Government Contract | Texas
Purchase of Steris BPS Model 6912 Sterilizer OR Functionally Equivalent

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Bid Information

Bid Alert No: 00002018614

Bid Title: Purchase of Steris BPS Model 6912 Sterilizer OR Functionally Equivalent

Agency Bid No. Title: 23-4540-ITB-1959

Received Date: 01/16/2020

Close Date: 01/30/2020

Purchase Type: Not Stated

Delivery Point: Texas A&M University, College Station, Texas

Delivery Date: Not Stated

Special Notices: Bidder Preregistration


Specifications include, but are not limited to: Steris BPS Model 6912 Sterilizer with SingleDoor ; GMP Model BPS0609125 ORFunctionally equivalent meeting or exceedingthe attached specifications.Equipment will be installed by personnelauthorized by Texas A&M University Centerfor Innovation in Advanced Development andManufacturing (CIADM) inside a Mobile CleanRoom (MCR) located in College Station,Texas.1. System requirementsa. Autoclave should be especially suitable for GMP regulated pharmaceutical companies. Designed for general purpose, sterile room supply, media preparation, or terminalsterilization applications performed in biopharmaceutical and pharmaceutical facilities b. The design and construction of the unit should be in compliance with Current GoodManufacturing Practice (cGMP) and Good Automated Manufacturing Practices (GAMPP.c. Temperature distribution within the chamber, including drain temperature, should beguaranteed to be within 0.5C (0.9F) of the process sterilization temperature(exposure setpoint).d. The sterilizer should be fully tested and prevalidated during factory qualification.Prequalification reports of the installation, operational, and performance qualificationsshould be provided, along with complete documentation on machine design,construction and control software.e. Sterilizer should be manufactured in an ISO 9001, ASME Section VIII Division 1, PEDModule H/H1 and EN7292 certified facility and should meet applicable requirements ofthe following listings and standards.i. GMPii. GAMP 5 iii. EN285iv. EN ISO 176651v. Underwriters Laboratory (UL) Standard 508vi. Canadian Standards Association (CSA) Standard C22.2 No. 125vii. ASME Code, Section VIII, Division 1 for unfired pressure vessels.viii. FDA 21 CFR Part 11 Compliant/EU Annex 11. STERIS FinnAqua develops,documents, and enforces policies and procedures that ensure security ofelectronic records and signatures according to 21 CFR Part 11. Together withour Customers, FinnAqua will help implement and enforce Part 11compliantsolutions involving validation, audit trails, and security of our computer systems.

Bid Related Documents

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Bid Related Attachments

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Product Code: 46590

Agency Information

Issuing Agency: Texas A&M University Health Sciences Center

State: Texas

Agency Type: State and Local

Contact: 330 Agronomy Road, P.O. Box 30013, College Station, Texas, 77842-3013




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