F-SOP-Z-3.7 WZÓR ZAPYTANIA OFERTOWEGO OBOWIĄZUJE W BLIRT S.A. Wersja 1 Ob. od

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1 Gdansk, Request for Proposal No. 11/2017/KT Subject: Bioreactor System for microbial fermentation with working volume of a 400 liters with training and installation CPV CODE: NAME AND ADDRESS OF THE CONTRACTING AUTHORITY: MODE FOR THE AWARD OF THE CONTRACT: ANNOUNCEMENT DATE OF THE QUOTATION: PROPOSAL CLOSING DATEE: LODGEMENT: DESCRIPTION OF THE CONTRACT S SUBJECT: BLIRT S.A., Trzy Lipy 3/1.38 St., Gdansk, Phone: , Fax: VAT ID: Submission and processing of offers is carried out in accordance with the competitiveness principle as defined in the section 6.5 of guidelines for eligibility of expenditure under the European Regional Development Fund, the European Social Fund and the Cohesion Fund for the period Deadline for offers submission: at 23:59. Offers submitted after the specified date will not be considered. Date and time of the offer receipt is decisive. The offer may be submitted: 1) Via Robert.Brodzik@blirt.eu, 2) By Fax: Fax No ) Paper version by post, courier or delivered in person to mailing address as below: BLIRT S.A. Kładki 24 Street, Gdańsk, POLAND The subject of this inquiry is a delivery of the bioreactor system for microbial fermentation with working volume of a 400 liters with training and installation. The system consists of the following components: I. Fermenter with working volume of a 400 liters II. Aeration System with emergency backup 1

2 III. Process steam generator (electric) with a productivity required by the supplied fermenter IV. Water-treatment system with a capacity suited to the requirements of the fermenter All supplied equipment and their components should be brand new, not used. TECHNICAL SPECIFICATIONS: I. Bioreactor with working volume of a 400 liters A) Culture tank characteristics 1. The working volume should be at least 400 liters with total volume minimum 500 liters. 2. Culture tank should be design according to pressure directive PED and made out of stainless steel 316L with high/diameter ratio 3:1, ASME/CE, mechanical polishing 0.5 micrometers of Ra. 3. Fermentation tank should be equipped with closed circuit jacket for heating or cooling that should have built-in two heat exchangers with ability to connect independently two cooling media (e.g. tap water and glycol-based system). The cooling circuits shall have ability to work independently or in parallel to each other or to heating circuit. 4. Tank s lid made of stainless steel with the appropriate ports for exhaust gas cooler, safety valve, pressure and foam and liquid level sensors, borosilicate sight glass with lamp, spray ball for the CIP, at least two additional ports with caps. 5. Tank s lid equipped with a mechanism to facilitate the opening and lifting. 6. Bioreactor should have at least 3 ports 1.5 ; 1 port of 2 ; 3 ports of 3 size at the vessel head plate; on the side of the vessel: 1 port of 0.75 NA-Connect; 5 ports of 0.5 Tapered Tri-Clamps; 1 port of 1.5 Tapered Tri-clamp; 1 port of 4 Tapered Tri-clamp; 2 ports of 0.75 NA-connects; 4 ports of 25 mm; 2 ports of 1.5 NA-connect; Bottom of the vessel: 1 port of 1 drain valve; 1 port of 1.5 NA-Connect 7. Exhaust gas cooler with hydrophobic, membrane, sterile, 0.2 μm filter. 8. Dosing port equipped with the membrane or 4-way port placed in the lid or on the top side of the tank. 9. Re-sterilization port for sampling equipped with drain valve at the bottom or in the lower side of the tank. 10. Aeration system: supply at least 2 gases entering the bioreactor through the overlay and the sparger, filter 0.2 μm; the ability to support gas flow in the amount of minimum 0-150% of the working volume of the tank per minute. 11. The system must have overlay module. 12. Pressure sensor coupled with the aeration system, the possibility of automatic adjustment of the pressure in the tank in the range of at least bar. 2

