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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 17, 2014 FBO #4527
DOCUMENT

65 -- 501-14-4-0157-0277 BOSCH GKF702 CAPSULE MACHINE - Attachment

Notice Date

4/15/2014
 

Notice Type

Attachment
 

NAICS

811310 — Commercial and Industrial Machinery and Equipment (except Automotive and Electronic) Repair and Maintenance
 

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

VA24014I0024
 

Response Due

4/22/2014
 

Archive Date

5/2/2014
 

Point of Contact

melissa.westfall@va.gov
 

E-Mail Address

melissa.westfall@va.gov
(melissa.westfall@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Sources Sought Notice ***THIS IS A SOURCES SOUGHT/REQUEST FOR INFORMATION ONLY. NO PRICING IS REQUIRED. THE VA IS ONLY SEEKING SOURCES AND INFORMATION. CONTRACTORS ARE WELCOME TO PROVIDE CAPABILITY STATEMENTS AND COMMENTS AND QUESTIONS CONCERNING FUTURE SOLICIATIONS*** Title of Project: Robert Bosch Packaging Technology Inc. Capsule Filling and Closing Machine GKF702, installation, and training on proper use. Performance Period: The estimated delivery is September, 2014. Install and training shall be within 30 days of delivery. Type of Contract: Firm Fixed Price Place of Performance: Department of Veterans Affairs Cooperative Studies Program Research Pharmacy Coordinating Center 2401 Centre Ave SE Albuquerque, NM 87106 VISN: 18 Requirements: The equipment requested is a Robert Bosch Packaging Technology Inc. Capsule Filling and Closing Machine GKF702 that must meet the following requirements: 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 (3) Integrated control cabinet. (4) The table top must be made of coated aluminum for easy cleaning (5) Guard doors must be made of high-impact acrylic material (6) Safety switches must be installed outside product areas (7) Coated parts must be coated with pharmaceutical compliant materials (8) Doors and switch cabinet must be made of non-corroding materials (9) Feed units can be docked (10) Powder hopper volume: must be approximately 12 liters (11) Capsule hopper volume: must be approximately 8.5 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 pellets into capsules and include the appropriate equipment including o For capsule size 00 i. A height adjustable dosing disk for filling powder or pellets into capsule size 00 ii. One set of tamping pins (30 count for Bosch) for capsule size 00 o For capsule sizes 00, 0, 1, 2, 3, and 4 i. Fixed dosing disks without height adjustment for each capsule size ii. Size parts for pellet dosing via dosing disk including: 1. 5 transfer pins, 2. Deflector size parts and 3. 6 slide gate panels 4. Any and all other miscellaneous equipment required to fill pellets into the referenced capsule sizes. (2) The equipment must be able to fill powder into capsules using tamping technology to provide consistent capsule fill weights. (3) The equipment must be able to fill pellets and powder into the same capsule during a continuous filling process. (4) The equipment must be able to fill liquids into capsules (5) The equipment must be able to utilize slide gate technology to allow for filling sticky product and to optimize batch yields. (6) The equipment shall include one over size closing pin assembly with clean out holes in pins for sizes 00 and 000. (7) The equipment shall include one over size closing pin assembly with clean out holes in pins for sizes 0 and 1. (8) The equipment shall include a dosing disk to segment alignment set for capsule size 00. (9) The equipment shall include a lower segment carrier alignment fixture. (10)The capsule filler must include a small R&D "Pilot or Mini-bowl" powder filling station for R&D/pilot/small batches can be integrated as part of the capsule filling machine. The "Pilot-bowl" system must include o Powder filling station with drive o Powder in-feed (auger in powder hopper) o Sorting station for feeding one capsule per segment o Any other equipment required for the "Pilot-bowl" system to run on the equipment. o Adjustable dosing disks must be included for the "Pilot-bowl" for capsule sizes: o 00 o 0 o 1 o 2 o 3 o 4 The "Pilot-bowl" system must include/have available 1 set of tamping pins (6 pieces) for the adjustable "mini-bowl" dosing disk for the following capsule sizes: o 00 o 0 o 1 o 2 o 3 o 4 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/when 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 use Bosch GKF701 capsule tooling sizes 4, 3, 2, 1, 0 and 00, currently owned by the VA CSPCRPCC to fill capsules at the line speeds supported by a Bosch GKF702 machine. It must also be capable of running tooling for capsule sizes 0 elongated and SUPRO-A, SUPRO-B, or SUPRO-C. h. Line Speed o The maximum mechanical output should be: o Powder filling: up to 700 capsules/minute o Pellet 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: o Width: 905mm with closed doors, 2474 with open doors o Depth: 1,675 mm o Height: 2,060 mm o Net weight: approximately 1,200 kg j. Electrical requirements are o Voltage: 480V + 10%, 60 Hz o Connection: 3 phase + PE o Total performance: 2.5 kW o Connected electric load: 4 - 5 KVA k. Compressed Air o 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 o Vacuum system shall include a ring blower for capsule separation, for external installation o Be suited for 460V - 480V, 60Hz o Have a mean operating range of approximately 40m3/h at -250mbar. Include vacuum monitoring which automatically stops the machine if vacuum drops below the limit. o Vacuum system must provide capsule segment cleaning to remove capsule residue and to clean the segment bores by immersing blow nozzles. Must be able to adjust time interval using operation panel. m. Suction air o Suction air: 200m3 at 1,500 mm water column n. Equipment Safety o Equipment must be complaint with EC regulations o. Capsule Orienting and separation station o Air filter must be integrated into suction tube o Capsule separation must be supported by pickup pins and vacuum o Capsule hopper must contain minimum and maximum level sensor. Machine must stop and provide an audible signal when it reaches a preset minimum fill level. p. Dosing Station must be capable of filling powder or pellets o The stepping gear must be separated from the production area and enclosed below the table top o Supply hopper for powder with fill nozzle must be made of high-grade pharmaceutical-compliant steel o Must include dosing disk bearing for holding size-dependent dosing disk o Fill hopper must have an encased proximity switch. Machine must stop and provide audible signal after preset minimum fill level reached o Must include 6-sectioned plunger carrier and reciprocating plunger guide ring for five tamping stations and one product