Handling of Foreign Particles in APIs and Excipients
Im Auftrag der ECA Academy

Handling of Foreign Particles in APIs and Excipients Im Auftrag der ECA Academy

Berlin, Germany

Seminar Nr. 16954


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Dr Rajnish Chhabra, QAR Solutions, The Netherlands

Jörg Gampfer, Hovione, Portugal

Martin Melzer, Chemgineering, Germany

Peter Mungenast, Merck KGaA, Germany

Dirk Overrödder, Cilag, Switzerland


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 pharmaceutical excipients is a topic of great interest and of 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 and excipients customers.

Particles have always been present in APIs and excipients but guidance from health authorities (EMA, FDA, others) or Pharmacopoeias (e.g. EP, USP) about particles is very limited. The APIC Guidance on Insoluble Matter and Foreign Particles in APIs and the IPEC Guide on “Technically Unavoidable Particle Profile (TUPP) are the only best practice documents so far providing guidance for a standard approach towards an appropriate control of foreign particles in APIs and pharmaceutical excipients.


This course addresses to employees and senior staff of pharmaceutical companies and manufacturers of APIs and excipients The course is of particular interest to all those working in quality assurance, Quality Control, production and purchasing departments.


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
Foreign Matter in pharmaceutical Excipients – how to deal with “Technically Unavoidable Particles” (TUPs)

Incident management – how to identify the source of insoluble matter
  • 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
Good practices to minimise the presence of particles in APIs – key preventive measures
  • 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
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
How can routine cleaning procedures detect or minimize the presence of particles in API production?
  • Guides and Industry Standards regarding cleaning
  • Equipment cleaning
  • Production environment cleaning
  • Equipment design considerations
  • Detection/removal methods of particles
  • Preventive measures
Foreign Particles in Excipients and Finished Product Quality and Safety
  • Contamination Profile of Excipients meets Finished Product Quality Target Product Profile
  • Excipient Process Risk Analysis and TUPP/ Particulate Contamination Profiling


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