PharmaForce Engineering Internship Summer 2015
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A presentation I gave at the end of my internship describing my projects and reflecting upon my experiences at PharmaForce Inc.
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PharmaForce Engineering Internship Summer 2015
- 2. 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 SOP’s New Albany Finished Goods Warehouse Lyman WFI Still Lyman Shutdown / Construction HVAC Ductwork WFI Piping
- 3. 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
- 4. 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
- 5. 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
- 7. 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
- 8. 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
- 9. 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
- 10. 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
- 11. 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
- 12. 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
- 13. 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
- 14. 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
- 15. 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
- 16. 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
- 17. 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
- 18. We even did our own little construction project on the side!
- 19. 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
- 20. 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
- 21. 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
- 22. Security Cameras Survey all security cameras On screen In person Create maps Plot location Plot span Label
- 23. 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
- 24. 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!)
- 25. Fun with Excel!
- 26. Mini Projects SOP Gap Analysis Match existing SOP’s to list of procedures / systems Find out what SOP’s need to be written Industrial Label Maker Set up software + hardware Isolating Enclosures Worked with Ben and Judie Safety of substance weighing Read reports
- 27. 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
- 28. Reflections Favorite Aspects Recommendations Exploratory, diverse Collaborative, inter-departmental Challenging Open-ended Flexible REAL projects Multiple projects, full plate Shadowing, mentoring Lunch-and-learns
- 29. Skills / Knowledge Gained Office / workplace skills, communication (internal and external to PharmaForce) Understanding drawings / P&ID’s, reading manuals, drafting SOP’s, filling PRF’s, creating MDT’s, DOCUMENTATION is everything! Understanding of drug development process from R&D proposal to consumer’s veins Battling with ambiguity
- 31. The End Images of PharmaForce facilities courtesy of Acock Associates Architects Questions?
Editor's Notes
- Good morning, my name is Jason Ng and I am a rising sophomore at the Duke University Pratt School of Engineering. This summer, I worked as an engineering intern under Paul Papali.
- I’ll go through each of these things a little more in my presentation but my general responsibilities included reporting to Paul for various engineering and facilities projects, such as….I also often helped out my fellow interns in their projects, whether it was …. I also had the opportunity to write some Standard Operating Procedures on the…. And finally, we wrapped up our internship at the Lyman facility, assisting Dan Holowecky and the subcontractors with construction projects during shutdown.
- My very first assignment from Paul was to look into a Flexicon PD12 peristaltic pump. This is a type of pump that will be used to fill vials with medicine on our future production line, and we wanted to order a tabletop unit to do some dosing tests.
- A peristaltic pump is essentially… I learned everything I could from their website and other resources, and I contacted the sales representative for my region and we started to put together an order. Unfortunately we won’t be receiving the pump until after I leave, so I won’t get to see or work with it, but we did meet with the representatives recently and had our concerns addressed.
- One of my first big projects was the stopper detection system that would go on the existing production line at Lyman. I worked with Tyler on this one, so we’ll both be commenting on aspects of the experience.
- Just as some background, all vials are plugged with a rubber stopper and then capped with a plastic and metal cap. The cap is compressed and crimped around the bottom lip to form a tight seal, ensuring product sterility. However, before the cap is placed, we must check to see if the stopper is properly seated or if it is flat out missing. If it is incorrectly positioned or missing, the cap will not crimp and seal properly, thus comprising sterility, which as you know is a big FDA no-no.
- So our solution was to use a Banner iVu imaging sensor. It is a smart camera that can capture a picture of the vial and stopper and determine if it is a pass or fail, by “teaching” it an image of a “good” stoppered vial. If the percentage similarity of the pixellation reaches a set threshold, the camera will decide that it’s a “match” and if it doesn’t meet that threshold, then it’s a fail. We basically learned how to configure it, how to provide good lighting, and get it to do what we wanted at our make-shift desktop laboratory. But scaling up we had to think about tests on the actual machine at Lyman. We contacted employees at Lyman, technicians at Banner, and figured out what parts we might need such as mounts, sensors that can trigger the camera to snap a picture, and power supply. We’re looking into how we’ll actually implement this on the capper machine and we’ll be meeting with a technician tomorrow. Unfortunately, we won’t get to finish this project since it was just very large and complex in scope, but it was a really good hands-on engineering and design experience, and we’ll be passing on our knowledge to an incoming process engineer so he can really expand and complete the project.
