Biomedical Engineering Reference
In-Depth Information
Single-use pressure sensing allows for rapid changeover of product contact
parts in both development applications and especially in early phase clini-
cal manufacture. For example, single-use pressure sensors from PendoTECH
were designed to enable pressure measurement with single-use assemblies
that have flexible tubing as the fluid path. These single-use pressure sensors
are gamma compatible (up to 50 KGy), and the fluid-path materials meet USP
class VI guidelines and are also compliant with European Medicines Agency
(EMEA) 410 Rev 2 guidelines.
On a single-use bioreactor, a sensor can be installed on a vent line to mea-
sure headspace pressure. Even though the sensors are qualified for use up
to 75 psi, the core sensor is accurate in the low-pressure range required for a
single-use bioreactor.
A better solution with respect to ease of operation and compatibility are
disposable pressure sensors, which are now available on the market. The
single-use sensors from PendoTECH (
www.pendotech.com
)
can be used
with tubing of various sizes (0.25 in. to 1 in. in diameter) and can be gamma
radiated with tubing and bag assemblies. They are the alternative low-
cost solution for use with tubing and bioprocess containers to the existing
stainless steel pressure sensors on the market. Available in caustic-resistant
polysulfone so they can be in-line during caustic sanitization processes.
The pressure sensors can be integrated for pressure measurement and con-
trol with a PressureMAT™ System (monitor/transmitter) or PendoTECH
Process Control System and depending on the number of sensors and pro-
cess requirements. The data collected by these systems can be output to
a personal computer (PC) or another data monitoring device. They also
can be integrated into other prequalified third-party pumps and monitors
(adapters for phone jacks can be made). The pressure sensors are very accu-
rate in the pressure ranges typically used with flexible tubing and dispos-
able process containers, and are qualified for use to 75 psi. Applications
include multistage depth filtration, tangential flow filtration (TFF)/cross-
flow filtration, and bioreactor pressure monitoring.
NovaSensor's NPC-100 (
www.ge-mcs.com
) pressure sensor is specifi-
cally designed for use in disposable medical applications. The device is
compensated and calibrated per the Association for the Advancement of
Medical Instrumentation (AAMI) guidelines for industry acceptability.
The sensor integrates a high-performance, pressure sensor die with tem-
perature compensation circuitry and gel protection in a small, low-cost
package.
The SciPres (
www.scilog.com
) combines pressure-sensing capabilities
and the convenience of disposability with easy setup. Each sensor is pre-
programmed and barcoded with a unique ID for easy traceability and
data documentation when combined with the SciLog SciDoc software.
Factory calibration data is also stored on each sensor's chip for out-of-box,
plug-and-play use. The SciPres comes in five different sizes to fit a variety
