Principles of Aseptic Pharmaceuticals

East Durham College are proud to host a range of CDP modules aimed at businesses in the Pharmaceutical Industry. 

These modules are fully funded and are available now as self-study. The modules are a great compliment to your CPD programmes for your employees in this sector and can be accessed individually. 

If you would like to discuss this further or you want to access the modules fill in the form below. 

Aseptic Manufacture & Preparation Processes

Module content includes:

  • Definition and importance of aseptic processing in pharmaceuticals.
  • Key steps in the aseptic manufacturing process.
  • Types of products commonly produced using aseptic techniques.
  • Best practices for minimizing contamination risks.
  • Case studies highlighting successful aseptic manufacturing.

Clean Room Design & Behaviours

Module content includes:

  • Principles of clean room design (airflow, pressure, and contamination control).
  • Classification of clean rooms based on ISO standards.
  • Importance of gowning and personal hygiene in clean environments.
  • Behaviours and protocols for personnel in clean rooms.
  • Common clean room equipment and its role in maintaining sterility.

Health, Safety & Reducing Risk in Aseptic Pharmaceuticals

Module content includes:

  • Overview of potential hazards in aseptic pharmaceutical environments.
  • Risk assessment methodologies specific to aseptic processes.
  • Strategies for mitigating health and safety risks.
  • Emergency protocols and response plans.
  • Importance of training and awareness in promoting safety culture.

Legislation, Regulations & Standards in Aseptic Pharmaceuticals

Module content includes:

  • Overview of key regulations governing aseptic manufacturing (e.g., FDA, EMA, MHRA).
  • Role of Good Manufacturing Practices (GMP) in ensuring product quality.
  • Importance of compliance with international standards (ISO, WHO).
  • Updates on evolving regulations and their impact on the industry.
  • Documentation and reporting requirements for regulatory compliance.

Maintenance and Calibration in Aseptic Pharmaceuticals

Module content includes:

  • Importance of equipment maintenance and calibration in ensuring aseptic conditions.
  • Overview of maintenance schedules and practices.
  • Types of equipment commonly used in aseptic processing and their calibration needs.
  • Documentation and record-keeping for maintenance and calibration activities.
  • Strategies for managing equipment lifecycle and performance.

Quality Management in Aseptic Pharmaceuticals

Module content includes:

  • Principles of quality management systems (QMS) in the pharmaceutical industry.
  • Role of quality assurance (QA) and quality control (QC) in aseptic processes.
  • Importance of continuous improvement and CAPA (Corrective and Preventive Actions).
  • Metrics and tools for measuring quality performance.
  • Integration of quality management with regulatory compliance and operational efficiency.

Register for Principles of Aseptic Pharmaceuticals Training

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