SOLICITATION NOTICE
66 -- Dissolution Apparatus System
- Notice Date
- 12/8/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, DO-ATL-Crawford, Rm 116 HFR-SE1, Atlanta, Georgia, 30309, United States
- ZIP Code
- 30309
- Solicitation Number
- 1081934A
- Archive Date
- 1/4/2011
- Point of Contact
- Thomas M Dumas, Phone: 404-253-1253
- E-Mail Address
-
thomas.dumas@fda.hhs.gov
(thomas.dumas@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, in conjunction with FAR 13.5, as applicable, and as supplemented with additional information include in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1081934-1. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-46 effective October 29, 2010. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 Analytical Laboratory Instrument Manufacturing with a small business size standard of 500 employees. This is a 100% small business set-aside. The Government intends to award a Firm Fixed-Price Purchase Order for, brand-name or equal to the following items to be shipped to Four (4) FDA, Locations: **Ship to FDA, San Juan, PR 00901: L1 1ea VK7025/8000/SP, 8Pos Dissolution System, 115V L2 - 8ea Paddle, Electropolished, V-Series L3 1ea AccKit 7025, 8 Pos, SSBskt Std clip L4 1ea AccKit 8000, 6/8 Vlv, 16x100mm Tray L5 1ea Service IQOQPQ L6 1ea IQOQPQ(combo)Qual guide VK7020/VK7025(Dup L7 1ea Qual guide, IQOQ, 8000 PP/SP, App 1/2/3/7 L8 1ea Bio-Dis, 42 Tube Capacity, 300ml, 115V L9 1ea Service IQOQPQ for Bio-Dis L10 8ea Basket, Slotted, Suppository L11 8ea Rotating Cylinder, Apparatus 6 L12 8ea Disk w/Screen Apparatus 5 (35mm) L13 1ea Tool to disassemble disk assy L14 8ea Sinker basket JP13 L15 Shipping and handling **Ship to FDA, Jamaica, NY 11433: L1 1ea VK7025/8000/SP, 8Pos Dissolution System, 115V L2 - 8ea Paddle, Electropolished, V-Series L3 1ea AccKit 7025, 8 Pos, SSBskt Std clip L4 1ea AccKit 8000, 6/8 Vlv, 16x100mm Tray L5 1ea Service IQOQPQ L6 1ea IQOQPQ(combo)Qual guide VK7020/VK7025(Dup L7 1ea Qual guide, IQOQ, 8000 PP/SP, App 1/2/3/7 L8 1ea Bio-Dis, 42 Tube Capacity, 300ml, 115V L9 1ea Service IQOQPQ for Bio-Dis L10 1ea IQOQPQ(combo)Qual Guide Bio-Dis (Dup) L11 8ea Basket, Slotted, Suppository L12 8ea Rotating Cylinder, Apparatus 6 L13 8ea Disk w/Screen Apparatus 5 (35mm) L14 1ea Tool to disassemble disk assy L15 8ea Sinker basket JP13 L16 1ea Billable Travel L17 3ea Billable PerDiem/Day L18 Shipping and handling **Ship to FDA, Bothell, WA 98021: L1 1ea VK7025/8000/SP, 8Pos Dissolution System, 115V L2 - 8ea Paddle, Electropolished, V-Series L3 1ea AccKit 7025, 8 Pos, SSBskt Std clip L4 1ea AccKit 8000, 6/8 Vlv, 16x100mm Tray L5 1ea Service IQOQPQ L6 1ea IQOQPQ(combo)Qual guide VK7020/VK7025(Dup L7 1ea Qual guide, IQOQ, 8000 PP/SP, App 1/2/3/7 L8 1ea Bio-Dis, 42 Tube Capacity, 300ml, 115V L9 1ea Service IQOQPQ for Bio-Dis L10 1ea IQOQPQ(combo)Qual Guide Bio-Dis (Dup) L11 8ea Basket, Slotted, Suppository L12 8ea Rotating Cylinder, Apparatus 6 L13 8ea Disk w/Screen Apparatus 5 (35mm) L14 1ea Tool to disassemble disk assy L15 8ea Sinker basket JP13 L16 1ea Billable Travel L17 3ea Billable PerDiem/Day L18 Shipping and handling **Ship to FDA, Irvine, CA 92612: L1 1ea VK7025/8000/SP, 8Pos Dissolution System, 115V L2 - 8ea Paddle, Electropolished, V-Series L3 1ea AccKit 7025, 8 Pos, SSBskt Std clip L4 1ea AccKit 8000, 6/8 Vlv, 16x100mm Tray L5 1ea Service IQOQPQ L6 1ea IQOQPQ(combo)Qual guide VK7020/VK7025(Dup L7 1ea Qual guide, IQOQ, 8000 PP/SP, App 1/2/3/7 L8 1ea Bio-Dis, 42 Tube Capacity, 300ml, 115V L9 1ea Service IQOQPQ for Bio-Dis L10 1ea IQOQPQ(combo)Qual Guide Bio-Dis (Dup) L11 8ea Basket, Slotted, Suppository L12 8ea Rotating Cylinder, Apparatus 6 L13 8ea Disk w/Screen Apparatus 5 (35mm) L14 1ea Tool to disassemble disk assy L15 8ea Sinker basket JP13 L16 1ea Billable Travel L17 3ea Billable PerDiem/Day L18 Shipping and handling Salient Characteristics: The Dissolution System is to comply with the USP requirements of the Apparatus from one to six. Apparatus 1 & 2 Basic Dissolution System Basic system should include a full dissolution bath with paddles and baskets and be fully programmable with collection sample unit capable to run unattended for immediate and extended release runs. This system should include accessories such as sinkers, basket and suppositories baskets. USP Apparatus 3: Capable of running unattended for periods of up to six days. Seven sample tubes automatically traverse six rows of corresponding outer tubes filled with different media. Virtually any solid dosage form can be accommodated including pellets, tablets and transdermal patches. Mesh disks retain the samples in the