STERIS VHP® LTS-V

LOW TEMPERATURE STERILIZER

APPLICATION

STERIS VHP® LTS-V Low Temperature Sterilizer is designed for

on-site low temperature surface sterilization1 of temperature
sensitive biological drug packages and drug delivery devices.
This sterilizer utilizes time proven STERIS Vaprox® Hydrogen
Peroxide Sterilant (EPA No. 1043-123) vapor in controlled
environment and vacuum conditions for maximum sterilization2
efficacy in low temperature conditions within typical range of
28-40°C (82-104°F), depending on product requirements.
Maximum sterilization temperature is 50 °C (122 °F).
1 Not for use in the terminal sterilization or reprocessing of critical or semi-
critical medical devices.
2 Sterility assurance level SAL 10-6

DESCRIPTION
STERIS VHP® LTS-V Low Temperature Sterilizer provides the
solution for cGMP and cGAMP compliant in-house terminal (Typical - details may vary.)
surface sterilization of packaged temperature or radiation
sensitive drug products as follows: STANDARDS
• Automated controlled process environment
STERIS VHP® LTS-V Low Temperature Sterilizer and products are
• Short cycle times (typically two to four hours) designed and manufactured to meet CE mark and applicable
• No toxic process by-products sections of the following European Union directives:
• Excellent material compatibility • Machinery Directive 2006/42/EC
• Maximized throughput in pre-designed high quality • Low Voltage Directive 2014/35/EU
stainless-steel chamber • Electromagnetic Compatibility (EMC) 2014/30/EU
• Fully tested STERIS process that includes feasibility testing • Pressure Equipment Directive 2014/68/EU
and full load Factory Acceptance Test (FAT) Cycle Common standards used during the design, manufacturing and
development tests with Customer product loads testing of the low temperature sterilizer is as follows:
• Complete IQ/OQ testing of equipment at factory testing • Canadian Standards Association (CSA) Standard
area prior to shipment C22.2 No. 125
• Standard configurations as well as customized • EN60204-1
arrangements to meet Customer needs • IEC 60204-1
• UL508
Following on-site installation, STERIS application specialists
also provide on-site acceptance testing and validation support STERIS quality system has been certified to meet the standard
services ensuring easy and time-saving procedures for ISO 9001:2008 Quality Management Systems.
validation of the process and equipment for the application STERIS follows the GAMP 5, A Risk-Based Approach to
environment and requirements. Compliant GxP Computerized Systems.

The Selections Checked Below Apply To This Equipment

 6912 (0.85 m3)  Two-Part Construction (Split Crating)  FAT Procedures and Results
 91515 (2 m3)  Trim Panel Set (Each Side)  Extended Control System Validation
 151818 (4 m3)  Laser Printer Documentation
 182124 (9 m3)  Sterilant Room Monitor  Installation Kit
 Mirror Construction, Chamber Right Side  Spare Parts Kit
 Air Differential Seal  Manufacturing Procedures Documentation
 Floor  Sterile Side xNon-Sterile Side  Extended Chamber and Piping Documentation
 Pit  Seismic Anchorage Restraints and Calculations  Product Feasibility Testing Services
 Enclosure Side Panels  Load Cycle Development Services
 Right xLeft  Validation Support Services
 Loading Cart System and Chamber Tracks
 Siemens PLC Control
 Transfer Trolley (6912, 91515)
 Chamber Surface Finish Inspection Report
* Double Door Standard

SD1020 (11/19/19)
STERIS develops, documents and enforces policies and
procedures ensuring the security of electronic records and Features Benefits
signatures according to 21 CFR Part 11. Together with our
Customers, STERIS helps implement and enforce Part 11- Factory Acceptance Fully tested at factory according to FAT
Test (FAT) procedures.
compliant solutions involving validation, audit trails and
security of our computer systems. The base system includes Sterilant Cartridge Only accepts Vaprox Hydrogen Peroxide
electronic records, electronic signatures, electronic batch Interface Sterilant Cartridges. Unit control
reports and audit trails. STERIS provides more details as automatically tracks amount of Vaprox
requested. Hydrogen Peroxide Sterilant used and
Sterilant expiration date. The control
FEATURES prompts the user on the control display
when a new Cartridge is needed.
STERIS VHP® LTS-V Low Temperature Sterilizer is designed to The proprietary Cartridge is equipped
meet Customer expectations for on-site surface sterilization of with a data matrix code to ensure the
temperature sensitive biological drug packages and drug correct Cartridge is used in the
delivery devices. The system is developed, manufactured and Sterilization Unit and that Cartridge
tested with the following features: contents are not expired; no Cartridge
code (or other information) needs to be
entered by the user.
Features Benefits
Standard Safety Redundant door interlock systems,
Dry Vapor Process STERIS patented process providing Systems Emergency Stop and pneumatic
consistent Vaporized Hydrogen Peroxide deactivation key switch are provided to
Sterilant for maximum penetration and ensure operator safety
distribution
Secure Access User access levels are password
Low Temperature Allows surface sterilization of heat and/or protected for secure access to the control
radiation sensitive materials

