58 BIOTECHNOLOGY
these plates to offer advice on proper selection of working volume and agitation to achieve users’ process goals. Cassettes are delivered beta-sterilised and sealed in a light shielding package.
A microbial bioreactor Eppendorf says its new BioBLU 0.3f is the first fully-instrumented single-use bioreactor designed specifically for microbial applications (Fig. 1).
Te BioBLU 0.3f joins the BioBLU 0.3c which was launched last year and is designed for the cultivation of animal and human cells. Both the BioBLU 0.3c and BioBLU 0.3f are specifically designed for use with the compact DASbox mini bioreactor system.
DASbox is a novel mini bioreactor system for parallel operation of four, eight or more mini-bioreactors and is well suited for design of experiment (DoE), bioprocess development screening and for use as a scale- down model.
With the new BioBLU 0.3f, the company says it is paving the way for users of conventional microbial-based biotechnology to take advantage of the time and cost benefits of single-use bioreactor technology – for
example in pharmaceutical product development.
Te fully-instrumented BioBLU 0.3f single-use bioreactor features working volumes of 65 to 250 ml and meets all requirements for microbial applications. Te rigid-wall, single-use bioreactor includes two Rushton impellers achieving oxygen intake levels comparable to industrial glass and stainless steel bioreactors.
All critical parameters, such as temperature, pH and dissolved oxygen, can be monitored and regulated using industry standard sensors. Integrated dip tubes permit the controlled feeding of liquids, easy sampling and massflow-controlled gassing. Te specially developed, magnetically-coupled overhead drive safely operates up to 2000rpm, ensuring that the BioBLU 0.3f supports the high agitation rates required for microbial applications. Te innovative liquid-free Peltier technology ensures that the temperature of the culture is precisely controlled, even with modern high cell density processes that generate extraordinarily high levels of heat.
A culture sparger According to Termo Scientific, its next-generation sparger technology sets new standards
B
for cell culture performance in its proprietary HyPerforma single- use bioreactor (SUB) BioProcess Container systems.
Cell growth is dependent on the availability of the right amount of oxygen in the bioprocess. Sparging controls the air and gas flow to create the optimal environment for cell growth. Termo’s new sparger is engineered to produce a consistent bubble size for predictable scale up and performance from the company’s 50l to its 2000l SUB. Te new dual sparger design consists of a micro- and macro-sparger integrated into the standard SUB BioProcess Container systems.
and dramatically increases CO2
“Tis new micro- and macro- sparge configuration is gentle on cell cultures at high gas flow rates, provides sufficient O2
delivery stripping capacity,” said
Millie Ullah, senior product manager for single-use systems at Termo Fisher Scientific. “Tis next-generation design sets a new standard of performance, flexibility, and ease of use during scale-up for all cell culture applications.”
Meanwhile Electrolab Biotech says its FerMac 310/60, 320 and 200 fermenter series of bioreactors are also ideal for microbial research.
Automation essential for batch predictability
ioreactor or fermentation processes are the core manufacturing process in the biotech industry. Implementation delays and process upsets can
result in the loss of millions of dollars in revenue through lost product and downtime. Automation helps companies using bioreactors or
fermenters as the key equipment in a manufacturing process achieve predictable execution of each batch. Whether a single vessel or large train, bench top or production scale, automation reduces project and production risk to achieve dependability in bioreactor operations. For bioreactor manufacturers, producing
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customised equipment and getting it quickly to the market is important to success in the biotechnology industry. Easy and predictable integration into a plant-wide
installation may set bioreactor manufacturers apart from the competition. To ensure dependable and consistent operation,
biotech companies need reliable control solutions that can be installed quickly allowing them to confidently manage the throughput and integrity of each batch Rockwell Automation enables OEMs to provide a
world class turn-key solution on their own or provide a turn-key bioreactor control solution.
To do this the company utilises its engineering
team, which has vast experience in life sciences implementations and validations, and which also can help reduce project and production risk while achieving reliability. Rockwell cites a number of benefits associated
with using this team, including: GAMP-4 methodology in design, implementation and testing provides a solution that is easily validated; design based on S88 methodology provides process flexibility, repeatability, and accountability; and it enables compliance with 21 CFR Part 11 requirements and, by validating production process and auditing, with IND and NDA/BLA approvals.
“Cell growth is dependent on the availability of the right amount of oxygen in the bioprocess. Sparging controls the air and gas flow to create the optimal environment for cell growth”
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