Disposable Technologies Implementation: Understanding and Managing Risks - In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to ma

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Disposable Technologies Implementation: Understanding and Managing Risks
In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.


BioPharm International
Volume 21, Issue 12

Aseptic Connectors

Millipore launched the Lynx ST 1-inch connector in May 2008, the only 1-inch steam-to-sterile connector available on the market. Sartorius has launched the OPTA SFT connector, which is available in sizes up to inch.

GE has rebranded its genderless connector as "Readymate" as part of its ready-to-process range. The connector is available in sizes up to -inch in a barb format and ⅝ inch with a miniature tri-clamp.

Sampling Systems

Several of Millipore's NovaSeptum components that have been available for sampling in stainless-steel systems are now available for use in Mobius single-use solutions. These components enable accurate volume sampling of disposable systems and sterile additions to stainless-steel systems, using a single-use fluid path.

Disposables for Freezing

Sartorius Stedim launched the Celsius FFT 6L, which combines the unique design of a flexible bag with an integral protective shell. The Celsius FFT 6L is specifically designed for freezing, thawing, and long-term frozen storage of biopharmaceuticals such as process intermediates and bulk drug substance. Celsius FFT is designed for use with common chest and upright freezers.

Sensors

Sartorius Stedim has launched single-use pH sensors to be used with Flexel 3D bags. These sensors are stored in wet conditions, are calibrated on line, have a measurement range of pH levels from 2 to 11 and accuracy according to calibration of 0.1 – 0.2.

Disposables for Fill–Finish

Sartorius Stedim has launched the Biosteam port, which is mounted on an autoclave with which it is sterilized so as to enhance stopper sterility assurance. Unlike Tyvek bags, single-use gamma irradiated Biosafe bags eliminate residual humidity. They also ensure safe aseptic transfer from the autoclave onto the filling line, avoiding the need for intermediate isolators.

Bosch Packaging technology has launched the PreVAS system, which is the first ready-to-use pre-assembled, prevalidated, and presterilized dosing system with scale-up capabilities from laboratory to high-speed commercial production. PreVAS is a positive displacement rolling diaphragm pump made of polycarbonate material with all of the hoses, connectors, and filling needles assembled as one unit which is then sterilized using gamma radiation and double bagged.

According to Bosch, the advantage of PreVAS over other disposable dosing systems is the positive displacement piston pump. Positive displacement ensures dosing accuracy over time, unlike other systems that tend to change and require constant adjustment.

The next Disposables Advisor technology roundup will take a more detailed look at market offerings for disposable mixing technology. We will examine the technical features of the various technologies and ask end-users who have worked with these systems for their feedback.

Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494 793 243,
Miriam is also the European chair of ISPE's Community of Practice for Disposable Technologies.

REFERENCES

1. Monge M. Production and economics of biopharmaceuticals. Bioprocess Int. Conference. 2008 SEPT. 23–26. Anaheim, CA.


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