Equipment and Processing Report
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.
Disposable bioreactor provides operational flexibility
EMD Millipore’s (Billerica, MA) Enhanced Mobius 3L CellReady single-use bioreactor includes additional features intended to enhance its operational flexibility. The unit’s headplate now incorporates a septum injection port for small-volume additions. The bioreactor also incorporates a subsurface fluid inlet–outlet port appropriate for operations such as perfusion, sampling, cell retention, and inoculation. In addition, the Enhanced CellReady bioreactor includes a sensing port for monitoring parameters such as carbon dioxide and viable cell density.
The CellReady 3L bioreactor exhibits cell-culture performance and physical-characterization properties (e.g., kLa values, heating profiles, and mixing times) similar to those of traditional glass bioreactors. EMD Millipore manufactures the device with lot-to-lot consistency to reduce the risks of improper assembly and help bring consistency to customers’ processes. The unit’s results can be scaled up to 15-L glass and 2000-L stainless-steel systems. The fully assembled, gamma-irradiated bioreactor has been designed to work with most existing benchtop bioreactor controllers.
Instrument performs many filter-integrity tests
The Sartocheck 4 plus instrument from Sartorius (Goettingen, Germany) performs a battery of filter-integrity tests such as diffusion, bubble point, diffusion–bubble point, water intrusion, water flow, customer-specific bubble point, customer-specific diffusion, and multipoint diffusion. The operator can select the test program manually or use a barcode reader to enter data into test programs. When the operator scans a filter’s barcode, the instrument recalls the appropriate test program for that filter automatically. The tester can connect to a network and exports results as PDF files that can be shared easily with other data systems.
In addition, operators can prompt the tester to clean itself automatically in about an hour. Users add cleaning solution into a separate vessel, and the tester cleans, rinses, and dries its entire pneumatic path. Operators thus do not need to send the instrument to the manufacturer for cleaning, and this feature reduces downtime and cost.