1 system description – K-Patents PR-23 for K-Patents User Manual

Page 9

The Pharma Refractometer

PR-23-AC with Laboratory Test

Cuvette LTC

2.1 System description

The system comprises of a Pharma Refractometer PR-23-AC unit, a Laboratory Test
Cuvette LTC, a computer for data logging and a microprocessor controlled thermostat.
A thermostatic water bath is used to accurate and reliable temperature regulation of the
liquid sample concentration in the Laboratory Test Cuvette during the off-line laboratory
measurements. With this temperature control system the temperature of the Lab Test
Cuvette test sample can be accurately adjusted and maintained.

2.2 Use of Laboratory Test Cuvette for validation and

sample testing

Any significant change in a process of making a pharmaceutical product is a regulatory
concern. Postapproval changes in the size of a batch from the pilot scale to larger or
smaller production scales call for submission of additional information in the application to
the Food and Drug Administration (FDA), with a specific requirement that the new batches
are to be produced using similar test equipment and in full compliance with GMPs and the
existing SOPs.

Manufacturing changes may also require new stability and dissolution testing. This is
especially true for equipment changes (change to equipment of a different design and
different operating principles) and the process changes (e.g. in mixing times and operating
speeds). The Laboratory Test Cuvette LTC with static sample feature can be used to further
study the sample characteristics. For instance the concentrations of the samples can be
tested in varied conditions, e.g. in accelerated, elevated temperature tests.

Also, the preparation of the laboratory pilot batch is required many times as an intermediate
step in a scale-up process. The Laboratory Test Cuvette LTC with the continuous sampling
feature is designed for testing samples in a laboratory pilot batch.

The benefit of K-Patents Pharma Refractometer with the Laboratory Test Cuvette is that it
allows the use of the same equipment in all test faces as well as in the full scale on-process
stage (see Figure 2.1).