Strengthening Cleanroom Performance

WITH OUR NEW INTERACTIVE MODULE

Aseptic Processing
Essential Personnel Practices

Personnel are the primary contamination risk in aseptic manufacturing environments. Every action in the cleanroom – from movement to equipment handling – can influence contamination risk. To support sites facing increasing regulatory expectations and the enhanced requirements of Annex 1, Skillpad has released Aseptic Processing – Essential Personnel Practices.

This module places learners inside a sterile manufacturing workflow, following the journey of a monoclonal antibody product through harvesting, purification, gowning transitions, aseptic filling, and final cleanroom exit. The result is a realistic, scenario-based experience that strengthens the habits and behaviors essential for maintaining aseptic integrity.

A Real Operator Journey

Learners progress through tasks exactly as performed in controlled environments, including:

• • Grade C entry: hand hygiene, PPE purpose, and PPE discipline.
  • Sterile equipment staging and sterile connection technique during harvesting.
  • Controlled movement around chromatography and purification systems.
  • Identifying contamination risks in purification and filling areas.
  • Correct and compliant responses to compromised gowning.
  • Health and hygiene checks before Grade B entry.
  • Glove sanitization decisions inside the filling suite.
  • Escalation of non-compliant behavior.
  • Response to process abnormalities such as filling leaks.
  • Correct gown removal and post shift hygiene.

These decisions are reinforced through interactive knowledge checks, risk-identification tasks, and realistic cleanroom scenarios.

Why it Matters for Annex 1 Alignment

The revised Annex 1 places increased emphasis on personnel behaviour, contamination awareness, and a deep understanding of why each action protects the product.

This Module builds this awareness by linking behavior directly to product sterility, product quality, and patient safety.

Designed for Cleanroom Operators and Aseptic Manufacturing Teams

This Module is ideal for cleanroom operators including:

• • Aseptic processing personnel.
  • Fill finish teams.
  • Upstream and downstream manufacturing staff.
  • Quality professionals supporting aseptic operations.

This Module supports consistent training across global teams and reinforces the correct response to contamination risks and deviations.

Raising the Standard of Aseptic Personnel Training

With regulatory expectations rising and greater emphasis on contamination prevention, organisations can no longer rely on informal or inconsistent training approaches. The Module provides structured, reliable, and Annex 1-aligned training that strengthens operator performance across the aseptic workflow.

To learn more or to adopt this module in your training program, contact our team for implementation support.