Big data collection in pharmaceutical manufacturing and its use forproduct quality predictions

Abstract

Measurement(s) Incoming raw material quality (particle size distribution, water content, impurities level, residual solvents, pH) • In process control measurements of tablet core and film coated tablets (weight, thickness, diameter, hardness, yield of a process) • Final medicine quality on a representative sample of film coated tablets (drug release in defined time, active ingredient content, impurities level, residual solven content) • Process time series of selected tablet compression parameters (every 10 s of the compression process) Technology Type(s) Laboratory based analysis (particle sizer using laser diffraction, loss on drying method, HPLC method, GC method) • Automatic IPC check machine (combining balance, hardness, thickness and diameter measurements) • HPLC (High performance liquid chromatography), GC (gas chromatography) • Tablet compression machine calibrated sensors for the following main parameters: main and pre-compression force, fill depth, cylindrycal height, ejection force, number of wasted tablets. Factor Type(s) batch • code • strength • size • start • api_code • api_batch • smcc_batch • lactose_batch • starch_batch • api_water • api_total_impurities • api_l_impurity • api_content • api_ps01 • api_ps05 • api_ps09 • lactose_water • lactose_sieve0045 • lactose_sieve015 • lactose_sieve025 • smcc_water • smcc_td • smcc_bd • smcc_ps01 • smcc_ps05 • smcc_ps09 • starch_ph • starch_water • tbl_min_hardness • tbl_max_hardness • tbl_av_hardness • tbl_min_thickness • tbl_max_thickness • fct_min_thickness • fct_max_thickness • tbl_min_weight • tbl_max_weight • tbl_rsd_weight • fct_rsd_weight • fct_min_hardness • fct_max_hardness • fct_av_hardness • tbl_tensile • fct_tensile • tbl_yield • batch_yield • time series: tbl_speed • time series: fom • time series: main_comp • time series: tbl_fill • time series: SREL • time series: pre_comp • time series: produced • time series: waste • time series: cyl_main • time series: cyl_pre • time series: stiffness • time series: ejection Sample Characteristic - Organism Selected medicine Sample Characteristic - Environment manufacturing process Sample Characteristic - Location Pharmaceutical industry