Sterile compounding education
Hands-on aseptic technique, cleanroom behavior, environmental controls, documentation, quality assurance, and competency assessment for future practitioners.
Core foundationUT Tyler College of Pharmacy · A vision for what comes next
Where sterile practice meets the next generation of therapy.
A center designed to teach the science of safe preparation, investigate better ways to deliver complex medicines, and prepare pharmacy teams for therapies that are increasingly precise, time-sensitive, and personal.
Aspirational concept; programs and services would phase in as funding, partnerships, and authorizations are established.
Illustrative concept visualization · not an existing facility
Learn → investigate → translateOne connected environment for people, process, and patient-specific therapies.
12,000–16,500 NSFearly core planning envelope
Education + researchbuilt on sterile practice and quality
Advanced therapeuticscell and gene therapy readiness
Phased by designtheranostics and cyclotron as options
The vision
A center that connects disciplines around the therapy.
Build a place where rigorous sterile practice becomes a platform for discovery, workforce preparation, and responsible translation of advanced medicines.
Compounding is the anchor, not the boundary. The Center would bring pharmacists, technicians, scientists, engineers, clinicians, and learners together to solve real problems in preparation, quality, handling, delivery, and access.
LearnPractice with feedback in realistic environments.
InvestigateTest processes, devices, and quality systems.
TranslateMove evidence into safer, better workflows.
What the Center could do
One platform. Several connected capabilities.
Explore the proposed capabilities by stage. The core builds enduring teaching and research capacity; specialized clinical and manufacturing activities require separate authorization and operational readiness.
Hazardous drug and high-risk practice
Teach containment, exposure prevention, device selection, spill response, decontamination, and safe handling across pharmacy and patient-care workflows.
Core foundationComplex sterile formulations
Study preparation challenges involving parenteral nutrition, pediatric and neonatal dosing, ophthalmics, preservative-free preparations, and delivery devices.
Core foundationApplied quality and process research
Investigate aseptic workflow, contamination control, human factors, environmental monitoring, stability questions, automation, and medication-use systems.
Core foundationCell and gene therapy readiness
Develop education and research in chain of identity and custody, time-critical receipt, cryogenic storage, thawing, preparation simulation, and clinical handoffs.
Radiopharmacy and theranostics
Build toward radiopharmaceutical education, quality control, shielded manipulation, and targeted diagnostic / therapeutic workflows with radiation-safety partners.
Cyclotron-produced medicines
Evaluate on-site isotope production only if regional need, distribution economics, partners, licensing, staffing, and lifecycle costs support a viable case.
Long-horizon optionPersonalized preparation science
Explore how decision support, micro-batches, automation, and individualized data could shape future preparation—under validated processes and human governance.
Research horizonProfessional development and partnerships
Offer a home for continuing education, technician development, interdisciplinary workshops, practice-based projects, and workforce upskilling.
A signature learning experience
Follow a therapy from signal to safe use.
Use one connected workflow to teach the thinking, controls, and handoffs behind complex medicines—not just the manipulations at the workbench.
01 · IdentifyPatient and product
Clarify the need, order, source, product status, and time constraints.
02 · ReceiveVerify and protect
Confirm identity, custody, temperature, integrity, and appropriate storage.
03 · PrepareControl the process
Use the right environment, equipment, people, calculations, and documentation.
04 · AssureReview and release
Apply independent checks, quality evidence, traceability, and escalation pathways.
05 · LearnImprove the system
Debrief, study performance, and turn insight into safer practice.
A learning and improvement engine
Teach the work. Rehearse the exceptions. Measure what learners can do.
The Center would connect classroom learning, repeated hands-on practice, realistic simulation, structured feedback, and later reassessment. It builds on existing pharmacy education by deepening integration, transfer, judgment, and retention.
Progressive instruction
Layer knowledge and practice across the learner’s development rather than treating aseptic technique as a one-time lab.
- PharmD foundations: hand hygiene, garbing, aseptic technique, calculations, cleanroom behavior, and quality principles.
- Advanced learners: verification, hazardous-drug workflows, complex cases, error recognition, and care-team handoffs.
- Working professionals: advanced practice, preceptor development, designated-person systems, and quality leadership.
Simulation for routine work and rare events
Scenarios can test decisions that are difficult to teach through demonstration alone: interruptions, discrepancies, suspected contamination, equipment failure, exposure concerns, and uncertain handoffs.
- Pre-brief, observed scenario, structured debrief, deliberate practice, and remediation.
- Cleanroom observation, video review, team communication, and human-factors analysis.
- Cell-therapy identity and custody, cryogenic logistics, and time-critical receipt simulations.
Evidence-based competency assessment
Use multiple forms of evidence to provide specific feedback and document progress. Course completion is educational evidence; it does not replace an employer’s required qualification, authorization, or competency program.
- Direct observation with transparent skill rubrics and trained assessors.
- Knowledge and calculation checks, documentation review, product-quality exercises, and scenario response.
- Deliberate practice plus later reassessment to examine retention and transfer.
Practice research that improves teaching
Begin with feasible questions in the instructional environment, then test useful changes with practice partners where approvals and data governance permit.
- Do video-supported feedback or structured debriefs improve error recognition?
- Which skills persist over time, and what practice supports retention?
- How do interruptions, workflow design, or team communication shape decision quality?
Professional education pathway: modular continuing education for pharmacists and technicians; designated-person and quality-leader development; preceptor and educator preparation; interdisciplinary workshops for nurses and other sterile-practice team members; and customized workforce education. Courses should be mapped to applicable standards and employer requirements, updated as those requirements evolve, and evaluated for learner performance—not just attendance.
Space that teaches and enables
A facility with visible learning and controlled workflows.