3 13. Liquid level sensor (dispensing/suppling) coupled with cascading control system equipped with touchscreen and peristaltic pump. 14. Foam sensor coupled with cascading control system with peristaltic pump. 15. The temperature sensor installed in a separate port, measurement range from 0 to 149 C. 16. DO electrode, measuring in the range of a minimum 0-100% dissolved oxygen in the culture medium. 17. ph electrode, measurement in the ph range Agitation system: Rushton type as standard, with 3 sets of removable 6 blades with the ability to change to a different type of disc impellers (High-pitched blade or Marine). 19. Agitation system: direct drive with double mechanical seal, lower or top with magnetic connection, speed minimum 50 to 500 rpm. 20. Tank equipped with 4 vertical removable baffles. 21. Piping and connections made of 316L stainless steel or a material resistant to corrosive substances, pressure up to 4 bars and high temperatures up to 149 C. 22. System should be supplied with a transfer line (minimum 5 meters) made of a material resistant to corrosive substances, pressure up to 4 bars and high temperatures up to 149 C. 23. The construction should be also flexible and gives the possibility to add options in the future. 24. System should be made according to cgmp standards. B) Control Unit 1. Operation and control of the control unit with the use of built-in touch screen display with a minimum of 13 inches diameter; compatibility with industry standards or from a computer directly connected to the control unit. 2. Software allowing for the remote control, programming and monitoring via computer over the LAN or Wi-Fi network all process parameters with automatic data entry, creating and exporting batch reports. 3. Bioreactor must have integrated SCADA software and module for remote control of the unit. The software must have a recipe management window, data logging system, visual/schematic representation of the process, block diagrams. Main screen should present process data from bioreactor with information of the quality of connection and time of last readings. Also it should be possible to set starting values for each control loop. The software must have a programming option in Visual Basic represented as graphical interface, to design sophisticated fermentation strategies. The software must have also possibility to generate fermentation reports and export the data to Excel file. The software must allow to bock the access to the control panel of the fermenter. OPC server should be included. 4. License for the software must be unlimited in time. 3

4 5. The ability to enter the alarm settings and notification of errors during the process; ability to view and send messages via SMS TXT and/or Minimum of 4 peristaltic pumps as a standard, all pumps must be used in cascade modes. 7. The ability to control the concentration of dissolved oxygen through speed mixing and gas flow changes. 8. The system should be equipped in automatic sterilization in place system SIP and should be prepared with sprayballs and valve controlling software for automated CIP 9. ph in the range of 2 to 12 calibration and control. 10. Calibration and control of DO in the range of at least 0-100%. 11. Temperature control system in the range of minimum 8 C above the cooling water temperature up to 50 C. 12. Automatic foam control system: pump starts in response to the sensor signal. 13. Automatic control of gas flow (two gases) with the help of mass flow controller and solenoid valves. 14. Quantitative calibration of peristaltic pumps. 15. Bioreactor should have minimum 6 input/output connections (4-20 ma) to connect external devices, and the logic controller should have the possibility to integrate the external devices into the system and control them using bioreactors control software. 16. The supplier must have international bioprocess center with specialist to provide support for the future user. 17. The supplier must have a Polish division with the local office; service of the producer must be located also in Poland 18. The supplier will help in technical advising and selecting, for choosing appropriate auxiliary devices such as: steam generator, water purification system, compressors, chiller, CIP station. 19. Compliance with industry standards with the possibility of validation. 20. Power supply: 230V-400V, Hz. II. Aeration System with emergency backup 1. Total efficiency of air pumping equal or larger to 1.5 working volume of the culture vessel (e.g. 600 liters/min. for 400-liter vessel). 2. Built-in tank for compressed air with a volume adjusted to the size of the culture tank. 3. Measurement and regulation of the air pressure in the tank and at the output. 4. System equipped with air dehumidifier and prefilter. 4. Protection against overheating. 5. Power supply: 230V-400V, Hz. 4

5 III. Steam generator (electric) of process steam with an efficiency required for the supplied bioreactor 1. Steam production efficiency: minimum of 120 kg steam per hour or adjusted to the needs of the bioreactor. 2. Automatic control of water level in the water reservoir. 3. Vapor pressure regulator in the output in range of minimum 1-6 bar. 4. Power supply: 230V-400V, Hz. IV. Water-treatment system with a capacity suited to the requirements of the bioreactor 1. System performance at least 200 liters of purified water per hour or higher to fully meet the needs of the production system. 2. Two levels of water treatment: reverse osmosis and ion exchange column. 3. The water quality at least 0.1 μs/cm. 4. Clean water tank with a capacity of at least 400 liters or adjusted to the size of the bioreactor. 5. Indication of water quality on both stages of purification. 6. Water level indicator in the storage tank. 7. Leak sensor system, protection against flooding. 8. Power supply: 230V-400V, Hz. In accordance with the Community Order Dictionary object of the contract is defined as: CPV: CONDITIONS OF TENDER: 1. Any Tenderers that may have any capital or personal ties or any other relation with the Ordering Party are not permitted to submit a tender. Capital or personal ties are understand as the interactions between the Ordering Party or authorized persons to enter into commitments on behalf of the Ordering Party or persons performing on behalf of the Ordering Party activities associated with the preparation and the procedure for selecting the Contractor and the Contractor, in particular by: 1. Participation in the company as a partner or partnership, 2. Possession of at least 10% of shares, 3. Role as member of the supervisory or management, procurement, proxy, 4. Remaining married, in consanguinity or affinity in a straight line, consanguinity or affinity of the second degree in the collateral line or by adoption or guardianship. 5

