Axys-Network – Aseptic process consulting
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SAL – Sterility Assurance Level

Sterility assurance level: control and demonstrate your SAL

SAL is a requirement for any process whose sterility or bioburden appears in the final specifications. It demonstrates process performance and makes it possible to score and classify the probability of a non-sterile unit, for aseptic processing as well as terminal sterilisation.

Our three-step approach

1. Training and internal workshops

Understand the requirements of ICH Q9, GMP and local regulations, then apply them to your processes and microbiological specifications to rank the critical steps.

2. Self-inspections and internal audits

Tailored questionnaires, checklists and coaching, with a simple scoring grid to prioritise remediation and CAPA.

3. Formal risk assessment

Collaborative work led by our experts on steps, equipment and systems, through to a formal risk map. The tool has been published and recognised as innovative by the scientific community.

What you gain

Stronger compliance with ICH Q9 and GMP requirements A high level of confidence in the sterility of your products Bioburden limits you can defend during inspections Actions targeted at the right step and the right procedure