Single Use Systems_Biotechnology

8/3/2019 Single Use Systems_Biotechnology

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Single Use Systems

- Rashad SyedIntern at Polybatics Ltd, Palmerston North, New Zealand


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Single use technology

Bioprocess bags Cell culture bioreactor bags

Separations and Purifications-Chromatography, TFF and filters Sterile connectors, tubing's and sealers

Integrated sensors


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Sartorius-Stedim Single use technologyInnovative Bioreactor, Sensor and Stirrer Technology

Completely single use bioreactor in traditional design, top driven stirrer withmagnetic coupling, application driven fully flexible gassing system, User-friendly touch screen interface for easy operation, Single use optical DO & pHsensors for measurement, Single use bags available with working volumes of 50L and 200L.


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Sartorius-Stedim Single use technologyFlexboy Bioprocessing Standard Ranges

Applications: Buffers and Media sterile storage & filtration, Bulk Harvest, Productpooling, Fraction collection, Sample collection, Bulk intermediate hold, Final productstorage and transport.


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Sartorius-Stedim Single use technologyFlexel3D Bioprocessing Bags

Buffers and Media sterile storage & filtration.Standard bags are available from 30L-1000L


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Sartorius-Stedim Single use technologySARTOFLOW Alpha plus SU

SARTOFLOW Alpha plus SU (Cross flow filtration with pre-sterilized Single usetechnology) is equipped with a gamma pre-sterilised loop. All product contacting surface

areas like self contained UF or MF unit, pressure domes, flow meters, valves, bags and

tubings provide sterility and highest process security.


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Advantages of using Single use systems


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Flexibility

Mobile skid Easily customizable

Cross contamination

Reduced risk of cross contamination fromproduct to product- a significant concern formulti product pilot plant facility.


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Time, space and cost savings

Occupy smaller footprint due to reducedpiping, valves and support structures.


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Time, space and cost savings

Disposable bag is Gamma sterilized -no CIPand SIP required- Utilities are reduced andamount of piping & valves greatly reduced

This effectively eliminatesCleaning and sterilization validationSimplifies automation and mechanical qualification

Reduces the time to startup the process/pilot plantfacility


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Comparison of space usage: (a) 1000-L stainless steel bioreactor versus(b) 1000-L SU bioreactor. ( Source: Robert et al., 2010)


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Budget matters

Single use(SU) Facility Reduction Potential versus Traditional 1000-L Stainless Steel (SS).Proforma is based on a 1000-L monoclonal antibody (Mab) facility


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Energy consumption

Total energy consumption for stainless steel and disposable systems.(Source: Bruce et al., 2009)


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Disadvantages of using Single usesystems


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Extractables and leachables Source: SU bioreactors, transfer tubing, filters,

vials, and bags, as well as secondary packing (e.g.overwraps, labels).

Adhesives, coatings, additives, and otherchemical components used in manufacturing of many SU products can potentially migrate intothe product.

Steam or gamma sterilization may result indegradation of polymeric components, makingthem more readily leachable.


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Process safety

Single use bags is a plastic bag and is susceptibleto

Punctures or tears if handled aggressively ormanufactured improperly

Melting if excessive temperature is applied Over pressurization if too much liquid or gas is

added, or exhaust filters clog.


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Scalability

Limited scalability, currently up to 3000L

Storage space Require additional storage space to maintain a

continuous stock of components


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Solid waste disposal

Large volume of materials to dispose- shakerflasks, media bags, bioreactor bags, filters,

several meters of tubing, and potentially manymore items.

Adds to the overall operating costs.


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Annual Costs for 2000-L SS versus 2000-L SU Bioreactors, including Capital, Installation,

Qualification, and Operating Costs. (Source: Robert et al., 2010)


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Challenges for Disposable system

Plastic durability to support large volumes Better mixing and aeration options for large

scale bioreactor bags Better risk assessment for extractables and

leachables Disposable sensors are limited


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Source

Robert et al., Single use systems, Encyclopaedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, John Wiley and Sons, Inc

Bruce Rawlings and Hlne Pora, 2009 environmental impactof single use and reusable bioprocess systems, BioProcessInternational February 2009.

http://www.sartorius-stedim.com
http://www.sartorius-stedim.com/http://www.sartorius-stedim.com/http://www.sartorius-stedim.com/http://www.sartorius-stedim.com/


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Thank You

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Single Use Systems_Biotechnology