TITLE / Declaration of compliance with the requirements of the contract’s technical parameters / Operates since 2016
OPERATES IN / BLIRT S.A. / Page/out of pages: 1/5
Place, date. ……..….
Attachment no. 3 to the Request for proposal
Declaration of compliance with the requirements of the contract’s technical parameters
Concerns:
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: 38500000-0.
Tenderer Tender’s Company’s name declares that the equipment offered meets the specifications as described in the table below:
No. / TECHNICAL SPECIFICATIONS / Parameter present in the offered equipment / Description of the parameter delivered in the offer [page, line]YES / NO
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. one tap water and one with glycol) and one for heating (e.g. utility steam). 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 0-1.5 bar.
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 2-12.
18 / 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.
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 e-mail.
6 / 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, 50-60 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.
5 / Protection against overheating.
6 / Power supply: 230V-400V, 50-60 Hz.
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, 50-60 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, 50-60 Hz.
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Signature, stamp