Particles in Parenterals

Particles in Parenterals

Vienna, Austria

Course No 16047


This conference already took place.

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Gabriel Anderson, Novartis

Dr Martin Becker, Siegfried Hameln

Martin Dearden, PaxVax Berna

Dr Helmut Gaus, Boehringer Ingelheim

Markus Keller, Fraunhofer IPA

Felix Krumbein, Roche Diagnostics

Dr Stephen Langille, FDA

Dr Roman Mathaes, Lonza

Dr Tobias Posset, Roche

Dr Bernd Renger, Immediate Past Chair of the European QP Association

Marcel Uijlen, MSD

Dr Klaus Wuchner, Cilag


Main topic of this conference is the detection of particles in injectables and their evaluation during batch release and continuous process improvement. Besides the current regulatory requirements with regards to particulate matter, routine 100% inspection of injectables will be addressed. Manual inspection as well as automated inspection systems will be covered, including training, AQL testing, trending, inspection equipment and batch release considerations.


In most cases particles found in parenteral medicines will lead to a quarantined product or even to the recall of the product – as we have seen in the last years in the cases of several pharmaceutical companies. Responsible staff in charge will have to start root cause analysis to find the source of the particles and will have to do an evaluation of batches already shipped.

There is still confusion within the global pharmaceutical industry with regard to the requirements for testing for visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. But still, lots of questions arise, e.g. concerning re-testing, detection capabilities and revalidation of inspection systems.

Furthermore there has been a recognisable trend towards automated inspection machines throughout the last years. The challenge for pharmaceutical companies is to find a suitable machine for their products and to determine reasonable inspection parameters during qualification and validation. But also during routine process there are questions arising like re-testing and the usage of test-sets, doing AQL Testing as well as the adjustment of parameters of the vision systems.

We will address those topics during the conference and discuss and answer questions on

  • The latest compendial requirements concerning particulate matter
  • FDA’s expectations on visual inspection
  • Threshold studies and validation of detection limits
  • Training in the manual visual inspection
  • Trending and monitoring of visual inspection data
  • Limitations of the AQL test
  • Re-inspection of defect fractions
  • Different validation approaches for automated inspections systems
  • Operation of automated system
  • Handling of inspection observations & findings
  • Particle analysis and identification

Target Group

This conference is directed at specialists and executives from sterile operations, that is manufacturing, quality assurance and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this conference.


The Participants of the Particles in Parenterals Conference receive the current version of ECA’s Best Practice Paper on “Visual Inspection” for free!


Regulatory Requirements for the visual inspection of parenterals

  • Compendial Requirements: 100 % visual inspection & AQL testing, PharmEur, USP, JP - similarities and differences
  • GMP Expectations : Manual inspection, Automated Inspection
  • Risk Management Considerations
Presentation and discussion of the ECA Best Practice Paper on Visual Inspection
The best practice paper has been originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. The first version of this paper has been published in September 2014 in Copenhagen. It has gained a broad acceptance in the industry afterwards. The current version as well as planned updates will be explained and discussed in Vienna.
FDA’s current thinking on particles and testing of parenterals
  • A summary of recent recall data due to visible particulates
  • The FDA’s take on AQL testing
  • Training and qualification of visual inspection staff
  • Automated inspection validation
  • A lifecycle approach to visible particle inspection and control
Particles in Parenterals: Methods for the root cause analysis
  • Isolation of single particles
  • Analysis of particles using FTIR, REM-EDX, and ICP-MS
  • Usage of witness-wafers
  • Intrinsic particles and their origin
  • What can we learn from aerospace research.
  • Examples
Qualification in manual visual inspection in a multi-product environment
  • Defects and defect categorisation in the manual visual inspection of vials and ampoules
  • Composition and qualification of test sets
  • Initial qualification of human inspectors
  • Bracketing of products in the context of the qualification of human inspectors
  • Requalification and continuous evaluation of the inspectors performance
  • Maintaining the qualified state of the test sets
Validation of an Automated Inspection System - Alternative Ways for the 5000 Test
  • General requirements: Requirements of the Pharmacopeia, Defect categorisation. Test kits for training, qualification and routine
  • Manual Inspection: Training and qualification of manual operators, Standardisation of working conditions, AQL in the manual inspection
  • Automated inspection: Setup of the vision system, Qualification of the machine in 3 steps, Detection verification using probabilistic models (i.e. Knapp-Test / Particle-Qualification-Kit), Detection verification using fixed detection rates (i.e. Standard-Defect-Kit), Man-machine-comparison during production run (test of 5000), Alternatives for the test of 5000
  • Others: System-Suitability-Test, requalification and revalidation
Visual Inspection and Health Authority Expectations & Observations
  • Observation at the AIM qualification
  • Comments to the 5000 test
  • Dealing with particles & complaints
Particle testing and the correlation with trending and Batch release
  • Why do we Monitor (What is it all about)
  • Data and Measurement
  • The AQL trap
  • Improvement Process Map
  • Investigation and Routine Analysis,
  • Release Process. “To AQL or not to AQL that is the Question”
  • Product Release: “Falling off a log”
Particles in Biotech Parenteral Products
  • Particles are a major challenge in the development, manufacture and analysis of Parenteral Products
  • The Pharmacopeias and guidances aim towards minimizing visible particulates, yet, the requirements not easy to translate into everyday practice
  • Particles can come from different sources and USP has suggested a categorization with particles being extrinsic, intrinsic or inherent, yet, clinical relevance and safety of these would not be necessarily different and identification is often not unambiguous
  • This talk aims to discuss approaches and practicality and industry perspective on Visible Particles in Parenteral Products containing active ingredients derived by recombinant manufacture (biologics)
Threshold testing between inspection method development and setup of a qualification set
  • Concepts for planning threshold tests
  • How to design the test to be representative for routine manufacturing conditions
  • Transformation of a threshold test into a qualification set
  • Other good use of threshold test (results)
(Re-) inspection of parenteral products
Different scenarios will be covered such as:
  • Re-inspection or additional inspection of “grey-chanel” units from (semi-) automated inspection
  • Re-inspection in case of exceeding alert limits or AQL failures
  • Focused re-inspection
  • Inspection approaches in case of investigations due to unexpected particles (e.g., to determine frequency of occurrence of visible particles when particles are found during release/stability testing
Development of a tool for determining the criticality of particles
  • Defining the appropriate AQL level for specific particles

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