Resources

Manuals

What the operating manual covers, what the qualification sequence looks like on a regulated site, and how to get the document itself.

What the OrionIR® manual covers

Unpacking, mounting and the tool-less 1/4″-28 flat-bottom connections to 1/8″ or 1/16″ tubing.
The one-hour warm-up before measurement, and why the instrument needs no cooling.
Running a background against a blank solvent, and importing up to three reference spectra in SPC format for live comparison.
The performance checks that tell you whether the instrument is within specification and whether the cell is clean.
Cleaning: 5–10 mL of a miscible, residue-free solvent, then air dry or flush with dry air, nitrogen or vacuum for at least ten minutes.
Export to SPC and CSV, and control over OPC UA.

How it works

Paeonia provides IQ and works with you on OQ and PQ. The Plant version under development uses EMA ICH Q7 as its GMP reference.

01

IQ — Installation Qualification

Components present, undamaged and connected; the system powers up and talks to the software; the environment meets the temperature, power and cleanliness requirements.
02

OQ — Operational Qualification

A two-hour warmed-up stability run with temperature logging, a wavenumber accuracy check against a known reference chemical, and the built-in diagnostics for drift and component health.
03

PQ — Performance Qualification

A chemometric model built on gravimetric mixtures or HPLC/UV-VIS reference values, then validated against known mixtures or offline comparison under representative process conditions. Recirculation loops with valves let standards be introduced directly, and the 0.1 mL void volume means very little sample is needed.

Datasheet

Tell us which instrument and which site, and we will send the current revision.

Say which framework you are working to and we will tell you what we can supply and what we cannot.