Attachment 2 Revision 1 Bioreactor System Manhattan KS Specifications.pdf

Attachment 002 Revision 1 Bioreactor/Fermentor System Manhattan KS Specifications

Background and Scope The USDA Biologics Development Module requires a modular, scalable, flexible bioreactor/fermentation system that can accommodate multiple volumes, and is compatible with bacterial, mammalian, yeast, and insect cell culture and can support perfusion processes.

Applicable Documents and Standards A. Contractor must warranty the proper function, parts, software, and workmanship of the bioreactor system for 1 year as part of the initial purchase price.

Bioreactor/Fermentor 50-200 L Specifications:

Three (3) Each bioreactor/fermentor system Brand Name or Equal to Sartorius Biostat STR system Salient Characteristics:

1. Must have a controller that can support control of two separate processes of different culture vessel sizes at the same time and independently of each other.

2. Must have a controller that can support both stainless steel and single-use (SU) culture vessels.

3. Must have controller software that conforms to ANSI-88 industrial standards.

4. Must work with generally available labware including peristaltic pumps and balances (to maintain compatibility with other supplies and procedures).

5. Must have components installed on mobile skids for flexible arrangement in lab space.

6. Must be equipped with an integrated, automatically-controlled gas mixing system with advanced sparger and overlay aeration.

7. Must be compatible with air, carbon dioxide, nitrogen and oxygen gases, as well as have thermal jacket compatible with cold and hot water for temperature control.

8. Must be able to accommodate single-use or conventional pH and dissolved oxygen (DO) sensors.

9. Must have ability to add one or more independent bag holders to already existing systems, with bag holders being configurable according to purchaser specifications. Bag holders must be able to be qualified via a customer-site acceptance test (SAT) to ensure compatibility with cGMP regulations.

10. 2 bioreactor/fermentor systems must accommodate cell culture processes up to 50 L in single-use bags to accommodate all needed uses; 1 bioreactor/fermentor system must accommodate cell culture processes up to 200 L in single-use bags to accommodate all needed uses.

Bioreactor/Fermentor 1-10 L Specifications:

Three (3) Each bioreactor/fermentor system Brand Name or Equal to Sartorius Biostat B-DCU system Salient Characteristics:

1. Must have a controller that can support up to 6 supply towers which can be controlled and configured independently of each other. Must support configurations for animal, plant and insect cell cultivation and microbial fermentation.

2. Must have standard measurement parameters and control loops (such as pH and DO). Must be able to support inline and online measurement systems for advanced parameters: glucose and lactate measurement; off-gas analysis; biomass determination; turbidity, ethanol and methanol measurements.

3. Must be compatible with software that allows for central and remote monitoring of bioprocesses.

4. Must be certified according to CE, UL, CSA and RoHS. Must have ethernet connections to supply towers.

5. Controller software must have security features for heating system in case of overheating;

password protection and manual control for all controller outputs; allow for control via remote external PCs; and have shutdown function for all process controllers.

6. Must work with generally available labware including peristaltic pumps and balances (to maintain compatibility with other supplies and procedures).

7. Must be compatible with air, carbon dioxide, nitrogen and oxygen gases, as well as have thermal jacket compatible with cold and hot water for temperature control.

8. Glass vessels designed for 1 L, 2 L, 5 L and 10 L cell cultures must be included with systems, and systems must accommodate both glass and single-use cell culture vessels.

Bioreactor/Fermentor Software Specifications:

One (1) Each bioreactor/fermentor software Brand Name or Equal to Sartorius BioPAT MFCS system Salient Characteristics:

1. Software must be able to support configuration of up to 32 process units.

2. Software must be applicable to shakers, bioreactors, fermentors, and crossflow systems.

3. Software must support alarm management according to the ANSI-18.2 standard.

4. Must support flexible data export as .csv-files.

5. Must support generation of random process values via a simulation device.

6. Software must be able to allow transfer of controller setpoints for remote operation of devices.

7. Software must allow for online and offline calculation of important bioprocess parameters.

8. Must allow visualization of running and completed processes in one chart.

9. Must have a multi-monitoring function to show charts and tables on different screens, and display applications on multiple screens.

10. Software must be able to: store results of offline analyses of samples; automatically assign date and time to samples taken; make snapshots to capture online data when samples are taken; allow export of offline and online data in a shared table; and schedule future samplings for multiple units.

Testing and Verification Qualification via a customer site acceptance test will be the verification standard.

Government Furnished Property None.

Data Requirements Required documentation must include operation manual, software manual, software installation procedures. Required software for operation must be included.

Packaging and Shipping All packaging, shipping, and shipping-insurance costs must be included with purchase price.