Reliance® 380PG

Pharmaceutical Grade Washer

APPLICATION
Reliance 380PG Pharmaceutical Grade Washer is intended for
thorough, efficient cleaning of various materials and
components utilized in biotechnology and pharmaceutical
manufacturing process industries, such as glassware,
vessels, filling line components and exchange parts.
DESCRIPTION
The Reliance 380PG Pharmaceutical Grade Washer is a
cabinet-type washer equipped with a programmable logic
controller system. It simultaneously accepts up to three
mixed loads of various sizes and shapes, increasing
productivity.
The washer is designed, manufactured, validated and
documented according to the latest global practices and
standards to facilitate Customer compliance with current
Good Manufacturing Practices (cGMP).
The washer is equipped with eleven adjustable cycles, three
of which are preprogrammed (light, medium and heavy).

Specifications
Size (W x H x L) Overall dimensions: 66-3/8 x 91 x 32" (1686 x 2311 x 813 mm) Add 12" (305 mm) to W with
TOC Monitoring option.
Chamber load capacity: 43-1/2 x 32-1/2 x 25" (1105 x 826 x 635 mm)
Loading height: 32" (813 mm) from floor
Weight Shipping: 1836 lb (833 kg) Operating: 1884 lb (855 kg)
Utility Requirements: Chilled Water (Looped Drain Discharge Cool Down Option) - Inlet and Outlet: 3/4" NPT or
BSPT

Cold Water 3/4'' NPT or BSPT

Sump Water Inlet (Port 1): 1" TRI-CLAMP® fitting1

Final Rinse Tank (Port 3) (If Option Applies) 1" TRI-CLAMP fitting
Steam: 1/2" NPT or BSPT. 2
Condensate Return (Steam Heated Unit Only): 1/2" NPT or BSPT . 2
Air: 3/8" (10 mm) OD

Vent: 6" (152 mm) inside diameter vent connection (not required if Non-Vented System option
is selected).
Electricity3: 480 V, 60 Hz, 3-Phase; or 380/400/415 V, 50 Hz, 3-Phase
Drain: 2" TRI-CLAMP fitting (See Note 8)

1. TRI-CLAMP® is a registered trademark of ALFA LAVAL INC.

2. NPT connection replaced by flange connection if option applies.
3. Siemens control requires 380/400/415 V, 50 Hz, 3-Phase.

Reliance® 380PG — PSSD928 Rev. A 1

 Connection to External UPS (If Option Applies): 120 V, 60 Hz; or 230 V, 50 Hz
* Total consumption per cycle is dependent on the number of treatments selected for each cycle and if drain discharge cooldown is activated.

