Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 12, 2013 FBO #4248
DOCUMENT

65 -- ABQ Tablet Coating System - Attachment

Notice Date

7/10/2013
 

Notice Type

Attachment
 

NAICS

333993 — Packaging Machinery Manufacturing
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Service Area Office (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

VA24013Q0170
 

Response Due

7/16/2013
 

Archive Date

7/31/2013
 

Point of Contact

Ms. Cheryl Ann Homison
 

E-Mail Address

cheryl.homison@va.gov
(cheryl.homison@va.gov)
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and shall not obligate the Government to award a contract. The purpose of this Sources Sought Announcement is for market research to gain knowledge of potential qualified sources interested and capable of performing the work and obtain their size classification relative to the North American Classification System (NAICS) Code 333993 with a size standard of 500 employees. A.GENERAL INFORMATION Background: The Department of Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) requires the purchase of a new tablet coater to replace a 16 year old unit, in order to modernize VA CSPCRPCC manufacturing capability to efficiently run pilot and scale up batches to coat active and placebo tablets for research clinical drug trials. Pharmaceutical equipment manufacturers stop supporting equipment after about seven years due to advances in the equipment and software technology. Because of the equipment age it is difficult to scale up or increase production sizes to larger equipment based upon the pilot runs conducted in this aging equipment. The Small Tablet Coater must have the ability to coat tablets with solvent based coatings in addition to aqueous based coatings. This will allow the CSPCRPCC to coat products that might disintegrate if we only had the ability to coat tablets with aqueous based coatings which is our only current option. The Small Tablet Coater must also coat pellets. This provides the CSPCRPCC with yet another option for developing products for use in VA research clinical trials. The machine has enhanced capabilities including a dust collector which resides in the manufacturing space and which assists with employee safety by minimizing their exposure to dust in the air created by the coating process. The dust collector also minimizes the potential for an explosion due to the dust. Vast improvements have been made in the ability to clean equipment and in the control systems for the equipment. These improvements will allow us to provide a better product for our veteran patients participating in research clinical trials. The new equipment has software technology that allows automated collection of the manufacturing parameters that influence successful tablet coating. This technology is not available on our current equipment. Scope of Work: The contractor shall provide a Tablet coating system, installation, training and all other resources required to deliver the requirements stated herein, except as may otherwise be specified in the statement of work. This is a salient requirement, and is not flexible. The following are the minimum salient characteristics that must be met: Coating System "The coating equipment must include four interchangeable, fully perforated pans with sizes that range from not less than 0.5 liters to no more than10 liters brimful to allow for the to allow for the manufacture of R&D batches, scale up batches and small clinical batches. The pans must include the appropriate air plenums insert(s)/baffles oThe equipment must be capable of coating small to large tablets for development and clinical use. oWe are replacing a coater with pan sizes of 0.5, 1.3, 3 and 6 liters. These exact pan sizes are not required, but a range of pan sizes to allow for scale up and flexibility in small batch sizes in the requested range is required and must be approved by the CSPCRPCC prior to purchase. oWe have a larger coater so that a pan capacity greater than 10 liters brimful is not required. "Pellet Coating: Because of increasing needs for additional capabilities, the machine must be capable of coating pellets. oPan capacity: The range of pans quoted should be approximately 8.5" to 12" pellet coating pans. oTwo interchangeable pans that encompass the small and large ends of the range to allow for R&D, scale up and small clinical batches are required. oBecause of limited floor and storage space we need the capability to coat tablets and pellets on the same equipment. "The coater and pans must be easy to clean. "The pans must be easy to remove and change "All product contact parts must have mirror finish coatings of 316L (approximately 0.4?m RA) "The non-product contact parts of the equipment must be made of pharmaceutical grade construction, 304 stainless steel or better. "The coater must be corrosion and rust resistant "The coater must have quick/ easy to release inlet and exhaust plenums "The coater must have sealed access doors "The coater must be a self contained system "The coater must include a process light to allow the operator to view the tablets as they coat. "The coater must have a cabinet drain with manual or automated valve "The coater must have a sampling probe on the coater door to allow the operator to take samples during the coating process. "The coater must include a pan cabinet differential pressure control with variable speed drive "The coater must include an exhaust filter differential pressure gauge to check for filter blockage Solvent Coating Because of the potential danger for explosions when coating with solvents, the coater must include the following to minimize/eliminate the potential for explosions and to protect the operators. "The coater must include ground sensor