Theory & Practice Sterilisation & Depyrogenation

Theory & P ractice Sterilisation & Depyrogenation Our highly regarded ‘Sterilisation and Depyrogenation’ Training Course has developed significantly for 2015 including a new Practical Training Centre offering access to Autoclaves, Water Systems, Clean Steam Generators and Parts Washer. A number of Training courses will be delivered from this new venue, including ‘Sterilisation and Depyrogenation’, ‘Pharmaceutical Engineering’, ‘Critical Utilities’, ‘Microbiology for non Microbiologists’, ‘Water and Steam systems’ and ‘Management and Control of Clean rooms’. The equipment control systems are networked with the air-­‐conditioned training room so that cycles being run can be reviewed or monitored live in the training room. All of the equipment is GMP compliant, maintained and calibrated accordingly. However for the duration of the training courses, the equipment is set up for changes to be made, fault’s to be introduced, and failure modes simulated. THEORY AND PRACTICE EPIC’S Training course is being delivered in Steritech UK’s Technical Centre situated near Gatwick airport in the UK. The Technical area is adjacent to the training room for lectures, this allows application specific lectures to be delivered followed by practical demonstrations and the opportunity for ‘hands on‘ Training Theory Elements Day 1 § The Spectrum of Sterilisation and Process Risk Assessment § Current Regulatory Framework and Emerging Standards § Introduction to Microbiology – Pyrogen Control, Sterility Assurance § Kinetics of Death, Moist Heat and Dry Heat § Equipment and Porous Load Sterilisation Practical Elements With a New Training Center EPIC can now offer hands on practical implementation of the Theory. Practical aspects of this course will include: • Porous Load Cycle d evelopment • Wet Loads investigations and CAPA • Trapped air consequences in Equipment loads • Fluids loads monitoring and control strategies • EN285 Benchmark testing • Air detector set up, ADPT, ADFT • Steam Quality Control and testing • Thermal monitoring equipment (V2K) • Biological challenges (BI’s) • Cycle Efficiency improvements o Fluids Loads o Porous Loads Day 2 § Porous Load Benchmark Challenges § Air Detector Installation, Set-­‐up and Performance Testing § Steaming in Place – Sanitisation, Bioburden Control and Sterilisation § Fluid Loads Sterilisation – Air Steam Mixtures, Water Spray and Water Cascade § Monitoring Fluid Load Sterilisation Processes Day 3 § Dry Heat for Sterilisation and Depyrogenation § Batch Ovens and Tunnel Ovens § Cycle Development and Load Definition for Process Efficiency § Criticality Assessment of Acceptance Criteria § Performance Qualification and Re-­‐Qualification Approaches § Operation, Routine Monitoring and Testing Reviewing Cycle Data, Use of Independent Records, Electronic Data Storage § Self-­‐Inspection and Annual QA Review, Role of the Subject Matter Expert § Course Assessment Efficiency, Process Improvement & Compliance Epic Consultancy and Training Ltd. www.EPIC-­‐ Tel: -­‐ +44 (0)1833 651945 | Email: -­‐ [email protected]­‐ | Registered in England and Wales No 07772209