SPECIFICATION. The System shall be easy to use and rugged enough to handle consistently high through performance of the activities.

Transcription

1 SPECIFICATION Gas Chromatography Mass Spectrometer (GC-MS) including Head Space Injection along with a computer, printer, analytical columns and solid phase micro-extraction assembly/fiber (SPME) 1. Scope This specification describes the requirements for a Gas Chromatography Mass Spectrometer GC-MS and accessories including head space injection, computer and printer, SPME assembly/fiber and analytical columns (hereinafter referred to as the System ) for analysis of pesticides and pesticide residues, veterinary drug residues, mycotoxins, various aromatic hydrocarbons in food and environmental samples as well as fatty acid profiling at Tanzania Food and Drug Authority, Tanzania (hereinafter referred to as the TFDA or the End-User ). 2. Applicable Documents The following documents shall be applicable for this Specification to the extent specified hereinafter: International Organization for Standardization (ISO) 9001; National standards that are equivalent to ISO 9001; and European Norm ISO/IEC : Definitions, Acronyms, and Abbreviations The following definitions, acronyms, and abbreviations shall apply throughout this Specification unless defined otherwise hereinafter: GC=Gas chromatography; MS = Mass spectrometer; SPME = Solid phase micro-extraction; ECD = Electron Capture Detector; EI = Electron Ionization 4. Requirements 4.1. Functional and Performance Requirements The System shall meet the following functional and performance requirements: The System shall enable screening, identification (qualitative analysis and quantification (quantitative analysis) of trace levels of food contaminants with a high degree of sensitivity; The System shall be easy to use and rugged enough to handle consistently high through performance of the activities. Page 1 of 5

2 Desirable requirements: The System should include provision for head space analysis/solid phase micro extraction and therefore a system with relevant accessories will offer an advantage. The System should demonstrate high sensitivity and specificity for various groups of chemicals. High increase in sensitivity with a possibility for simultaneous quantitative/qualitative analysis and library searching of various analytes are required Technical Requirements The System shall meet the following technical requirements: Gas Chromatography (GC) overview Computer controller and software run; Gas flows controlled by electronic pressure controlling method; adjustable pressure in increments of PSI or better. Conforms to International safety standards. Automatic gas flow stop in case of system shut down (unexpected or not). Column Oven Operating temperature range from near ambient to 450 C. Can house at least 2 columns. Temperature stability: ± 0.1 C or better. Temperature programming and overheat protection facility. Pneumatics Programmable Electronic control; can compensate for variations in ambient temperature and pressure for maximum stability. Direct setting of split flow rates and ratios. Automatic leak testing/detection. Pneumatic program rates such as psi/min or ml/min 2 or cm/s min or better. Modes of operation including but not limited to: Constant flow, constant pressure, programmable flow, programmable pressure Injection ports/modes Different operation modes: such as but not limited to split, splitless, split/splitless, pulsed split/splitless, large volume injections packed column simulation; with Head Space Detectors: Quadrupole Mass spectrometer and Electron Capture Detector (ECD) Auto sampler/ (and head space injector) Compatible with GC-MS above Tray for between vials or better Page 2 of 5

