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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 15, 2013 FBO #4282
DOCUMENT

66 -- Capsule Filling and Closing machine software - Attachment

Notice Date

8/13/2013
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation 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

VA24013Q0192
 

Response Due

8/16/2013
 

Archive Date

8/26/2013
 

Point of Contact

Mrs. Cheryl A. 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 (NACIS) Code 325412 with a size standard of 750 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 Capsule Filling and Closing Machine to replace an older unit, to modernize manufacturing capabilities, and to efficiently run pilot and scale up batches to manufacture powder filled capsules for research and clinical trials. Pharmaceutical equipment ages quickly due to advances in the equipment and software technology. Scope of Work: The contractor shall provide the equipment, installation, validation package, training and all other resources required to deliver the requirements stated in this SOW. This contract is for the purchase of a Capsule Filling and Closing Machine which the VA CSPCRPCC will use to fill powder, including pilot batches of active pharmaceutical ingredient (API) or pellets into capsules that will be consumed by veteran patients participating in VA research clinical trials residing in the U.S. and throughout the world or that will be used for R&D and pilot batch purposes. This is a salient requirement, and is not flexible. The following are the minimum salient characteristics that must be met: "The capsule and filling machine must be able to work with Bosch GKF701 tooling, which is currently owned by the CSPCRPCC.to fill capsule sizes 00, 0, 1, 2, 3, and 4. "Must include an insert for a mini-bowl or pilot batch sized (Pilot) powder filling station into the equipment to allow the VA CSPCRPCC to conduct R&D capsule filling for small fills. "Must include the appropriate parts to support the "Pilot" bowl including adjustable dosing disks for sizes 00, 0, 1, 2, 3, and 4 capsules and a set of tamping pins (6 of each size) or equivalent for capsules sizes 00, 0, 1, 2, 3, and 4. "Must include any equipment required to align or run the "Pilot bowl". This equipment for the Pilot bowl must run on the capsule filling and closing machine which eliminates the need for the VA CSPCRPCC to purchase an additional machine on which to conduct R&D, and pilot batch small scale fills. The CSPCRPCC facility has limited manufacturing space which prohibits the addition of another piece of equipment. The "Pilot-bowl" may reduce formulation development time because process parameters developed using it can be more easily transferred to the full scale capsule filling and closing machine than to another type of equipment. Additionally the use of the "Pilot bowl" minimizes the amount of Active Pharmaceutical Ingredient used in R&D. This helps save research budget dollars because many active ingredients are very expensive. "Have the ability to fill pellets and liquids into capsules, which would expand the capabilities of the CSPCRPCC. The parts necessary to fill these items into capsules are not being requested in this quotation. a.Equipment quality and reliability to include: (1)The accuracy of the fill volume for the capsule filling and closing machine must have a standard deviation of S<2.5% b.Machine quality of construction, including but not limited to: (1)Housing: must be made of non-corroding material (2)Base frame with enclosure must be made of brushed pharmaceutical compliant stainless steel with integrated control cabinet. (3)The table top must be made of coated aluminum for easy cleaning (4)Guard doors must be made of high-impact acrylic material (5)Safety switches must be installed outside product areas (6)Charging ports must be on top for loading empty capsules, powder or pellets (7)Coated parts must be coated with pharmaceutical compliant materials (8)Doors and switch cabinet must be made of non corroding materials (9)Must be able to dock the feed units (10)Powder hopper volume: must be approximately 11 - 13 liters (11)Capsule hopper volume: must be a approximately 8 - 9 liters c.Safety features including: (1)Safety barriers must be located around moving parts. (2)There must be appropriate safety features for electrical components. (3)There must be adequate shielding of mechanical and electrical components to minimize powder contact to include safety locks on cabinets where appropriate. d.Versatility and capability of the equipment: (1)The equipment must be able to fill powder into capsules (2)The equipment must be able to fill pellets