M/s. Thermo fisher Scientific

Transcription

1 CLARIFICATIONS AND RESPONSES IN THE PRE BID MEETING HELD ON 19 TH AUGUST 2013 IN OUR COMMITTEE ROOM FOR THE PROCUREMENT OF DIOXIN ANALYSER (GC-MS/MS) File No : PUR/IMP/178/14 Description of Item : DIOXIN ANALYSER (GC-MS/MS) M/s. Thermo fisher Scientific SL. No NIIST Point No 1 Point No 8 2 Point No 13 3 Point No 23 NIIST Programmable Inlet upto 10 Ramps Autoinjector / Sampler to handle minimum 15 samples at one time. Mass filter: Heated maintenance free quadrapole rods & fast quadrapole scanning Amendment required by Thermo fisher scientific Programmable temperature vaporizer inlet up to 3 ramps Autoinjector / Sampler to handle minimum 8 samples at one time. Mass filter Unheated /Efficient maintenance free Quadrupole rods with pre filter and fast quadrapole scanning Amendments if any Accepted Accepted Adequate mechanism to avoid contamination of quadrapole and should be demonstrated during training to the personnel and before commissioning.

2 II. M/s. Agilent Technologies Sensitivity Please note the correct method to evaluate the sensitivity of a Mass spectrometer is by the detection limit & not by Signal-to-noise ratio. (Refer to attached technical note about the same). Due to this reason Agilent does not stipulate S/N ratio as a parameter for sensitivity estimation of mass spectrometers. S/N ratio can be easily manipulated. Also we request to change the detection limit to 1 fg or lesser for the reasons below: Dioxin and furans analysis requires an ultrasensitive equipment in order to quantify Pico- gram level analyte in complex matrix. a. EU keep reducing MRL for dioxin and furans, refer attached two recent regulations on food which require ultra low sensitivity of about 0.5 fg : Refer find attached slide and compare the MRL had reduced in 2006 and 2013 by EU In all food matrices MRL reduced by 3 times. For environment very soon the MRL is expected to be reduced substantially so you certainly need an ultra sensitive mass spectrometer. b. Refer our application note(attached) Where Feed with lesser MRL Comparison of HRMS versus GCMS/MS was done at European reference lab for Dioxin as a collaborative project by Agilent. The agreement between the results obtained on the GC-HRMS and 7000 GC- MS/MS for food and feed samples at levels between 0.5 pg TEQ/g were within the range of +/- 10% +/_ 20%. Only those animal feed stuff samples with results of pg TEQ/g ( below EU action level) of 0.5 pg TEQ/g gave results > 20% between HRMS and GCMSMS equipment. Even for feed analysis deviations lesser action level would be minimized by higher sensitive equipment like 7010 Agilent GC-MS/MS. To summarize, We need higher sensitive equipment in order to achieve detection limit of 0.5 fg and considering future reduced MRL by EU & other regulations.

3 Reply: Instrument detection limit is accepted as a better method to evaluate sensitivity than signal to noise ratio. 3fg or less of OFN derived at the 99% confidence level from area precision of eight sequential injections of 1 ul. For eight sequential injection of 1 ul of 3 fg OFN standard, the signal must be 10 times higher than the rms noise value. M/S. SHIMADZU SL. No NIIST Point No 1 Point No 8 2 Point No 13 3 Point No 17 4 Point No. 23 NIIST Programmable Inlet upto 10 Ramps & 450 degree celcius heating Autoinjector / Sampler to handle minimum 15 samples at one time. Mode of Operation: Electron ionization Mass filter: Heated maintenance free quadrapole rods & fast quadrapole scanning Amendment required by M/s. Shimadzu Programmable temperature vaporizer inlet up to 3 ramps or better & 450 degree celcius heating Autoinjector / Sampler to handle minimum 12 samples or more at one time. Mode of operation : EI (Electron Ionization) with CI (Chemical Ionization) with Ion Gauze for confirmation Mass Filter : Prefilter or Pre-rods maintenance free quadrupole rods Amendments if any Accepted Autoinjector / Sampler to handle minimum 8 samples at one time will remain unchanged. As per European Union regulations chemical ionization mode is not recommended. Adequate mechanism to avoid contamination of quadrapole and should be demonstrated during training to the personnel and before

