1. 4. AF Assessment
1.1. 4.1 Mannheim
1.2. 4.2 Shanghai
2. 2. Implementation Package
2.1. 2.1 AF Guidelines
2.2. 2.2 Implementation Requirements Specification
2.3. 2.3 Validation Package
2.3.1. ?
2.4. 2.4 Template Update/Change Documentation Process
2.5. 2.5 Templates Library
3. 1. Global Templates
3.1. 1.1 Definition of the Equipment Units
3.1.1. 1.1.1 Interview sessions with specialists
3.1.1.1. DS
3.1.1.1.1. Antonio Orosco - Process Automation SSF (16.07)
3.1.1.1.2. Eric Fallon - Senior Director PTI and MSAT DS (20.07)
3.1.1.1.3. Salvador Toscano - Principal Engineer VV (16.07)
3.1.1.1.4. Thorsten Kaiser Head Technical Acceleration Team - Global MSAT DS PTI MSAT MFG - MPET (05.08)
3.1.1.1.5. MPET (25.08)
3.1.1.2. DP
3.1.1.2.1. Gianfranco Gabriele - Head of OE DP (20.07)
3.1.1.2.2. Inga Schuster - Head of Packaging Operations KAU (24.07)
3.1.1.2.3. Joachim Wolf - Head MSat Bio DP Manufacturing BS & KAU (06.08)
3.1.1.2.4. Tatiana Rosa - KAU Head Steriles Manufacturing Operations Kaiseraugst (05.08)
3.1.1.2.5. Steve Zoeller - HTO Director Manufacturing (27.07)
3.1.1.2.6. Mark Ostermayer - MSAT Mannheim (03.08)
3.1.1.2.7. PENTA (20.08)
3.1.1.3. Global
3.1.1.3.1. ASPIRE
3.1.1.3.2. Engineering/ Automation
3.1.1.3.3. F&E
3.1.1.3.4. SNAC
3.1.1.3.5. Basecamp
3.1.2. Michael Schneider - Head of PTI DP (28.07)
3.1.2.1. Will send an SMEs list
3.1.3. 1.1.2 Iteration round with decision makers
3.1.3.1. Global Automation Lead
3.1.3.2. Head of DP PT IX
3.1.3.3. Head of DS PT IX
3.1.3.4. Head of DP Manufacturing Excellence
3.1.3.5. Site Heads/ MSAT Heads?
3.1.4. 1.1.3 Communicate to site heads and MSAT heads
3.1.4.1. Go back to DxTC?
3.1.4.2. Send newsletter
3.2. 1.2 Define parameters with SMEs, Build and Test the Templates
3.2.1. 1.2.1 DP
3.2.1.1. Isolator
3.2.1.1.1. 14.Oct - Meeting with Willian Gonzales and Shazia Malik. The Robustness team will build the requirements for Isolators, Sterile-tunnels and Autoclaves. Next step is to explain/ present the needs to the Robustness team.
3.2.1.2. Sterile-tunnel
3.2.1.2.1. 14.Oct - Meeting with Willian Gonzales and Shazia Malik. The Robustness team will build the requirements for Isolators, Sterile-tunnels and Autoclaves. Next step is to explain/ present the needs to the Robustness team.
3.2.1.3. Autoclave
3.2.1.3.1. 14.Oct - Meeting with Willian Gonzales and Shazia Malik. The Robustness team will build the requirements for Isolators, Sterile-tunnels and Autoclaves. Next step is to explain/ present the needs to the Robustness team.