protection "The coater must include a touch screen interface Class I Div II (Zone 2) for solvent coating "The coater must include an explosion proof (XP) supply fan with 100mm tri-clover inlet connection (or appropriate connection for coater purchased) for safe remote air "The coater must include an explosion proof (XP) Supply / Exhaust fan motor "The coater must include a spark resistant exhaust fan with 100mm outlet connection (or appropriate connection for coater purchased) "The coater must include a control, purged operator panel and drive enclosure "The coater must include intrinsically safe instrumentation "The coater must include an Explosion Proof (XP) electric heater "The coater must meets or exceed OSHA Class I, Div II, GRP. D rating standards and European Union Zone 2, ATEX Category 3 directive for solvent coating systems. "The coater must include a Lower Explosion Limit (LEL) concentration sensor for safety compliance on exhaust duct "Static ground wire and lugs on system where necessary "The vendor must provide Calibration Gas Specification for local supply "The coater must include an explosion resistant dust collector with grounded media filters Spray System "The spray rate for aqueous coating must be at least 10 - 60 ml/minute( depending on pan size) "The spray rate for solvent coating must be approximately 15 to 80 ml/min "The spray gun supplied must be a Schlick Anti-bearding (ABC) spray gun/nozzle with appropriate orifice size (in range of 0.8 mm - 1.2 mm), and adjustable pattern "The solution line and air lines must be on a swing out boom or equivalent designed for safety and ease of us "The peristaltic pump must be integrated into or built into the front of the coater "The fittings, tubing, atomizing and pattern air regulators must be included "A timed purging needle must be included. "A solution scale with Loss-in-Weight indication and Solution Flow Measurement g/min must be included Air Handling Unit "The coater must supply appropriate air flow for coating which should be in the range of Air flow rate: 85 - 240 m3/h ( 50-140cfm) which varies depending on pan size "The coater must have an inlet filter (30%) that at a minimum meets F7 Certification "The coater must include inlet air processed through at a minimum a HEPA filter 0.3? at 99.97% and preferably a HEPA filter at 99.99% (H13) efficiency. "The coater must include a supply fan "The coater must include electric heat with silicone control rectifier (SCR) control "The coater must have a temperature range of at least: 45 ° to 85 °C at coater or equivalent "The coater must include a process air volume monitoring station "The coater must include a washable, high efficiency exhaust filter rated at 0.5 ? at 99.95% or better "The coater must include an exhaust fan with 100mm tri-clover outlet connection or equivalent connection that will work with equipment to which it will be mated. Control System "The coater must include an HMI (Human Machine Interface) Touch screen, preferably in color "The coater control system must include Programmable Logic Controller (PLC) "The coater control system must include process air volume control with variable speed drive using a proportional-integral-derivative controller (PID) "The coater control system must include process temperature control (PID) "The coater control system must include pan cabinet differential pressure control with variable speed drive (PID) "The coater control system must include solution flow rate control "The coater control system must include pan speed control with variable speed drive in a range approximating at least 3-30rpm "The coater control system must include atomizing and pattern air pressure control "The coater control system must include exhaust temperature display "The coater control system must include an emergency stop Utility and Other "The coater footprint must not exceed Width 40", Depth 32", height 70" because of limitations in the size of the manufacturing room, FDA, EU and other regulatory body regulations for having adequate space to run the equipment, and personnel safety requirements "The coater must use standard western U.S. voltage, 1 phase 220 V, 50/60 Hz (25 amps aqueous). Different utility requirements must be pre-approved by the CSPCRPCC to assure the manufacturing facility is capable of accepting different equipment requirements. "The coater must use Compressed air requirements of: oAqueous coating:15.3 m ³/h at 6 bar - 9 CFM @PSI oSolvent coating: 70m ³/h at 6 bar - 41 CFM @PSI oDifferent utility requirements must be pre-approved by the CSPCRPCC to assure the manufacturing facility is capable of accepting different equipment requirements. "The coater must be portable and on caster wheels to allow moving between rooms "The coater price must include full packing, crating, loading and shipping Support Systems "The coating system must include a portable cart for holding the scale and solution container during coating runs "The coating system must include a 6-pan storage rack or equivalent to minimize use of limited storage space. "The coating system must include a USB connection at the control touch screen (HMI) to allow for exporting batch information/batch report printout "The coating system must include a spare parts kit for wear and product contact spare parts "The vendor must maintain spare parts such that they can be ordered and received within 24 to 48 hours. "The vendor must have technical support personnel available to visit the Albuquerque manufacturing location when needed for emergencies, preferably within 72 hours Dust collection system "The VA group responsible for our facility management will not allow us to penetrate any portion of the building to allow us to meet the appropriate regulatory requirements for dust