Validation Services

Many of the vendors that Betatek represents specialize in manufacturing instrumentation designed primarily for highly regulated industries, including pharmaceutical and food. These instruments are specifically designed to be validatable.

Betatek has years of experience working in concert with our manufacturers and customers, offering a complete range of validation options to meet your needs and your budgets. We can also supply, were appropriate, software which is validatable and compliant with 21 CFR Part 11.

Our packages cover the installation (IQ), operation (OQ), and in some cases performance (PQ) qualification. Depending on your needs, we can supply documentation only, or a complet validation package. A trained representative from Betatek or one of our suppliers, can perform the entire IQ/OQ.

A partial list of instrumentation for which we offer validation includes:

• Distek Model 2100C-Dissolution Test System
• Distek Model 5100-Waterless Dissolution System
• Distek DS4300 Dissolution Autosampler
• Betatek Automated Dissolution System
• Powers & Percival Stability & Photostability Chambers
• Schleuniger-8M Tablet Hardness Tester
• Schleuniger-AT4 4-Way tester, TM-200 Cap Torque Tester
• Schleuniger-Schleuniger Testlink
• Microtrac Particle Size Analyzer
• Thermo Spectronic UV-VIS Spectrophotometer
• Stony Brook Falling Needle Viscometer

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