Specifications for Brand Name of Equal.pdf

Please fill out the matrix below and return a sign copy as part of the submission. The Vendor SHALL comment on each specification as instructed in the Buy Terms, Technical Evaluation of Quotes (Brand Name or Equal).

If bidding exact item, it is acceptable to write “Exact Match” in each of the categories below”. Vendors offering “Equal” shall NOT write “Complies”, “Equal”, “Yes”, etc in the Vendor Submission column of this matrix, vendors shall write the exact specification they are offering as an equal for each line of this matrix. Failure to meet this requirement will result in your offer being found “Technically Unacceptable”.

Brand Name requested: Steris Life Sciences

Signature:

Specifications (Do not include Pricing in matrix)

Vendor's Submission: Brand Name or Equal, Please read provision 52.211-6 and all buy terms.

Item Number 0001

• Must be capable of achieving levels of Hydrogen Peroxide (H2O2) between 300 parts per million (ppm) and 1500 ppm depending on size of enclosure to be decontaminated

• Must operate with peroxide levels that remain below the dew point and avoid condensation

• Must have standardized external interfacing allowing data downloading to a host PLC or PC

• Must display error messages in complete phrases with no codes to cross-reference

• Must display any abnormal conditions that may exist either in or out of a cycle

• Must provide software with precise control and documentation sufficient to meet GAMP standards

• Must meet EMC and low voltage directives

• Must contain high capacity control memory maintaining a database of cycle records and provide duplicate print capabilities

• Must be GAMP compliant and CE marked

• Must meet ISO 13485 certification

• Must be registered with the EPA

Item No 002

• Must be portable

• Must be handheld

• Must measure H2O2 levels in real-time

Item No 003

• 1.5” stainless steel Tri-Clamp Adapter for flexible connection hose

• Tri-Clamp Swivel Clamp

• Tri-Clamp Gasket

• Hose band clamp

Item No 004:

• Two (2) 1.25 inch to 1 inch MNPT male adapters for inlet and outlet of unit

• Two (2) 1.25 inch to 1.25 inch hose barb female adapters

• Four (4) hose clamps

• Two (2) 10 foot 3.18 centimeter hoses

Item No 006:

• Must be capable of achieving levels of Hydrogen Peroxide (H2O2) between 300 parts per million (ppm) and 1500 ppm depending on size of enclosure to be decontaminated

• Must operate with peroxide levels that remain below the dew point and avoid condensation

• Must have standardized external interfacing allowing data downloading to a host PLC or PC

• Must display error messages in complete phrases with no codes to cross-reference

• Must display any abnormal conditions that may exist either in or out of a cycle

• Must provide software with precise control and documentation sufficient to meet GAMP standards

• Must meet EMC and low voltage directives

• Must contain high capacity control memory maintaining a database of cycle records and provide duplicate print capabilities

• Must be GAMP compliant and CE marked

• Must meet ISO 13485 certification

• Must be registered with the EPA

Item No 007:

• Must measure temperature in real time and relay information to decontamination control unit

• Must measure relative humidity in real time and relay information to decontamination control unit

• Must measure hydrogen peroxide vapor concentration and relay information to decontamination control unit

Item No 009:

• Execute the STERIS Installation/Start-up Checklist for the equipment

• Verify that building utilities are to the design specification of the equipment

• Verify that the installation was adequately performed and documented

• Verify that the operational requirements are met

Item No 010: Calibration Services

Item No 0011:

Start-Up Services

• Execute the Installation/Start-up Checklist for the equipment

• Verify that building utilities are to the design specification of the equipment

• Verify that the installation was adequately performed and documented

• Verify that the operational requirements are met

Item No 0012:

• Calibration services for Generator

Item No 0013:

For the development of 1 cycle, this package includes:

• First pass cycle parameters

• Air Flow Balance and Distribution (if applicable)

• VHP Engineering Cycle

• Cycle verification with biological indicator incubation

& interpretation (1 cycle) inclusive of a map showing where Biological Indicators were placed in the space

• Cycle Development Report

• Owner observation of procedures

First pass cycle parameters:

Establish initial cycle parameters based on similar applications, applicable standards

Airflow balance and distribution Balancing Airflows VHP Engineering Cycle

Cycle verification with B.I. incubation & interpretation - 1 cycle:

Cycle development report

Item No 0014:

• First pass cycle parameters

• Air Flow Balance and Distribution (if applicable)

• VHP Engineering Cycle

• Cycle verification with biological indicator incubation

& interpretation (1 cycle) inclusive of a map showing where Biological Indicators were placed in the space

• Cycle Development Report

• Owner observation of procedures

First pass cycle parameters:

Establish initial cycle parameters based on similar applications, applicable standards.

Airflow balance and distribution Balancing Airflows VHP Engineering Cycle Cycle verification with B.I. incubation & interpretation - 1 cycle Cycle development report:

Item No 0015:

• First pass cycle parameters

• Air Flow Balance and Distribution (if applicable)

• VHP Engineering Cycle

• Cycle verification with biological indicator incubation

& interpretation (1 cycle) inclusive of a map showing where Biological Indicators were placed in the space

• Cycle Development Report

• Owner observation of procedures

First pass cycle parameters:

Establish initial cycle parameters based on similar applications, applicable standards

Airflow balance and distribution Balancing Airflows VHP Engineering Cycle Cycle verification with B.I. incubation & interpretation - 1 cycle Cycle development report

Item Number 0016: Design Review

Customer Document review and/or site visit to inspect and review items such as facility layout and design, HVAC, distribution piping, components, control integration and communication, and equipment designs for integration with the VHP process.