- Now this assignment came about because during operational qualification and requalification, Validations found that a detailed SOP for the Finished Goods Warehouse was not available.
- So I gathered as much information as I could on the Finished Goods Warehouse at New Albany by looking at past documents and similar documents at Lyman, as well as conferring with various members of Materials Management, Validations, Quality Assurance, and Engineering.
- I also drafted an SOP for the start up, operation, and maintenance of the Steris Finn Aqua Multi-Effect Still, which produces ultra pure and sterile water for injection (WFI) at our Lyman facility.
- I read 2, 150-page manuals on the maintenance and operation of the still and worked with Paul and Ben Logsdon to understand how a multi-effect still works. It’s really amazing how it’s designed to use the laws of thermodynamics and heat transfer in a very energy efficient manner.
- This involved sourcing all the log sheets and control systems used to record measurements. Some are digital, some are paper, some are write by vendors, some are written by us. So I was supposed to help compile all of this into one standardized format. I had to learn about many process and utilities systems, like in these pictures you can see the plant steam boilers, RO pretreatment, and purified water. But I had a lot of help from Don Johnson in maintenance.
- Here, we worked on an air balance study to evaluate the needs for change to our current air flow system, whether that meant installing new dampers or larger ducts. As you know, maintaining air pressure gradients is critical to the sterility of the clean rooms, so experimenting with how we could manually and automatically adjust those controls was important.
- We did this first by surveying and labeling all air handling components in the plenum of the Manufacturing Mezzanine space above the clean rooms. The using Siemens BAS, we’d switch from automatic to manual control of the Suite 2 Clean Room air pressures. Proper air pressure gradients and air flow handling are not only important to sterility of clean rooms, but to those working in the Manufacturing Mezzanine plenum, so that we shield any maintenance technicians from potentially harmful airborne compounds.
- Finally, we wrapped up our internship at the Lyman facility, assisting Dan Holowecky and subcontractors with construction projects during annual shutdown. I personally oversaw mechanical, HVAC, and WFI piping.
- We studied proposed plans, drawings, and schedules for the construction of a new production line as well as renovations to surrounding areas. It was amazing to really see the drawings come to life! Our duties were primarily to document activities, assist contractors with whatever they needed, and report progress in daily meetings. We also oversaw safety and security of the construction space, inspecting for damage, fires, tenting and taping off areas, and ensuring that all workers sign in and out. We were able to meet with many contracting service people, mechanics, and Lyman employees. With Tyler, I worked on getting measurements and planning the logistics and purchase of a ladder for access to a technical space. I got to observe many processes, such as the passivation of a WFI pipe post-welding, concrete footer construction, beam and lintel erection, and HVAC damper installments.
- We even did our own little construction project on the side, patching over a hole that was created to investigate the flooring structure.
- My next project was to work on the electronic RFID card access system so that we could document all the card readers and improve our ability to access information and grant appropriate access levels to employees.
- This involved surveying all the card access points, and creating maps and spreadsheets that contained information on them. I often had to refer to the existing eMerge database. However, I found that this database was riddled with typos, inconsistent naming practices, and plain errors, so I was able to clarify and correct some of those.
- Under Pat Seymour, I worked on the security cameras as well, which was similar to the card access project. The purpose was to provide information on the security camera locations and ensure that we have proper coverage of our facilities to prevent and follow-up on potential incidents.
- In order to do this, I went all around the interior and exterior of the New Albany facilities marking out where the security cameras were. Then, I’d refer to the focal range you can see on the control screen, or the computer screen monitored by the security guard. Some cameras had narrow angles, others had wider and I had to account for those when I’d transfer all this information to the facility drawings.