3 Programmable vial sequence At least three 2-4mL wash vials, and one waste vial Sample size (0-0.5 µl in 0.1 µl steps with a 0.5-µL syringe, 0-5 µl in 0.5 µl steps with a 5-µL syringe, and 0-50 µl in 5 µl steps with a 50-µL syringe) Suitable for multiple injection modes Mass Spectrometer Detector (electron multiplier type) to support Electron ionization (with a possibility for Chemical Ionization); extraction/inert (or related) ion source heatable to degrees Celsius; and has the option for electronic scan rate of 10,000 to u/s; robust quadrupole mass filter capable of withstanding heating temperatures of degrees Celsius; maximum mass of 10, u; diffusion pump L/s or better; turbomolecular pump (70-80 L/s) or better; mass stability of 0.1 amu or better over a 48 hour period; electronic dynamic range of 1x10 6 or better; High sensitivity in (a) EI scan mode s/n of 300:1 to 1500:1 or better upon injection of 1 pg/µl of octafluronophthalene and scanning between u (typically for 272 u); (b)instrument detection limit of 10 fg to 30 fg on injecting 100 fg octafluronophthalene and monitoring for 272 u in ESI-SIM splitless mode. Installation and validation/quality control kits Power Supply: V 50Hz With user s, service and maintenance manuals in English With UPS that can hold power for a minimum of 1 hour With instrument control: Both manual and remote operation using a software that supports simultaneous qualitative and quantitative data analyses With analyte/mass spectral library Including head space analyses (manual and a head space sampler) and solid phase microextraction. Head space sampler shall include provision for software control; electronic pneumatic control; up to 100 or more vial capacity; automatic vial leak detection; including sample heating. Easy access of and proximity to technical/customer service delivery and plan for continued support to end user Desktop Computer The System shall include a computer with specifications such as (but not limited to): Suitable operating system and interphase such as general purpose interface bus (GPIB) workstation; Dual/intel core processor, 2.66 gigahertz, 2 gigabyte Random Access Memory (RAM, 500 Gigabyte, RAID 1, DVD RW; Intel HD Graphics Keyboard; Mouse; Compatibility with latest version of GCMS software above; 19 inch Color LCD flat screen monitor Printer specifications such as (but not limited to) Print speed black (draft, A4): up to 22 ppm; Print speed colour (draft, A4); Up to 18 ppm Page 3 of 5

4 Duty cycle (monthly, A4): Up to 500 pages; Processor speed: 220 MHz; Memory, standard: 64 MB Duplex printing: Manual (driver support provided) Wireless capability: Wireless compatibility, Bluetooth EDR; with USB port and compatible with LPT-USB adapter Compatible with various operating systems such as Microsoft Windows 7, Windows Vista (x32 and x64), Windows XP Professional x32, Windows Server 2003, Windows Server 2008; Mac OS X v 10.5 or higher GC analytical columns: Three (3) SP-2560, 100 m x 0.25 mm I.D., 0.20 µm GC columns Three (3) SP-2560, 750 m x 0.18 mm I.D., 0.14 µm GC columns Three (3) HP-5MS Ultra Inert 30m, 0.25mm, 0.50 µm GC columns Three (3) HP-5MS Ultra Inert 30m, 0.32mm, 1.0 µm GC columns Three (3) VF-1701 Pesticides 30 m x 0.25 mm, 0.25 µm SPME fiber/assembly SPME fiber assembly Polydimethylsiloxane/Divinylbenzene (PDMS/DVB): d f 65 µm, needle size 23 ga, StableFlex, for use with autosampler SPME fiber assembly Polydimethylsiloxane/Divinylbenzene (PDMS/DVB) d f 65 µm (partially cross-linked phase), needle size 24 ga, for use with manual holder 5. Marking The System shall have all manuals/training material, software and safety markings safety markings in English. 6. Packing For the shipment by air to the End-User in Tanzania, shall be packed in accordance with international standards that are applicable for the shipment of GCMS by air to prevent damage (including after delivery to the End-User before unpacking). 7. Quality Requirements 7.1. The System shall be manufactured, shipped and installed in accordance with the ISO 9000 quality assurance system or an equivalent quality assurance system The Contractor shall document the compliance with this quality assurance system. Page 4 of 5

5 8. Testing and Acceptance The GCMS system with its accessories specified herein, prior to shipment, shall be tested for conformance of the System with manufacturer s performance specifications and the minimum requirements specified herein. The GCMS system with its accessories, after installation, shall be tested by the Contractor together with the End-User to demonstrate that the performance meets the manufacturer s performance specifications and the minimum requirements specified herein as determined by the IAEA and the End-User in Tanzania. The results of the testing shall be documented by the Contractor in an acceptance protocol that shall be signed by the End-User. 9. Installation and Training The Contractor shall install the System at Tanzania Food and Drug Authority (TFDA) The Contractor shall provide at least one week training (preferably 2 weeks) for no less than six staff of the End-User in the operation and maintenance of the System immediately after the installation. The training course and all training material shall be in English. 10. Deliverable Data Items The Contractor shall provide two complete sets of operation and servicing manuals to the End-User for all equipment components listed above and any other relevant literature in English to enhance optimum utilization of the equipment. Page 5 of 5