Seamless integration of aseptic behavior training into your APS qualification workflow.
Ensure Operator Qualification for Aseptic Process Simulation. We provide High-Efficiency training through a data-driven focus on your SOP 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 training program that focuses operator time where it has the greatest impact.
Focus
Relevance
Efficiency
Streamlining Media Fill
Qualification.
We help pharmaceutical manufacturers prepare their operators for qualification in aseptic process simulations (APS), with a clear focus on qualification-critical behaviors.
Efficient Training Approach
Instead of a general training approach, we identify exactly what needs to be trained based on the risks specific to your process.
By screening your SOPs, we uncover critical actions, objects, and hazards and translate them into targeted learning goals. This approach streamlines training efforts while maximizing relevance and qualification readiness.
Embedded Micro-Learning
Our embedded micro-learning is built on a set of modular training components, such as VR modules, explainer videos, and interactive exercises. All components are designed to work together and can be flexibly combined to fit your specific training needs.
This modular approach allows us to configure each qualification program to match the specific risk profile of a site or line, using modular elements configured for consistency and efficiency across lines or sites.
From Analysis to Training:
A 1-Month Plan
Our process outlines the key steps to develop and implement a tailored training plan. From initial risk analysis to the launch of the training program, this timeline illustrates the objective, modular approach we use to create a focused and efficient solution.
This is a closed-loop process that continues after the first qualification round, where we analyze new risks and optimize training to reduce the risk of qualification failure and accelerate operator readiness.
Analysis
Didactics
Methodology
Training Plan
SOP Screening & Risk Identification
We define what to train and at what intensity
We propose when and how to train
We create a tailored plan using standardized modules
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Ensure Operator Readiness with Innerspace
We help pharmaceutical companies build training programs that take into account how operators actually learn: in context, under pressure, with little time.
With our Qualification Service, you can align your team with regulatory expectations without pulling them away from their daily work.
Maximize the impact of your training efforts.
Innerspace delivers:
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
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
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.