Introduction and regulatory requirements
- Fundamentals and requirements for a maintenance concept
- Impacts on a pharma facility
- GMP-Requirements & advice from guidelines and Standards
- Planning maintenance during the qualification Phase
- General objectives of maintenance, priorities
- Maintenance as part of the life cycle of manufacturing Equipment
- Responsibilities: system owner / operator, technician, quality assurance, contractors
- Evolution of maintenance and current thinking in industry
- Digital systems, computer aided facilities management
Development of a maintenance system in the GMP Environment
- Definition of the maintenance strategy: proactive, reactive, predictive
- Service Levels, Increasing equipment availability, product safety
- System Impact (priority, importance, ranking)
- Inventory of equipment, HVAC, utilities
- Maintenance / service level Matrix
- Controlling limits and ranges, strategy for setting Limits
- Handling of repairs and replacements
- Determining spare part requirements
- Measuring maintenance performance, reports
A Risk-based approach to maintenance
- Internal versus external maintenance
- Are supplier’s instructions for maintenance sufficient?
- Establishing maintenance items by risk Analysis
- Determination of adequate materials to be used
- Evaluation of available GMP documentation to fix intervals
- Deviations, CAPAs
- Log-books
- Maintenance documentation
- Cost savings
Organization of Maintenance
- Maintenance schedule, planned maintenance
- Execution of maintenance, flowcharts
- GMP-compliant documentation, paper based vs.electronic Solutions
- GMP-Logbook, SOP´s, Change Control
- Labeling and marking
- Staff organisation, qualification
- Workflow Management
- Transfer of responsibilities
- Hazard and risk analysis
GMP-compliant Calibration
GMP compliant calibration is a main aspect of maintenance within the pharmaceutical industry. Scope of this presentation is an introduction to the extensive requirements for instrument calibration. Beside a structured calibration system aspects of uncertainty and test equipment for calibration are presented. An example of executed calibration and its GMP-compliant documentation cover aspects of practical experience within this lecture.
- Structure of a GMP-compliant calibration System
- Traceability
- Requirements for measuring devices
- Uncertainty and how to avoid Errors
- Execution of calibration - an example
- Calibration certificates and documentation
- Determination of calibration intervals
Hygiene aspects in maintenance work
- Requirements for tools and auxiliary materials
- Typical weak points in maintenance work
- Sources of contamination:
- Workmen
- Tools and auxiliary devices
- Internal vs. external employees
- Logbooks, SOPs
- Restoring operational readiness
- Case study 1: Use of ladders in clean rooms
- Case study 2: Wipe mop, wash-machine, cleaning water
- Case study 3: Oil sealing for SS-surfaces in clean rooms
Case Study: Maintenance of a pharmaceutical Water System
- Construction of water systems and components requiring maintenance
- Spare parts, intervals
- Special technical features for maintenance and repair
- Ozone + UV lamps
- Seals & Hoses
- Rouging
- 3.1 certification
- IT Security, Remote Maintenance & Life-Cycle
- Vibration analysis, thermography, ultrasonic analysis
Case Study: Maintenance of an HVAC System
- Fundamentals and requirements for an HVAC System
- Main parameter in a cleanroom
- Test procedures and measurement methods
- Execution of maintenance, checklists
- Case study, examples
Maintenance of manufacturing equipment: examples
- Special requirements and tips & tricks
- Pumps
- Vessels
- Filling equipment
“Maintenance 4.0” – Digital & Paperless
- Case study CSL: implemenation of a paperless maintenance System
- Usage of predictive maintenance tools
- Downtime reduction & cost savings