Appendix 5 Overview of requirements in English

Appendix 5 Overview of requirements in English This document is a translation of Appendix 4 (Bilag 4) section 2. This translation is meant as a service for the bidder and in case of any differences between this document and Appendix 4, it is the Danish version which must be applied. Criteria Technical quality Requirement Description no. & type Mass spectrometer: 1 MK Mass spectrometer must be an MS/MS instrument e.g. QTOF with an API ion source that is connectable to an HPLC. (see 3.1.1.a) 2 MK Mass range: at least m/z 100 10000. (see 3.1.1.b) 3 I The bidder should indicate the mass range. (see 3.1.1.b) 4 MK Resolution: 20000 FWHM and 40000 FWHM in high resolution mode. (see 3.1.1.c) 5 I The bidder should indicate the resolution as well as indicating whether the resolution is different in positive and negative mode respectively. (see 3.1.1.c) 6 MK Dynamic range: > 4 orders of magnitude in both positive and negative mode. (see 3.1.1.d) 7 I The bidder should indicate the dynamic range for both positive and negative mode. (see 3.1.1.d) 8 MK Scan speed: 30 spectra/second in both MS and MS/MS mode. (see 3.1.1.e) 9 I The bidder should indicate the scan speed and indicate whether it is affected by ion mode switching. (see 3.1.1.e) 10 MK Mass accuracy: MS: 1 ppm RMS. MS/MS: 2 ppm RMS. (see 3.1.1.f) 11 I The bidder should indicate the mass accuracy (for MS and MS/MS) for both internal and external calibration as well as indicate whether the value is different in positive and negative mode respectively. (see 3.1.1.f) Fulfilment Page 1 of 12

12 K Re calibration (besides the use of lockmass) should not be necessary to maintain mass accuracy for at least 12 hours of continual use of the instrument. (see 3.1.1.g) 13 K Sensitivity: S/N should be at least 500:1 RMS for reserpine. The bidder should indicate the sensitivity as well as how it is defined, in both MS and MS/MS mode. (see 3.1.1.h) 14 K Ion mode switching: the instrument should be able to switch between positive and negative mode during analysis. The bidder should indicate whether this affects the instruments performance. (see 3.1.1.i) 15 I The bidder should indicate whether the reference solution is introduced via an external pump or via a built in system. (see 3.1.1.j) Vacuum pump: 16 MK The mass spectrometer must be supplied with an oil free vacuum pump. (see 3.1.2) Ion sources: 17 K Infusion of the reference solution into the mass spectrometer should be via a separate probe i.e. one probe for the sample and another probe for the reference solution. The bidder should indicate how this is done. (see 3.1.3.a) 18 K Cleaning of the ion source should be able to be carried out without breaking the vacuum. (see 3.1.3.b) 19 MK The mass spectrometer must be supplied with an electrospray ion source (ESI). (see 3.1.3.1) 20 MK The mass spectrometer must be supplied with an Atmospheric Pressure Chemical Ionisation (APCI) ion source. (see 3.1.3.2) 21 K OPTION 1: The bidder should provide specifications for a multimode ion source that can perform both ESI and APCI. (see 3.1.3.3) Page 2 of 12

22 K OPTION 2: The bidder should provide an offer for an ion source that can analyse a sample without the need for sample preparation i.e. direct analysis of e.g. solid phase. The bidder should briefly describe the principle and indicate whether additional instrumentation or gases other than nitrogen are necessary. (see 3.1.3.4) HPLC Gradient pump: 23 K Maximum operating pressure: 800 bar. The bidder should indicate the maximum operating pressure. (see 3.2.1a) 24 K Flow range: 0.01 2.0 ml/min. The bidder should indicate the flow range. (see 3.2.1.b) 25 K Flow precision: RSD 0.1 % within the entire flow range. The bidder should indicate the flow precision. (see 3.2.1.c) 26 K Flow accuracy: maximum ± 1.0 % within the entire flow range. The bidder should indicate the flow accuracy (see 3.2.1.d) 27 K Dead volume: should be as small as possible. The bidder should indicate the dead volume. (see 3.2.1.e) 28 K Number of solvent channels: at least 2 The bidder should indicate the number of channels. (see 3.2.1.f) 29 K ph range: 2 12. The bidder should indicate the ph range. (see 3.2.1.g) HPLC Autosampler: 30 K Variable injection volume: 0.5 40 µl. The bidder should indicate the minimum and maximum volume. (see 3.2.2.a) 31 K Precision: RSD < 1.0 %. The bidder should indicate the precision. (see 3.2.2.b) Page 3 of 12

