The Therapeutic Goods Administration (TGA) requires from suitably qualified and experienced providers a HPLC System to support the physico/chemical analysis of biological medicines.

Biochemistry section requires a configurable and customisable HPLC system for analytical testing and evaluating of biological medicines, proteins and polysaccharides with focus on the quality attributes.

The proposed system requires:
A pump capable of delivering precise quaternary gradients and including an integrated solvent degasser
An auto-sampler
with a minimum injection volume range of 0.1 – 100 µL.
with demonstrated low carry over between injections.
with a sample compartment thermostatted from 4 – 40 °C.
that is compatible with standard 2 mL HPLC vials
A column compartment
With capacity for at least two 300 x 7.8 mm HPLC columns
Capable of temperature control from ambient to 80°C

Details for options such as active preheaters, column switching valves and cooling of column compartment should be provided.

Detectors
1) Options for a photodiode array detector (for each HPLC system) must be included. The detector should have:
* A minimum wavelength range of 190 - 600 nm
* A minimum wavelength accuracy of ±1 nm
* A minimum data sampling rate of 80 Hz (that is the max)

2) Options for one additional UV-Fluorescence detector must be included.
The detector should have:
Excitation range 200-1200 nm and emission range 200-1200 nm
Minimum 74 Hz data acquisition rate
Long life lamp (>4000 hr)

The systems must be integrated into an existing Waters Empower CDS environment. Software to perform Preventative maintenance and instrument diagnostics must be provided with the instrument (or details of how to perform PM in a Waters Empower CDS environment).