SOURCES SOUGHT
65 -- Validation System for Temperature Chambers
- Notice Date
- 7/16/2010
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- P177375
- Archive Date
- 8/12/2010
- Point of Contact
- Brian J. Lind, Phone: 301-402-0735
- E-Mail Address
-
LindBJ@cc.nih.gov
(LindBJ@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought/Market Survey Notification The National Institutes of Health (NIH) Clinical Center Pharmacy Department is conducting a market survey to determine the availability and technical capability of qualified small businesses, including (8A) small businesses or HUBZone small businesses capable of providing the following services; The NIH Pharmacy, Pharmaceutical Development Services (PDS), is engaged in building a new facility in compliance with FDA current Good Manufacturing Practices (cGMP) and in order to comply with requirement a Validation System for Temperature Chambers (i.e.cold room, refrigerators, freezers, incubators, and autoclave) used for storing active pharmaceutical ingredients, components, and drug products, and chambers used for sterilization and processing environmental samples are required. These environmental chambers must be qualified, calibrated, and maintained to ensure the integrity of the drug product and provide assurance of control throughout the manufacturing process. Qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These Validation System for Temperature Chambers must meet the standards outlined in United States Pharmacopeia (USP) chapters 467 and 621 and monographs that specify assay by GC and the Food and Drug Administration (FDA)/ Current Good Manufacturing Practices (cGMP) requirements as described in Code of Federal Regulations chapter 62, pp 67380 to 67381. The NIH/PDS is seeking a contractor to provide a Validation System for Temperature Chambers meeting the following specifications: Technical Specifications The NIH Pharmaceutical Development Section is seeking a vendor that is recognized in the pharmaceutical manufacturing field as a quality manufacturer of validation equipment for the intended purposes stated above. A vendor is considered recognized when they can show a significant presence in the regulated pharmaceutical industry through past and current client lists. This solicitation is for the purchase of the following equipment: Item Description Quantity 1.5 inch cryo rigid sensor with pointed tip 18 Pressure/temperature logger 1 Data reader 1 Temperature liquid bath with range of -80 to 30 C and includes a removable basket and calibration certificate 1 Halocarbon oil for bath, one gallon with usable range -80 to 30C 1 IRTD400 standard system with accuracy of plus of minus o.ozsc.range -195 to 420 C and calibration certificate. 1 The equipment purchased will be sufficient to complete qualification, including temperature mapping studies of the following environmental chambers. • Refrigerators (storage conditions 2°C to 8°C) • Freezers (storage conditions -20 to -70°C) • Incubators (incubation temperatures between 20°C to '35°C) • Temperature mapping and pressure studies for the autoclave The vendor shall provide the following: • a complete solution for current and future validation requirements. • setup and training support : • validation support for purchased equipment • ongoing services, where applicable, for required periodic calibration and maintenance of purchased equipment • initial and future services with quick turn-around times to meet PDS business needs Any proposed system for validation must be established and have a proven track-record of use in regulated pharmaceutical manufacturing for validation. a) Specifications System must have the ability to measure up to 16individual temperature locations inside the environmental chambers operating between -85°C and 140°C. The thermal validation systems shall be specifically designed to conform to 21 CFR Part 11 and international and European norms (EN28S, ENSS4), which provide validation for pharmaceutical, biotech, and medical device manufacturing plants. System shall be a wireless process validation and monitoring system designed around the measurement and reporting requirements of the most intensely regulated industries. This wireless system simplifies access to hostile, remote and hard-to-reach environments by eliminating hard-wired sensors, greatly reducing setup time and associated costs The system's intelligent resistant temperature device (IRTD) is a secondary standard with a completely self-contained measurement system, including electronics for calibration and temperature conversion. IRTD shall provide ultra-high accuracy temperature data to a computer with no additional measurement or readout equipment required. The system's temperature bath shall provide an accurate and stable environment for calibrating temperature sensors and is part of the overall validation system. The validation