What's New?
Steve Kuwahara has become an advisor to  
Marathon Products and a consultant to their
customers. Marathon Products manufactures
temperature recording data loggers that are highly
versatile and small enough to be used in many
locations. Their microdl device has a wide dynamic
range that makes it suitable for use at freezer
temperatures and at room temperature. Ultra low
temperature devices are also available. The device
may be used to monitor shipments and also to
monitor the temperature distribution in incubators
and warehouses.
The microDL can also come with a remote (RfD)
monitoring feature that reduces the leg work in
monitoring large spaces. Steve finds these devices
ideal for Cold Chain Management and Environmental
Monitoring of facilities.
Because of their size, they can also be used to
monitor temperatures inside of various
configurations of loads in incubators and
environmental chambers, without the need for
multiple probes an extensive wiring.

Contact Marathon Products for more information on
their device and contact us for consulting services
on performing shipping and other validations using
these devices.
STEVE LOOKS FORWARD
TO WORKING WITH YOU
AND DEALING WITH YOUR
GMP-RELATED QA/QC
PROBLEMS.

To provide you with things
to think about he has
provided the items below.

An appetizer for the mind.  
A Tutorial
The MicroDL shown between two Wisconsin
quarters. The device is 1.2 cm thick with a diameter of
2.8 cm
In addition to our usual services related to the GMP
and GLP of Drugs and Biologics, we are now
working in the area of nutraceuticals. In particular,
we are now familiar with the Draft GMP for Nutritional
Supplements that will appear as 21 CFR 111.

We have specific expertise in the areas of quality
control and quality assurance. Quality Control
laboratory operations and analytical methods for
biologicals have long been a primary activity.

With over 30 years of experience with drugs and
biologics, we can assist our clients in all areas of
compliant manufacturing and testing.
We provide training in GMPs and areas related to
GMPs, operations and techniques for the QC
Laboratory, and basic laboratory statistics.
Assessments in the form of Quality Audits of your
facilities and activities or those of your suppliers and
contractors are another specialty
Visit us again.

This site will be periodically updated with new
mental appetizers and tutorials.

See the links.
GXPBioTechnology is a
consulting firm founded by
Steven S. Kuwahara, Ph.D.
GXPBIOTECHNOLOGY LLC
BACKGROUND DATA
Working Regulations
Steve Kuwahara's Bio
We work with the following:
21CFR58, draft 21CFR111,
21CFR210 & 211,
21CFR312 & 314,
21CFR600 & 610,
21CFR820, 21CFR1270 &
1271.
With over 30 years of experience with drugs and
biologics, we can assist our clients in all areas of
compliant manufacturing and testing.