Pharmaceutical Sterilisation Course: Principles in Practice®(Virtual)

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Course Dates

  • Pharmaceutical Sterilisation: Principles in Practice® (Virtual)

    14th March 2023 - 16th March 2023

    Location: Virtual Training
    Course Price £1695.00
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  • Pharmaceutical Sterilisation: Principles in Practice® (Virtual) 2023

    19th September 2023 - 21st September 2023

    Location: Virtual Training
    Course Price £1695.00
    Select options
  • Pharma Sterilisation: Principles in Practice®

    We have produced an overview of the course information available online, available here in a handy PDF Prospectus.

    Download Course PDF
Course Terms & Conditions

Sterilisation Course: Principles in Practice®(Virtual)

About the sterilisation course: According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise the risks of contamination, with much depending on the skill, training and attitudes of the personnel involved. In particular, managing sterilisation processes is critical to the manufacture of both terminally sterilised and aseptically prepared products.

This Pharmaceutical Sterilisation training: Principles in Practice® provides delegates with a comprehensive understanding of moist heat and dry heat sterilisation processes from theoretical foundation through to the practical aspects of validation and biological indicators. The sterilisation course highlights the GMP requirements and current industry expectations for the routine operation, monitoring and control of sterilisation processes and gives practical examples of how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and US regulatory requirements.

This is a highly practical sterilisation course based on our knowledge within the industry which includes case studies, workshops and practical examples designed to allow our delegates to put the principles into practice.

Honeyman is renowned for industry-leading GMP knowledge-transfer, lectures, consultancy and courses delivered face-to-face.  Our Virtual Training helps you ‘keep your space’ and stay at the top of your game.

To view our full range of training courses please download the Honeyman Training Prospectus.  Book your place now or enquire about our other Pharma Courses – Honeyman Training

For practical assistance with outsourced monitoring for contamination control in pharmaceutical manufacturing visit www.honeymanlaboratories.com

sterilisation course

Course Objectives

Key learning objectives of the course are:

  • To have increased awareness of the development of the current regulatory requirements and standards for sterilisation processes and how this has shaped the way the industry approaches sterilisation
  • To be able to make risk-based decisions based on science during the qualification and routine operation of sterilisation processes
  • To be able to drive sterilisation process improvement initiatives in the workplace and improve compliance for sterilisation processes
  • Be able to implement value adding test plans for Equipment Qualification based on science, experience and compliance with GMP principles
  • To participate in the most up to date review of future international sterilisation standards and changes to the Pharmacopoeias.

This course includes a combination of Presentations, Workshops, Group Activities and Demonstrations to allow you to put the Principles into Practice.

Who Should Attend This Course?

The course is regularly attended by Engineers, Microbiologists, Technical, QA and QC personnel as well as Production and Operational personnel.

Course Content

  • Development of Current Sterilisation Standards Regulations and Guidance including Future Requirements
  • Principles of Moist Heat Sterilisation
  • Lessons learnt from the Devonport Incident
  • Steam Quality Generation Distribution and Use
  • Porous Load Sterilisation, Air Detectors and EN285
  • Terminal Sterilisation of Fluids and Qualification Strategies
  • Dry Heat Sterilisation, Depyrogenation and the application of EN20857
  • Instrumentation and Control of Sterilisation Processes
  • Steam In Place Design, Operation, Validation, Control
  • Risk Assessment Workshops for Sterilisation processes
  • Including selection of worst case load items for Validation
  • Quality System Requirements to ensure compliance with
    GMP requirements for sterilisation processes
  • Auditing Sterilisation Processes and Preparing for a Regulatory Inspection
  • Application of risk assessment during sterilisation equipment lifecycle Validation
  • Use and Application of Biological Indicators (D-Value, Z Value, Organism selection, D value Determination)
  • Validation Strategies for Sterilisation Processes (Overkill, Bioburden, BI/Bioburden)
  • Qualification activities including URS, DQ, FAT, IQ, OQ, PQ and Requalification
  • Cycle Development and Performance Qualification
  • Process improvement for Routine Operation of Sterilisers and hazard analysis
  • Continual Compliance Assurance

Course Dates / Costs Description

Please note: Our online booking system works in £GBP.  Honeyman Training & Consultancy Limited reserves the right to amend any prices at any time.

All advertised prices are exclusive of any applicable VAT or local taxes.

14th March 2023
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19th September 2023
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Training prospectus 2023

We have produced an overview of the course information available online, available here in a handy PDF Prospectus.

Our Customers

Our team has trained and works with the world's leading Pharmaceutical companies, including …

Latest News

19th January 2023

Technical Briefing (PDF): Cleanroom Classification

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7th October 2022

Glossary (European) – Manufacture of Sterile Medicinal Products

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2nd September 2022

Technical Briefing (PDF): Airborne particle counting using LSAPC

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6th May 2022

Planetary Protection – ESA

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12th April 2022

Sterilisation Critical Control Points

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12th June 2021

Risk Management of Contamination (RMC)

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3rd May 2021

Annex 1 Revision 2020

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