Streamlined Approach for Moist Heat Sterilization (Autoclave) in Pharmaceutical and Healthcare Industries

Engineering and Validation

Laboratory

Operations

Quality

rd

Target Level

• Validation and Qualification scientists, Supervisor and Manager
• Production supervisors or Manager
• Quality Department (QA, QC (Microbiology), Regulatory Affairs and Compliance)
• Medical Lab Supervisor
• Hospital sterilization related staff
• Maintenance technician/engineer and team who are authorized to work inside Sterile Manufacturing Facility
• Professionals from service organizations, contractors, designers, and vendors who provide services for pharmaceutical Industries/clients.
• Regulatory bodies involved in pharmaceutical industries.
• Internal/External Auditors and consultants.
• calibration technicians/ engineers

Description

Objectives and Expected Results

• Participants will understand all cGMP trends required for the Sterilization process/methods that are followed in the Pharmaceutical and Healthcare industry.
• Participants will understand how all Qualification & Validation (Q&V) for "moist heat sterilization process" activities will interact together by the user department or among different departments to achieve an ideal qualification approach within team-work spirits and integrity.
• Participants will have proper knowledge about Steam Sterilizer cycle parameters, in addition to awareness about the mathematical concepts for lethal dose and overkill approach.
• Participants will have proper knowledge about cycle development studies for a variety of load patterns to assure the sterility of products and commodities.
• Participants will understand the regulatory basics for Steam sterilizer "Autoclave" Qualification, Engineering Requirements for the parenteral pharmaceutical industry in both manufacturing and Quality Control facilities.
• Participants will be familiar with Q&V related topics required by different regulatory bodies, i.e. European, US FDA, and other international requirements expectations and how they are reflected and implemented on the field.
• Participants will be familiar with Q&V related require by European, US FDA and other international requirements expectations and how they are reflected and implemented it’s on field
• Participants will be conscious to save time, money, and increase the compliance by following streamlining approach to autoclave qualification and optimize utilization during production and downtime periods.
• The participant will have an idea about Moist Heat Sterilizer "Autoclave" lifecycle starting from setting User Requirement Specifications (URS), Issuing Risk Assessment (RA), handling Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification(PQ) including protocols execution, implementation and system development in addition to the implementation of requalification, change control system and finally System Retirements.
• Participants will be able to make evaluations "within his/her firm" for the acceptable or best practices for Qualification of moist steam sterilizer "Autoclave".
• Participants will be able to maintain the qualification status for Moist Steam sterilizer "Autoclave" during both operation time and after change control action.

The participant will be able to discuss and handle Q&V/Engineering aspects that may have an impact on product quality  of "Moist Steam Sterilizer" that can be discussed with inspectors if any issue raised

Others Training Materials

• Workshop, Sheets, and case studies paper will be conducted and implemented during training.
• Documentary Videos will be presented.

Target group