Mastering sterilization processes — Principles, standards and validation
Sterilization is a special process within the meaning of ISO 13485 and MDR 2017/745: its result cannot be fully verified after the fact. Mastering its principles, selecting the right process, conducting rigorous validation and maintaining routine compliance are critical skills for any manufacturer of sterile medical devices. This training provides you with the regulatory foundations and the operational tools to meet these challenges.
Audience Production engineers and technicians, QA/Methods managers and staff, regulatory affairs officers involved in the qualification or monitoring of sterilization processes.
Learning objectives
- ▸ Distinguish the main sterilization processes applicable to medical devices (gamma and electron-beam irradiation, ethylene oxide, steam, atypical agents) and identify their respective fields of use
- ▸ Decode the requirements of the reference standards (ISO 11137-1/2/3, ISO 11135, ISO 17665, ISO 14937) and link them to the documentary obligations of MDR 2017/745 and ISO 13485
- ▸ Build a validation plan for a sterilization process following the IQ/OQ/PQ sequence and draft the associated protocols and reports
- ▸ Calculate or interpret the initial biocontamination load (bioburden, ISO 11737) and derive from it the validation parameters for the sterilizing dose or cycle
- ▸ Set up a routine control program and manage process deviations in compliance with regulatory requirements
- ▸ Assess the impact of a product or process change on sterile status and decide on the necessary revalidations
Expected outcomes
- ✓ At the end of the training, participants have a decision grid for process selection, validation protocol templates that can be directly adapted to their context, and the ability to read the ISO standards of the sterilization family autonomously.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
No formal prerequisites. Familiarity with the basics of ISO 13485 and/or MDR 2017/745 is recommended to optimize learning.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and cannot be funded through OPCOs
- ·Funding from own resources or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Sterilization processes: overview and selection criteria (2 h)
- ·Definition of a special process according to ISO 13485 and MDR 2017/745
- ·Overview of processes: gamma irradiation, electron-beam irradiation, ethylene oxide (EO), steam (autoclave), hydrogen peroxide and atypical agents (ISO 14937)
- ·Selection criteria: material compatibility, packaging configuration, regulatory constraints, outsourcing or in-house control
- 02
Normative and regulatory framework (1 h 30)
- ·Architecture of the ISO 11137 family (parts 1, 2 and 3): scope, articulation and points of vigilance
- ·ISO 11135 (EO) and ISO 17665 (steam)
- ·Link with ISO 13485 requirements (§ 7.5.2) and the GSPRs of MDR 2017/745 relating to sterile devices
- ·Role of the technical file in justifying the sterilizing process
- 03
Bioburden and microbiological fundamentals (1 h 30)
- ·Concept of microbial load (bioburden) according to ISO 11737-1
- ·Enumeration and interpretation methods
- ·Bioburden as input data for dose validation
- ·Sterility assurance level (SAL 10⁻⁶)
- ·Traceability requirements
- 04
Validation of a sterilization process (3 h)
- ·Validation sequence: installation qualification (IQ), operational qualification (OQ), performance qualification (PQ)
- ·Establishing the sterilizing dose (VDmax method, dose audit method — ISO 11137-2)
- ·EO cycle validation and steam cycle validation
- ·Practical exercise: critical reading of an existing validation protocol and identification of gaps
- 05
Routine control and deviation management (2 h)
- ·Process control parameters in routine
- ·Release of sterilized batches: documentary criteria and release decision
- ·Management of non-conformities and process deviations
- ·Annual review of the sterilizing process
- 06
Changes, revalidation and subcontractor interface (2 h)
- ·Assessment of the impact of a product or packaging change on sterile status
- ·Revalidation triggers according to ISO 11137 and MDR
- ·Drafting the technical specifications for a sterilization service provider
- ·Subcontractor monitoring: indicators, audits and documentary management
- ·Exercise: building a criticality matrix for process changes
- 07
Synthesis and integrative case study (2 h)
- ·Cross-cutting case study: starting from a fictitious medical device file, reconstruction of the complete approach to selection, validation and maintenance of the sterilizing process
- ·Identification of the required documentary deliverables
- ·Collective correction and questions and answers
Assessment of learning
Assessment methods
20-question QCM at the end of the training, covering normative principles, validation reasoning and deviation management. Supplemented by a self-assessment of competencies at the beginning and end of the session (progression grid).
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in both days. This certificate does not constitute a certification recognized by the RNCP or the Répertoire Spécifique (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Complete training material (PDF)
- ·Validation protocol templates
- ·Process decision grid
- ·Change criticality matrix
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
1 490 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and cannot be funded through OPCOs
- ·Funding from own resources or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.