4 5 Point 27 Collision cell : For the effective bombardment of precursor ions using quantified collision energies and effective MRM Collision cell : For the effective bombardment of precursor ions using Argon gas and effective MRM commissioning. will remain unchanged 6 Point 28 Software for data handling and reporting Sensitivity Software for data handling and reporting with smart MRM database to create optimal MRM methods of different matrices automatically 7 Pont 30 EI MRM OFN 100 fg EI MRM m/z OFN 100 fg S/N > m/z :1 272 or -222 S/N > higher. 3fg or less 8,000: OFN 1 or higher. derived at the IDL 99% 4fg or less OFN confidence level from derived area at the 99% precision of eight sequential confidence level from injections of 1 ul. area precision of eight (n = 8) sequential injections of 1 ul will remain unchanged - We require an appropriate software to provide us the required data specified in the tender. IDL of 3fg or less OFN derived at the 99% confidence level from area precision of eight sequential injections of 1 ul. For eight sequential injection of 1 ul of 3 fg OFN standard, the signal must be 10 times higher than the rms noise value. Dioxin analysis requires lower detection limits especially in the

5 8 Point fg on-column GC injection of OFN should give IDL of less than 3.0 fg 100 fg on-column GC injection of OFN should give IDL of less than 4.0 fg case of vegetable oils and fats. IDL should be 3fg or less for such samples. S/N ratio is removed as IDL is more practical. Rejected (See reply to Point 30) 9 Point 32 For ten sequential injections For ten sequential %RSD should be <5% injections of OFN standards %RSD should be <5% 10 Point 37 Detection limit of 3 fg or less as specified in No. 30 is mandatory Detection limit of 4 fg or less as specified in No. 30 is mandatory For ten sequential injections of dioxin standards %RSD should be <5% Rejected (See reply to point 30) 1. The Title of the indent should be modified as Triple Quadrupole based Gas Chromatograph- Mass Spectrophotometer for Screening & confirmation of Dioxins with EI in environmental matrices & with CI for additional capability of handling Food, Feed, Herbs & Spices as per EPA & EU. Since as discussed, no Global reputed Vendors make any dedicated Dioxin Analyzer based on TQ-GCMS as such nor we do manufacture any dedicated DIOXIN ANALYZER in Shimadzu facility in Japan. Reply: The equipment is dedicated for dioxin analysis and hence the end user has every right to name it as Dioxin Analyzer. In addition

6 it is clearly mentioned in the detailed specificiations that Dioxin analyzer should be Triple Quadrupole based Gas Chromatograph- Mass Spectrophotometer. As per European Union regulations electron ionization (EI) method is only being recommended. Hence CI mode is not required. 2. All of our Pre-configured TQ-GC-MS system comes (as per the purchase order) after thorough, stringent Quality Checking without fail before dispatched to any countries along with certifications with standards like OFN (EI) & NCI & BZN for PCI. For additional testing at factory for Dioxin analysis report of the same model can be submitted from our Q.C. Lab or would be done and possible at your installation site only. Reply: End user has every right to scrutinize the efficiency of the equipment before shipment. 3. The system set up and validation would be done and possible of our offered model at installation site in presence of the end user at an additional charges apart from the cost of the instrument. To do it at other site or any deviation to do it would unnecessarily attract additional charges at consignee s account. Reply: Instrument training and compliance justification at vendor s facility is one of the requirements in the tender. The end user should be ready to bear the charges for 10 working days training for the personnel at factory site, charges if any for the training should be quoted separately. Additional Amendments/ Additions by the indentor Point No 5: Amendment: Necessary columns for dioxin analysis has to be provided Three columns for dioxin analysis should be quoted. Point No 11: Split/ splitless (Capillary) injector. Split ratio upto 7500:1 to

7 avoid column overload Amendment: Split/ splitless (Capillary) injector. Split ratio upto 7500:1 or better to avoid column overload. Point number 20: Ion source temperature: 150 to 350 Degrees Amendment: Ion source temperature: 150 to 350 Degrees Celsius Point number 43: 3 year comprehensive warranty for the complete system and free maintenance after warranty period for three years. Amendment: 3 year comprehensive warranty for the complete system and Comprehensive maintenance contract (CMC) for next three years including consumables except gases during warranty period as well in CMC period. Please quote for the additional warranty asked for. Quote separately for CMC for next 3 years. Additionally please quote for Annual Maintenance contract (Labour Only) for 3 years after the 3 years of comprehensive warranty. Additions Addition 1: Addition 2 : Addition 3: Our personnel should be provided minimum of 10 working days training for instrument handling and analysis at the factory laboratory facility. Charges if any should be quoted separately. Additional consumables to be supplied a. syringes 5 Nos b. Liner Split/ splitless, PTV liner 20 Nos each c. O- rings 20 Nos d. Septa 20 Nos e. Screw capped vials 20 Nos f. Gold Seal 10 Nos g. Nuts and ferrules suitable for columns h. vacuum pump oil 3 litres Operation qualification/ Performance Verification Services (OQPV) should be done every year during warranty period and CMC.

8 The tender stands amended to the extent as given above. The due date for the tender is extended up to 5 th June HRS (IST) and tenders would be opened at HRS(IST) on the same day. Bidders who are interested to participate in the tender opening can be present by HRS (IST) on the same day. Stores & Purchase Officer