data).

Generator Drain

1/2" ODT

Electrical - Controls

120 Volt, 50/60 Hz, 1-phase, 9.5 Amp

International:

230 Volt, 50/60 Hz, 1-Ph, 1.5 Amp

Electrical - Generator

208 Volt, 50/60 Hz, 3-phase

240 Volt, 50/60 Hz, 3-phase

480 Volt, 50/60 Hz, 3-phase

600 Volt, 60 Hz, 3-phase

International:

380/415 Volt, 50/60 Hz, 3-Ph, (Prevacuum Units)

1. External Supplied Steam (Facility Steam/Stand-Alone Steam Generator)

Table 1. Recommended Feed Water Quality for Sterilizers

Condition Nominal Conditions Maximum Conditions

Temperature 40°-60°F (4°-16°C) 70°F (21°C)

Total Hardness as CaCO3 * 50-120 mg/L 171 mg/L

Total Dissolved Solids 100-200 mg/L 500 mg/L

Total Alkalinity as CaCO3 70-120 mg/L 180 mg/L pH 6.8-7.5 6.5-8.5

Total Silica 0.1 - 1.0 mg/L 2.5 mg/L

* 17.1 mg/L = 1.0 grain hardness

Table 2. Required Feed Water Quality for Carbon-Steel Steam Generators

Condition Nominal Conditions Maximum Conditions

Temperature 70-140°F (21-60°C) 140°F (60°C)

Total Hardness as CaCO3 * 0-17 mg/L 130 mg/L

Total Dissolved Solids 50-150 mg/L 250 mg/L

Total Alkalinity as CaCO3 50-100 mg/L 180 mg/L pH 6.8-7.5 6.5-8.5

Total Silica 0.1 - 1.0 mg/L 2.5 mg/L

Resistivity † 2 - 6 k·cm 26 k·cm

* 17.1 mg/L = 1.0 grain hardness

† WARNING-BURN HAZARD: Never use supply water with resistivity exceeding 26 k·cm, as doing so may cause malfunction of steam genera-tor level control, resulting in sterilizer operator being severely burned by scalding water. If supply water resistivity exceeds 26 k·cm immediately contact STERIS Service Engineering.

NOTE: Do not connect tap water to stainless-steel steam generator. Use of water not meeting the required feed water quality will invalidate the warranty and is a violation of ASME Boiler Codes.

Table 3. Required Feed Water Quality Stainless Steel Generators

Type of Water Deionized Water, Distilled or Reverse Osmosis

Temperature 70-140°F (21-60°C)

Minimum Specific Resistivity 1.0 M·cm

Refer to the Following Equipment Drawings for Installation Details

Equipment Drawing Number Equipment Drawing Title

AMSCO 110LS

387362-169 110LS, SINGLE DOOR, RECESSED, STEAM HEAT

387362-170 110LS, SINGLE DOOR, CABINET, STEAM HEAT

387362-171 110LS, SINGLE DOOR, RECESSED, ELECTRIC STEAM

387362-172 110LS, SINGLE DOOR, CABINET, ELECTRIC STEAM

387362-173 110LS, DOUBLE DOOR, RECESSED 1 WALL, STEAM HEAT

AMSCO 250LS

387362-159 250LS, SINGLE DOOR, RECESSED, STEAM HEAT

387362-160 250LS, SINGLE DOOR, CABINET, STEAM HEAT

387362-161 250LS, SINGLE DOOR, RECESSED, ELECTRIC STEAM

387362-162 250LS SINGLE DOOR, CABINET, ELECTRIC STEAM

387362-163 250LS, DOUBLE DOOR, RECESSED 1 WALL, STEAM HEAT

387362-164 250LS, DOUBLE DOOR, RECESSED 2 WALLS, STEAM HEAT

387362-165 250LS, DOUBLE DOOR, RECESSED 1 WALL, ELECTRIC STEAM

387362-166 250LS, DOUBLE DOOR, RECESSED 2 WALLS, ELECTRIC STEAM

a b ls n c d e f

A

ENGINEERING DATA

Model & Chamber Size in (mm) Heating

MAXIMUM OPERATING

WEIGHTa lbs (kg)

Based on chamber fully loaded with water flasks.

HEAT LOSSb

BTU/hr at 70°F (21°C)

At 70°F (21°C).

Single Door Double Door

Single Door Double Door

Cab’t Enc Recessed Recessed One Wall Recessed Two Wal

To Room Front of Wall

Back of Wall

Front of Wall

Back of Wall

At Each End

Betwee Walls

AMSCO 110LS

16 x 16 x 26

(406 x 406 x 660)

Steam 750 (340) 989 (449) 4300 1600 2700 1600 3500 N/A N/A

Electric 890 (404) N/A 6050 2300 3750 N/A N/A N/A N/A

AMSCO 250LS

20 x 20 x 38

(508 x 508 x 965)

Steam 1231 (558) 1606 (728) 7000 2500 4500 2500 5300 2500 2800

Electric 1371 (622) 1726 (782) 8750 3300 5450 3300 6250 3300 2950

Model & Chamber Size in (mm) Heating

UTILITIES CONSUMPTION

Waterc

Backflow preventer device in water line, when required by local codes, is not provided by STERIS.

Steam Cold Hotd

Hot water recommended for units equipped with electric steam heat.

Peak gpm (lpm)

Per Cyclee gal/cycle (l/cycle)

Idle gph (lph)

Peak gpm (lpm)

Per Cyclee gal/cycle (l/cycle)

Based on Prevac cycle, 3 pulses, 30 minute exposure time and 5 minute dry time. Tested with empty chamber.

Idle gph (lph)

Peakf lb/hr (kg/hr)

Per Cyclee lb/cycle (kg/cycle)

Idle lb/hr

(kg/h

AMSCO 110LS

16 x 16 x 26

(406 x 406 x 660)

Steam 6 (23) 68 (257) 7 (27) N/A N/A N/A 180 (81) 18 (8) 7 (3)

Electric 6 (23) 68 (257) 7 (27) 1 (4) 3 (11) 1 (4) N/A N/A N/A

AMSCO 250LS

20 x 20 x 38

(508 x 508 x 965)

Steam 6 (23) 70 (265) 10 (38) N/A N/A N/A 180 (81) 21 (10) 7 (3)

Electric 6 (23) 70 (265) 10 (38) 1 (4) 4 (15) 1 (4) N/A N/A N/A

Peak steam demand (lbs/hr) may vary depending on operating conditions.

dditional utilities are required for units with the following options:

Double Door Units w/Interlocks (Compressed Air) Liquid Air Cool (Compressed Air) Decontamination Cycle (Compressed Air) Bio-Seal (Optional Compressed Air Backup) Vacuum Pump (3-Phase Voltage) Stainless-Steel Piped Units (Treated Water) Steam Source (one of the following):

>> Integral Steam Generator - Carbon Steel or Stainless Steel (3 Phase Voltage) >> Indirect Steam Generator; Minimum 75 psig Steam Required

Consult Customer service for specially configured equipment drawings.

F

SD

CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH

APPLICABLE LOCAL AND NATIONAL CODES AND

REGULATIONS.

The base language of this document is ENGLISH.

Any translations must be made from the base language document.

or further information, contact:

STERIS Corporation 5960 Heisley Road Mentor, OH 44060-1834 • USA 440-354-2600 • 800-548-4873 www.STERISLifeSciences.com

This document is intended for the exclusive use of STERIS Customers, including architects or designers. Reproduction in whole or in part by any party other than a Customer is prohibited.1026 ©2016, STERIS Corporation. All rights reserved. (04/01/16)