Particles in Parenterals
Im Auftrag der ECA Academy

Programm

Particles in Parenterals Conference

• Compendial Requirements: 100% visual inspection & AQL testing; PharmEur, USP, JP - similarities and differences
• News from the Annex 1 revison
• GMP Expectations: Manual inspection; Automated Inspection
• Risk Management Considerations

• 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 Hamburg.

• 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”

• Different scenarios will be covered such as:
• Re-inspection or additional inspection of “grey-channel” 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

• Standard machine vision particle detection use only three or four algorithms. Already available and used in multiple industries are powerful algorithms which start to give you more information about the particle that has been detected. Using real case studies it will be shown how these new tools are adopted in the most recent automatic visual systems.
• Present visions inspection systems that are used for CCI checking of vials work with 2D images which are analysed by the vision software. This can lead to false fails because the closure condition is extrapolated from a 2D image. Using more advanced 3D laser profiling results in more human like data available to make judgments. Example what crimp angle is optimal and how far have we crimped the vial. This data is available real time and speeds can match the fastest AVI available at present.

• A new technique for particle detection in LVP containers will be presented with very low bubble influence combined with detailed detection and monitoring of process related quality aspects for container integrity and cosmetic defects. Includes an outlook using the technique as an application for IV Bags.

• Preparation of defect sets
• Sensitivity / threshold studies
• PQ & Knapp-Test studies
• Training and qualification of MVI operators

• Implementation of the system: Qualification concept, Knapp studies & test sets
• Routine use of the system: AQL testing, Re-inspection, Re-validation of the system

• General requirements: USP 1790: Composition of test kits for training, qualification and routine; Inspection conditions (inspection time, illumination, etc.)
• Manual Inspection: Training and qualification of manual operators; Modified Knapp-Test
• Threshold study under different inspection conditions

• The final draft for comments of Annex 1
• Contamination Control Strategy
• New requirements on process simulation
• PUPSIT
• Container Closure Integrity requirements
• New expectations on Visual Inspection

• Observation at the AIM qualification
• Comments to the 5000 test
• Dealing with particles & complaints