6 2. Supplier s experience in the construction of bioreactors with similar characteristics as this query (volume liters) documented in the form of a list of completed deliveries (minimum of 5). 3. Due date: minimum 30 days from the invoice date. 4. Negotiable terms of the order prepayment. 5. The minimum warranty period: 12 months. 6. Separate bioreactors valuation (position I) and each peripheral device (II-IV). 7. Submission of partial tenders is not allowed. DEADLINE FOR DELIVERY OF THE PROPOSAL SUBJECT: EVALUATION OF PROPOSALS: 1. Delivery service will be processed by the Contractor up to 26 weeks from the order date. Execution time assessed during offers selection process. The evaluation process will be undertaken with the aim of determining which Proposal represents best value for money to the Contracting Authority. The criteria will be assessed according to the 0 to 10 points scale, where: - 10 is the maximum number of points awarded to the Proposal with the best value of the evaluated criteria; the value of the Proposal criteria, which was granted 10 points is the benchmark for other Proposals, - 0 is granted to the Proposal, which did not meet the criteria or criteria was not included in the offer. - all values are calculated according to the formulas in the table below. Lp 1 Price 2 Criteria Warranty and postwarranty service Description of evaluation criteria The Proposal with the lowest price will receive 10 points The proposal offering the longest period of warranty above 12 months, will receive 10 points Points Calculation Method Criteria Weight PriceMin P1cena x10 80% Price Tender Warrantyperiod P2 Tender serwis x10 20 % Warrantyperiod Max The sum of points awarded to the tenderer will be calculated in the following way: Sum tenderer 1 P1 pricex0,8 P2servicex0,2 6

7 In case if two Proposals received an equal number of points, the Proposal with more favorable impact on the environment (less energy intensity) will be selected. All Tenderers will be notified about the selection process results via . CONTENT AND FORMAT OF THE PROPOSAL: 1. The identity of the tenderer (name, address, NIP, KRS/EDG). 2. The date of the offer preparation and its validity (min. 30 calendar days from the last day of the Proposal submission into the competition). 3. The description of the product (s): name, part number, other requirements, according to the description the Contract subject. 4. The total gross and net price including transport. 5. The conditions and due date. 6. Execution time of the Contract subject. 7. Other specific terms of delivery (if applicable). 8. Contact person (first name, surname, telephone number, address), 9. Signature of the person authorized to issue the Proposal. 10. The Tenderer s written statement concerning the feasibility of the order in accordance with Appendix no A written statement confirming lack of ties with the Customer according to Appendix no A written statement confirming a compliance of technical parameters of the query item according to Appendix A list of completed projects (deliveries) of the construction of bioreactors with similar characteristics as this query (volume liters, minimum of 5 deliveries in past 5 years). The lack of any of the above may result in a rejection of the Proposal. ANY CHANGES TO THE CONTRACT: ADDITIONAL INFORMATION: The Ordering Party holds the right to change the contract with the winning Tenderer for any of the following reasons: 1. Significant changes the implementation of the Proposal subject. 2. Objective reasons independent of the Ordering Party or the Tenderer. 3. Due to circumstances called force of Nature. 4. Changes in the law at the date of the agreement signing. 5. While the Ordering Party receives a decision from the Project financing institution concerning significant changes to the scope of tasks, terms of execution or any other changes to the Contract, the Ordering Party is obliged to comply with. 1. The Tenderer has the right to change or withdraw the offer before the end of the period for Proposals submission. 7

8 2. The Ordering Party reserves the right to reject any submitted Proposal offering used equipment. 3. The Ordering Party reserves the right to change or cancel the tender at any time without giving any reason or prior notice. 4. The tenderer whose tender has been selected in the proceedings is obliged to sign a contract with the Ordering Party within 7 calendar days from the date of closing the evaluation process. 5. This procedure is not carried out according to the provisions of the Act of 29 January 2004 public procurement law. INQUIRIES ABOUT THE SUBJECT OF THE TENDER: For any information concerning the subject of the contract, please contact: Robert Brodzik Tel: Robert.brodzik@blirt.eu Appendix 1: Declaration of enforceability of the Tender Appendix 2: Statement of lack of ties with the Customer Appendix 3: Statement of the technical parameters 8

F-SOP-Z-3.7 WZÓR ZAPYTANIA OFERTOWEGO OBOWIĄZUJE W BLIRT S.A. Wersja 1 Ob. od

F-SOP-Z-3.7 WZÓR ZAPYTANIA OFERTOWEGO OBOWIĄZUJE W BLIRT S.A. Wersja 1 Ob. od Gdansk, 24.03.2017 Request for Proposal No. 10/2017/KT Subject: Bioreactor System for microbial fermentation with working volume of a 400 liters training and installation CPV CODE: 38500000-0 NAME AND

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