Sterile Compounding

Overview of the Issue

https://bpsweb.org/compounded-sterile-preparations-pharmacy/

Sterile compounding is a critical component of pharmacy practice, involving the preparation of medications in aseptic environments to prevent contamination, especially for high-risk medications like chemotherapy or ophthalmic solutions. However, pharmacy education in Canada struggles to provide students with adequate hands-on experience in sterile compounding due to high facility costs, safety concerns, and logistical limitations. This gap in experiential learning is particularly concerning as the healthcare system increasingly relies on pharmacists to perform these complex tasks with precision and care.

Who is Impacted?

This issue directly affects university pharmacy students who must develop sterile compounding competencies before entering clinical practice. It also impacts pharmacy educators, academic institutions, and regulatory bodies responsible for ensuring training standards. Ultimately, patients are affected, as improperly compounded medications can lead to serious health risks. Clinical preceptors and healthcare facilities are also involved, as they are often responsible for supplementing students’ practical training.

History and Causes

Traditionally, pharmacy education has emphasized theoretical instruction with limited access to sterile compounding labs. High costs, space constraints, and the complexity of maintaining cleanroom environments have made it difficult for many institutions to offer consistent, hands-on training. For example, some universities have unused sterile compounding areas due to logistical challenges. Additionally, strict regulatory standards (e.g., NAPRA) and the risk of contamination during training further complicate efforts to provide real-world practice opportunities.

Addressing the Issue

To overcome the limitations of traditional sterile compounding training, Virtual Reality (VR) offers a promising solution. VR can simulate cleanroom environments and aseptic procedures, allowing students to gain hands-on experience in a safe, scalable, and cost-effective way.

Labster complements VR-based learning by offering interactive, science-based simulations that reinforce the pharmacy concepts. Students can engage with Labster's virtual pharmacy labs through a VR headset.

(Altoura, 2024)

Challenges in Integrating VR into Pharmacy Education

While VR presents many benefits, its integration into pharmacy curricula comes with several challenges:

Cost:
- High Costs: Initial investment in VR headsets, software, and infrastructure can be significant.
Technical Challenges:
- Technical Expertise: Instructors and students may require training to use VR tools effectively.
- Technical Issues: Hardware or software malfunctions can disrupt learning and require IT support.
- Field of view (FOV): Inadequate FOV or low frame rates can increase disorientation and induce motion sickness.
- Prolonged use discomfort: Headset weight and eye strain can limit session length.
- Storyline design in VR may limits player autonomy

Pedagogical Integration:
- Curriculum Alignment: Incorporating VR into existing courses may require redesigning learning objectives, content, and delivery methods.
- Assessment: Developing valid and reliable methods to assess student performance in VR environments remains complex.
- User onboarding: New users often require guided orientation before meaningful use.
Realism and Effectiveness:
- Realism: While VR can simulate visual and procedural elements, it may lack tactile feedback that is essential for mastering certain manual skills.
- Effectiveness: Research is ongoing to determine how VR compares to traditional methods in achieving long-term learning outcomes.

Sample Unit Plan

Module 1: Aseptic Hand Washing Techniques VR Training Module is a step-by-step, interactive guide to aseptic handwashing practices designed to minimize the risk of microbial and particulate contamination in controlled environments. Using real-time feedback and UV light visualization, learners will see how improper technique can leave behind hidden contaminants—even when hands appear visibly clean.

Through guided practice, learners will observe and apply the validated sequence for washing and scrubbing hands and forearms prior to gowning. This life-like VR training reinforces both the "how" and the "why" of proper technique—developing muscle memory and contamination awareness critical to maintaining cleanroom sterility.

Skills covered in this module include:

Contamination Awareness
Proper Hand Washing Sequence
Thorough Coverage Techniques
Timing and Repetition Discipline
Use of Visualization Tools (UV Simulation)
Preparation for Aseptic Gowning

Aseptic Work Famasia (2024)

Module 2: Gowning Procedures VR Training Module is a fully interactive, simulation-based training experience that prepares personnel to properly gown for ISO 5–6 clean room environments. This training ensures learners understand and execute the proper gowning techniques to minimize contamination and comply with GMP standards.