32 K Accuracy: the bidder should indicate the accuracy as well as indicate for which volume this applies (see 3.2.2.c) 33 K Temperature range: 4 40 C. The bidder should indicate the temperature range. (see 3.2.2.d) HPLC Detector: 34 MK The detector must be a DAD detector. (see 3.2.3.a) 35 K Wavelength range: 190 600 nm. The bidder should indicate the wavelength range. (see 3.2.3.b) 36 K Flow cell: should be suitable for 2 mm columns. The bidder should indicate the flow cell s volume and type as well as indicate if the cell can be used over the entire flow range. It should also be easy to replace the flow cell. (see 3.2.3.c) 37 K Data collection rate: the bidder should indicate the rate. (see 3.2.3.d) 38 K Linear absorbance range: 0 2 AU. The bidder should indicate the range. (see 3.2.3.e) 39 I The bidder should provide information on the following: a. Indicate if there are different sizes of flow cell for the detector (DAD) b. Light source in the detector (DAD) c. The lamps life time (DAD) d. Wavelength resolution (DAD) e. Wavelength accuracy (DAD) f. Noise, state wavelength (DAD) g. Drift, state wavelength (DAD) (see 3.2.3.f) HPLC Column oven: 40 K Temperature range: 10 60 C. The bidder should indicate the temperature range. (see 3.2.4.a) 41 K Temperature accuracy: ± 0.5 C. The bidder should indicate the temperature accuracy. (see 3.2.4.b) Page 4 of 12

42 K Temperature stability: ± 0.3 C. The bidder should indicate the temperature stability. (see 3.2.4.c) 43 K There should be space for a column of at least 250 mm in length. The bidder should indicate the maximum column dimensions (length and diameter). (see 3.2.4.d) Syringe pump: 44 K OPTION 3: The bidder should provide an offer for a syringe pump (if not included as standard). The bidder should provide specifications. (see 3.3) Nitrogen generator: 45 K OPTION 4: The bidder should provide an offer for a nitrogen generator. The generator should not require a separate air compressor. The bidder should provide specifications for the generator. (see 3.4.a) 46 K OPTION 4: The nitrogen generator must deliver nitrogen at a flow of at least 30L/min. (see 3.4.b) Bench/table for the instrument: 47 K OPTION 5: The bidder should provide an offer for a bench/tablet for the HPLC and mass spectrometer respectively. The bidder should indicate the dimensions of the benches/tables. (see 3.5) Software: 48 K The offer must include the latest stable release versions of the software for controlling the instrument and the data processing. (see 3.6.1.a) 49 K If a new version of the software is introduced within 2 years of installation, an upgrade (if we so wish) should be included in the offer without extra charge). (see 3.6.1.b) 50 I The bidder should indicate which version of software is the current version and whether there are plans for a new version in the coming year. (see 3.6.1.c) Page 5 of 12

51 K Both the mass spectrometer and the HPLC should be controllable from the same software. (see 3.6.1.d) 52 K The software used to control the instrument should be the same software used to process the raw data obtained from both the mass spectrometer and the HPLC. (see 3.6.1.e) 53 K Tuning and full mass calibration should be able to be carried out automatically from the software. (see 3.6.1.f) 54 K The software should be able to calculate and suggest elemental composition from the obtained masses and isotopic pattern. (see 3.6.1.g) 55 I The bidders should briefly describe how the elemental composition is calculated and how the results are ranked. (see 3.6.1.h) 56 K It should be possible to use the obtained molecular weight and automatically search for possible compounds with the same mass in a database or list. (see 3.6.1.i) 57 K It should be possible to build personalized libraries that contain MS spectra, MS/MS spectra and UV spectra etc. (see 3.6.1.j) 58 K It should be possible to search in a raw data file for a specific mass for target screening of a particular compound e.g. active pharmaceutical ingredient, potency enhancing compound. (see 3.6.1.k) 59 K The software should be compatible with CFR part 11 with regards to qualification levels, passwords and login control. (see 3.6.1.l) 60 K Instrument settings (including HPLC) should be automatically saved together with the raw data. (see 3.6.1.m) 61 K It should be possible to copy spectra, TIC, etc. to Microsoft Word and Excel. (see 3.6.1.n) 62 K It should be possible to produce a report that contains the masses of the found peaks. (see 3.6.1.o) 63 K It should be possible to carry out deconvolution of multiply charged ions of large molecules. (see 3.6.1.p) 64 K It should be possible to carry out quantitative determination from both TIC and UV (DAD). (see 3.6.1.q) Page 6 of 12

