PDA EU00192 Manage Your Aseptic Filling Line

Wednesday, 04 September 2024

9:00
Welcome and Introduction

9:15
Lecture 1: Annex 1 Requirements on  Aseptic Processing

• Annex 1 and requirements for aseptic filling
• Filling Line Set Up
• What types of Barriers are available and what are their limitation?
• Surface Decontamination
• Gloves
• Material Transfer overview in the Barrier System and Filling Line
• Cleaning requirements and cross-contamination prevention

10:15
Lecture 2: First Air

• Explanation of first air
• Where is first air important to consider
• Examples of first air design
• How to prevent to interrupt first air

10:35
Coffee Break

11:00
Lecture 3: General Filling Line Design

• General differentiation of primary packaging containers and corresponding filling line technology support by visual materials
• Description of different filling technologies with a focus on single use systems vs. conventional filling systems incl. a pro and con overview
• Explanation and distinguishing of indirect product contact parts based on visual materials.
• Understand the sequence of unwrapping the equipment
• General reference to current regulatory guidance documents 

12:00
Lunch Break

13:00
Exercise 1: Set-Up of the Indirect Product Contact Parts

• Short filling line walk through to identify points of interest from the theoretical training session incl. a short machine run to understand the process
• Installation of indirect parts as open-door intervention for bigger parts and closed-door interventions for smaller parts using barrier glove system
• Perform sequenced unwrapping with barrier glove system
• Experience first air requirements 

15:00
Coffee Break

15:30
Exercise 2: Set-Up of the Filling Path (PP & RPP)

• Hands on explanation of the filling system peristaltic pump and rotary piston pump
• Hands on explanation of a SUS filling kit from needle to surge bag 
• Installation of the filling path with closed doors and barrier glove system
• Hands on explanation and differentiation of the function of the indirect product contact parts
• Understand hands on the different wrappings of the indirect parts incl. the sequence of unwrapping.
• Installation of indirect parts as open-door intervention for bigger parts and closed-door interventions for smaller parts using barrier glove system
• Perform sequenced unwrapping with barrier glove system
• Experience first air requirements 

17:00
Q&A and Questionnaire

17:40
End of Training Course Day 1 & Networking Event

Thursday, 05 September 2024

8:30
Lecture 4: Environmental Monitoring Risk Analysis

• Presentation of the environmental risk analysis (EMRA) from the training machine
• Understanding of the principles and execution of an EMRA for passive/active viable and total particle
• Understand the principles of requirements to surface sampling and swapping incl. reference to respective surfaces
• References to current regulatory guidance documents
• Execution of an own high level EMRA

9:30
Exercise 3: Filling Line Set-Up Monitoring Handling

• Handling of settle plates and active viable monitoring incl. opening of wrapping, positioning, opening, and closing as well as discharging it from the barrier
• Handling of contact plates incl. application on parts of the filling line. Closing of contact plates and discharging it from the barrier.
• Handling of swabs incl. application on parts of the filling line. Closing of the swab tube and discharge from the barrier

10:10
Coffee Break

10:40
Exercise 3 (cont.): Filling Line Set-up Monitoring Handling

• Handling of settle plates and active viable monitoring incl. opening of wrapping, positioning, opening, and closing as well as discharging it from the barrier
• Handling of contact plates incl. application on parts of the filling line. Closing of contact plates and discharging it from the barrier.
• Handling of swabs incl. application on parts of the filling line. Closing of the swab tube and discharge from the barrier

11:20
Lecture 5: Sterile Filtration

• Regulatory requirements for sterile filtration: Annex 1 is the baseline
• Filter validation to ensure bacterial retention, to evaluate adsorption and leachables, to ensure compatibility
• Filter integrity test: PUPSIT or risk assessment, bubble point or diffusion?
• Filtration process considerations: is redundant filtration a must?
• Keep it closed: the filter as part of a closed single-use system

12:30
Lunch Break

13:30
Exercise 4: Set-Up of Sterile Filtration

• Best design practice: build your filtration set -> two groups
• Handling of sterile connection device to connect to the filling operation
• Handling of filtration process: wetting, flushing, filter integrity testing

15:00
Coffee Break

15:30
Wrap-Up & Questionnaire

16:20
End of Training Course