546-0174/01 – Sterilization and Clean Rooms (SCP)

Gurantor department	Department of Environmental Engineering	Credits	4
Subject guarantor	Mgr. Kristina Čabanová, Ph.D.	Subject version guarantor	Mgr. Kristina Čabanová, Ph.D.
Study level	undergraduate or graduate	Requirement	Compulsory
Year	3	Semester	summer
		Study language	Czech
Year of introduction	2024/2025	Year of cancellation
Intended for the faculties	HGF, FMT, FEI	Intended for study types	Bachelor

Instruction secured by
Login	Name	Tuitor	Teacher giving lectures
PIK012	Mgr. Kristina Čabanová, Ph.D.

Extent of instruction for forms of study
Form of study	Way of compl.	Extent
Full-time	Credit and Examination	2+1
Part-time	Credit and Examination	8+4

Subject aims expressed by acquired skills and competences

The aim of the subject is to present individual sterilization methods and requirements in relation to the relevant regulations applicable to medical devices. Requirements for sterilization, disinfection and cleaning of medical devices will be related to individual phases of design, development and production.

Teaching methods

Lectures
Seminars
Project work
Field trip

Summary

Compulsory literature:

RUTALA, William A.; WEBER, David J. Disinfection, sterilization, and antisepsis: An overview. American journal of infection control, 2016, 44.5: e1-e6. RUTALA, W. A.; WEBER, D. J. Infection control: the role of disinfection and sterilization. Journal of Hospital Infection, 1999, 43: S43-S55.

Recommended literature:

SEAVEY, Rose. High-level disinfection, sterilization, and antisepsis: current issues in reprocessing medical and surgical instruments. American journal of infection control, 2013, 41.5: S111-S117.

Way of continuous check of knowledge in the course of semester

Credit in the form of an individual project presentation and examination in the form of a written test

E-learning

Other requirements

There are no other special requirements for the student

Prerequisities

Subject has no prerequisities.

Co-requisities

Subject has no co-requisities.

Subject syllabus:

Method selection, risk analysis, process characterization, equipment, product and process definition • Validation • Review, revalidation • Release of the product from sterilization • Conformity assessment – fulfillment of MDR requirements • Standards applied in the area of sterilization • Sterilization quality management system • Requirements for clean rooms • Monitoring of clean spaces • Selection of packaging materials from the point of view of sterilization • Properties of the microbial barrier in terms of sterilization • Design and development of deep packaging from the point of view of sterilization • Sampling plan, justification for the selection of suitable tests, criteria from the point of view of sterilization • Proof of intactness of the sterile barrier system after sterilization and during the subsequent test of functionality from the point of view of sterilization • The packaging process and its validation in terms of sterilization

Conditions for subject completion

Full-time form (validity from: 2024/2025 Winter semester)

Task name	Type of task	Max. number of points (act. for subtasks)	Min. number of points	Max. počet pokusů
Credit and Examination	Credit and Examination	100 (100)	51
Credit	Credit	33	17
Examination	Examination	67	34	3

Mandatory attendence participation: Minimum 80% mandatory attendance at exercises.

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Conditions for subject completion and attendance at the exercises within ISP: Fulfillment of all assigned tasks within individually agreed-upon deadlines.

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Occurrence in study plans

Academic year	Programme	Branch/spec.	Spec.	Zaměření	Form	Study language	Tut. centre	Year	W	S	Type of duty
2024/2025	(B0788P270002) Innovation and design of medical devices				P	Czech	Ostrava	3			Compulsory	study plan

Occurrence in special blocks

Block name	Academic year	Form of study	Study language	Year	W	S	Type of block	Block owner

Assessment of instruction

Předmět neobsahuje žádné hodnocení.