65 K It should be possible to set up different users and user access levels in the software. There should also be an audit trail. (see 3.6.1.r) 66 I The bidder should describe the user access model for the software. (see 3.6.1.s) 67 I The bidder should indicate the possibility of using a third party software to run the instrument. (see 3.6.1.t) 68 K OPTION 6: Danish Health and Medicines Authority would prefer the bidder to provide information about ready made libraries e.g. NIST that are relevant to the types of analysis described in the introduction. (see 3.6.1.1.a) 69 K OPTION 7: Danish Health and Medicines Authority would prefer the bidder to provide information about any extra software for the analysis of peptides and proteins. (see 3.6.1.1.b) IT: 70 I The Danish Health and Medicines Authority currently uses: Windows XP Professional Service Pack 3 Danish Microsoft Office2007 SP2 Danish It is expected to pass to Microsoft Office2007 SP3 Danish at the beginning of July. Microsoft Internet Explorer 8 Danish F Secure Antivirus 9.31 The supplier should indicate whether the client software can run in interaction with the above client versions and describe any specific setup requirements that differ from a standard installation. The supplier should also indicate the compatibility with any newer versions of the above software suite and any deviations from Danish standard installations.(see 3.6.2.1) Page 7 of 12

71 K It should be possible to save data directly on a file server or another system that enables central backup of raw data. The bidder should indicate which is the case. (see 3.6.2.2.a) 72 I The bidder should explain how data from the system and clients can be transferred to a file server. (see 3.6.2.2.b) 73 K The bidder should supply software for processing the instrument s raw data for at least 5 office computers. The bidder should indicate whether the data processing software is included in the offer. (see 3.6.2.3.a) 74 I The supplier should indicate the possibility of placing the client software on a central Microsoft Terminal Server, which can be accessed from any office PCs. If there are special requirements for setting up the Terminal Server aside from a Danish standard installation, the supplier should indicate this. (see 3.6.2.3.c) 75 I The supplier should indicate how remote access support actually works and whether there are any specific requirements to the customer's network setup or security settings. The supplier should also indicate whether this requires additional software. (see 3.6.2.4) Service and Terms 76 K OPTION 8: The bidder should provide an offer for a computer that controls the instrument. (see 3.6.3.a) 77 I OPTION 8: The bidder should indicate specification requirements for the computer such as performance requirements and operating system including language requirements of the OS. (see 3.6.3.b) 78 I OPTION 8: The bidder should indicate whether these specification requirements mean that the Danish Health and Medicines Authority's own IT department is unable to provide the computer. (see 3.6.3.c and requirement no. 70) Delivery and Qualification: Page 8 of 12

79 K The supplier is responsible for delivery and qualification of the equipment. (see 3.7.a) 80 I The bidder should indicate installation requirements with regards to the room, electricity, gas etc. (see 3.7.b) Delivery time: 81 K Delivery and installation/qualification (IQ/OQ) should take place within 2 months from data of order. Delivery time should be indicated in the offer. (see 3.7.1) Qualification: 82 MK All installations must be documented. (see 3.7.2.a) 83 K Installation Qualification (IQ) og Operational Qualification (OQ) should take place in connection with delivery i.e. within 2 weeks of delivery to the laboratory at the Danish Health and Medicines Authority. If this is not possible, the timeframe should be indicated in the offer. (see 3.7.2.b) 84 K The installation should include the installation of any nitrogen generator. (see 3.7.2.c) 85 I The bidders should describe the extent of the qualification of the equipment. (see 3.7.2.d) Training: 86 K Introduction to maintenance of the instrument (both HPLC and MS) as well as introduction to the software should take place in connection with installation and qualification of the equipment. (see 3.8.1.a) 87 K Onsite training for at least 3 employees should be included in the offer. Indicated the number of days. (see 3.8.1.b) 88 K Extended onsite trained is desired, 3 to 6 months after installation for at least 3 employees. (see 3.8.1.c) Service: 89 K Indicate the guarantee period as well as describing what the guarantee includes for the instrument (HPLC and MS) and any nitrogen generator. (see 3.8.2.a) 90 K A service of the instrument (HPLC and MS) is desired prior to expiry of the guarantee period. (see 3.8.2.b) Page 9 of 12