Non-Toxic Water and oxygen are the only CYCLE DESCRIPTION

Byproducts byproducts of the process
STERIS VHP® LTS-V Low Temperature Sterilizer Sterilization
Complete Cycle Surface sterilization and aeration can be Cycle consists of three phases:
completed in one process
1. Pre-Conditioning
Chamber Manufactured from AISI #316L stainless 2. Sterilant Exposure
steel (see CONSTRUCTION Section for
3. Post-Conditioning
more details)
The Sterilization Cycle is a dry vapor, vacuum process. Cycle
Jacket Full AISI #304 stainless-steel jacket for uses a deep vacuum for process purposes. Cycle development
temperature control (see aims for optimal total Cycle time. Optimization of total Cycle
CONSTRUCTION Section for more time depends on device and package materials, product
details) sensitivity to vacuum (depth and rate), surrounding
Chamber Sterilant Chamber inlet design provides uniform atmospheric conditions (room temperature and humidity,
Inlet sterilant distribution product storage temperature) and processing temperature.

Chamber Validation One dedicated port is provided for PRE-CONDITIONING

Ports sensing and validation purposes This phase is essential for Sterilization Cycle as it controls the
environment by removing air and moisture from the chamber
Room Monitoring Optional sterilant room monitoring
sensor(s) provided to detect even and packaging and heating the load to specified temperature.
minimal hydrogen peroxide sterilant The chamber is evacuated down to a programmed vacuum
presence in the room. level for the moisture removal.
Temperature control is supplied for heating at this phase only.
Vacuum Pump Vacuum levels to allow for maximum
Optimal and typical operating temperature range is 28-40 °C
packaging penetration
(82-104°F). Lower load temperatures may result in longer Cycle
Leak Test Customer can ensure chamber is sealed times.
if leak rate is within acceptable limits
STERILANT EXPOSURE
PLC Control Standard, commercially available, PLC Vaporized Hydrogen Peroxide Sterilant is introduced into the
control system platform
chamber and maintained for a specific time. Vacuum conditions
Operator Interface Color touch screen with Cycle enable penetration of the sterilant through Tyvek®3 packaging
parameters, alarms and component and into the load. Hydrogen peroxide injection depends on load
status configuration, temperature, materials (packaging, adhesives,
plastics, etc.) and chamber size.
3 Tyvek is a registered trademark of E. I. duPont de Nemours and Company.

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POST-CONDITIONING Jacket material is AISI #304 as a standard.
The load is aerated using a series of vacuum pulses to remove Chamber and jacket components are designed to monitor and
the sterilant from the load and chamber prior to Cycle control the Cycle via the PLC and communicate Cycle
completion. The sterilant is converted to water and oxygen conditions to the operator. Components are selected to deliver
using a built in catalytic converter system. The chamber is reliable performance while being subjected to the varying
equalized with sterile air. pressure conditions of the Sterilization Cycle.

