Training of Aseptic Behavior
Why Aseptic Behavior Matters
In aseptic environments, safeguarding product quality hinges not only on what operators know, but on how they act. Movements, decisions, and responses directly affect contamination risks.
Regulatory authorities consistently underscore that human behavior is a key contributor to contamination. This is why theoretical knowledge alone is not enough.
Trusted by the industry
Traditional training methods in aseptic environments often fall short in preparing operators effectively. SOPs and e-learning modules alone don’t provide the hands-on practice necessary to develop the muscle memory required for aseptic execution.
Trainers are tied up supervising repeated sessions, despite limited cleanroom access, which makes scaling difficult. Qualification relies heavily on subjective judgment, and audit expectations are shifting toward objective, behavior-based evidence.
Limited practical behavioral training
High trainer and cleanroom resource use
Subjective qualification decisions
Rising audit demands for objective proof
Aseptic Behavior Training with Immersive Technologies
Immersive training technologies enable consistent practice of correct behaviors in high-risk scenarios. Interactive, repeatable environments strengthen muscle memory, raise situational risk awareness, and reinforce appropriate actions in key moments, from cleaning and disinfection to aseptic interventions.
Principle-Based Training that Sticks
Effective aseptic behavior starts with understanding principles of why First Air matters, how fast movements cause turbulence, and what contamination paths look like. Training with Innerspace begins by anchoring these risks in intuitive, visual explanations.
Trainees don’t just memorize rules, they experience the logic behind them. By making invisible risks visible and tangible through interactive VR, we help learners build internalized habits they can apply across any process. This approach bridges the gap between knowing and doing, preparing personnel for consistent performance, even under pressure.
From Knowledge to Routine
The Innerspace VR Cleanroom Simulator lets operators practice aseptic techniques in authentic training scenarios with real-time feedback on every movement. Whether managing glass breakage, positioning hands under laminar airflow, or performing environmental monitoring, trainees develop the patterns and confidence they need to act reliably in risk-intensive situations.
Effective Aseptic Training Programs
Training only works when it fits your operations. We support building a holistic training program that aligns with your roles, risks, and processes. From initial setup to operational excellence, we’re a partner in implementation.
Support for implementation, validation, and ongoing program evolution
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Our Solutions
Better Knowledge.
Smarter Decisions.
Quality Risk Management
Automate process design and risk assessment in aseptic manufacturing with data-driven insights from our Process Knowledge Database. Reduce risks, accelerate time-to-market, and ensure quality and compliance.
Training Programs
Eqip your team with the expertise needed for excellence in aseptic manufacturing through scalable, data-driven digital training solutions. Our Frame-by-Frame method ensures effective knowledge transfer.
GMP-compliant, Modular and Risk-based
The solution is designed to prepare staff for regulated environments from step one. Every component, from content design to data handling is built to meet the highest cGMP standards, support audit-readiness, and ensure training relevance where it matters most.
Innerspace is official partner of the Parenteral Drug Association (PDA) for designing and delivering data-driven training solutions.
Our Frame-by-Frame®-powered programs enhance PDA’s courses, providing high-quality education even without traditional cleanroom environments.
What the industry says about us
“Normally, there is a certain subjectivity in training. With the Simulator the judgement on mistakes is transparent, and reproducible.”
“The virtual reality environment of the Simulator allows our operators to make mistakes, see consequences and learn from them.”
“In critical aseptic environments, employee qualification is crucial. Innerspace provides the effective training package that complements our program.”
“Since the start of our collaboration 5 years ago, Innerspace made enormous progress in establishing outstanding training tools.”
“I have integrated the VR Simulator at a customers site into an existing training program and was amazed by how easy and fast this project was going.”
“We are thrilled to partner with Innerspace to provide our members and the industry with innovative and effective training solutions that brings the VR cleanroom into any location.” Read more: Press Release 19 June, 2023
FAQ’s
Innerspace offers a comprehensive cGMP – compliant training solution that combines both principle-based and process-specific components to equip operators with the knowledge, risk awareness, and behaviors essential for aseptic manufacturing.
The principle-based training focuses on core cGMP concepts and cleanroom behavior. It is delivered through immersive simulations in generic cleanroom environments—such as RABS, isolators, or BSCs—without the need to replicate specific production processes. This enables operators to master fundamental behaviors that can be directly transferred to their individual work environments.
This principle-based training solution is available off the shelf and can be implemented independently of any process-specific content. To complement this, Innerspace also offers the development of process-specific training content using the capabilities of Frame-by-Frame®. Rather than recreating production lines in virtual reality, we use right-wrong process execution videos to highlight critical actions, common mistakes, and process-specific risks.
Together, these components form a blended training package that addresses both foundational principles and context-specific operational challenges—ensuring a scalable and effective training experience tailored to your production needs.
