1. 1. General Responsibilities Report to Paul for engineering and facilities projects Peristaltic Filling Pump Missing Stopper Detection / Inspection Camera System Air Balance Study Security Cameras, Card Access Employee Access Card Creation Maintenance Operating Logs Mini Projects Assist Tyler and David in their tasks Drawing Control Blue Mountain RAM Pest Control Sound Monitoring Draft SOPs New Albany Finished Goods Warehouse Lyman WFI Still Lyman Shutdown / Construction HVAC Ductwork WFI Piping
2. 2. Peristaltic Pump Who: Jason Ng, Paul Papali, Watson- Marlow Fluid Technology Group What: Order a tabletop peristaltic filling pump unit and controller When: 5/21/15 - Ongoing Where: New Albany Facility Why: Initial use for dosing accuracy tests / optimization of parameters / familiarity, understanding of implementation in Marchesini production line
3. 3. Peristaltic Pump Learn about peristaltic and other pump solutions (e.g. rolling diaphragm) Mechanics Pros and cons What Flexicon can offer Contact Watson-Marlow Flexicon Sales Reps Purchase requests Dosing tests, use in production line Meeting with reps
4. 4. Stopper Detection Who: Jason Ng, Tyler Warner, Lyman employees, Banner Engineering What: Stopper inspection system for fill line When: 5/22/15 Ongoing Where: Lyman Facility Why: Ensure product sterility and success of capping mechanism by ensuring proper stopper placement on vials
5. 5. Stoppering / Capping Process
6. 6. Stopper Detection Learn how to use camera Match percentage Area with motion Continuous monitoring Contact Banner technicians Acquired mounts, trigger, power supply Small scale tests Used voltage meter Implementation Capper machine wiring Shut off Indicator light Passing the torch
7. 7. Finished Goods Warehouse Who: Jason Ng, Paul Papali, Stuart Falds, Quinn Parks, Kiana Calvin, Joshua Craig, Faith Denney What: Create an SOP on operation and maintenance of the New Albany Finished Goods Warehouse When: 6/16/15 7/7/15 Where: New Albany Facility Why: Provide a more detailed guide / reference to those who oversee the Finished Goods Warehouse
8. 8. Finished Goods Warehouse Gather resources and knowledge on warehouse Draft SOP based on past documents, parallel documents from Lyman Confer with Quinn, Stuart, Kiana, Faith, Paul for edits
9. 9. WFI Still Who: Jason Ng, Paul Papali, Ben Logsdon What: Create an SOP on start-up, operation, and shutdown of the Lyman Steris Finn Aqua WFI Still When: 6/23/15 7/22/15 Where: Lyman Facility Why: Provide a guide / reference to engineers and mechanics who operate the WFI still, make information easily accessible
10. 10. WFI Still Read 2, 150-page manuals on Maintenance and Operation Learn the science and engineering behind the design of a multiple- effect water still Draft SOP Consult with Paul and Ben for guidance and revision
11. 11. Maintenance Operating Logs Who: Jason Ng, Paul Papali, Don Johnson, Maintenance Department What: Create daily log sheets for various process, utilities, equipment readings When: 7/2/15 - Ongoing Where: New Albany Facility Why: Streamline / reformat daily readings, encourage daily record-taking, help new maintenance employees gain a feel for reading values
12. 12. Maintenance Operating Logs Source all logs and control systems used to record measurements Compile logs into one standardized format Understanding of many different process, utilities systems e.g. purified water, plant steam, RO, etc. Learn from Don about maintenance operations
13. 13. Air Balance Study Who: Jason Ng, David Stanislav, Tyler Warner, Paul Papali, Ben Logsdon What: Assist in air balance study adjusting pressures in clean rooms When: 7/15/15 7/17/15 Where: New Albany Facility Why: Evaluate need for change to air handling system, develop understanding of current airflow system
14. 14. Air Balance Study Survey and label components in plenum Siemens Building Automation System Control air pressure in Suite 2 Clean Rooms Manual damper adjustment vs. automatic PID controls Evaluate need for change Problem solving, critical thinking, reasoning Improper installation of damper handles Coordinating air supply and return to achieve set points Finding the source of unexpected results
15. 15. Lyman Shutdown Who: Jason Ng, David Stanislav, Tyler Warner, Dan Holowecky What: Assist contractors in construction projects, look over HVAC and WFI piping When: 7/24/15 - Ongoing Where: Lyman Facility Why: Creation of new production line area, additions to piping and HVAC and so on
16. 16. Lyman Shutdown Study drawings See drawings come to life Document, assist, report, etc. Safety / security (tape, logs) Meeting contractors, mechanics, etc. Tech Space ladder Observing WFI pipe tie-in passivation Various welds Digging out floor for footers Erecting beams, lintels Installation of isolation dampers
17. 17. We even did our own little construction project on the side!
18. 18. Card Access Who: Jason Ng, Pat Seymour What: Surveying Card Access Readers When: 5/20/15 - 6/30/15 Where: New Albany Facility Why: Improve access system for ease of adjustability, define access levels
19. 19. Card Access Survey all card access points Create maps, spreadsheets eMerge system Improve database Fixing typos and inconsistencies Add to drawings Define levels of access
20. 20. Security Cameras Who: Jason Ng, Pat Seymour, Stephanie Dietz What: Survey security camera system When: 6/2/15 - 6/5/15 Where: New Albany Facility Why: Make information on security camera system readily available, ensure proper coverage
21. 21. Security Cameras Survey all security cameras On screen In person Create maps Plot location Plot span Label
22. 22. Employee Access Cards Who: Jason Ng, Tyler Warner, Paul Papali What: Upgrade to new style cards When: 6/10/15 Ongoing Where: All PharmaForce Facilities Why: Security/safety, clarity and consistency among badge styles
23. 23. Employee Access Cards Track roster of all employees Retrieve information from Gina and HR Communicate and plan logistics Take pictures Edit and print cards Deliver and assemble cards So far, finished and distributed 174 new cards (8 more to go!)
24. 24. Fun with Excel!
25. 25. Mini Projects SOP Gap Analysis Match existing SOPs to list of procedures / systems Find out what SOPs need to be written Industrial Label Maker Set up software + hardware Isolating Enclosures Worked with Ben and Judie Safety of substance weighing Read reports
26. 26. Internship x Coursework International Law and Global Health FDA regulation, legal documents Electrical and Computer Engineering RFID technology, iVu wiring Thermodynamics WFI Still, energy efficiency Calculus PID Controls Biology, Chemistry Drug characteristics MFG Considerations
27. 27. Reflections Favorite Aspects Recommendations Exploratory, diverse Collaborative, inter-departmental Challenging Open-ended Flexible REAL projects Multiple projects, full plate Shadowing, mentoring Lunch-and-learns
28. 28. Skills / Knowledge Gained Office / workplace skills, communication (internal and external to PharmaForce) Understanding drawings / P&IDs, reading manuals, drafting SOPs, filling PRFs, creating MDTs, DOCUMENTATION is everything! Understanding of drug development process from R&D proposal to consumers veins Battling with ambiguity
29. 29. The End Images of PharmaForce facilities courtesy of Acock Associates Architects Questions?