PDA EU00186 How to Handle Test Sets in Visual Inspection

Markt Schwaben, Germany
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Program Highlights

This two-day training course will take place at Körber Pharma Inspection.

Visual inspection test sets are essential for operator qualification and validation of a visual inspection systems to be compliant with all pharma regulations, GMP requirements, and company specific quality standards.

As test sets are individually designed and developed based on the product specifications as well as the manufacturing processes, no “one-size fits all” solution is possible. Its variability regarding size, content, and purpose makes management along the life cycle of a test set even more difficult. Starting from the creation of a test set to the vision evaluation up to the correct application along the manufacturing process reflects the high level of complexity.

This training course will take place at the Körber Pharma Inspection Site in Markt Schwaben, Germany. In order to fully understand the “why do I need”, “when do I need”, “what do I need” combined with “how do I create”, “how do I apply”, and “how do I manage” a test set, experts will share their expertise based on best practices and years of experiences within the pharmaceutical industry.

    Learning Objectives
  • Understanding compliant VI test set design, qualification, and lifecycle management: purposes, process, and applications
  • Understanding the current regulatory expectations and quality risk management of VI and particle control
  • Understanding the different types of defects and their potential impact on quality
  • How to develop a test kit for the visual inspection (risk analysis, what defects should be included)
  • How to build up a test kit for the visual inspection (practical introduction)
  • How to handle a test kit (shelf life, storage and more)
  • Hands on experience on manual & automatic inspection
  • The importance of a defect sample set for an AVI project
  • How to handle DIP on AVI

Standard Pricing

Standard Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 13 February 2024

9:00
Welcome & Introduction of Trainers and Participants

9:15
1.1 Introduction to Test Sets for Manual Visual Inspection

  • What is in principle a test set?
  • Why do we need test sets?
  • When should a test set be created?
  • Overview of agenda of the training course
    • naming the different types of test sets covered in the course
    • main purpose
    • timing when this type of test set will be covered during the course
  • Distinction of test sets required for visual inspection from test sets required for CCI testing

9:45
1.2 Purposes of Test Sets and Background to the Test Set Qualification Process

  • 100% VI and AQL
  • QC testing (e.g. stability)
  • Generation of supportive data for quality investigations/ Inspection support - justification of qualification process and control system

10:15
Coffee Break

 

10:45
1.3 Design of Test Sets

  • Introduction into a flowchart that has all the necessary steps to decide on the design of the test set (the flowchart should be one of the main course deliverables)
  • Why do I need a risk assessment?
  • How do I perform the risk assessment?
  • What must the test set look like?
  • Which primary packaging do I have in the facility?
  • Which particle sources do I have in the facility?
  • Which product defects do I regularly see in the facility?
  • Which defects must be included in my test sets?
    • Relevance to quality investigations: criteria for assessment of the criticality of quality events
      • Frequency of occurrence
      • Typical vs Atypical
    • Relevance to QC testing
    • Introduction into US FDA classification
      • Intrinsic
      • Extrinsic
      • Inherent
  • Generic vs. product-specific test sets

11:45
1.4 Particles and Defects

  • Overview of types of particles
    • Spherical particles (balls)
    • Irregular glass fragments
    • Adhering particles
  • Overview of other defects
    • Container defects (Cracks, Scratches, Leaking)
    • Stopper defects
    • Cap defects or crimping defects
    • Contaminations (inside outside)
    • Solution defects
  • How many containers must be included in the test set?
    • “Defect-free” containers
    • “Defective” containers
  • What must my associated defect library look like?
    • Types of defects
    • Sizes of defects
    • Major defect
    • Minor defects
    • Critical defects
  • Which classes of defects must be included in the test set?