Yes, our training solution is aligned with cGMP requirements and is specifically designed to support implementation in regulated environments. As an official partner of the Parenteral Drug Association (PDA) for training course design and delivery, we collaborate closely with leading industry experts who review and validate our content to ensure regulatory relevance and quality.
Our training content reflects the latest EU GMP, FDA 21 CFR Part 211, and ICH guidelines, and is continuously updated to stay ahead of evolving standards.
To further support compliance, we provide ready-to-use validation documentation that simplifies implementation and integration into your existing quality systems. Combined with precise and robust learner progress tracking and audit-ready records, our solution helps ensure your teams are trained to cGMP standards.
Yes, Innerspace provides structured implementation support to ensure a smooth and efficient rollout of the training solution at your
facility. We offer clear blueprints and best practices for integration into your existing training programs and compliance framework.
Our Customer Success team—comprised of training specialists, industry experts, and IT professionals—works closely with your team to tailor the onboarding process to your specific needs. This includes guidance on configuration, deployment and validation.
We also provide ready-to-use cGMP validation documentation, helping you meet regulatory requirements and bring the solution into a validated state with minimal effort.
For our principle-based training solution, we offer robust behavior tracking and analytics to monitor trainee learning progress and ensure training effectiveness.
When integrated with a Learning Management System (LMS), each learner’s progress is stored and visualized within the LMS— providing a comprehensive overview of staff performance across training modules.
Key features include:
This data-driven approach ensures measurable learning outcomes and actively supports your Contamination Control Strategy by identifying behavioral risks and closing knowledge gaps before they impact operations.
The principle-based training content is standardized to ensure consistency, regulatory alignment, and expert-reviewed quality across all training deployments. While the core content itself is not customizable, the solution is designed to be flexible and adaptable to your organization’s needs.
We offer:
The principle-based training solution is available in multiple languages to support global teams and ensure accessibility across regions. The standard language package includes English, German, French, Italian, Spanish, Portuguese, Japanese and Korean.
We understand the importance of delivering training in the native language of operators to ensure clarity, engagement, and effective learning.
If your organization requires additional languages, we’re open to discuss language extension options upon request, enabling broader and more inclusive deployment across your workforce.
All updates to Innerspace’s training solution follow a formal change control process in line with cGMP expectations. This ensures that any modifications—whether related to content, functionality, or system behavior—are evaluated, documented and communicated appropriately.
Our change control process includes:
This approach ensures that updates enhance the training experience while maintaining compliance with your quality management system and regulatory requirements.
The principle-based training solution is designed to be relevant across a wide range of production environments, even when site-specific procedures vary. It uses authentic, illustrative scenarios within a generic cleanroom setting— such as isolator, RABS, or BSC—to emphasize core cGMP behavioral principles rather than replicating individual production processes.
The training covers fundamental principles, including contamination awareness, the influence of operator behavior in cleanroom environments, aseptic techniques, cleaning and disinfection practices, the concept of first air, and environmental monitoring.
To ensure the training has the intended impact, it is important that the principle-based content is linked to existing internal training materials and procedures. This connection helps operators transfer what they’ve learned into the context of their day-to-day work.
Our implementation team actively supports your organization in mapping the training solution to your existing training program, ensuring alignment with your internal standards and procedures and learning objectives.
This approach supports the development of foundational behavioral competencies that apply across different roles and cleanroom operations. After completing the training, operators gain a clearer understanding of the cleanroom context, which can help them interpret and learn process- specific knowledge more effectively.
We offer a comprehensive, modular training solution designed to support a variety of aseptic operational roles within cleanroom environments. The program focuses on core cGMP principles and operator behaviors that are critical across sterile manufacturing.
Key topics covered include cleanroom behavior, principles of cleaning and disinfection, principles of first air, and fundamentals of environmental monitoring.
To reflect the practical context of different roles and facility setups, customers can choose from three cleanroom environments: RABS, isolator, or BSC. This ensures the training environment aligns with the specific equipment and operational realities of each site.
The modular structure enables organizations to build role-specific curricula, while maintaining alignment with regulatory expectations and best practices in contamination control.
Yes, the Innerspace training solution can be seamlessly integrated with your existing Learning Management System (LMS). We support SCORM 2004 (4th edition), enabling standardized communication between the training content and your LMS platform.
This integration makes it possible to track learner progress and completion status directly within your LMS, store session results to support audit readiness and compliance, and manage all training records alongside your existing internal learning content.
Each training module is divided into submodules, which can be individually embedded into LMS courses—allowing you to configure tailored learning paths for different roles within your organization.
The training content is fully version-controlled, and we provide the relevant validation documentation with each release version to support your cGMP compliance requirements. Our implementation team is available to assist with mapping and integrating the solution into your LMS environment efficiently.
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