Handling of Foreign Particles in APIs

Handling of Foreign Particles in APIs

Barcelona, Spain

Course No 15869


This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org


Nils Dickfeld, Meliscout, Germany

Jörg Gampfer, Hovione, Portugal

Peter Mungenast, Merck KGaA, Germany

Dirk Overrödder, Cilag, Switzerland

Luisa Paulo, Hovione, Portugal

Jordi Ruiz-Combalia, Spain


During this course all relevant aspects regarding the control of particles in APIs will be discussed. You will learn

  • How potential sources of insoluble matter can be identified
  • Which acceptance criteria for particles can be applied
  • How good practices to minimise the presence of particles in APIs can look like
  • What has to be considered regarding control of particles during plant and equipment maintenance and cleaning
  • How particles in Raw Materials and Packaging Materials can be minimised or avoided


Visible particles, insoluble particles or matter or foreign particles in Active Pharmaceutical Ingredients (APIs) and related intermediates is a topic of great interest and importance to the pharmaceutical industry.

A number of inspectional observations from various Regulatory Authorities related to visible particles in Drug Products and APIs has risen considerable concern. Moreover inappropriate methods of investigation, controls and preventive and corrective actions were all subjects of citations by authorities and observations by API customers.

Particles have always been present in APIs but guidance from health authorities (EMA, FDA, others) or Pharmacopoeias (e.g. EP, USP) about particles in APIs is very limited. The APIC Guidance on Insoluble Matter and Foreign Particles in APIs is the only document so far providing guidance for a standard approach towards an appropriate control of foreign particles in APIs.

Target Group

This course is designed for all persons involved in the manufacture of APIs. In particular, the seminar will be of interest to personnel from Quality Assurance, Quality Control and production.


Particles and insoluble matter in API manufacturing: why is it a topic of great interest?

  • Definition of particles
  • Types of particles
  • Possible reasons for the elevated presence of visible particles
  • Hints in guidances on how to deal with visible particles
  • Inspectional observations
  • Expectations of API manufacturers, API users, API suppliers and supervisory authorities regarding visible particles in APIs
Analytical control methods for particle detection and identification
  • General conditions: design of an appropriate sampling process
  • Application of different inspection techniques: filter test, visual inspection etc.
  • Metal detectors, metal separators
  • Weighing and/or visual inspection of pieces of equipment
  • Periodic review of security sieves and/or filters
Incident management
  • Potential sources of insoluble matter
  • Root cause analysis – examples of investigation techniques and aids
  • Risk assessment: topics to be considered during the investigation/disposition decision
Acceptance criteria for particles in APIs
  • Types of dosage forms and routes of administration
  • Typical limits for particle size seen via a filter test
  • Proposal for limits
  • Typical construction materials in API manufacturing plants as source of particles
  • Effective cleaning procedures
  • Pretreatment of equipment/product contact utilities
  • Inspection of equipment before and after production
  • Cleaning after repairs
  • Essential written procedures covering maintenance and cleaning procedures Environmental conditions during open handling in final stages of API manufacturing
  • Effective training of operators
How can routine cleaning procedures detect or minimise the presence of particles in API production
  • Routine cleaning activities to reduce cross contamination and particle contamination
  • Pretreatment of the equipment train before use
  • Rinsing of the equipment to detect particles
  • Inspection of equipment before and after production
  • Cleaning after repairs
  • Cleaning of packaging materials (drums, IBCs)
Case Study:
Automatic detection and removal of visible foreign particles in APIs

  • Foreign particles removal in powders and granules
  • Types of foreign particles materials
  • Concept of automated foreign particles detection and removal
Particles in Raw Materials and Packaging Materials
  • Potential particles in raw materials/packaging materials
  • Standard checks by QC
  • Qualification of raw materials suppliers
  • Communication with suppliers

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