tubes as they move through the medium. Media volume can vary from 100ml, 300ml (USP) or 1000ml. Features Include: Allows you to fill up to six rows of vessels with different media Bio-Dis transports each sample from one medium to the next automatically, without operator intervention. Fully programmability dip speed, time, hold time, drain time, etc. in each row Stores up to 25 programs USP APPARATUS 3 (Bio-Dis III) Standard Seven Tube System to include One microprocessor programmable drive unit with real time display of dips per minute One Report Center II dot matrix printer One 7-position manifold and three 7 x 2 outer tube cassette carriers Seven inner tubes and evaporation caps for test samples Seven upper and lower caps for inner tubes 25 polypropylene, 20-mesh / 840-micron screens 25 polypropylene, 40-mesh / 405-micron screens 25 polypropylene, 78-mesh / 177-micron screens 25 polypropylene, 100-mesh / 149-micron screens 25 polypropylene, 160-mesh / 74-micron screens 25 stainless steel type 316, 20-mesh / 840-micron screens for USP calibration 42 USP outer tubes, 300ml One acrylic water bath One Thermistor probe for VK 750D One VK 750D External Heater/Circulator Bio Dis III Testing Station, 115V, 60HZ USP Apparatus 5: Accessories to be used with Basic Dissolution System to become Apparatus 5 to include: Removable disposable 40-mesh screen and Teflon locking ring. Type 316 stainless steel ring to retain screen in place Paddle over disk assembly Replacement Screens Type 316 s/s 40 mesh screens pkg/100 Toot to disassemble disk assembly USP Apparatus 6: Accessories to be used with Basic Dissolution System to become Apparatus 6 to include: Type 316 stainless steel with removable extension. The precision mechanical assembly provides surface area to both small and larger size patches. Rotating Cylinder two piece assembly The following FAR clause applies to this solicitation and is incorporated by full text: 52.211-6 BRAND NAME OR EQUAL (AUG 1999) (a) If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Governments needs. The salient physical, functional, or performance characteristics that equal products must meet are specified in the solicitation. (b) To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications. (c) The Contracting Officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation. (End of provision) EVALUATION AND AWARD: The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible offerors within the competitive range and whose proposal conforms to the terms and conditions of the solicitation. Cost will be evaluated for price reasonableness. The Government reserves the right to make its decision on the basis of initial quotations received and not have discussions. Therefore, each initial quotation should contain the offerors best terms from both a price and technical standpoint. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offerors equipment. The Government is not responsible for locating or securing any information, which is not identified in the proposal. Failure to comply with the below terms and conditions may result in offer being determined as non-responsive. Offerors must include a complete copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications Commercial Items with its offer. (OCT 2010) Applicability of FAR PROVISIONS: THE FOLLOWING FEDERAL ACQUISITION REGULATION (FAR) PROVISIONS AND CLAUSES APPLY TO THIS REQUEST FOR QUOTES AND ARE INCORPORATED BY REFERENCES: 52.212-1, INSTRUCTIONS TO OFFERORSCOMMERICAL, 52.212-4 CONTRACT TERMS AND CONDITIONSCOMMERCIAL ITEMS (JUN 2010). 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUES OR EXECUTIVE ORDERSCOMMERCIAL ITEMS (OCT 2010); THE FOLLOWING CLAUSES ARE APPLICABLE: 52.203-6; 52.219-6; 52.219-8; 52.219-14; 52.219-28; 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52.222-37; 52.222.39; 52.222-50; 52.225-1; 52.225-3; 52.225-13, AND 52.232-33. FULL TEXT OF CLAUSES AND PROVISIONS CAN BE OBTAINED AT http://www.acquisition.gov CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. "NEW EQUIPMENT ONLY" - No remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty. **PROPOSAL MUST BE GOOD FOR 90 CALENDER DAYS AFTER CLOSE OF SOLICITATION
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1081934A/listing.html)
- Place of Performance
- Address: FDA:, San Juan, PR 00901, Jamaica, NY 11433, Bothell, WA 98021, Irvine, CA 92612, United States
- Zip Code: 92612
- Zip Code: 92612
- Record
- SN02340550-W 20101210/101208234051-9ecc8b4521bcf0038ed472d29743ae0a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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