In this hands-on module, learners will explore the reasons behind gowning protocols and practice each step of the top-down gowning approach, the preferred method for protecting lower garments from upper-body contamination. Through real-time, guided simulations, users will select PPE, don garments in the correct order, and follow best practices for maintaining gown sterility during and after the process.

Trainees will navigate a realistic gowning room environment where they must gown without compromising the cleanroom’s integrity, gaining the muscle memory and awareness needed to consistently perform in real-world operations.

Skills covered in this module include:

Understanding Contamination Risks
Clean room Gowning Protocol Awareness
Top-Down Gowning Technique Execution
Proper PPE Selection and Handling
Aseptic Donning Technique
Behavioral Discipline in Gowning Rooms
GMP and SOP Compliance

Centers for Disease Control and Prevention (2020)

Module 3: Laminar Airflow Workbench (LAFW) and Biosafety Cabinet Setup (BSC) and Aseptic Technique VR Training Module immerses learners in the foundational practices of preparing and working within a sterile compounding environment. This module focuses on the correct setup of the LAFW and BSC, the principles of first air, and the execution of aseptic manipulations to maintain sterility throughout the compounding process.

Learners will engage in realistic simulations that reinforce spatial awareness, proper material placement, and sterile handling techniques. Through guided practice and real-time feedback, they will learn to identify and correct common errors that compromise airflow and increase the risk of contamination.

Skills covered in this module include:

Identify the major parts of a Class II BSC
Demonstrate how to maintain positive airflow within a BSC
Demonstrate how to prepare for work in a BSC
LAFW Cleaning and Setup Procedures
Understanding and Preserving First Air
Proper Staging of Supplies and Equipment
Aseptic Handling of Syringes, Needles, and Vials
Avoiding Touch and Shadow Contamination
Workflow Discipline and Critical Site Awareness
Demonstrate how to decontaminate and shut down a BSC and LAFW
Conduct emergency shutdown procedures in a BSC and LAFW

Module 4: Sterile Compounding Procedures and Final Product Preparation VR Training Module guides learners through the complete process of preparing compounded sterile products using aseptic technique within a controlled environment. This module emphasizes accuracy, precision, and sterility throughout the compounding workflow—from ingredient verification to final inspection.

Learners will simulate real-world scenarios involving the reconstitution of medications, withdrawal and transfer of fluids, and labelling of finished products. The module reinforces critical thinking, attention to detail, and adherence to USP <797> standards, while providing real-time feedback on technique, contamination risks, and procedural accuracy.

Skills covered in this module include:

Interpreting and Following Compounding Instructions
Aseptic Reconstitution and Fluid Transfer
Syringe and Needle Handling for Accuracy and Safety
Labelling and Documentation Requirements
Final Product Inspection and Quality Assurance
Responding to Errors and Maintaining Sterility

Sterile Compounding Procedures and Final Product Preparation VR Training Module Lesson Plan.pdf

Sample Lesson Plan

Sample lesson plan for Sterile Compounding Procedures and Final Product Preparation.

Reflection Assignment.pdf

Reflection Assignment

Case Study Discussion.pdf

Case Study Discussion

Module 5: Quality Assurance and Environmental Monitoring in Sterile Compounding VR Training Module introduces learners to the essential practices that ensure the ongoing safety, sterility, and compliance of sterile compounding environments. This module emphasizes the importance of routine monitoring, documentation, and corrective actions in maintaining cleanroom integrity and meeting regulatory standards, such as USP <797>.

Through interactive VR simulations, learners will explore the procedures for surface sampling, air sampling, and personnel monitoring. They will also practice interpreting environmental data, identifying trends, and responding to out-of-specification results in a timely and compliant manner.

Skills covered in this module include:

Principles of Environmental Monitoring
Surface and Air Sampling Techniques
Personnel Monitoring and Glove Fingertip Testing
Interpreting EM Data and Recognizing Trends
Documentation and Reporting Requirements
Responding to Contamination Events and Deviations

Alignment with NAPRA

The following outlines the NAPRA Models standards that are taught in Module 1 and Module 2.

Policies and Procedures for Compounding of Sterile Preparations

*Bolded requirements are covered in the VR modules. (NAPRA, 2016)

Aseptic Compounding of Sterile Preparations

*Bolded requirements are covered in the VR modules. (NAPRA, 2016)

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