SAFETY FEATURES Chamber Doors

The chamber doors are manufactured from AISI #316L stainless
Emergency Stop Button, located on both sterile (ST) and non-
steel. Double door is the standard chamber configuration, as
sterile (NS) sides of the Unit, returns valves to safe condition
it provides a pass-through from NS loading side and opens to
and halts Cycle processing when pressed. Once pressed,
ST unloading side after Cycle.
operator chooses to either abort or continue Cycle operation.
Security Access Codes provide restricted access of Piping
unauthorized users to critical operational modes. Three access All piping connections terminate within the confines of the Unit.
levels are available: Pipe connection types, materials and other features include
1. Operator Level: Allows operator to select and start Cycle, stainless steel, PTFE and Tri-Clamp®4, threaded or flanged
view Cycle parameters and order control to print limited connections as per defined.
reports. 4 Tri-Clamp is a registered trademark of ALFA LAVAL INC.
2. Service Level: Allows operator to select and start Cycle,
view Cycle parameters, print reports, calibrate instruments MOUNTING ARRANGEMENT
and activate/deactivate inputs and outputs, edit common
settings, change date/time and view service diagnostics. Sterilizer is designed for freestanding or recessed mounting
through one or two walls. All sterilizer components are integrally
3. Administrator Level: Allows operator to select and start
Cycle, view Cycle parameters, print reports, calibrate mounted within sterilizer footprint (refer to Equipment drawing).
instruments and activate/deactivate inputs and outputs, Each sterilizer is equipped with adjustable leveling legs.
edit common settings, change date/time, view service
diagnostics and edit passwords.
OPTIONAL FEATURES
Compressed Air Back-up for door gaskets. Pit-Mounting Installation (floor-mounting is standard) option
Door Sensing Device automatically stops door if an is designed to enable the frame assembly to be installed in a
obstruction is detected while the door is closing. pit to align the bottom of the chamber with the finished floor.
Door Interlock allows only one door to be opened at a time, Pit-mounted installation is provided with the following features:
and during processing, prevents either door from being opened • Unit is designed to be recessed into a 300 mm (12") deep
until Cycle is complete. pit.
Pressure Relief Device on chamber limits the amount of • AISI #304 stainless-steel exterior fascia panels are
pressure buildup so rated pressure of vessel is not exceeded. extended to the finished floor to provide a clean installation.
• Stainless-steel transition plate is provided for easy rolling
Pneumatic Key Lock feature for doors provides a safety lock
of carts to/from the Unit.
system for disabling all the chamber door functions during
service and cleaning operations. • No transfer trolleys are required with this configuration.
Two-Part Construction (Split Crating) design allows
CONSTRUCTION separation at the installation site and facilitates rigging into
restricted openings or spaces. Typically selected by Customers
Chamber/Jacket with entry restrictions that limit the equipment's size. If pit
Chamber is manufactured from AISI #316L stainless steel with mounted installation is selected with this option, then the unit
an operating pressure range from full vacuum to 0.34 bar (g) must be reassembled prior to being set into the pit.
pressure. Trim Panel Set (Each Side) are provided with for sealing the
Chamber is passivated with a solution that is composed of gap between the Unit fascia panels and facility wall opening
hydrofluoric acid, nitric acid, and de-ionized water after for recessed one or two wall installations. Panels are
fabrication. The process (solution concentration, exposure time manufactured of AISI #304 stainless steel. Select this option
and temperature, etc.) is controlled by specific Quality when other sealing methods such as dry wall installation or on-
Assurance Procedures to ensure proper processing. Chamber site sheet metal fabrication are not available. Customer’s room
is rinsed with de-ionized water and cleaned with pure steam layout drawing is required for designing the trim panels.
after exposure. A chamber passivation certificate is included. Stainless-Steel Frame provides enhanced frame material
NOTE: Chamber net size is 300 mm smaller in height (#304 stainless steel) with an external glass beaded finish.
compared to the nominal chamber size. For example, 91515 Laser Printer is remotely mounted on the stainless-steel
chamber size has 91215 net size and volume. enclosure to provide paper printout of the Cycle batch reports.

