Sterilization - too Hot to Handle?

Operations Quality Assurance @Biotech Training Facility

Sterilization is a crucial part of GMP processes in the pharmaceutical en biotech sector and in hospitals. This training course provides a solid foundation in the theory and practice of sterilization, tailored to the applicable GMP guidelines and expectations of inspecting authorities such as IGJ, EMA and FDA.

Location

Biotech Training Facility

Duration

2 dagen

Course fee

€ 1,790.00 (excl. VAT)

Short description

The sterility of the materials used during operations and in the production of medicines and medical devices is of vital importance. In addition to the mechanical activities, there are also procedures that require a high degree of expertise and a critical attitude on the part of the employees.

The following aspects are therefore covered in detail in this course:

  • Checking and testing the functionality of machines.

  • Assessment of the status and functioning of materials before starting the sterilization process.

  • Evaluation of the data obtained from the sterilization cycles.

  • Execution of a correct registration in order to identify and trace the entire sterilization process of materials.

Next to routine operations, a great deal of attention is also paid to practical cases and how to deal with them. During this course, we can use a washing machine, bottle washing machine, autoclave and hot air steriliser.

Why choose this training?

  • GMP knowledge: according to the latest guidelines (EU-GMP Annex 1, FDA)

  • Directly applicable: with practical examples from production

  • Experienced trainers: with in-depth knowledge of sterile production and validation

  • Interactive: room for questions, discussion and practical assignments

Average score for the Sterilisation Training in June 2025: 8.8

Targets

What can you expect from this Sterilisation Methods Course?

You will gain essential knowledge for working with sterile products, including:

  • The basic principles of sterilisation (physical, chemical, aseptic)

  • Sterilisation methods: steam, dry heat, gas (EO), filtration, radiation

  • The importance of validation and control (biological indicators, F-value, D-value)

  • GMP requirements for sterilisation and aseptic processes

  • Documentation, monitoring and dealing with deviations

  • Practical do's and don'ts for sterile processes and cleanroom behaviour

  • Inspection points and considerations during audits

Target group

This training course is highly suitable for:

  • QA/QC staff

  • Production and laboratory staff

  • Operators in aseptic processes

  • Anyone involved in setting up, executing or assessing sterilisation processes

Program

Get your sterilisation knowledge up to speed – and keep it there. Reach out to us for dates, availability, or custom options.

This course is available for group registrations of 6 or more participants.

email to Biotech Training Facility
‘Good pace, good content, good balance between theory and practice.’ ‘I learned a lot in a great setting.’