24 August 2023

Particle Size Distribution vs. Data Integrity?

Although analytical sieving is the most common test in IPC labs to determine the particle size distribution of powders and granulates, recording multiple weight measurements and protocolling all steps has remained a complicated and error-prone process.

Particle Size Distribution (PSD) affects several key properties of a drug product, including its flowability, compressibility, and dissolution rate. Therefore, particle size distribution is a critical quality attribute that must be controlled during the develpment and manufacture of many drug products. The most common test method is 'analytical sieving' using a shaker / agitator and an analytical balance. This method is described in the relevant harmonised pharmacopoeias as "analytical sieving":

  • USP <786>: Particle Size Distribution Estimation by Analytical Sieving
  • Ph. Eur. 2.9.38: Particle Size Distribution Estimation by Analytical Sieving

Performing the test requires strict execution of a defined sequence of process steps by the operator – including recording multiple weight measurements, protocolling the serial numbers of all sieves used during the test, writing down meta data such as date and time per step executed, calculating the net weight per sieve by transcribing results into Excel, and signing the final report. In a nutshell: a manual, cumbersome, and error-prone process with questionable data integrity.

Sounds familiar? Then q-doc® software may be just what you need to make your particle size distribution process easier and compliant. Operators are guided step-by-step through the complete process and weight measurements are recorded automatically. Use q-doc® to protocol all steps performed and forget about manual transcription. A standard report is automatically created at the end of each test. Just like other tests performed using q-doc®, all results can be consolidated into one batch record and/or transferred to your LIMS or MES system if needed.

Today, various tests in IPC labs typically require a high level of manual recordings and transcriptions. Save time, reduce costs and improve data integrity with q-doc® to get one step closer to achieving a paperless lab, where processes are electronically documented and data flows seamlessly (digitally) without the need of reformatting between paper journals and computerized systems.