3.2.1.4. Modfiller (VanRx)
3.2.1.4.1. Urs is creating the template with local spocs and Alex Glunz
3.2.1.4.2. Seeq PoC ongoing
3.2.1.5. Fluid Bed Dryer (SM)
3.2.1.5.1. Ready
3.2.1.6. Packaging
3.2.2. 1.2.2 DS LM
3.2.2.1. CIP
3.2.2.1.1. Andy Brewer, Cleaning & Contamination Control Network Technical Leader
3.2.2.2. Bioreactor
3.2.2.2.1. 22-Oct - Meeting with Felix To. Minutes/. Results by week 46
3.2.2.3. Centrifuge
3.2.2.3.1. 19-Oct - Meeting with Elizabeth Maione. Minutes/ Results 11.11
3.2.2.4. TFF Filtration
3.2.2.4.1. 19-Oct - Meeting with Kim Tran. Minutes/ Results 09.11
3.2.2.5. Virus Filtration
3.2.2.5.1. 19-Oct - Meeting with Kim Tran. Minutes/ Results 09.11
3.2.2.6. Chomatography
3.2.2.6.1. 15-Oct - Meeting with Grant Luchsinger. Minutes/ Results 10.11
3.2.2.7. Media Tanks
3.2.2.7.1. 14-Oct - Meeting with Marion Traverse. Meeting minutes/ Results 09.11
3.2.3. 1.2.3 DS SM
3.2.3.1. ?
3.3. 1.3 Documentation
3.3.1. ?
3.3.2. 1.3.1 Publicize in the Website's Library
4. 3. AF Implementation
4.1. 3.1 Kaiseraugst
4.1.1. 3.1.1 Local AF (until the equip. unit)
4.1.1.1. 3.1.1.1 Send Implementation Package
4.1.1.2. 3.1.1.2 As-Is Assessment
4.1.1.3. 3.1.1.3 Request Information
4.1.1.3.1. 3.1.1.3.1 Stakeholder Map
4.1.1.3.2. 3.1.1.3.2 List of Equipment (SAP?)
4.1.1.3.3. 3.1.1.3.3 List of Tags/ Attributes/ KPIs
4.1.1.3.4. 3.1.1.3.4 P+ID/ Physical Layout
4.1.1.3.5. 3.1.1.3.5 Production Process
4.1.1.4. 3.1.1.4 R&R - for AF implementation
4.1.1.5. 3.1.1.6 Initiate local change request
4.1.1.6. 3.1.1.5 Access rights to local systems
4.1.1.7. 3.1.1.7 Create V1 of the local AF
4.1.1.7.1. Iteration with Stakeholders
4.1.2. 3.1.2 Local implementation of the templates
4.1.2.1. 3.1.2.1 Instantiation of the pre-defined equipment unit's templates
4.1.2.1.1. Test and document
4.2. 3.2 Penzberg
4.2.1. Local AF (until the equip. unit)
4.2.2. Local implementation of the templates
4.3. 3.3 INeST
4.3.1. Local AF (until the equip. unit)
4.3.2. Local implementation of the templates
4.4. 3.4 CSC
4.4.1. Local AF (until the equip. unit)
4.4.2. Local implementation of the templates
4.5. 3.5 Hillsboro
4.5.1. Local AF (until the equip. unit)
4.5.2. Local implementation of the templates
4.6. 3.6 Kaiseraugst LSL
4.6.1. Local AF (until the equip. unit)
4.6.2. Local implementation of the templates
4.7. 3.7 Vacaville
4.7.1. Local AF (until the equip. unit)
4.7.2. Local implementation of the templates
4.8. 3.8 SSF
4.8.1. Local AF (until the equip. unit)
4.8.2. Local implementation of the templates
4.9. 3.9 Singapore
4.9.1. Local AF (until the equip. unit)
4.9.2. Local implementation of the templates
4.10. 3.10 Basel PI Platform
4.10.1. Local AF (until the equip. unit)
4.10.2. Local implementation of the templates
4.11. 3.11 Basel B.50
4.11.1. Local AF (until the equip. unit)
4.11.2. Local implementation of the templates
4.12. 3.12 Basel B 29/31
4.12.1. Local AF (until the equip. unit)
4.12.2. Local implementation of the templates
4.13. 3.13 Basel Biotech
4.13.1. Local AF (until the equip. unit)
4.13.2. Local implementation of the templates
4.14. 3.14 Oceanside
4.14.1. Local AF (until the equip. unit)
4.14.2. Local implementation of the templates