Consultancy & Validation
Sterility Assurance Risk Management and Strategy

Consultancy & Validation

Our Sterility Assurance team, consisting of Microbiologists, Engineers and Validation professionals, develop bioburden and contamination control strategies, as well as undertaking risk assessments using tools such as FMEA, HACCP and RMC.

Projects include:-

• Risk assessments for non-viable /viable particle monitoring
• Sterile Process Equipment audit & Troubleshooting
• Sterile Product Manufacturing Remediation investigation
• Process Improvement
• HACCP for Bioburden control
• Bioburden Assessment for sterilisation dose audits

Our consultancy can include assistance with system designing, performing qualification activities, staff-training, mentoring & coaching.

We understand the sensitive nature of processes and products, to discuss your requirements with one of our experts in a confidential manner, please contact us with your details and a brief introduction, so we can arrange a call back at a time convenient to you.