Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 20, 2003 FBO #0629
SOLICITATION NOTICE

66 -- ASEPTIC SYRINGE FILLER MACHINE

Notice Date

8/18/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

9000 Rockville Pike Bldg. 10/1n226; Bethesda, MD 20892
 

ZIP Code

20892
 

Solicitation Number

CC263-03-Q-LL-1129
 

Response Due

8/21/2003
 

Archive Date

9/20/2003
 

Point of Contact

Andrea McGee 301-402-0735
 

Small Business Set-Aside

N/A
 

Description

NA Buyer: NIH Clinical Center 9000 Rockville Pike Bldg. 10/1n226 Bethesda MD 20892 Reference Number: CC263-03-Q-LL-1129 Required By: 08-21-03 Delivery By: 09-15-03 Delivery FOB: Y Small Business Set-aside: N FAR: 52.219-1 SMALL BUSINESS CONCERN REPRESENTATION 84041 SIC: 3579 FSC: 6640 Simplix Key: 7T0JR080 Delivery Destination: dorworth, thomas; 10 Center Drive; Bethesda, MD 20892 LINE ITEM 01: 1 Each ASEPTIC SYRINGE FILLER MACHINE ADDITIONAL PROVISIONS AND REPRESENTATIONS: NO PHONE CALLS PLEASE, INQUIRE VIA EMAIL AMCGEE@CC.NIH.GOV, FAX QUOTES TO 301-594-5920. To buy a new ASEPTIC SYRINGE FILLER MACHINE for the NIH Pha rmacy, Pharmaceutical Development Services ( PDS) , Cleanroo m operations (10/1D-52), to support the increase demand on f ormulations of injectables in pre-filled syringes for the NI H Clinical Center Protocols. OBJECTIVE: Such machine will fill automatically and aseptically various types of syringes with sterile solutions manufactured by NI H/PDS, to be used as vaccines for children , vaccines for Ho meland Security (NICHD), Bone Marrow support media, Heparin Injections ( NHLBI), etc. Characteristics of such machinery: This bench-top machine module will avoid the need for hand filling and consequently decrease contamination, fatigue of the operator and increase the capabilities of production wit h a nearly 100% reliability rate. It is a machine that can be entirely steam sterilized. Manufactured with 316 stainless steel frame (12 X 18 dime nsions approx.) to work in limited space of a custom laminar flow hood. Easily assembled for cleaning and decontamination. Can be handled by 2 trained operators Will fit our custom made Sterile Biological Hood, currentl y operational in the Clean-room , NIH Bldg 10/Rm 1D-52. The module must automatically fill various types of syringe s,( B-D plastic 10 mL syringes with luer-lock screw tip cat# 8000667, B-D plastic 3 mL syringes slip tip cat# 309586 , B -D glass Hypak syringes SCF 1 mL LLA-W1883 gray barrels w/ E Z grip TCII w/out needle), from the tip side, minimizing ma nual contact with the syringes. The module has to place the stopper into the barrel for B-D Hypak syringes Fill Volumes must vary from 0.2 mL to 50 mL The module fills the syringes with water like liquids with an accurate and easy to operate pump, such as --( Watson Mar low 505DZ), or equivalent. The module applies press fit luer-lock caps to the plastic and glass syringes The module must remove the commercially applied slip-tips f rom the syringes. The module will accept our silastic tube filling medical gr ade 1/8 X 1/4 in Helix Mark cat# 60-011-21 The module must have disposable stainless steel needles The module must have Control Sensors for volume and discard mechanism selection Programmable Logic controls ( Power On/Off, Emergency-stop, Run, Stop, Single step, Syringe carrousel advance, luer-loc k cap advance) must be in place. The module must have capabilities for gas purge of the syri nges Easy set up, lift off components and serviced with minimal training. Performance: The module must fill and stopper at least 600-900 syringes per hour The module must be designed to accommodate a broad variety of containers to allow for change of components or produc tion demands Change over of components should be done under 15 minutes 1000 of each components ( syringes, stoppers, pistons , cap s) should be allowed per batch operation. There should be no particulate forming from the mechanism of the parts during operation, inside the class 100 asepti c hood. Preferable that the module should show previous positive p erformance . Environment: The module must be designed to operate in a class 100 asept ic environment. The module must fit our current vertical biologic hood, Bld g 10, RM 1D-52, which has a frontal opening of 15 inches. M aximum Height of 22 inches , depth of 19 inches and length of 30 inches. The module must fit our AMSCO autoclave with maximum height of 16 with cart, width of 18 and length of 34. The unit must be operator friendly to roll onto a stainless steel cart SELECTION CRITERIA Selection will be based on Best Value to the government.
 

Web Link

Simplix
(http://www.simplix.com)
 

Place of Performance

Address: 10 Center Drive

Zip Code: 20892

Country: USA
 

Record

SN00404694-W 20030820/030818213320 (fbodaily.com)
 

Source

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

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