Particles in Parenterals

Particles in Parenterals

Barcelona, Spain

Course No 15266


This conference already took place.

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Dr Martin Becker, Siegfried Hameln

Martin Dearden, PaxVax Berna

Dr Helmut Gaus, Boehringer Ingelheim

Al Goodwin, Amgen

Dr Dana Guazzo, USP

Dr Stephen Langille, FDA

Sunao Murai, Chugai Pharmaceutical

Dr Tobias Posset, Roche

Dr Heino Prinz, Rommelag AG

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

Dr Christoph Stark, Novartis

Marcel Uijlen, MSD


Main topic of this conference is the detection of particles in injectables and their evaluation. 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 2012, 2013 and 2014 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
  • Trending and monitoring of visual inspection data
  • How to set up a robust vision system
  • Re-inspection of defect fractions
  • - Operation of automated system from qualification to routine
  • - Reducing the particle load coming from process and packaging materials
  • - Inspection of plastic/BFS containers

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
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 life-cycle approach to visible particle inspection and control
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 Barcelona

Re-inspection of defect fractions - statistical evaluation
  • Mathematical description of inspection processes
  • Strategies for reinspection of defect fractions
  • Acceptance criteria for reinspection of defect fractions
  • Statistical evaluation
  • Design of the reinspection processes
Particle Testing and the interaction of production and QA
  • Monitoring and Trending
  • Improvements
  • Release process
Case Study MSD: Qualification/Validation of an automated system and routine operation
  • Training/Development test set
  • Qualification test set
  • Daily set up test set for automated system
  • Creating defects
  • Process Control Limits
In-line automated visual particle inspection of "Blow Fill Seal" containers for injectable drug products
A case study for line integration and validation in combination with related threshold studies
In this presentation a new 100% particle inspection machine at full production speed is presented along with real time case studies for line integration and threshold studies of current pharmaceutical products. It highlights also the benefits of this inspection process in relation to sensitive products like proteins or highly foaming liquids, which usually are disliked by machine vision inspection. Also a validation approach using threshold studies from human inspections based on a Knapp test approach as well as the related pseudo Knapp test results are presented.
Reduction and identification of particles
  • Handling of the particle load within the production area
  • Projects to reduce visible particles
  • Analytics and identification of visible particles
  • Example: particles on stoppers - analytic-limits and requirements
Case Study Amgen: How to set up in-line and desktop AVI systems
Summary of in-line AVI systems with focus on detection capability
Desktop AVI systems and where they can be used
Qualification of a desktop AVI system
One future roadmap for Automatic Visual Inspection
Quality requirements for injections shipped to the Japanese market
  • Japanese sensitivity for qualities of general and pharmaceutical products
  • General requirements for cosmetic qualities by Japanese medical agencies
  • Requirements for direct container suppliers by Japanese pharmaceutical companies
  • Requirements for qualities and production/inspection control by Japanese pharmaceutical companies/authorities/pharmacopeia
  • Control of packaging materials: Visual inspection of glass containers
    • Avoiding particles and other defects during glass manufacture
    • IPCs and final quality tests the suppler site
    • Vision Systems, machine setup and specifications

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