The early concept combines instructional environments, applied research, advanced therapy readiness, and spaces for collaboration. Areas shown in planning documents are program envelopes, not final room assignments.
Learn
Sterile compounding teaching suite
Purpose-designed cleanroom learning stations with ante / garbing practice, simulation, cleanroom observation, and equipment support.
Observe
Classroom, debrief room, and studio
Flexible instruction, video capture, case work, competency feedback, and demonstrations that do not require unnecessary entry into controlled areas.
Investigate
Process development and quality labs
Applied research in aseptic processes, analytical methods, environmental monitoring, formulation, human factors, and quality improvement.
Prepare
Advanced therapy readiness suite
Dedicated capacity for cell-therapy receiving, monitored cryogenic storage, identity / custody workflows, handling simulation, and preparation research.
Support
Materials, equipment, and facility backbone
Receiving and quarantine, released-material storage, clean / dirty support, waste holding, IT, monitoring, maintenance access, and equipment staging.
Expand
Radiopharmacy and cyclotron option
A separately studied controlled suite for shielded handling, radiochemistry, hot cells, QC, waste, and—if justified—a cyclotron production module.
Planning principle: separate people, material, product, waste, and maintenance flows. Keep instructional observation distinct from any regulated or radiation-controlled operation. Final layouts must be designed and qualified for the actual scope, equipment, and applicable requirements.
Research agenda
Questions that improve practice now—and build the next capability.
The research engine should be practical and collaborative: produce evidence that can improve reliability, training, access, and appropriate use of advanced therapies.
See the program brief01
Aseptic process science
First-air practices, workflow design, environmental monitoring, contamination control, equipment placement, and how people interact with the environment.
02
Formulation, compatibility, and delivery
Preparation and administration questions across complex infusions, pediatric dosing, ophthalmic therapies, pumps, tubing, and specialized dosage forms.
03
Human factors, training, and decision quality
Measure how simulation, feedback, check design, information access, and team communication affect reliability and professional judgment.
04
Advanced therapy operations
Study identity / custody, cryogenic logistics, time-critical handoffs, radiopharmaceutical workflows, and the quality systems needed around novel therapies.
05
Data and responsible automation
Prototype decision support, process analytics, and automation that aid pharmacists and technicians; retain human accountability, validation, and governance.
06
Access and resilient practice
Explore shortage response, rural and regional access, workforce readiness, and models that bring complex preparation expertise closer to patients.
Build in stages
Ambitious end state. Disciplined sequence.
Make the first phase independently valuable, while protecting the option to grow into more specialized work as partnerships and resources mature.
Program and feasibility
Confirm partners, operating model, site, utilities, room program, cost range, and decision ownership.
Core Center
Launch teaching cleanrooms, studios, research / quality labs, support spaces, and digital backbone.
Advanced therapeutics
Add dedicated cell-therapy readiness and radiopharmacy / theranostics capabilities when authorized and supported.
Cyclotron decision
Proceed only if demand, partners, licensing, staffing, logistics, and lifecycle economics form a credible case.
Cyclotron: preserve the option, earn the investment.
IAEA facility guidance describes a dedicated vault and support block alongside production, QC, access, storage, and radioactive-waste functions. The selected accelerator and isotope portfolio drive the actual scope, so this deserves its own feasibility and business case.
A strategy for distinctiveness and scale
Own the learning core. Grow capability with partners.
Publicly described programs show that sterile-compounding education, cleanroom simulation, and professional training already exist elsewhere. UT Tyler’s opportunity is to connect them into a pharmacy-led platform that links instruction, observed competency, practice research, and a regional advanced-therapy network.
Pharmacy and technician education
Health-system practice sites
Cell and gene therapy programs
Nuclear medicine and oncology
Research and quality scientists
Equipment and technology partners
Regional and rural health
Professional organizations
The durable academic core
Distinctive capabilities that anchor the Center and directly serve learners and regional workforce needs:
- Teaching cleanrooms, simulation, studios, and competency assessment.
- PharmD, technician, continuing, preceptor, and quality-leader education.
- Applied research in process reliability, human factors, learning, and medication-use systems.
Practice-linked translation
Capabilities that become stronger with clinical operations, research, and patient-care partners:
- Practice-based studies and implementation of tested improvements.
- Advanced-therapy readiness, clinical workflow, and interprofessional education.
- Shared workforce development and quality-improvement projects.
Specialized infrastructure
Use experienced facilities while UT Tyler establishes need, governance, expertise, and a sustainable operating case:
- Cell / gene therapy GMP manufacturing and regulated release testing.
- Cyclotron production, clinical radiopharmacy, and specialized isotope workflows.
- Highly specialized services beyond the Center’s initial academic scope.
Benchmarks and potential pathways: VCU describes compounding practice and research with cleanroom education; the University of South Carolina offers sterile-compounding training; and Fairleigh Dickinson’s Lewis Center combines classroom, e-learning, and simulation. Potential regional expertise includes UT Southwestern, Baylor College of Medicine / Texas Children’s, and MD Anderson. These are benchmarks and possible pathways only; no partnership or access is represented as secured.
Read the working plans
Two briefs to take the conversation forward.
Download the program concept and the companion space / capital planning document. Both are planning materials for discussion and refinement.
Vision · Program
Facility & Program Brief
Purpose, organizing vision, program areas, signature learning cycle, initial facility concept, partnerships, governance, and development phases.
Space · Capital
Space Program & Capital Planning Brief
Preliminary area ranges, adjacencies, building systems, phased options, capital estimate structure, and decision gates—including a separate cyclotron path.
Planning and standards references
A vision worth building toward
Prepare people for medicines
that do not yet exist.
Start with a strong sterile-practice foundation. Bring the right partners together. Create room for discovery. Grow into advanced therapies when the science, need, and stewardship align.