The Particulate Identification Database Solution

Particulate Databases as a Critical Need

Sourcing foreign particulate matter in the pharmaceutical, medical device and cell/gene therapy industries is critical for remediation of a contamination issue. Understanding what the foreign material is composed of is only half of the equation; taking the next step to understanding where in the manufacturing process the material was introduced is the other half. Reference databases catalog data and information for known materials, process and product related materials, and archived foreign particulate. In a simple process with few particulates and few reference materials, a hard copy catalog with pictures and spectra may suffice. However, for operations that generate numerous particulate with many lots and products, digital data storage is key to an efficient particulate characterization program. Reference databases can contain optical information, spectral files, chemical data and important information associated with non- conforming particles. This allows for mining of data, to aid in comparison to known materials, as well as to determine common lots, facilities, times, or any other information that may foster root cause analysis. Digital data management systems fall within the overall compliance strategy of the organization.

Key To Particle Contamination Management Lifecycle

The inspection, detection, characterization and source determination of foreign particulate matter in parenteral drug products is a critical aspect to the drug manufacturing process. Methodologies exist to address many of these phases. However, a cohesive program is vital to any parenteral drug manufacturer to manage the entire particulate management lifecycle. The main phases of a thorough
particulate management lifecycle includes process and product QBD initiatives, visual inspection, detection of foreign particulate, laboratory analysis, source determination, impact and future remediation. The methodologies implemented in these phases directly impacts the overall quality system as it relates to foreign particulate investigations. Understanding of an overall particle management lifecycle approach and introduction to supporting methodologies and particle characterization strategies is imperative to proactively manage particle studies and non-conformance investigations. The Particle ID Database enables manufacturers, quality control engineers, scientists and investigators to leverage this knowledge in one cohesive program.

Sample information and easy to use data input allow for simple logging of samples and searching.

Fields can be utilized to your needs to designate pertinent information.

Complete Particulate Database: Analysis, Comparison, Reporting.

A Robust Data Management System

A Particulate Characterization Database enables the user to compile, store, search and mine analytical data to optimize processes for foreign particulate and materials investigations. The ability to create internal known laboratory reference collections or utilize existing commercial databases adds significant value to an investigation. All manufacturing environments contain a variety of product, process and environmental sources. A robust data management system is critical to efficiently access the variety of materials needed to accurately identify the source of foreign materials.

Critical Industries for Foreign Particulate Characterization

  • Pharmaceutical
  • Medical Device
  • Cell and Gene Therapy
  • BioPharmaceutical
  • Drug Research and Development
  • High-Technology Manfacturing
  • Forensic Analysis

Key Functions

  • Searchable
  • Custom Reporting
  • Data Comparison
  • Spectral Comparison
  • Spectral Overlay
  • Customizable
  • Easy Data Upload