into capsules (3)The equipment must be able to fill liquids (4)The capsule filler must include a small R&D"Pilot-bowl" powder filling station for R&D/pilot/small batches that is easily integrated as part of the capsule filling machine. The "Pilot-bowl" system must include "Powder filling station with drive "Powder in-feed (auger in powder hopper) "Sorting station for feeding one capsule per segment "Any other equipment required for the "Pilot-bowl" system to run on the equipment. "Adjustable dosing disks must be included for the "Pilot-bowl" for capsule sizes: o00 o0 o1 o2 o3 o4 "The "Pilot-bowl" system must include 1 set of tamping pins (6 pieces) for the adjustable "mini-bowl" dosing disk for the following capsule sizes: o00 o0 o1 o2 o3 o4 (5)Ability to fill liquids e.Technical capabilities of manufacturer, including but not limited to: (1)The manufacturer must be able to provide spare parts or additional tooling within a reasonable time frame, if required. (2)Technical support must be available Monday through Friday from 7:00 a.m. to 4:30 p.m. (MST). (3)Technical support personnel must be available to visit the equipment location in Albuquerque for emergencies, preferably within 72 hours, when needed (Monday through Friday from 7:00 a.m. to 4:30 p.m. MST) f.Company and equipment reputation for quality and reliability: (1)The manufacturer must provide at least 3 references of people currently using the equipment that can be contacted to discuss their impression of the capsule filling and closing machine. g.Compatible with Tooling (1)The capsule filling and closing machine must be able to run Bosch GKF701 capsule tooling to fill capsule sizes 4, 3, 2, 1, 0 and 00 (currently owned by the VA CSPCRPCC) and be capable of running tooling for capsule sizes 0 elongated and SUPRO-A, BUPRO-B, or SUPRO-C. h.Line Speed "The theoretical mechanical output should be: oPowder filling: up to 700 capsules/minute oPellet filling: up to 600 capsules/minute i.The foot print of the equipment, in order to assure adequate space in the room in which the equipment is operated should not exceed: "Width: 905mm with closed doors, 2474 with open doors "Depth: 1,675 mm "Height: 2,060 mm "Net weight: approximately 1,200 kg j.Electrical requirements are "Voltage: 480V + 10%, 60 Hz "Connection: 3 phase + PE "Total performance: 2.5 kW "Connected electric load: 4 - 5 KVA k.Compressed Air "Compressed air requirement 0.5 m3 at 5 bar, i.e. 3.0 m3 at 5 bar, if vacuum augmenter (Option) implemented l.Vacuum System/Vacuum Connections "Vacuum system must have non-lubricant vacuum pump for capsule separation which shall "Include rotary slide valve vacuum pump (non-lubricant) for external mounting "Be suited for 200-460V, 60Hz "Provide maximum displaced volume: 19m3/h at 0.2 to 0.5 bar "Provide maximum under-pressure - 850mbar "Vacuum system must provide capsule segment cleaning to remove capsule residue and for cleaning of the segment bores by immersing blow nozzles. Must be able to adjust time interval using operation panel. "Insufficient vacuum must trigger fault message on touch screen m.Suction air "Suction air: 200m3 at 1,500 mm water column n.Equipment Safety "Equipment must be complaint with EC regulations o.Capsule Orienting and separation station "Air filter must be integrated into suction tube "Capsule separation must be supported by pickup pins and vacuum "Capsule hopper must contain minimum and maximum level sensor. Machine must stop and provide an audible signal when it reaches the minimum fill level. p.Dosing Station must be capable of filling powder or pellets "The stepping gear must be separated from the production area and enclosed below the table top "Supply hopper for powder with fill nozzle must be made of high-grade pharmaceutical-compliant "Must include dosing disk bearing for holding size-dependent dosing disk "Fill hopper must have an encased proximity switch. Machine must stop and provide audible signal after preset minimum fill level reached "Must include 6-sectioned plunger carrier and reciprocating plunger guide ring for five tamping stations and one product transfer station "Tamping ring bearing must allow height micro-adjustment and powder extraction at the tamping ring q.Fail-capsule station "Fail-capsule station must reject non-separated capsules and capsules with two caps r.Capsule closing station "Must use concave closing pins and a ground counter stay. Includes integrated dust exhaust s.Capsule discharge station "Capsule discharge station must include dust extraction to pre-clean capsules t.Cleaning station "Must include station to clean capsule cap and body segments through dust extraction point. u.Drive Range "Drive range