IMPORTANT: Refer to equipment drawing 920- • EN 61326-1:2013 Electrical equipment for measurement,
515-291 for installation details and specifications. control and laboratory use - EMC requirements - Part 1:
General requirements
• EN 55011:2009/A1:2010 Industrial, scientific and medical
STANDARDS equipment - Radio-frequency disturbance characteristics -
The Reliance 380PG Pharmaceutical Grade Washer complies Limits and methods of measurement
with the applicable requirements of the following standards,
as certified by ETL:
• Underwriters Laboratory (UL): UL 61010-1 Safety FEATURES
Requirements for Electrical Equipment for Measurement, Control (single or double door) is a programmable logic
Control, and Laboratory Use - Part 1: General controller (PLC) system provided with operating interfaces,
Requirements, 3rd Edition optional thermal printer, and all required hardware. Note the
double-door configuration includes the PLC on the load-side
• Canadian Standards Association (CSA): CAN/CSA C22.2 and the following indicators and buttons on the non-
No. 61010-1-12 Safety Requirements for Electrical operating/ unload end: alarm light, cycle status light, silence
Equipment for Measurement, Control, and Laboratory Use alarm button and emergency stop button. Memory can
Part 1: General Requirements, 3rd Edition contain up to 11 processing cycles (programmable according
• International Electrotechnical Commission (IEC): IEC to Customer preferences). Cycle phase times, temperatures
61010-1: 2010 Safety requirements for electrical and other key process parameters are also programmable.
equipment for measurement, control, and laboratory use - Once cycle is started, programmed cycle values are locked
Part 1: General requirements; AMD1:2016 Consolidated and cannot be changed until cycle is complete.
version, 3rd Edition Two standard programmable logic controllers are available:
• Current Good Manufacturing Practices for Finished • Allen-Bradley® CompactLogix™ controller series with
Pharmaceuticals (cGMP): CFR Title 21, Part 211, Subpart PanelView Plus™ 7 1000 operator interface.4
D - Equipment
• Siemens S7-1500 Controller with TP1200 Comfort
• Quality System Regulation (QSR): CFR Title 21, Part 820 Operator Interface.
• Federal Communications Commission (FCC): CFR 47, Part Automatic damper is pneumatically operated to control vapor
15, Subpart B, Class A Unintentional Radiators. exhaust from unit, for enhanced temperature control and
• California Building Standards Code (California Code of vapor removal. Damper controls pressure during exhaust
Regulations, Title 24): for Seismic Anchoring removal.
Requirements. One sump inlet port is provided on standard units.
• Bioprocessing Equipment for sanitary design: ASME BPE Automatic vertical sliding door(s) operated by pneumatic
2016 standard. cylinders using control panel. Door(s) is (are) automatically
pressed against silicone gasket to ensure complete air and
• Good Automated Manufacturing Practices (GAMP®5) water tightness. Door interlock system permits only one door
• Software architecture and programming languages of to be opened at a time without aborting the cycle. During a
the control program within PLC: IEC 61131-3 cycle, neither door can be opened without first pressing STOP
on touch screen. Each door is insulated, provided with a
The Reliance 380PG Pharmaceutical Grade Washer complies safety switch and an obstruction sensor.
with the applicable requirements of Machinery (Directive
2006/42/EC). Dual spray system includes two automatic manifold
connectors at chamber bottom that automatically connect to
The Reliance 380PG Pharmaceutical Grade Washer complies a combination of accessory spindle headers that can be used
with the applicable requirements of Conformity to Other with a single load. One sanitary rotary spray arm is positioned
Applicable Directives: on top of wash chamber to ensure total coverage and even
• Electrical equipment designed for use within certain spray pressure on all surfaces of items being washed.
voltage limits (Directive 2014/35/EU) Service panels (two on front and on one side of washer)
• Electromagnetic Compatibility Directive (2014/30/EC) provide access to all components, including piping, valves,
electrical components and wiring.
The Reliance 380PG Pharmaceutical Grade Washer complies
with the applicable requirements of standards applied to Detergent injection pump (one peristaltic pump) is provided
demonstrate conformity to the directives: with foot valve, low level sensor and pickup tube. Chemical
containers are stored outside unit up to 50' away (15 m).
• EN 61010-1: 2010 Safety requirements for electrical
equipment for measurement, control, and laboratory use -
Part 1: General requirements, 3rd Edition.

