Relevant case studies

Blog post: 01/10/2025 3:10 pm

Author: Spark Team

VR SOP Training for Biologics & Cell/Gene Therapy Manufacturing

Custom-built VR that protects product integrity, embeds GMP, and accelerates competency

Advanced therapy medicinal products (ATMPs) and biologics introduce exacting requirements for asepsis, chain of identity, and chain of custody. Spark Emerging Technologies Ltd designs and builds bespoke VR SOP training that mirrors your actual cleanroom layouts, Grade classifications, single-use systems, and closed processing steps—so operators and QC teams can practise high-risk procedures without jeopardising irreplaceable patient lots.

Sector pain points we address

• Chain of identity/custody: mislabelling or mix-ups during receipt, staging, and batch release.
• Aseptic behaviours: interventions at biosafety cabinets/ISO hoods, flow disruptions, and touchpoint control.
• Single-use assemblies: sterile connections, welds, and tube sets with correct orientation/torque.
• Deviation handling: excursions, alarm responses, and rapid CAPA execution.
• Documentation under GMP: ALCOA+ principles, contemporaneous entries, and audit readiness.

How our bespoke VR build works

1. Discovery & SOP capture: map gowning matrices, material/personnel flows, and batch records.
2. Risk-based scenario design: media fills, aseptic interventions, sterile weld connection, and EM responses.
3. AI avatar guidance: enforces your exact wording for critical steps, hold points, and line clearance.
4. Assessment analytics: touchpoint heatmaps, dwell times, error flags, and re-training prompts.
5. Integration: LMS/quality systems linkage, multilingual packs, and role-based pathways.

Operational outcomes

• Reduced contamination risk and batch loss.
• Faster time-to-competence for new hires and cross-trained staff.
• Defensible evidence for inspections and client audits.
• Stronger adherence to chain-of-identity/custody requirements.

Why Spark

No off-the-shelf content—every scene, prompt, and assessment metric is tailored to your site’s SOPs, equipment, and quality system.

Protect every batch with a bespoke VR SOP programme. Contact Spark.

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