must be separated from production range. "Drive range doors must be equipped with safety switches. "Drive range must be adjustable via touch screen "Drive range must include integrated digital speed indicator and working hour meter v.Connection capsule infeed "Shall include capsule fill nozzle with TriClamp connection NW 100 mm for supply hopper at the orienting station w.Product dosing via dosing disk "The powder metering unit must be composed of o5 tamping pin mounts oAttachment for product rejector oTamping pin ring x.Product Infeed Connection "Must include product fill nozzle with TriClamp connection NW 100mm for supply hopper of dosing station y.Capsule Discharge Unit "Capsule discharge unit must have TriClamp connection NW = 50mm z.Dust Extraction and Connections "Must use in-house connection for dust extraction "Must include hoses, inside diameter of 38mm with Nilfisk bayonet connections NW = 38mm "Must provide for merging of hoses "Must interface to in-plant dust extraction system: Inside diameter of hose = 38mm ab.Electronic recording meeting 21CFR part 11 "Machine software functions must meet the requirements of FDA for electronic records under 21CFR part 11. Must include "User identification and password query for access protection "Automatic logout after user defined time period "Request for password change after user defined time period "Verification procedures for password protection including minimum length and disabling of old passwords "Ability to create and administer access rights by one user "Able to disable individual access rights "Records failed access attempts "Audit trail for changes to product and quality-relevant data and parameters. Maintains histories with identification of user, date, time and action "Version management of size and product date for times, counters and cams "System to not allow user access to operating system level "Ability to check stored and saved data for manipulation "Ability to generate exportable electronic reports as printout acPowder Chamber Format Parts for Dosing Wheel "The compressed air system must be integrated to prevent product from sticking to the dosing wheel ad.The equipment must be calibrated using 3 point calibration on critical sensors using calibrated reference equipment traceable to national standards. The calibration must be documented and provided to the CSPRPCC. ae.Written IQ and OQ validation documents must be provided for the capsule filler and closer that are compliant with FDA regulatory requirements and guidelines. Assistance in performing the validations must be provided during installation. The validation packages and/or other information must include: "Technical documentation for qualification and validation specific to the equipment and include version check "References to relevant standards and guidelines "Piping and Instrumentation Diagram, graphic illustration of the technical equipment with information on type and task for Electric measuring Points and Regulating Constants (EMSR points) according to DIN 28 004 "Component specification and additional technical information regarding process-critical devices including manufacturer record/data sheets when available "Sensor/actuator plan which includes machine illustrations (plan view/side views) with location of sensors and actuators, with type, operating means designation and a legend "Material specifications for product-contact surfaces with surface calculations for those surfaces where the drug directly contacts the machine "Drawing of measuring circuits to be calibrated "Structure of electric equipment "Annotated control software, with program printout "Overview of all machine fault messages and machine functions. "GMP compliant test logs for checking functions and the effects of fault messages on the following structure: "Purpose of the test, "Acceptance criteria, "Testing procedure, "Testing reference and "Test result. "Execution of software function tests for all fault messages and functions in the CSPCRPCC facility. 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), Friday, August 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/fe72104ecfb5fb5ccdfc5cf92a496f2c)
 

Document(s)

Attachment
 

File Name: VA240-13-Q-0192 VA240-13-Q-0192.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=944713&FileName=VA240-13-Q-0192-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=944713&FileName=VA240-13-Q-0192-000.docx

 

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

Record

SN03147148-W 20130815/130813235647-fe72104ecfb5fb5ccdfc5cf92a496f2c (fbodaily.com)
 

Source

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

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