12:15

1.5 Introduction to Test Sets for Automated Visual Inspection

  • How to handle test sets during a project?
  • Test set for validation of automated visual inspection machine including AVI development test set
  • Test set for daily performance check of automated visual inspection machine
  • Knapp test set

12:30
Lunch Break

 

13:30
1.6 Tour to the Körber Vision Laboratory

Vision evaluation of a test set, step by step

  • Check test set for completeness
  • Visibility of defects
  • Mechanical set up for test set evaluation
  • How do particles behave
  • Definition of camera stations and illumination for AVI
  • Creation of vision configuration for AVI, based on test set
  • Definition of detection rate & false eject rate of AVI

15:00
Coffee Break

 

15:30
1.7 Special Test Sets - What Do They Need to Look Like? 

  • Lyophilized products
  • Difficult to inspect products
      • ATMPs
      • Colored glass containers
      • Emulsions
      • Suspensions
      • Turbid liquids
  • Substitute solutions versus real product

16:00
1.8 Technical Considerations on Test Sets for Difficult-to-Inspect Products

  • Small volume and large volume containers
  • Lyo containers
  • Infusion bags
  • Solutions with turbidity
  • Colored solutions
  • Colored containers
  • Solutions with high viscosity

16:30
1.9 Challenges of Difficult to Inspect Products for Automated Visual Inspection

  • Products prone to air bubbles
  • Foaming products
  • Highly viscous products
  • Toxic products
  • Lyophilized products
  • Emulsions / Suspensions / Turbid liquids

17:00
Wrap up training course day 1

17:45
End of Training Course Day 1

from 18:30
Get-together

Day 2

Wednesday, 14 February 2024

09:00
What Are Your Practical Challenges with Test Sets?

09:10
2.1 Challenges from a Pharma Perspective

  • Syringes/cartridges with sticky particles (due to siliconization)
  • Glass defects in tubular glass containers vs molded glass containers
  • Highly viscous products
  • Toxic products
  • Foaming products
  • Air bubbles in product

09:20
2.2 Challenges from a Laboratory Perspective

  • Syringes/cartridges with sticky particles (due to siliconization)
  • Glass defects in tubular glass containers vs molded glass containers
  • High viscose products
  • Toxic products
  • Foaming products
  • Air bubbles in product

09:40
2.3 Challenges from the Machine Supplier’s Perspective

  • Sticking/floating particles
  • Glass defects in tubular glass containers vs molded glass containers
  • Large volume containers
  • Low fill products
  • Unstable containers
  • Overlapping needle shield
  • Amber glass

10:00
Coffee Break

 

10:30
2.4 Lifecycle Management of Test Sets

  • Required data and documentation:
    • Certificate of manufacturing (expected characterization data)
    • Qualification report
    • Training certificates
  • Lifecycle management:
    • Storage and shelf-life
    • „Disappearing“ defects
    • Replacement of units
    • Re-qualification 
  • Multi-site setup (same product different facilities) - harmonization of practices
  • Phase-appropriate approaches:
    • early phase vs. BLA and commercial

12:00
Lunch Break

 

13:00
2.5 Facility Tour at Körber Pharma Inspection Site

  • Hands-on exercise 4
    • Demonstration of a „simple“automated inspection machine
  • Hands-on exercise 5
  • Demonstration of „sophisticated” automated inspection machine

14:30
2.6 Requirements Related to Automated Visual Inspection

  • Transformation of the main principles from manual visual inspection to automated visual inspection

15:30
Coffee Break

 

16:00
Wrap-up training course day 2

16:30
Final Wrap-up of training course

16:45
End of Training Course

Featured Trainers

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotels:

Gästehaus am Turm
Gschmeidmachergasse 2
85570 Markt Schwaben
Germany

The hotel is located 12 minutes walk from the training course venue.

Hotel Gutsgasthof Stangl
Münchener Straße 1
85646 Neufarn/Vaterstetten
Germany

The hotel is located 15 minutes car drive from the training course venue.

Bader Hotel
Heimstettener Str. 12
85599 Parsdorf bei München
Germany

The hotel is located 15 minutes car drive from the training course venue.

How to Get Here
By Air Closest Airport: Airport Munich, 34 Kilometers distance to training course venue. Reachable by car or public transport
By Car Lilienthalstr. 8, 85570 Markt Schwaben, Germany