PFI-TT: Virtual Reality Training for Active Pharmaceutical Ingredient Manufacturing Operations

如果成功，该创新合作伙伴关系 - 技术转化 (PFI-TT) 项目的更广泛影响/商业潜力将解决药品制造行业专业领域（例如活性药物成分 (API) 的生产）技术劳动力短缺的问题。拟议的技术包括用于 API 制造流程的用户友好的虚拟现实和增强现实 (VR/AR) 培训框架。当前的培训方法，包括课堂学习和基于计算机的学习，不能充分解决制造操作员所需的关键技能，导致操作和维护关键工艺设备的困难。因此，会出现计划中断和批次失败的情况，并造成重大的时间和金钱损失。拟议的基于 VR/AR 的培训预计将弥补制药培训流程的不足，这些不足会导致操作员持续出错并延迟药物供应，正如在 COVID-19 大流行期间所见证的那样。所提出的虚拟模拟提供协调的视觉空间感知反馈线索，以发展程序知识和记忆的运动技能。交互式培训积极吸引学员探索行动和结果之间的联系，构建模式，并开发 API 制造操作的详细、准确的心智模型。 最佳培训可以为有需要的患者提供负担得起的、精确的和优质的仿制药和个性化药物给药。拟议的项目将开发一个交互式、逼真的 VR/AR 框架，用于培训活性药物成分 (API) 操作的技术人员。 当前的虚拟模块无法跨多个设备进行扩展，并且在构建时并未考虑到最终用户的定制。该项目推进了多模式（增强现实、混合现实和桌面 VR）支持，可通过头戴式显示器、手持平板设备和/或台式电脑进行访问，以适应不同的学习方式。该项目的目标是：1) 识别 VR/AR 特定的视觉、听觉和触觉线索，以增强 API 操作中的培训转移和保留，2) 明智地使用这些功能来设计和实施多模式访问的虚拟培训。逼真的模块将包括高度详细的 API 操作、组件组装/拆卸程序以及通过交互式参数修改进行的替代场景可视化/模拟。可定制的界面功能允许用户启用或禁用指导/查询功能、字幕和音频。经过适当的 VR 培训后，将观察参与者的表现以纳入迭代增强功能。智力优势包括可定制 VR/AR 界面的新颖设计，减少认知负荷并优化视觉、听觉和触觉刺激的整合，以实现训练转移和记忆。成功的衡量标准将侧重于准确性、进度优化和安全性，以展示 VR 在制药培训中的效率。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project, if successful, is to address the shortage of skilled workforce in specialized areas of the pharmaceutical manufacturing industry, such as production of active pharmaceutical ingredients (API). The proposed technology consists of a user-friendly Virtual Reality and Augmented Reality (VR/AR) training framework for API manufacturing processes. Current training methods, including in-class and computer-based learning, do not adequately address the critical skills that manufacturing operators need, resulting in difficulties in operating and maintaining key process equipment. Consequently, schedule disruptions and batch failures occur and cause significant losses of time and money. The proposed VR/AR-based training is expected to remedy the inadequacies of pharmaceutical training processes that cause continued operator errors and delay drug availability as witnessed during the COVID-19 pandemic. The proposed virtual simulation offers coordinated visual spatial perception feedback cues to develop motor skills for procedural knowledge and memory. The interactive training actively engages trainees to explore the connections between actions and outcomes, build schemas, and develop detailed, accurate mental models of API manufacturing operations. Optimal training may provide affordable, precise, and quality drug delivery for generic and personalized medicines to needy patients.The proposed project will develop an interactive, photorealistic VR/AR framework for training technicians in Active Pharmaceutical Ingredient (API) operations. Current virtual modules are not scalable across multiple devices and are not built with the end user customization in mind. This project advances multimodal (augmented reality, mixed reality, and desktop VR) support, accommodating access via head mounted displays, hand-held tablet devices, and/or desktop computers to accommodate diverse learning styles. The project goals are to: 1) identify VR/AR-specific visual, auditory, and haptic cues to enhance transfer of training and retention in API operations, 2) judicious use of these features to design and implement virtual training for multimodal access. The photorealistic modules will include highly-detailed API operations, component assembly/dismantling procedures, and alternative scenario visualization/simulation through interactive parameter modification. Customizable interface functionalities allow users to enable or disable guidance/query features, captions, and audio. Following proper VR training, participant performance will be observed to incorporate iterative enhancements. The intellectual merit involves the novel design of customizable VR/AR interfaces reducing cognitive load and optimizing integration of visual, auditory, and haptic stimuli for training-transfer and retention. The metrics for success will focus on accuracy, schedule optimization, and safety in order to demonstrate the efficiency of VR in pharmaceutical training.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.