Project Info
G160.73902 G16073902 5
SSF PTD B00 Cell Banking of Tomorrow Accelerated (BOTA) Closeout 12-01-2022
07-31-2019 01-21-2021 01-22-2021 -38 days 1221 days
1221 days
Active Purchase, install and qualify new cell banking single-use production equipment. Update Cell Banking suites in Building 5 to accept equipment.
Jennifer Kunkler Isabel Lacson Patti Viri-Cruz 05-30-2023
1/1/23 -Project is in closeout. - Project is trending under budget due to underuse of single-use component, translation service, deviation and covid-related allowances.
Change Records
GC/A/E
Dome 9/29/2021 -  Sartorius Instrumentation Dwgs were submitted by Eichleay.

8/6/2021 - Project team submitted Parker Cryobag Filler Electrical Schematics record set on 7/30.
5/26/2021 - Vendor drawings for record were submitted.
DGA Eichleay
Yes 03-20-2023
Yes 09-07-2023
Master Drawings
Yes
Site Ops SPOC
David Francis
Yes
Yes
Yes
Yes
08-19-2021
Reliability Engineering
Yes
Yes
G16073902
G16073902
DC20-021
DC20-021 0.00
[SEP-18-20 Aaron Asilo] Meeting with PM on 9/25 to discuss RE scope. 

[NOV-20-20 Ravel Ravel] FLs for 4 BOTA systems (CRYOBAG FILLER, FERMENTOR, HFF, FILLIT): Complete 
FLs for Gases System (CPA, O2, CO2): In Progress 
EINs for BOTA systems and Gases: Pending
Gases SOP/IP: Pending
MS/WI Master data for BOTA system: Pending
MPs: Pending 
LOTOs: Pending
BOMs: Pending
Spare Parts: Pending
Original Quote to be updated.

[DEC-22-20 Ravel Ravel] FLs for 4 BOTA systems (CRYOBAG FILLER, FERMENTOR, HFF, FILLIT): Complete 
FLs for Gases System (CPA, O2, CO2): Complete
EINs for Cyrobag Filler and Gases:  Complete 
EINs for BOTA systems (FERMENTOR, HFF, FILLIT): Pending
Gases SOP/WI: Pending
MPs: Pending 
LOTOs: Pending
BOMs: Pending
Spare Parts: Pending
Original Quote updated: Complete

[JAN-28-21 Ravel Ravel] FLs for 4 BOTA systems (CRYOBAG FILLER, FERMENTOR, HFF, FILLIT): Complete 
FLs for Gases System (CPA, O2, CO2): Complete
EINs for Cyrobag Filler and Gases:  Complete 
EINs for BOTA systems (FERMENTOR, HFF, FILLIT): In Progress
Gases MS Tec document/WI: In Progress
MPs: Pending 
LOTOs: Pending
BOMs: Pending
Spare Parts: Pending
Original Quote updated: Complete

[FEB-25-21 Ravel Ravel] FLs for 4 BOTA systems (CRYOBAG FILLER, FERMENTOR, HFF, FILLIT): Complete 
FLs for Gases System (CPA, O2, CO2): Complete
EINs for Cyrobag Filler and Gases:  Complete 
EINs for BOTA systems (FERMENTOR, FILLIT): Complete
EINs for BOTA systems (Pallet Tank, Ph Meter):  In Progress
Gases MS Tec document/WI: MS TEC-0207912 condor approved, WI1538 in review.
Gases PI: Created WO for qualification verification of PIs.
LOTOs: Pending (required for the Cell Banking equipment)
BOMs: Pending
Spare Parts: Qualification spare parts list being developed, once the list is finalized Hannah will order the parts for project under one PO. I will create BOM DPI for qualification spares.  
Original Quote updated: Complete