4. CompactLogix™ and PanelView Plus™ are trademarks of Allen-Bradley, a Rockwell Automation Company.

Reliance® 380PG — PSSD928 Rev. A 2

Process observation window in chamber door and an interior SAFETY FEATURES
light allow operator to ensure spray arm is rotating and Safety door switch prevents a cycle from starting if door is
accessory spindles are not blocked. not fully closed and also stops washer operation if a door is
High Efficiency Air (HEPA) Filter (8 x 8" [203 x 203 mm]) is opened during a cycle.
provided on the Chamber Air Intake, including DOP Validation Power disconnect switch has a lockable, 3-phase non-fused
Ports. disconnect switch located on cover of high-voltage electrical
Removable stainless-steel debris filter, located in bottom of box.
wash chamber (sump), prevents large debris from entering Safety edge sensor located at door bottom prevents door
piping system and pump. Perforated stainless-steel filter from closing should an obstruction be detected.
prevents clogging of spray nozzles. Filter is easily removed
for cleaning. Additional sanitary water level sensor is provided to abort
cycle and automatically drain sump should an overflow
Drain Discharge Cool Down is provided on the unit with cold situation occur.
water connection for effluent cool down. Cold water is
automatically mixed with effluent to cool down from 180°F Pressure switch mounted on the air supply line shuts off the
(82°C) to at least 140°F (60°C) while being discharged to unit if air pressure drops below operating level.
building drain system. This feature can be disabled in the Emergency stop button(s) is (are) supplied at the load end
control system. (and unload end if it applies) to de-energize all outputs to
Stainless-Steel tag (for instrumentation) is attached to each safe position when pressed in case of emergency.
instrument. Identification numbers are assigned by the
factory.
CYCLE DESCRIPTION
Factory Acceptance Testing(FAT) includes the verification of Reliance 380PG Pharmaceutical Grade Washer features
the configuration of the unit and accessories, verification of 11 programmable cycles. Possible standard treatments
instrumentation calibration, verification of alarms and cycle include: one to five pre-wash, one to five wash, one to five
operation, testing of all inputs and outputs, review of rinse, and one to nine final rinse treatments. Once cycle is
engineering, manufacturing and software validation selected, washer automatically processes load through the
documentation. Demonstration that the unit can reproduce programmed treatments.
the cycle parameters recommended by the Process And
Cleaner Evaluation study (PACE) is also included, if applicable. Washer is programmed with three factory-set processing
cycles: LIGHT, MEDIUM and HEAVY. All three factory-set
Validation documentation (provided on USB Stick as cycles can be modified by the operator to include the
Standard) includes the following documents. Hard copies are following treatments:
available as an option.
• PRE-WASH: Sump is filled with selected water. Solution is
• User's Manual including: recirculated under pump pressure for preset time. On
– Uncrating/Installation Instructions completion of treatment, water is sent to drain.
– Operator and Maintenance Instructions including • WASH: Sump is filled with selected water and chemical (if
recommended spare parts selected) is injected. Solution is heated and recirculated
under pump pressure for preset time. On completion of
– Manufacturer’s parts cut sheets treatment, water is sent to drain.
• Manufacturing and Qualification Documentation • RINSE: Sump is filled with selected water. Solution is
including: heated and recirculated under pump pressure for preset
– Calibration Procedures time. On completion of treatment, water is sent to drain.

– Seismic Anchorage Report • RECIRCULATED FINAL RINSE: Sump is filled with selected
water. Pure water or WFI is heated and recirculated under
– Factory Acceptance Test Procedure and Report (FAT) pump pressure for preset time. On completion of
treatment, water is sent to drain.
– Cleaning and Passivation Procedure and Report (if
option applies) • NON-RECIRCULATED FINAL RINSE(if option applies): Pure
heated water or WFI from optional feed tank is sprayed
– Coverage Test Report (if option applies)
under pump pressure, on a once-through basis, for preset
• Control System Validation Documentation including: time. On completion of treatment, water is sent to drain.
– Functional Specifications • DRYING(if option applies): HEPA filtered, heated air is
circulated under pressure for preset time through final
– Organization Chart
rinse tank (if applicable), piping, spray nozzles and
– Software Development Procedure chamber to ensure all load items surfaces, chamber and
final rinse tank are thoroughly dried.
– Application Source Code Listings
• VAPOR REMOVAL: Vapor is removed from the chamber
for preset time.
• CHAMBER COOL DOWN SEQUENCE: After the last
treatment, fresh air is recirculated in the chamber until
selected setpoint is reached (dryer option required).