system will provide: • High accuracy temperature and pressure measurement to meet regulatory requirements (cGMP) • Operator programmable sample rates from 1sec to 12 hours with at least the ability to record 24 hours of data at the minimum interval • Configurable start, change, and Stop events • Cost effective field-replaceable battery • Durable construction, 316 stainless steel for the temperature probes • Factory calibrated (NVLAP accredited - N1ST National Voluntary Laboratory Accreditation Program) (NIST-traceable (National Institute of Standards and Technology) with user calibration • System must maintain an uncertainty ratio (UR) or 1:4. For example, the process limits are ±0.1°C from o°c to 140°C, an instrument with an uncertainty of +/-0.025 deg C should be used and calibrate the instrument with a traceable standard with an uncertainty of +/0.006 Deg C • Regulatory Compliance with UL (Underwriters Laboratory) and CE (CE Mark for European Countries - European Conformity) • System software in compliance with FDARegulation 21 CFR Part 11 for electronic signature and records • The rigid temperature sensor probes shall have: o Temperature Range and Accuracy ±0.1°C from o°c to 140°C ±0.25°C from -85°C to o°c o Operate under the following environmental conditions: Temperature -85°C to 140°C Humidity 0% to 100%, condensing Pressure 0 to 130psai o Data Storage 10,000 samples retained EEPROM (Electrically Erasable Programmable Read-Only Memory) non-volatile memory o Battery (1600 hours at 1sec at 20°C/180 hours at 1sec at -85°C) • The combined temperature and pressure logger shall have: o Temperature Range and Accuracy ±25mb from >O°C to 120°C ±10mb from >120°C to 135°C ±25mb from >135°C to 140°C o Operate under the following environmental conditions: Temperature -60°C to 140°C Pressure oto 5 bar absolute (0 to 73 psai) o Data Storage 5000 samples per sensor retained in EEPROM (Electrically Erasable Programmable Read-OnlyMemory) non-volatile memory o 21 CFR Part 11 compliant software that automatically calculates the saturated steam pressure from the reading of the temp/pressure data • The data reader is the communications link between the loggers and the computer and shall have: o RS 232 serial port connection o Programs and collects data from up to 100 loggers per study / 10at a time o Connects to the Kaye IRTS during temperature calibration or verification o Communicate with the Part 11 compliant software for extracting data • The IRTD shall have: o Part 11 compliant software o Temperature Range and Accuracy ±0.025°C from -195°C to 420°C Resolution 0.001°C o N1ST Traceable Calibration o Measurement rate 30 readings per second • The temperature liquid bath shall have: o Temperature Range and Set-Point Accuracy -Bo°C to 30°C Accuracy o.soC o Temperature Stability ± 0.01°C o Temperature Uniformity ± 0.0012°C o RS-232ComputerInterface o i-gallon tank o Includes submersion basket for IRTDstandard and 10-VaIProbe® sensors The intended procurement will be classified under the North American Industrial Classification (NAIC) code 334516 with a size standard of 500. All respondents are requested to identify their firm's size and type of business. Interested firms must also provide descriptive literature or other materials that demonstrates their ability to meet the forgoing requirements along with their capability statements. Firms with the capability of providing the required equipment as listed above and can demonstrate experience in carrying out Installation and Operational Qualifications for the instrument to withstand FDA inspection (Guidance for Industry Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients) are required to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502(b) whether or not this procurement will be set aside for any of the programs described above. The capability statement should not exceed 25 pages and be in sufficient detail so that the Government can determine the experience of your firm to provide the requirements above. Capability statement must be received no later than 3:00 PM EST on July 28, 2010 and can be either hand delivered to: Mr. Brian J. Lind Contract Specialist 6707 Democracy Boulevard Suite 106F Bethesda, MD 20892 Or by email at Lindbj@cc.nih.gov. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. This Is Not a Request for Proposals. The Government will not award a Purchase order or Contract based upon vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information"
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P177375/listing.html)
- Place of Performance
- Address: National Institutes of Health, 10 Center Drive, Room 1N-249, Bethesda, Massachusetts, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02208291-W 20100718/100716234816-e549f90f733114735f1137acbfb2d6da (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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