transfer station o Tamping ring bearing must allow height micro-adjustment and powder extraction at the tamping ring q. Fail-capsule station o Fail-capsule station must reject non-separated capsules and capsules with two caps r. Capsule closing station o Must use concave closing pins and a ground counter stay. Includes integrated dust exhaust s. Capsule discharge station o Capsule discharge station must include dust extraction to pre-clean capsules t. Cleaning station o Must include station to clean capsule cap and body segments through dust extraction point. u. Drive Range o Drive range must be separated from production range. o Drive range doors must be equipped with safety switches. o Drive range must be adjustable via touch screen o Drive range must include integrated digital speed indicator and working hour meter v. Connection capsule infeed o Shall include capsule fill nozzle with TriClamp connection NW 100 mm for supply hopper at the orienting station w. Product dosing via dosing disk o Shall include a powder auger for installation in the powder hopper o Shall include a pellet feeder for installation into the product hopper, to guide pellets into the dosing disk o Shall include a powder metering unit composed of: o 5 tamping pin mounts o Attachment for product rejector o Support ring Fit our for slide-gate-system x. Product Infeed Connection o Must include product fill nozzle with TriClamp connection NW 100mm for supply hopper of dosing station y. Capsule Discharge Unit o Capsule discharge unit must have TriClamp connection NW = 50mm z. Dust Extraction and Connections o Must use in-house connection for dust extraction o Must include hoses, inside diameter of 38mm with Nilfisk bayonet connections NW = 38mm o Must provide for merging of hoses o Must have capability to interface to in-plant dust extraction system: Inside diameter of hose = 38mm aa. Electronic recording meeting 21CFR part 11 o Machine software functions must meet the requirements of FDA for electronic records under 21CFR part 11. Must include: o User identification and password query for access protection o Automatic logout after user defined time period o Request for password change after user defined time period o Verification procedures for password protection including minimum length and disabling of old passwords o Ability to create and administer access rights by one user o Able to disable individual access rights o Records failed access attempts o Audit trail for changes to product and quality-relevant data and parameters. Maintains histories with identification of user, date, time and action o Version management of data o System does not allow user to access operating system level o Ability to check stored and saved data for manipulation o Ability to generate exportable electronic reports as printout ab. 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. The vendor must provide individual certificates per measuring point. o Process relevant magnitudes of pressure and speed shall be calibrated. o Process relevant sizes will be calibrated at the CSPCRPCC. ac. 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: o IQ o Documentation with version check for the following (or equivalent): " Test target " Test Scope " Procedure " Acceptance criteria " Structure of IQ as Target and comparison to actual " Process critical components " Hardware Loop Check of PLC inputs and outputs " Software version statuses of media connections, the documentation, written work instructions " Ability to document as conduct IQ OQ o Documentation with version check for the following (or equivalent): " Test target " Test Scope " Procedure " Acceptance criteria " Results summary " Individual tests with target, scope and procedure " Implementation of one deviation procedure and change control " Compilation of results and raw data o Technical documentation for qualification and validation (TDQV)specific to the equipment and include version check o References to relevant standards and guidelines o 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 o Component specification and additional technical information regarding process-critical devices including manufacturer record/data sheets when available o 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 o Material specifications for product-contact surfaces with surface calculations for those surfaces where the drug directly contacts the machine o Drawing of measuring circuits to be calibrated o Structure of electric equipment o Annotated control software, with program printout o Overview of all machine fault messages and machine functions. o 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. o TDQV for: o Bosch GKF702 Capsule Filling Machine o Each additional filling station for the mini bowl o Each additional filling station for pellet feed at station 5 via dosing disk/slide gate o Test logs for testing the additional functions, o Performance of software function tests once, for each additional filling station of all fault messages and functions of the technical documentation and qualification package at CSPCRPCC for the mini-bowl. o Performance of software function tests once, for each additional filling station of all fault messages and functions of the technical documentation and qualification package at CSPCRPCC for filling pellets at station 3. o Performance of software function tests of all fault messages and functions of the technical documentation and validation at the CSPCRPCC. o The TDQV will be converted onto PDF files and saved to a VA compatible system. ad. Vendor price includes installation, set-up and training provided by a trained, English speaking technician for six business days at 8 hours per day at CSPCRPCC site. Includes travel expenses and per diem. Delivery and Retrieval Requests: Delivery to the facility shall be accomplished during regular business hours; Monday - Friday, 8am - 4:30pm. Contracting Officer POC: Melissa Westfall melissa.westfall@va.gov No phone calls will be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/015e5ef2f5fdb65ad205abd698d8adfb)
 

Document(s)

Attachment
 

File Name: VA240-14-I-0024 VA240-14-I-0024.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1309319&FileName=VA240-14-I-0024-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1309319&FileName=VA240-14-I-0024-000.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: Department of Veterans Affairs;Cooperative Studies Program;Research Pharmacy Coordinating Center;2401 Centre Ave SE; Albuquerque, NM 87106

Zip Code: 87106
 

Record

SN03339104-W 20140417/140415234914-015e5ef2f5fdb65ad205abd698d8adfb (fbodaily.com)
 

Source

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

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