Reliance® 380PG — PSSD928 Rev. A 3

OPTIONAL FEATURES • Final rinse water is pumped from tank to spray arms and
Electronic Data Security (Siemens or Allen-Bradley) injection accessories without going through filters or being
recirculated.
• Upgraded Siemens or Allen-Bradley control package
provides 21 CFR Part 11 and EU Annex 11 capability. • Water is supplied from built-in stainless-steel cylindrical
System includes Electronic Batch Report Data, Audit trail storage tank mounted to unit side.
and batch cycle data that is viewable from the HMI screen • Tank is equipped with level control sensor, automatic fill,
via appropriate password setting, E-signature for final overflow with sanitary check valve, temperature
batch verification/acceptance, local removable memory for transmitter, hydrophobic filter and #316L stainless-steel
temporary data storage of audit trail and batch cycle data, vacuum switch.
and data export capability.
• For steam heating: tank is equipped with stainless-steel
Electronic Data Security with Data Archiving and Enhanced coil, steam valve and steam trap.
Batch Reporting (Siemens or Allen-Bradley) Upgraded
Siemens or Allen-Bradley control package provides 21 CFR • For electric heating: tank is equipped with electrical
Part 11 and EU Annex 11 capability. System includes heating element and over temperature switch.
Electronic Batch Report Data, Audit trail and batch cycle data • Up to nine pure water rinses may be selected. Tank is
(formatted into a PDF file) that is viewable from PC screen via completely drained at end of each cycle and can be dried
appropriate password setting, E-signature for final batch by selecting appropriate cycle (if drying option is available).
verification/acceptance, local hard drive for data storage of
audit trail and batch cycle data, and Data export capabilities. Non-Vented system (Drying option required). Vapor can be
exhausted through a condenser to the room, eliminating the
Air differential seal. An air differential seal is installed on the
need to vent the unit. Includes vapor removal fan.
clean side of the unit (double-door configurations only) to
minimize air flow between dirty and clean sides of barrier Condensate return to drain. The condensate return outlet is
wall. internally connected to the drain outlet of the washer.
Condensate is mixed with cold water prior to being
Second detergent injection pump. Another peristaltic pump
discharged.
can be provided with a low level sensor and a pick-up tube.
Additional day for FAT (per day). FAT is extended by one day
Inlet valve for final rinse tank. Standard unit has no inlet
to allow Customer to perform additional tests.
valve. Pilot valve is supplied as standard. Optional sanitary
diaphragm valve may be connected to the final rinse tank Connection to external Uninterruptible Power Supply (UPS).
inlet port on top of the unit. Main electrical system is modified to accommodate easy
interfacing with external UPS system to prevent loss of cycle
Inlet valve for wash chamber. Standard unit has no inlet
data should electrical power be lost during a wash cycle.
valve. Pilot valve is supplied as standard. Optional sanitary
diaphragm valve may be connected to inlet port on unit top. Chamber cool down (drying option must also be selected).
The chamber air temperature is lowered by circulating fresh
Single point wash/rinse water inlet. Standard unit has no
air into the chamber. Once the set temperature is reached,
inlet valve. Pilot valve is supplied as standard. Optional,
the air circulation stops and unload door can be opened.
sanitary multi-port diaphragm valve may be connected to
chamber inlet port and to final rinse tank inlet port on top of Looped drain discharge cool down system. Heat exchanger
unit to supply washer with only one connection point. using chilled water cools effluent to lower than 140°F (60°C).
System eliminates use of cold water for cooling and so
Stainless-Steel tags for instrumentation (with Customer
reduces water consumption. Note that this option is not
assigned numbers). Stainless-steel tag identification
available for systems using the non-vented system option.
numbers for instrumentation are provided by the Customer.
Spray arm monitoring. Chamber top spray arm rotation is
Steam and Water Utility Isolation Valves and Pressure
monitored by proximity sensor. An alarm is generated if spray
Gauges. Provides manual shutoff ball valves and a gauge on
arm stops rotating for more than a few seconds.
the domestic water, steam, air and condensate return lines to
isolate the washer from the utility lines. Manifolded drying system. Washer is provided with a HEPA
filtered system to dry both inner and outer surfaces of
Flange connection on steam. NPT or BSPT connections are
washed items. All heated surfaces downstream of HEPA filter
replaced by bolted flanges.
are made of #316L stainless steel. Drying system is supplied
Coverage test. A coverage test is performed on Customer with validation ports located on each side of the HEPA filters.
provided or representative components, using Riboflavin soil
Stainless-Steel Cabinet Enclosure Panels. Panels are
and ultraviolet light as an inspection method.
constructed of #304 stainless steel with #4 stainless-steel
Cleaning and passivation treatment. A phosphoric acid finish and enclose sides of Unit.
solution removes any ferrous contamination from surfaces,
Extended Manufacturing Documentation.
providing a better corrosion-resistant surface. Solution also
passivates entire recirculation, chamber, sump and final rinse Folder on USB Stick includes the following:
system.
• HEPA Filter Certificate (if applicable)
Heated, non-recirculated final rinse. Final rinse treatment
can be programmed to spray load with fresh, non- • Piping Assembly Drawing
recirculated, heated Pure Water or WFI. Features include: • Heat Number Certificates
• Material Certificates