[MAR-18-21 Ravel Ravel] -FLs for 4 BOTA systems (CRYOBAG FILLER, FERMENTOR, HFF, FILLIT): Complete 
-FLs for Gases System (CPA, O2, CO2): Complete
-EINs for Cyrobag Filler and Gases:  Complete 
-EINs for BOTA systems (FERMENTOR, FILLIT): Complete
-EINs for BOTA systems (Pallet Tank, Ph Meter):  Submitted for review 
-EINs for BOTA systems (New TT and RTD, Portable Biosealer and Biowelder ):  In Process
-Gases MS Tec document: MS TEC-0207912 condor approved,
- Gases WI: FAC-0200277 condor approved
-Gases PI: Created WO for qualification verification of PIs.
-LOTOs: Pending (required for the Cell Banking equipment)
-BOMs: Pending
-Spare Parts: Qualification spare parts list being developed, once the list is finalized Hannah will order the parts for project under one PO. I will create BOM DPI for qualification spares. Bioreactor Part Numbers are being confirmed by the project team, before the order could be placed. 
-Original Quote updated: Complete

[APR-22-21 Ravel Ravel] Completed: 
- FLs for 4 BOTA systems (CRYOBAG FILLER, FERMENTOR, HFF, FILLIT) and Gases System (CPA, O2, CO2): Complete 
- EINs for BOTA systems (FERMENTOR, CYROBAG FILLER, FILLIT, Pallet Tank, Ph Meter) and Gases: Complete
- Fls/EINs for BOTA systems (New RTDs, Biosealer, Welder):  In Progress
- Gases MS Tec document: MS TEC-0207912 Condor approved,
- Gases WI FAC document: FAC-0200277 Condor approved 

For next 3 months:
- Complete FLs/EINs for BOTA systems (New RTDs, Biosealers, Welders)
- Complete Gases PI Verification: Created WO for qualification verification of PIs. Three PIs failed, need to be replaced and retested. 
- LOTOs: Pending (4 LOTOs required for the Cell Banking equipment)
- BOMs: Pending
- Spare Parts: Qualification spare parts finalized, Hannah is currently ordering parts, Complete BOM DPI for qualification spares.
- Start creating MPs (PM02s and PM07s), once the MS and WIs are finalized.   



[AUG-01-21 Ravel Ravel] 6/28/21
In Progress/Completed
- EINs affixed stickers to equipment/instruments.
- EINs BOTA systems (Biosealers, Welders): EINs auto created per new asset number alignment process, EIN Change Completed. 
- BOTA System (Bioreactor, Palletank, Chiller) CAL and PM MPs: Completed
- Gases LOTO in Progress. 

For next 3 Months
- Complete change EINs for BOTA systems (Biosealers, Welders)
- Draft LOTOs for Process Gases
- Fill GPN Creation Spreadsheet for Qualification spares (BOM), link ordered spare parts to GPNs after completion of qualification.  
-Spare Parts: Pending

[OCT-29-21 Ravel Ravel] FL/EIN/MP: Complete for all CRYOBAG FILLER, FERMENTOR, HFF, FILLIT, Gases System. 
BOM/GPN/Spare Parts: Pending 
CO: PM informed and CO given to PM for substantial BOM/parts and vendor challenges.  

[JAN-27-22 Ravel Ravel] Cora Update. 

[JUN-27-22 Ravel Ravel] COD submitted to SPOC for Review. 

[JUL-24-22 Ravel Ravel] COD approved by SPOC. Project ready for final bill. 

[AUG-12-22 Denise Weretka] Final Bill 8/12/2022
Capital Finance
Yes
Yes
Project Financials
Carmen Ho
Yes
Yes
Yes
Yes
Final Project Info
Purchase, install and qualify new cell banking single-use production equipment. Update Cell Banking suites in Building 5 to accept equipment.
Yes
Scorecard
X
X
12-01-2022
Closed
G160.73902
08-30-2019
Created on Aug. 30, 2019 at 11:58 AM (PDT). Last updated by Bisson, Jim on Feb.  1, 2023 at  2:25 PM (PST). Owned by Lacson, Isabel.
Isabel Lacson
Jim Bisson
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