Efficient Operator Qualification Training for Aseptic Process Simulation (APS).
We ensure highest Training relevancy by structuring Training around your specific process risks.
When aseptic process simulation fails, production comes to a halt. Therefore, it’s critical to reduce the risk of operator failure.
We help you qualify with confidence by identifying the most relevant risks in your APS process. Based on that, we build a qualification program that focuses operator training where it has the greatest impact.
Focus
Relevance
Efficiency
Efficient Media Fill
Qualification Approach.
We help pharmaceutical manufacturers prepare their operators for qualification in aseptic process simulations (APS), with a clear focus on qualification-critical behaviors.
Hazard Screening
Instead of a general training approach, we identify exactly what needs to be trained based on the risks specific to your process.
We perform Hazard Screening by analyzing your SOPs for critical objects and actions. This process allows us to objectively define risks and immediately translate those findings into targeted learning goals, which streamlines your training efforts and maximizes qualification readiness.
Effective Training Approach
Effective training programs must integrate fundamental knowledge and risk awareness with role-specific, behavior-focused training to ensure both compliance and operational excellence.
Our qualification program is constructed from a set of modular training components. This modular architecture enables us to configure each qualification program to precisely match the specific risk profile of a site or line, utilizing these modular elements to ensure both consistency and efficiency across different lines or sites.
To maximize the impact of your qualification efforts, our solution is structured around the three pillars of effective aseptic manufacturing training:
From Analysis
to Value Capture.
The training process begins with Hazard Screening of your SOPs to objectively identify critical objects and actions. This data-driven approach prioritizes specific hazards and sequences them into a precise training plan, with modules starting six to four months prior to the APS.
To verify success, Oversight receives a digital checklist of critical tasks—linked directly to the qualification schedule—proving the training concept’s effectiveness by confirming operators consistently apply trained behaviors. Below, you will find an exemplary timeline detailing this process, from initial Hazard Screening to the APS.
4+ months prior
3 months prior
2 months prior
1 month prior
Hazard Screening in SOPs
Definition of Learning Objectives
Training Program Development
Module: Hand Movement Speed
Module: First Air Awareness
Module: First Air Training
Module: First Air Assessment
Module: Fix Stopper Blockage
Module: Active Air Sampling
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Business Weeks
APS
Measurable Outcomes
We help pharmaceutical companies build training programs that take into account the real hazards that need to be trained, enabling the development of a highly-relevant qualification program.
Furthermore, the training is inherently effective as we combine knowledge, risk awareness, and behavior training within our modular training setup.
The Innerspace Operator Qualification Service delivers demonstrable results:
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.
Unlock Your Training’s Full Potential
We begin with a data-driven analysis of your SOPs to precisely identify process-specific risks. Our experts then provide a clear roadmap that directly targets these risks, optimizing your training for compliance and effectiveness.
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
Innerspace Blog
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How Innerspace’s data-driven approach efficiently prepares operators for media fill qualification
In aseptic manufacturing, operator errors are the leading cause of media fill failures. Innerspace’s data-driven Operator Qualification Service uses risk-based…
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4minutes read
FAQ’s
The Operator Qualification Service is a comprehensive training and oversight solution designed to prepare operators for Aseptic Process Simulation (APS) qualification. We provide a risk-based approach that utilizes SOP-embedded micro-learning to ensure operators are both technically and behaviorally ready for their qualification. This service focuses on aligning the training directly with media-fill requirements, providing a solution that is both efficient and highly targeted to the specific needs of your processes.
Innerspace’s data-driven approach prepares operators for media fill qualification by first analyzing your SOPs to identify specific, process-related risks. Using our Frame-by-Frame® methodology, we pinpoint the critical actions, objects, and hazards that matter most, replacing broad training with a targeted, modular program. This allows us to build a highly efficient training plan that focuses only on the most relevant behaviors, dramatically reducing training time and accelerating operator readiness without compromising on compliance or quality.
Read more: How Innerspace’s data-driven approach efficiently prepares operators for media fill qualification
As operators read SOPs, micro-learning prompts (e.g., video, checklist, recall quizzes) appear inline to reinforce critical behaviors.
Yes, supervisors use digital checklists, capturing real-time behavior data and eliminating handwritten logs.
We design our training methods to align with GMP, Annex 1 expectations for sterile processing, QRM best practices, and media-fill qualification standards.
Ready to Qualify with Confidence?
Thinking about streamlining your operator qualification and reducing validation risk?
Learn more about our Qualification Service and request your SOP analysis today.