You are on page 1of 22

Single Use Systems

- Rashad Syed Intern at Polybatics Ltd, Palmerston North, New Zealand

Single use technology
• Bioprocess bags • Cell culture bioreactor bags • Separations and PurificationsChromatography, TFF and filters • Sterile connectors, tubing's and sealers • Integrated sensors

application driven fully flexible gassing system. Userfriendly touch screen interface for easy operation. Single use bags available with working volumes of 50L and 200L. Sensor and Stirrer Technology Completely single use bioreactor in traditional design. . Single use optical DO & pH sensors for measurement. top driven stirrer with magnetic coupling.Sartorius-Stedim Single use technology Innovative Bioreactor.

Fraction collection. Bulk intermediate hold. Sample collection.Sartorius-Stedim Single use technology Flexboy® Bioprocessing Standard Ranges Applications: Buffers and Media sterile storage & filtration. Product pooling. . Bulk Harvest. Final product storage and transport.

Standard bags are available from 30L-1000L .Sartorius-Stedim Single use technology Flexel®3D Bioprocessing Bags Buffers and Media sterile storage & filtration.

. flow meters. bags and tubings provide sterility and highest process security. All product contacting surface areas like self contained UF or MF unit. valves. pressure domes.Sartorius-Stedim Single use technology SARTOFLOW® Alpha plus SU SARTOFLOW ® Alpha plus SU (Cross flow filtration with pre-sterilized Single use technology) is equipped with a gamma pre-sterilised loop.

Advantages of using Single use systems .

a significant concern for multi product pilot plant facility.Flexibility • Mobile skid • Easily customizable Cross contamination • Reduced risk of cross contamination from product to product. .

valves and support structures.Time. space and cost savings • Occupy smaller footprint due to reduced piping. .

space and cost savings • Disposable bag is Gamma sterilized -no CIP and SIP required.Utilities are reduced and amount of piping & valves greatly reduced • This effectively eliminates  Cleaning and sterilization validation  Simplifies automation and mechanical qualification  Reduces the time to startup the process/pilot plant facility .Time.

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

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 .

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

Disadvantages of using Single use systems .

vials. additives.g. • Steam or gamma sterilization may result in degradation of polymeric components. • Adhesives. and bags. and other chemical components used in manufacturing of many SU products can potentially migrate into the product. . transfer tubing. overwraps. coatings. filters. labels). making them more readily leachable.Extractables and leachables • Source: SU bioreactors. as well as secondary packing (e.

Process safety Single use bags is a plastic bag and is susceptible to • Punctures or tears if handled aggressively or manufactured improperly • Melting if excessive temperature is applied • Over pressurization if too much liquid or gas is added. or exhaust filters clog. .

Scalability • Limited scalability. currently up to 3000L Storage space • Require additional storage space to maintain a continuous stock of components .

filters.Solid waste disposal • Large volume of materials to dispose. several meters of tubing. and potentially many more items. media bags. bioreactor bags. • Adds to the overall operating costs. .shaker flasks.

(Source: Robert et al. Qualification.. and Operating Costs. including Capital.Annual Costs for 2000-L SS versus 2000-L SU Bioreactors. 2010) . Installation.

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 .

BioProcess International February 2009. and Cell Technology.Source • Robert et al.com . John Wiley and Sons. Single use systems. Bioseparation.sartorius-stedim.. 2009 environmental impact of single use and reusable bioprocess systems. Inc • Bruce Rawlings and Hélène Pora. • http://www. Encyclopaedia of Industrial Biotechnology: Bioprocess.

Thank You .

fnf  ¾f°  fnf  ¾ W n D  fn¾ f°¾€   °– € ¾ f¾ f° f–¾ f¾   f¾ ¾ n° f ½fn°– % –  f½¾ f ¾% W   ¾ ¾ nf°–¾ f  ¾ f°   n ¯nf n¯½° °¾ ¾ ° ¯f°€fn°– € ¯f° D ½ n¾ nf° ½ °f ¯–f °  ½ n W  f¯  –f¯¯f ¾ f° ¯f  ¾ ° –f f° € ½¯ n n¯½° °¾ ¯f°–  ¯ ¯  f   fnf  .

°–€ n ¾¾  ¯½ f ¾f½½  W  ½ ¾¾f°€¯n –f¾¾ f  f¾€ ¾n– .9n ¾¾¾f€  °– ¾  f–¾¾f½f¾n f–f° ¾¾¾n ½    W 9°n ¾ f¾€f°  f–– ¾¾  ¯f°€fn ¯½½  W .

nff  W ¯ ¾nff  n °½ f– ¾½fn W   f °f¾f– ¾½fn ¯f°f°f n°°¾¾n€n¯½° °¾ .

 f¾  ¾½¾f W f– ¯ €¯f f¾ ¾½¾ ¾f  €f¾¾ ¯ f f–¾   fn f–¾ € ¾  ¾  f¯  ¾€ °– f° ½ °f¯f° ¯  ¯¾  W  ¾  f½ f°–n¾¾ .

°°f.

¾¾€  ¾¾ D  fn¾ °n °–.

f€nf° f° ½ f°–.f½f °¾ff°  .

¾¾ %n   f % .

.

f °– ¾€¾½¾f  ¾¾ ¯ W 9f¾n f ¾½½f– ¯ ¾ W  ¯°–f° f f°½°¾€f–  ¾nf   fn f–¾ W  ¾f¾¾ ¾¾¯ °€ fnf  ¾f°   fnf  ¾ W ¾½¾f  ¾ °¾¾f ¯ .

n W   f °– ¾ ¾¾ ¯¾ °nn½f f€° ¾f  n°–  ½n ¾¾  ¾ ½ff° f° .

 @ n°– °J f° °¾ °n W n f°–¾f° x ° 9f  °°¯ °f¯½fn €¾°– ¾ f°  ¾f   ½n ¾¾¾¾ ¯¾  9n ¾¾ ° °f°f f W ½ $$ ¾f¾ ¾ ¯ n¯ .

@f° .