A Purdue-related startup is developing the first USP 797 certified, virtual pharmacy cleanroom laboratory for students and other industry professionals to gain hands-on experience in creating sterile and quality pharmaceutical compounds to help prevent compounding errors.
Steve Abel, Purdue associate provost for engagement and professor in the College of Pharmacy, and John B. Hertig, associate director of the Purdue College of Pharmacy Center for Medication Safety Advancement and assistant professor in the College of Pharmacy, co-founded the startup Penguin Innovations Inc. to commercialize the technology.
“Sterile compounding meets an important health care need, however, concern associated with compounding errors in recent years has led to closer scrutiny of pharmacies and sterile techniques,” Hertig says. “Effective learning of compounding procedures requires students and other professionals to be actively involved in the process to avoid errors that could cause infections or more serious health outcomes.
“Currently, many learners do not have open access to hospitals and other certified cleanrooms, so training defaults into really low-fidelity simulation, like a lab or benchtop where future pharmacists practice. This does not adequately prepare students entering a real-world environment.”
Penguin Innovations’ virtually interactive cleanroom reflects a realistic pharmacy environment. The virtual cleanroom is the only one of its kind that adheres to United States Pharmacopeia USP <797> compliance, which was implemented to protect patients by preventing the contamination of compounded sterile preparations.
“The purpose of this virtual laboratory was to introduce learners to a sterile environment and to train on aseptic technique, process flow and regulations that guide the safe use and compounding of sterile medications and safe practices related to parenteral drug therapy. It’s a perfect supplement to didactic training,” Hertig says. “Through the simulation students encounter a variety of case-based scenarios and problem sets they have to navigate and complete on an electronic device, including proper cleansing and garbing procedures, medication calculations, compounding, inappropriate object identification, proper cleanliness and disposal of waste, product selection and verification.”
The company has segmented the medication activities into easy, medium and difficult categories so students are able to learn at their appropriate level.
Abel says this technology can also help schools and other facilities save on costs.
“There is an issue of cost to build a cleanroom facility and to actually get the compounds required for the practice. We can make a virtual exercise of a very expensive medication, but it doesn’t cost anything because it’s all virtual,” he says. “It’s also easier for the platform to be updated and modified as regulations change. All someone needs to participate is an internet connection and a computer, and it can be accessed from anywhere in the world.”
Penguin Innovations envisions the technology being integrated into pharmacy courses. Hertig says it could also prove beneficial in other customer segments.
“Originally the technology was developed for pharmacy students, but we realized pharmacy technicians who do a lot of sterile compounding or even currently registered or licensed pharmacists who need a refresher, are great markets for this,” he says. “It could even be beneficial to sales or marketing staff in big pharma or medical device companies, so that when an employee make a sales call, they are not seeing a cleanroom for the first time.”
Technology used by Penguin Innovations has been licensed through the Purdue Research Foundation Office of Technology Commercialization. Penguin Innovations is a member of the Purdue Startup Class of 2016. Purdue has 27 startups based on Purdue intellectual property that were launched in the 2016 fiscal year. A video about Penguin Innovations can be found at https://youtu.be/bHuOnNP3FQo.
Penguin Innovations utilized the Envision Center for Data Perceptualization at Purdue University to help develop the platform. The Envision Center provides state-of-the-art high performance immersive computation to assist researchers, instructors and leaders in their quest for new knowledge and innovative products. Penguin Innovations was able to test the technology through the Envision Center’s virtual environment which is used for training and simulation and is deployable to mobile devices, web and the VR Theatre. A video of the company’s platform created at the Envision Center can be found at http://envision.purdue.edu/Cleanroom3.0/Cleanroom%20Demo%20Complete.mp4.
Penguin Innovations is also a client of Purdue Foundry, an entrepreneurship and commercialization accelerator located on Purdue’s campus.
Penguin Innovations has tested its product at Purdue and has an ongoing study at the University of Michigan.
“Initially we found that only around 30 percent of students had been in an actual cleanroom, which isn’t many. After using our training, about 97 percent of those surveyed says they felt more prepared when going into the real environment,” Abel says. “Students reported improved confidence in their ability to fulfill the manipulations and in knowing where to find information relative to the products that are being prepared. Students also reported a nearly 50 percent improvement in comfort as to training others on proper technique.”
– Hillary Henry, http://bit.ly/2jIuKI8
Above: John B. Hertig and Steve Able, founders of Penguin Innovations, move through a virtual pharmacy clean room environment developed by the company. The certified virtual clean room allows pharmacy students and industry professionals to gain hands-on experience in creating sterile and quality pharmaceutical compounds to help prevent compounding errors. (Purdue Research Foundation)