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Sterilant Room Monitor is used to detect even very low polymer based and are compatible with sterilant. Shelves
concentrations of hydrogen peroxide sterilant in the area. The are customized for each project and product via the special
monitor alarms if sterilant levels exceed acceptable limits (> 1 sales quotation (SSQ) system.
ppm). • Tracks in chamber are installed to guide the cart(s) during
Mirror Construction reverses standard positioning of sterilizer loading and unloading procedures. Tracks are AISI #316L
chamber and service area. In mirror construction, as viewed stainless steel. A transfer trolley is required with this option
from operating end, sterilizer chamber is relocated to right side if the unit is not pit mounted (91515 size chamber only).
and service side is relocated to left side. Standard configuration Transfer Trolley (6912 and 91515 only) is designed to support
is chamber on left and service on right side (as viewed from and convey the loading cart to and from the chamber and
operating side). throughout the facility. A mechanical interlock system is
Air-Differential Seal (Sterile Side) is provided at the sterile provided to lock the transfer trolley to the Unit’s chamber while
end of the Unit to maintain pressure difference between the Unit loading/unloading the cart. Another mechanical interlock
service area and classified area. The seal is fabricated from system is provided to lock the loading cart to the transfer trolley
AISI 304 stainless steel. Silicone caulking is used to seal the to enable safe movement of the combination. The total weight
panels within the Unit frame. Adjustable interface panels are on the transfer trolley is not to exceed 450 kg (1000 lb).
provided at the top, bottom and both sides with a silicone gasket Features:
to seal the system to the facility structure. Air differential seal • Constructed of AISI #304 stainless steel
on both sides is a special quotation offer.
• Includes two swivel wheels with brakes and two fixed
Air Differential Seal (Non-Sterile Side) is provided at non- wheels without brakes
sterile end of Unit to maintain pressure difference between Unit
• Wheels are constructed of polyamide with an exterior
service area and classified area. Seal is fabricated from AISI
polyurethane coating and stainless-steel mounting
#304 stainless steel. Silicone caulking is used to seal panels
hardware
within Unit frame. Adjustable interface panels are provided at
top, bottom and both sides with a silicone gasket to seal system FAT Procedures and Results were developed for the purpose
to facility structure. Air differential seal on both sides is a special of providing written qualification procedures that can be
quotation offer. implemented into a Customer's validation plan for FAT Testing.
Procedures and Results Package integrates detailed written
Seismic Restraints and Calculations provide Unit with
procedures and test plans into the FAT report. This material
seismic anchorage designed to meet seismic zone four
may then be used as a basis for the customer's Standard
requirements. Angle brackets and frame mounting hardware
Operating Procedures (SOPs) used to complement their IQ/OQ
are manufactured from AISI #304 stainless steel and are
requirements during Site Acceptance Test (SAT).
provided by STERIS. The Hilti type, or equivalent, floor anchors
are provided and embedded (not by STERIS) into the concrete Extended Control System Validation Documentation
floor. Calculations are per latest California UBC as standard Package adds the following material to the standard package:
and certified by a California registered Engineering Company. • Hardware Specification
Other calculations are available on request and may require • Software Test Documentation
additional cost. Seismic calculations are located in the
• PLC Change Control Documentation
Manufacturing Documentation.
NOTE: Validation and customer defined requirements remain
Enclosure Side Panels (stainless steel) are installed on the
the sole responsibility of the customer.
right and/or left side of Unit framework as specified.
Installation Kit provides a set of counter flanges or clamps
Loading Cart System and Chamber Tracks are custom and their gaskets and clamp connectors to make Unit
designed and used to support and convey assorted products connection to utility piping installation easier.
in the loading, sterilizing and unloading process. Loading
Spare Parts Kit containing selected mechanical and electrical
equipment is a critical component for the process and
components is provided to fulfill the need for two years normal
throughput of the Unit. Product details need to be provided to
maintenance and operation of the Unit. Components typically
optimize design of the load pattern, size and weight. Some
provided are valve rebuild kits, solenoid valve, temperature
typical features include:
sensor, pressure sensor, door gaskets and other applicable
• Stainless-steel frame design components. Additional parts may be required for other
• Cart size (chamber net size) is 300 mm lower in height to features.
nominal size (e.g., 91515 cart and chamber size is 91215)
Extended Chamber and Piping Documentation can be
• Equipped with four fixed wheels (two swivel casters for pit supplied. Vessel codes require manufacturers to maintain
mounted units) material certificates and traceability documentation at factory
• Multiple carts can be provided depending on chamber to provide evidence of proper manufacturing. As standard,
size to help facilitate loading and minimize weight. Note STERIS archives these documents at factory for reference
standard arrangement is one cart for 91515, two carts for purposes. Option is for Customers requiring extended vessel
151818 and four carts for 182121 size chambers. Any documentation to be on-site. Package also provides detailed
different cart arrangement from this standard must be piping inspection information, material certificates and weld
quoted separately as SSQ (special sales quotation). information for Customer record purposes.
• Cart(s) are supplied with shelves depending on product
load configuration. Materials are typically stainless steel or
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Product Feasibility Testing Services is available for NOTES
Customers defining the initial process feasibility of their
products with low temperature surfaces sterilization (e.g., if 1. The VHP options are to be used by trained and certified
considering a new device material, pressure range, Applicators who have successfully completed both the
temperature, package type or material, etc.). A customized test STERIS Training and Certification Course for applicators
of Vaprox Hydrogen Peroxide Sterilant and the VHP
plan will be drafted and executed at the STERIS factory by a
pertinent Sterilization System Operator Course.
qualified STERIS representative. Feasibility testing time will be
Certification must be active and in force for all Applicators
quoted per day. Typical procedures with feasibility testing is to of Vaprox Hydrogen Peroxide Sterilant.
run product samples in Sterilization Cycle and study device
and package exposure, self-contained biological indicators 2. Consult Vaprox Hydrogen Peroxide Sterilant SDS, label
and package insert for information regarding storage and
and/or chemical indicator tests for product integrity. Typical
handling of Cartridges.
outcome for test deviations from agreed scope of test plan will
require additional days. 3. Refer to equipment drawings showing all utility and space
requirements for actual installation specifications.
NOTE: All cycle development services are quoted on a Clearances shown are minimum required for servicing
customized basis for the application. Feasibility testing is equipment. Floor surface must be hard and level.
carried out at STERIS Finn-Aqua R&D Science Room by
dedicated R&D personnel. STERIS Finn-Aqua holds national
Finnish Medicinal Manufacturing License that enables easy
shipping and handling of Customer's product samples used
for feasibility and load cycle development tests.
Load Cycle Development Services and testing is encouraged
to be part of the FAT for new applications. This development
test is to ensure a Cycle can be run with a full load in the chamber
and is a starting point for Cycle optimization or Performance
Qualification (PQ) activities. This testing is expected to be
conducted over a specified time period and is performed after
the FAT document is executed.
Validation Support Services is available for Customers
required to validate their equipment. Validation support
services time will be quoted per day. Validation support typically
includes on-site support in validation test runs at customer site.
Additional Copy of User's Manual or Document File option.
An additional hard copy of the complete documentation set is
provided, including the user's manual, Factory Acceptance
Test documentation, as well as the manufacturing and control
system documentation (standard and optional). Manufacturer's
booklets and CDs for installation, operation and maintenance
for control systems, instrumentation and components are
excluded.
Manufacturing Procedures Documentation binder provides
the following internal procedures:
• Mechanical Grinding and Polishing Procedure
• Pickling and Passivation Procedure
• Surface Roughness Measuring of Vessels Procedure
Chamber Surface Finish Inspection Report option. As
standard, the procedure for inspection of the Chamber surface
finish is by random inspection during manufacturing by the
quality assurance (QA) department. With this option the
instrument documentation and data of the surface finish
measurements are provided with the Manufacturing
Documentation.

