In
the highly regulated manufacturing environments Betatek services,
such as Pharmaceutical and Food, it is necessary to supply instrumentation
which is validatable. Betatek, with our high level of expertise
and our close association with our suppliers and customers, offer
a complete range of validation options to suit your needs and budget.
In many cases we wrote and developed these packages in house.
The software we supply is 21 CFR Part 11 compliant where applicable.
Our packages cover the installation
(IQ), operation (OQ), and in some cases performance (PQ) qualification.
Our product offering in this area varies depending on your needs.
We can supply only the documentation or we can provide the full
service where a trained representative from Betatek can perform
the entire IQ/OQ.
Below you will find a partial list of
instrumentation for which we offer validation:
| Instrumentation |
Documentation |
Performance |
| Distek
Model 2100C-Dissolution Test System |
X |
X |
| Distek
Model 5100-Waterless Dissolution System |
X |
X |
| Distek
DS4300 Dissolution Autosampler |
X |
X |
| Betatek
Automated Dissolution System |
X |
X |
| Powers
& Percival Stability &
Photostability Chambers |
X |
X |
| Schleuniger-8M
Tablet Hardness Tester |
X |
X |
| Schleuniger-AT4
4-Way tester, TM-200 Cap
Torque Tester |
X |
X |
| Schleuniger-Schleuniger
Testlink |
X |
X |
| Microtrac
Particle Size Analyzer |
X |
X |
|
ThermoSpectronic UV-VIS Spectrophotometer |
X |
X |
| Stony
Brook Falling Needle Viscometer |
X |
X |
| Plus
more.............................. |
X |
X |
|