Reliance® 380PG — PSSD928 Rev. A 4

• Surface Finish Report for Chamber • Main circulation pump outlet pressure is constantly
monitored to ensure optimal mechanical action.
• Welding Documentation*5
• Thermal printer is provided to keep records of the cycle
Hard Copy of Documentation. A hard copy of complete
data.
documentation set is provided. Manufacturer’s booklets and
USB Stick for installation, operation and maintenance for • A sampling port enables safe collection of wash and rinse
control systems, instrumentation and components are water samples.
excluded.
• Non-Vented System and Loop Drain Discharge Cool Down
Extended Control System Validation Documentation. Folder System options cannot be ordered together.
on USB Stick includes the following:
Total Organic Carbon (TOC) monitoring (includes Process
• Software History monitoring package). This system is used to ensure a high
level of cleaning and rinsing is consistently achieved by
• Hardware Design Specifications (Includes I/O List)
monitoring the TOC level in the last final rinse water.
• Software Design Specifications
Instrument Index/ISA Style Data Sheet and Loop Diagram.
• Software Test Documentation (System Acceptance Includes ISA style component data sheets for main process
Testing) instruments. The data sheet information consists of critical
data such as STERIS item numbers, component type/usage,
Process monitoring package. Several systems are used to manufacturer, model number, pressure and temperature
monitor critical cleaning process parameters including: range, material of construction, functional connections, etc.
• Conductivity system used to monitor chemical This option also includes individual loop diagrams provided
concentration during wash phases. This conductivity for each control loop or inter-connecting wiring between
system is also used to monitor final rinse water associated equipment and apparatus in the system. The
conductivity, ensuring thorough rinsing is achieved prior to components tag number(s), terminal number(s) and wire color
drying process. are indicated in each diagram.

A-weighted Equivalent: Surface Sound Pressure Level 65.6 dB

Maximum Water Consumption:

per Recirculated Treatment6 14.5 U.S. gal (55 L)
per Non-recirculated Treatment6 16.9 U.S. gal (64 L)

Heat Loss (at 75°F [24°C], 40% R.H. ambient 7000 Btu/h (2051 w)

Maximum Steam Consumption: per Heated Treatment6 23 lb (10.5 kg)

ACCESSORIES 4. Connections should be in accordance with local codes.

Refer to SD645, Accessories for Reliance Pharmaceutical Grade 5. Unit crate size 48.5 x 101 x 72.5" (1232 x 2565 x 1842
Washers. mm)
6. Construction of the exhaust duct system from stainless
PREVENTIVE MAINTENANCE steel is recommended. Seal the joints by welding to
A global network of skilled service specialists can provide assure a corrosion resistant and leakproof system for
periodic inspections and adjustments to help ensure low-cost removal of condensed vapor. The duct should have drip
peak performance. STERIS representatives can provide leg(s) installed at any low point(s).
information regarding annual maintenance programs. 7. Condensate to be connected to a non-pressurized
gravity return main or vented condensate receiver. Add
1/2 psi (3.45 kPa) for each 12" (305 mm) of condensate
NOTES head pressure to the minimum dynamic steam
1. Customer must ensure machine stands on non- pressure. Maximum rise not to exceed a total of 15'
combustible floor. (4.57 m) head.
2. Shut-off valves, vacuum breakers and fused disconnect 8. A 4" (102 mm) O.D. floor drain is recommended with
switch (not provided by STERIS) should be installed on floor sink.
utility lines as required on the equipment.
9. All values are based on LIGHT cycle, with an incoming
3. Pipe sizes shown indicate terminal outlet only. water temperature of 87°F (30.5°C).