collection and subsequent release/exhaust of air to the external environment. This restriction has hampered our ability to fully use our coaters. Thus a dust collection system must be capable of integrating with and safely handling dust collection for ? The coater being purchased for both aqueous and solvent based coatings and ? A Vector VHC/VPC-1355 Pan Unit which uses compressed air at 45 SCFM@100 PSIG or 76m3/hr - 1019 m3/hr and has a design airflow without product of 120 SCFM (Min) - 600 SCFM (Max.) or 204m3/hr - 1019m3/hr. "The dust collector foot print cannot exceed 785 X 770 X 2639 mm or 30.9 X 30.32 X 104 in (width, depth and height) due to space constraints of room and access doors. "The dust collector must have an 800 CFM built in blower or equivalent with a stainless steel housing. "The dust collector must have a variable speed frequency drive with differential pressure control "The dust collector housing must be made of stainless steel to meet ASTM 304. All other materials shall be of stainless steel or Pharmaceutical grade construction and will withstand cleaning in a controlled environment room. "The dust collector must have a stainless steel filter control center with microprocessor or equivalent control system for start up and cleaning "The dust collector must have an explosion containment design to handle up to 590 bar.meters/sec or equivalent and the requirements of both coaters. The Vector coater does not have solvent coating capabilities. "The dust collector must have a working HEPA filter of at least H13 or 99.95% efficiency with cleaning system with bag-in/bag-out for employee safety or equivalent "The dust collector must have a safety filter with bag-in/bag out capability for employee safety "The dust collector must have a dust collection container with bag liner "The dust collector must have a single filter stage such that the filter is cleaned at end of the coating process "The dust collection and change of filter cells shall occur to minimize or eliminate operator contact with potentially hazardous dust "The dust collector must include test lances "The dust collector must include the appropriate connections to tie in with facilities and both coaters "The dust collector must be grounded and pressure shock resistant "The dust collector must be qualified for dusts up to Kmax = 590 bar m/s. "The dust collector must be certified to conform to ATEX 100a, Equipment class II, category 2D2G. Training, Installation, Calibration, Qualification "The contractor must provide onsite training at the CSPCRPCC "The contractor must provide onsite installation at the CSPCRPCC "The contractor must provide assistance with onsite Installation Qualification and Operation Qualification as needed "The contractor must provide onsite calibration as required for the equipment "The contractor must provide electronic copies of IQOQ blank protocols Factory Acceptance Testing (FAT), "The contractor will provide documented FAT with tablet coating and process reports provided to CSPCRPCC using placebo or customer tablets at 100% of machine build, at contractor's facility. The vendor will allow a CSPCRPCC representative to be present at FAT testing upon request. Documentation to be Provided "The Contractor must supply: o Electronic copies of the operating, installation and maintenance manuals including "Two (2) copies of agreed upon drawings "General arrangement of machine and system components "General arrangement of exhaust and drive "Piping and instrumentation (P&I) drawing "Pneumatic schematics "Control panel layout and site drawing Warranty "The vendor will supply a commercial warranty Technical Support: The contractor will provide technical support Monday through Friday from 7:30 a.m. to 4:30 p.m. Mountain Standard Time. REQUESTED INFORMATION: STATEMENT OF CAPABILITY: Submit a brief description (five [5] pages or less) that shows your company can provide the required services. One additional page may be included explaining experience in performing these services to the VA, other government agencies, or for private facilities. Potential sources should identify business name, point of contact, business size and any applicable business socio-economic category (i.e. small business, SDVOSB, VOSB, SB, etc), DUNS number, address, and any additional information felt to be pertinent. All vendors must be registered in SAM https://www.sam.gov/portal/public/SAM/ prior to contract award. Responses to this notice should be electronically mailed in PDF format or word format to Cheryl.Homison@va.gov. Telephone responses will not be accepted. Written responses must be received no later than 3:00 PM (EST), Tuesday, July 16, 2013. Contracting Office Address: Department of Veterans Affairs; Service Area Office East, 323 North Shore Drive, Pittsburgh PA 15212. Delivery and Place of Performance: Equipment is to be delivered and installed by the contractor at the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center located at 2401 Centre Avenue, SE, Albuquerque NM 87106-4180. Type of Contract: Stand Alone Contract. Point of Contact(s): Cheryl Homison Contracting Officer 412-822-3493 Cheryl.Homison@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/0b61801580387b2b99fe26ebd9e33f2a)
 

Document(s)

Attachment
 

File Name: VA240-13-Q-0170 VA240-13-Q-0170.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=862089&FileName=VA240-13-Q-0170-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=862089&FileName=VA240-13-Q-0170-000.docx

 

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

Record

SN03112364-W 20130712/130710235246-0b61801580387b2b99fe26ebd9e33f2a (fbodaily.com)
 

Source

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

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