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FOOTPRINT
Refer to equipment drawing for installation details and
specifications.

EQUIPMENT DIMENSIONS (SI-UNITS - millimeters)

Equipment Chamber

UNIT SIZE W H D Weight [kg] LW LH LD VOLUME [L]

6912 2580 1931 1780 1920 650 735 1200 850

91515 2880 2531 2080 3035 950 1330 1500 2000
151818 3780 2831 2380 4085 1550 1635 1800 4000
182124 4380 3118 2980 8800 1850 1835 2400 9000

EQUIPMENT DIMENSIONS (US-UNITS - inches)

Equipment Chamber

UNIT SIZE W H D Weight [lb] LW LH LD VOLUME [L]

6912 101 1/2 76 70 4234 25 1/2 29 47 850

91515 113 1/2 99 1/2 82 6692 37 1/2 52 1/2 59 2000
151818 149 111 1/2 93 1/2 9008 61 64 1/2 71 4000
182124 172 1/2 123 117 1/2 19405 73 72 94 1/2 9000

UTILITY REQUIREMENTS CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH

APPLICABLE LOCAL AND NATIONAL CODES AND
Refer to equipment drawing for installation details and REGULATIONS.
specifications.

Utility Data
The base language of this document is ENGLISH. Any translations must
be made from the base language document.
Vaprox Hydrogen STERIS patented process providing
Peroxide Sterilant consistent Vaporized Hydrogen Peroxide
Sterilant for maximum penetration and
distribution

Softened Water 2-5 bar

(29-73 psig)
570-770 L/h (150-203 gph) during cycle
(depending on unit size and cycle type)

Instrument Air 5-8 bar

(73 - 116 psig)

Drain Gravity Discharge

Vent Exhaust

Chamber Safety Release to open air, no back pressure

Relief Device

Unit Electricity 200-600 V

50-60 Hz
3 Phase

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Loading STERIS VHP LTS-V Low Temperature Sterilizer (Typical)

Transfer Trolley (Typical)

7
For 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
SD1020 ©2017, STERIS Corporation. All rights reserved. (09/19/19) a Customer is prohibited.