Microbial Risk Management During Cleanroom Operations

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Course Dates

  • Microbial risk Management During Cleanroom Operations

    22nd November 2022 - 23rd November 2022

    Location: Virtual Training
    Course Price £1195.00
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  • Microbial Risk Management During Cleanroom Operations

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

    Download Course PDF
Course Terms & Conditions

About the course

The course will provide a basic understanding of the Risk Management of Contamination (RMC) system that can be utilised for the control of contamination during manufacturing operations in cleanrooms.

Microbial contamination of aseptically prepared pharmaceutical products will be considered but the methods presented can also be applied to various cleanroom healthcare products and other manufacturing activities. The mechanisms of microbial contamination explained are also applicable to inert particle contamination and the principles covered can also be utilised for this application.

The course will provide an understanding of the fundamental mechanism of contamination transfer, via surface contact or from airborne deposition, and how this mechanism is used to provide the most accurate methods of assessing risk, defined as the number of microbes likely to be deposited into a product. All general sources of cleanroom contamination, their routes of transfer and the associated control methods will be discussed and a method of assessing their risks to product explained.

Further methods, to assess the risks to product from activities associated with a particular manufacturing process within the critical cleanroom areas, will be detailed. An understanding of how the identified risks, or their methods of control, can be monitored and limits set to ensure that contamination is adequately controlled are outlined. Additionally, a method for determining the risk to the patient, from aseptically manufactured products, by considering factors relating to the chance that it contains sufficient microbes to initiate an infection, will be presented.

For more information on RMC, see the article Risk Management of Contamination (RMC)

Who Should Attend This Course?

The course is suitable for all personnel involved in the management and operation of cleanrooms including Production Managers and Supervisors, Quality Assurance, Microbiologists, Sterility Assurance Specialists and Sterility Assurance Engineers.

Course Objectives

  • Delegates will be able to identify the sources of contamination, routes of transfer to the product and contamination control measures and apply this in their facility.
  • The course will provide a scientific assessment of the fundamental mechanism of contamination transfer, via surface contact or from airborne deposition, and how this mechanism is used to provide the most accurate methods of assessing risk of microbial contamination of product.
  • Delegates will recognise how the identified risks, or their methods of control can be monitored and limits set to ensure that contamination is adequately controlled are outlined.
  • Delegates will recognise the advantages of using a quantitative system to assess and prioritise risk based on actual process data.
  • Methods of periodic verification that the contamination system is under control will be presented.
  • Delegates will participate in risk assessment workshops lead by industry experts to enhance learning and facilitate debate.
  • Methodology will be presented to determine the microbial risk to patient from aseptically prepared products.

Course Content

Full course notes and a certificate of attendance will be issued to each delegate who attends the full course. Certification is for knowledge gained, not just attendance. Assessment for Aseptic Filling Process.

Day One

  • Risk Management of Contamination (RMC) during Cleanroom Manufacture, choice of Microbial Risk Assessment Method and Fundamental Mechanism of Contamination Transfer
  • Identification of Sources of Contamination, Transfer Routes, Key Control Measures and the use of Risk Diagrams
  • Risk Assessments for General Cleanroom Areas
  • Risk Assessment for Aseptic Filling Processes
  • Risk System, Assessment of Manufacturing Stage Risks and Areas for Aseptic Improvement

Day Two

  • Risk Assessments for Critical Area Contamination, Airborne Deposition
  • Risk Assessments for Critical Area Contamination, Surface Contact
  • Establishment of an Effective Monitoring Programme, Regular Verification of the Risk System, Documentation and Staff Training
  • Assessing Microbial Risk to Patients from Aseptically Manufactured Products

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.

22nd November 2022
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Training prospectus 2022

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 …

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