- Now, probably one of the larger projects in scope, Tyler and I worked on the employee access cards, upgrading all cards to a new style format. [Hold up example of old card]…The problem with the old cards was that they said PharmaForce right on the front, so if any employee lost theirs, a stranger could pick it up and gain access to our facilities. Another problem was that the pictures were often dark, and had inconsistent backgrounds and cropping. To remedy this, we made cards that were very plain with only a partial logo, a clear picture, name, and a colored outline in the case that employees were contract workers or temporaries.
- This project involved an enormous amount of data filtering. I had to sort through an electronic roster of over 1300 entries of employees who had access to our facilities, and filter out who already had a new style badge, who is terminated, who is only a service technician and doesn’t need a picture, who’s a Luitpold employee, and dozens of other exceptions to whom we needed to gather new pictures and print new cards for. As you can imagine, it took quite a bit of collaboration between me and Gina and HR to figure out who needs new cards. It involved the logistics of gathering pictures, editing and printing, and delivery and assembly. We had many picture days at all three facilities, and would generally get new cards back within a week. There are still a few who we have to print or take pictures of, but we have communicated with and accounted for them (some are currently away or are waiting to have their picture taken). Otherwise, we have accounted for every single person on our list of 182 employees who needed new badges. Tyler and I are both pretty proud of how that turned out.
- This is just an example of some the excel work on a regular basis to update the roster and figure out who we’ve taken care of and who we need to take care of. It was a surprisingly hefty amount of work.
- Some smaller projects I worked on included filling out a database of processes that needed matching SOP’s. This would allow us to see where we have gaps in our SOP base. Then, I set up the hardware and software for an industrial label maker, which we will use to print labels for pipes and machinery. I also got to work with Ben and Judie on evaluating the need to purchase a Flow Science enclosure. Enclosures are intended to isolate operators from dealing directly with potentially harmful compounds, whether they were transferring chemical substances or weighing powders. This involved reading several laboratory reports and bringing together results on the enclosure’s efficacy.
- Connections between internship and coursework. In my International Law and Global Health class we learned about the FDA and reading legal documents, which was applicable when deciphering codes of federal regulation. My project on access card creation dealt with RFID technology, which I actually spent a lot of time on in my Electrical and Computer Engineering course, where I built a robot that could detect specific RFID tags. Thermodynamics was very apparent in learning the mechanisms of the WFI still. Calculus is the basis for PID controls, which are used to maintain the setpoints of everything from tank temperatures to room air pressures. And finally, a general understanding of biology and chemistry was necessary to understand the drugs we produce. Characteristics such as solubility and viscosity are also important to consider in the manufacturing process, and came up in things like when we discussed the suitability of the peristaltic pump to fill Beta Beta.
- My favorite aspects were that I got to explore all the facilities. Projects were diverse and collaborative, and I met people from all departments. It was also challenging, open-ended, flexible, and real hands-on experience. I always had multiple projects to work on, so I could switch between tasks when I got stuck on one. As for recommendations, perhaps a shadowing or mentorship program where we follow an engineering employee on a routine basis, and really delve into their projects and learn how PharmaForce employees operate. Another possibility might be hosting lunch-and-learn sessions where over a casual lunch, employees, professionals, or other speakers talk about their career and how they got to where they are.
- As for skills and knowledge, just learning how to fit in and communicate within an office, whether on phone, by email, in person, with PharmaForce employees, or with outside vendors/services was really beneficial to me. Also documentation, whether it’s understanding drawings, reading manuals, drafting SOP’s, etc. was a key takeaway. Learning about the drug development process from start to finish gave me insight to the pharmaceutical industry. And most importantly I learned how to deal with uncertainty and ambiguity. While it’s easy to feel like “Oh, I’m just an intern. I don’t know what I’m doing!” Well, I found it was a great way to challenge myself to figure out how to ask for help and get the information I need when I need it.
- So that’s it. Thank you so much PharmaForce for everything you’ve provided me. I’ve really appreciated the time I’ve spent here, and the people I’ve met along the way.
- The End! Any questions?