Aseptic process training
To embed good practice for the long term, we deliver on-site modules directly linked to our expert assignments.
APS – Media Fill Test
Aseptic process simulation test: preparation, interventions, reading and conclusion. See the Media Fill Test topic →
Sterility assurance
Manufacture of sterile medicinal products, good practices, sterilising filtration, behaviour and gowning in cleanrooms, personnel qualification. See the Sterility assurance level topic →
Annex 1
The requirements of EU GMP Annex 1 and the contamination control strategy (CCS), applied to your site. See the Annex 1 topic →
Sterilisation
Sterilisation fundamentals, from moist and dry heat to low-temperature processes. The module gives production, quality, validation and development teams the basis to select, validate and control a sterilisation method, for a medicinal product as well as for a medical device.
Selecting the sterilisation method
Terminal sterilisation in the final container remains the reference route, and the use of aseptic processing must be justified. The module covers the EMA decision trees for the finished product, the active substance, excipients and primary packaging, and the selection criteria: thermal stability and radiation sensitivity of the formulation, material compatibility, bioburden, target sterility assurance level, availability of facilities.
Knowing the methods
Moist heat (autoclaves, air-overpressure cycles, F0 and lethality), dry heat (sterilisation and depyrogenation in tunnels or ovens), ionising radiation (gamma, electron beam, X-ray, dose setting), ethylene oxide (preconditioning, aeration, residues), sterilising filtration (integrity and bacterial retention validation), low-temperature hydrogen peroxide processes. For each method: principle, critical parameters, biological indicators, load configuration, validation and requalification.
Regulations: medicinal products and medical devices
For medicinal products: GMP and Annex 1, European Pharmacopoeia (chapter 5.1.1 and monographs), EMA guidelines, FDA requirements. For medical devices: Regulation (EU) 2017/745, ISO 17665 (moist heat), ISO 20857 (dry heat), ISO 11135 (ethylene oxide), ISO 11137 (radiation), ISO 14937, ISO 11737 (bioburden and sterility tests) and EN 556-1 for the “sterile” claim. The module also covers drug-device combination products, at the boundary between the two frameworks.
Sterilisation issues
Case studies: wet loads at autoclave unloading, biological indicator failures, drift of a critical parameter, ethylene oxide residues, bioburden excursions. Investigation approach, root causes and CAPA.
Isolators for aseptic filling
A 2-day course, with theory and case studies, to support the start-up of an isolator filling line. It is intended for people involved in a new isolator project, and for those who want to strengthen their knowledge of good practice in the use of isolators for aseptic filling in light of the new Annex 1 requirements.
Objectives
- review the GMP and regulatory requirements for isolators, in particular those of the new version of Annex 1;
- understand the different isolator designs;
- understand the principles of isolator qualification and validation, in particular the constraints linked to hydrogen peroxide;
- know the contamination risks associated with the use of production isolators and the preventive measures that limit them;
- understand how the new GMP requirements on first air and on the management of indirect product-contact parts can be deployed in aseptic filling isolators.
Short module also available: glove handling in isolators.
Trainer: Marc Besson
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