91 K The service organization should be located in Denmark. (see 3.8.2.c) 92 I The bidder should indicate the number of service technicians, response time as well as indicate if the technicians are trained in both HPLC and MS. (see 3.8.2.d) 93 K Supply guarantee for spare parts of at least 10 years. (see 3.8.2.e) 94 K OPTION 9: Danish Health and Medicines Authority would prefer that the bidder offers service in the form of Preventive Maintenance (PM) and indicate the extent of this. Service should include HPLC, MS and the data system. (see 3.8.3.a) 95 K OPTION 10: Danish Health and Medicines Authority would prefer that the bidder offers an annual service contract and the bidder should indicate the extent of service (service visits, travel time, spare parts, telephone support, remote support and others things). If more than one level exists they should be described separately. (see 3.8.3.b) 96 K OPTION 11: Danish Health and Medicines Authority would prefer that the bidder offers a 2 to 3 year service contract after the guarantee period has expired and the bidder should indicate the extent of this. (see 3.8.3.c) Quality guarantee: 97 MK The supplier must guarantee that the equipment after installation meets the supplier s product specification. (see 3.9) Documentation: 98 MK The following documentation must accompany the equipment: Report with results of the Installation Qualification (IQ) and Operational Qualification (OQ). The report prepared during IQ/OQ. (see 3.10.a) Page 10 of 12

99 MK The following documentation must accompany the equipment: Manual that describes the principle, use and maintenance of the equipment (electronic version is fine). (see 3.10.b) Price 100 MK The bidder must provide a binding price for the instrument (HPLC and MS) and software as well as installation of the entire instrument and software 101 K OPTION 1: The bidder should indicate the price of a multimode ion source that has both ESI and APCI capabilities. (see 3.1.3.3) 102 K OPTION 2: The bidder should indicate the price of an ion source that can analyse a sample without the need for sample preparation i.e. direct analysis of e.g. solid phase. (see 3.1.3.4) 103 K OPTION 3: The bidder should indicate the price of a syringe pump. (see 3.3) 104 K OPTION 4: The bidder should indicate the price of a nitrogen generator. (see 3.4) 105 K OPTION 5: The bidder should indicate the price of a bench/table for the HPLC and mass spectrometer respectively. (see 3.5) 106 K OPTION 6: The bidder should indicate the price of any readymade libraries e.g. NIST that are relevant to the types of analysis described in the introduction. (see 3.6.1.1.a) 107 K OPTION 7: The bidder should indicate the price of extra software for the analysis of peptides and proteins. (see 3.6.1.1.b) 108 K The bidder should offer advantageous binding price for extra client licenses for up to 5 years. The bidder should also provide the price of offering new versions of client and/or system software. (see 3.6.2.3.b) Page 11 of 12

109 K OPTION 8: The bidder should indicate the price of a computer that controls the instrument. (see 3.6.3) 110 K The bidder should provide a price list for spare parts/consumables that will normally be replaced within 5 years. (see 3.8.2.f) 111 K OPTION 9: The bidder should indicate the price of a service in the form of Preventive Maintenance (PM). The service should include HPLC, MS and the data system. (see 3.8.3.a) 112 K OPTION 10: The bidder should indicate the price of an annual service contract (service visits, travel time, spare parts, telephone support, remote support and other things). If more than one level exists, they should be described separately. (see 3.8.3.b) 113 K OPTION 11: The bidder should indicate the price of a 2 to 3 year service contract (from expiry of the guarantee period). (see 3.8.3.c) Page 12 of 12