Loren Data's SAM Daily™

FBO DAILY ISSUE OF NOVEMBER 08, 2012 FBO #4002
DOCUMENT

65 -- RB-82 GENERATOR - Attachment

Notice Date

11/6/2012
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Central Texas Veterans HCS;1901 S. 1st Street;Temple TX 76504
 

ZIP Code

76504
 

Solicitation Number

VA25713I0153
 

Response Due

11/8/2012
 

Archive Date

11/23/2012
 

Point of Contact

Patricia Chandler
 

E-Mail Address

.
 

Small Business Set-Aside

N/A
 

Description

Request for Information (RFI) 1. Please provide a response if you company is capable of providing Cardiogen-82 Generators and Patient Infusion Lines. 2.Provide responses via email by 4:00 pm CST on 11/8/2012 to Patricia Chandler at Patricia.Chandler2@va.gov. 3.Below is an estimated list of VA's requirements: NORTH TEXAS HEALTHCARE SYSTEM, DALLAS, TEXAS ITEMDESCRIPTION 1Item 0270-0103-20; Rb-82 Generator For Elution of Rubidium Chloride Rb 82 Injection Diagnostic: Intravenous DESCRIPTION Cardiogen-82 ® (Rubidium Rb 82 Generator) contains accelerator produced strontium Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means for obtaining sterile nonpyrogenic solutions of rubidium chloride Rb 82 injection. The chemical form of rubidium 82 is 82RbCl. The amount (millicuries) of Rb-82 obtained in each elution will depend on the potency of the generator. When eluted at a rate of 50 mL/minute, each generator eluate at the end of elution should not contain more than 0.02 microcurie of strontium Sr 82 and not more than 0.2 microcurie of strontium Sr 85 per millicurie of rubidium chloride Rb 82 injection, and not more than 1 microgram of tin per mL of eluate. PHYSICAL CHARACTERISTICS Rubidium Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds. External Radiation The specific gamma ray constant for Rb-82 is 6.1 R/hour-millicurie at 1 centimeter. The first half-value layer is 0.7 centimeter of lead (Pb). For example, the use of a 7.0 centimeter thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Strontium Sr 82 decays to rubidium Rb 82 with a strontium Sr 82 half-life of 25 days (600 hrs). The Sr-82 is produced in an accelerator by proton spallation of molybdenum, Mo (p, spall) Sr-82 or by the reaction Rb-85 (p, 4n) Sr-82. The Sr-82 produced has no carrier added. CLINICAL PHARMACOLOGY Following intravenous administration, rubidium Rb 82 rapidly clears the blood and is extracted by myocardial tissue in a manner analogous to potassium. In human studies, myocardial activity was noted within the first minute after injection. When areas of myocardial infarction are detected with rubidium chloride Rb 82 injection, they are visualized within two to seven minutes after injection as photon-deficient or "cold areas" on the myocardial scan. Uptake is also observed in kidney, liver, spleen, and lung. INDICATIONS AND USAGE Rubidium chloride Rb 82 injection is a myocardial perfusion agent that is useful in distinguishing normal from abnormal myocardium in patients with suspected myocardial infarction. Cardiogen-82 (Rubidium Rb 82 Generator) must be used with an infusion system specifically labeled for use with the generator and capable of accurate measurement and delivery of doses of rubidium chloride Rb 82 injection not to exceed a single dose of 2220 MBq (60 mCi) and a cumulative dose of 4440 MBq (120 mCi) at a rate of 50 mL/min with a maximum volume per infusion of 100 mL and a cumulative volume not to exceed 200 mL. These performance characteristics reflect the conditions of use under which the drug development clinical trials were conducted. Adequate data from clinical trials to determine precise localization of myocardial infarction or identification of stressinduced ischemia have not been collected. Positron emission tomographic (PET) instrumentation is recommended for use with rubidium chloride Rb 82 injection. DOSAGE AND ADMINISTRATION General As with all radiopharmaceuticals, only the lowest dose of rubidium Rb 82 necessary to obtain adequate visualization should be used. A lower dose provides less patient radiation and is consistent with the achievement of ALARA. Most procedures do not require use of the maximum dose of rubidium Rb 82; the dose to be used should be carefully individualized and factors such as: age; body size; anticipated pathology; degree and extent of visualization required; structure(s) or area to be examined; disease processes affecting the patient and; equipment and technique to be employed; should be considered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration 2Patient Infusion Lines (25 lines per package) DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VACTHCS674/VACTHCS674/VA25713I0153/listing.html)
 

Document(s)

Attachment
 

File Name: VA257-13-I-0153 VA257-13-I-0153_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=519268&FileName=VA257-13-I-0153-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=519268&FileName=VA257-13-I-0153-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Dallas, TX

Zip Code: 75216
 

Record

SN02925524-W 20121108/121106234419-ab6033186fd63e5f8b4ebefc0d82b8f7 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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