5. Welding documentation is provided for the chamber, process piping and final rinse tank.
6. Total consumption per cycle is dependent on the number of treatments selected for each cycle and if drain discharge cooldown is
activated.

Reliance® 380PG — PSSD928 Rev. A 5

10. This unit is not designed for use in areas that require
explosion proof rated equipment.

Refer to the Following Equipment Drawing for Installation Details

Equipment Drawing Number Equipment Drawing Title
920-515-291 Reliance 380PG Pharmaceutical Grade Washer (Typical)

Selections Checked Below Apply To This

Equipment
CONTROL OPTIONS (Continued) OPTIONS (Continued)
Allen-Bradley (50 Hz or 60 Hz) Flange Connection on Steam Inlet/ Steam and Water Utility Isolation
Outlet Valves and Pressure Gauges
Siemens (50 Hz Only)
Stainless-Steel Tags for Additional Day for Factory
HEAT
Instrumentation With Customer Acceptance Testing (FAT) – (Per Day)
Steam Assigned Numbers
Instrumentation Index/ISA Style
Electric Electronic Data Security – Siemens Component Data Sheets and Loop
Diagrams
VOLTAGE Electronic Data Security – Allen-
Bradley Coverage Test
• 480 V, 3-Phase, 60 Hz
Electronic Data Security with Data Stainless-Steel Cabinet Enclosure
• 380/400/415 V, 3-Phase, 50 Hz Archiving and Enhanced Batch Panels (Single or Double Door)
DOOR TYPE Reporting – Siemens
• Single Electronic Data Security with Data
Archiving and Enhanced Batch
• Double Reporting – Allen-Bradley
ACCESSORIES (See SD645) Hard Copy of Documentation
OPTIONS (Complete Set)
Manifolded Drying System Loop Drain Discharge Cool Down
System9
Cleaning and Passivation Treatment
Extended Manufacturing
Second Chemical Injection Pump Documentation
Inlet Valve for Final Rinse Tank7 Extended Control System Validation
Inlet Valve for Wash Chamber Non-Vented System (Drying Option
Heated Non-Recirculated Final Rinse Required)9
Chamber Cool Down System (Drying Connection to External
Option Required) Uninterruptible Power Supply (UPS)
Total Organic Carbon Monitoring Air Differential Seal (Clean Side Only)
(TOC) – Includes Process Monitoring
Package8
Process Monitoring Package (without
TOC)
Condensate Return to Drain
Chamber Spray Arms Monitoring

Item:
Locations:

7. This valve cannot be ordered if Heated Non-Recirculated Final Rinse Option is not installed on your Unit.
8. Also available for units in the field.
9. Non-vented system and loop drain discharge cooldown system cannot be ordered together.

Reliance® 380PG — PSSD928 Rev. A 6

For Further Information, contact:
STERIS Corporation
The base language of this document is
5960 Heisley Rd.
ENGLISH. Any translations must be
Mentor, OH 44060–1834 • USA
made from the base language
440–354–2600 • 800–548–4873
document.
www.steris.com

CUSTOMER IS RESPONSIBLE FOR

COMPLIANCE WITH APPLICABLE LOCAL
AND NATIONAL CODES AND
REGULATIONS.
©2020, STERIS Corporation. This document is intended for the exclusive use of STERIS Customers, including
All rights reserved. architects or designers. Reproduction in whole or in part by any party other than a
Customer is prohibited.

Reliance® 380PG — PSSD928 Rev. A 7