FprEN ISO 18362

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016)

ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'.
ISO 18362:2016 is not applicable to:
- procurement and transport of cell-based starting material used in processing of a CBHP,
- cell banking,
- control of genetic material,
- control of non-microbial product contamination,
- in vitro diagnostics (IVDs), or
- natural medicines.
EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.
ISO 18362:2016 does not define biosafety containment requirements.
ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

Herstellung von zellbasierten Gesundheitsprodukten - Kontrolle der mikrobiellen Risiken während der Verarbeitung (ISO 18362:2016)

Fabrication de produits de santé à base de cellules - Contrôle des risques microbiologiques durant le procédé (ISO 18362:2016)

Proizvodnja izdelkov za zdravstveno nego na osnovi celic - Kontrola mikrobnega tveganja med obdelavo (ISO 18362:2016)

General Information

• Status: Not Published
• Publication Date: 02-Nov-2020
• Withdrawal Date: 02-May-2021
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 4098 - Decision to abandon - Enquiry
• Completion Date: 14-Dec-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: oSIST prEN ISO 18362:2018 - Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016)

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2018
Proizvodnja izdelkov za zdravstveno nego na osnovi celic - Kontrola mikrobnega
tveganja med obdelavo (ISO 18362:2016)
Manufacture of cell-based health care products - Control of microbial risks during
processing (ISO 18362:2016)
Herstellung von zellbasierten Gesundheitsprodukten - Kontrolle der mikrobiellen Risiken
während der Verarbeitung (ISO 18362:2016)
Fabrication de produits de santé à base de cellules - Contrôle des risques
microbiologiques durant le procédé (ISO 18362:2016)
Ta slovenski standard je istoveten z: prEN ISO 18362
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL ISO
STANDARD 18362
First edition
2016-02-01
Manufacture of cell-based health care
products — Control of microbial risks
during processing
Manufacture de produits de soins de santé fondés sur les cellules —
Contrôle des risques microbiaux durant le processus
Reference number
ISO 18362:2016(E)
©
ISO 2016
ISO 18362:2016(E)
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

ISO 18362:2016(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Quality system elements . 5
5 Process definition . 5
5.1 General . 5
5.2 Risk management . 6
5.2.1 General considerations . 6
5.2.2 Cell-based starting material risk assessment . 7
5.2.3 CBHP process risk assessment . 7
5.2.4 Use of risk assessment methods and tools for supply of CBHPs for use in
clinical trials . . 8
6 Manufacturing environment . 8
6.1 General . 8
6.2 Alternative processes . 8
6.3 Manufacturing environment design . 8
6.3.1 Containment area . 8
6.3.2 Construction containment features . 8
6.4 Layout . 9
6.5 Material and personnel flow . 9
6.5.1 General. 9
6.5.2 Equipment . 9
6.5.3 Handling of waste material . 9
6.6 HVAC system .10
6.7 Utility services and ancillary equipment .10
6.8 Environmental and personnel monitoring programmes .10
7 Equipment .10
7.1 General .10
7.2 Additional requirements .10
8 Personnel .11
8.1 General .11
8.2 Personnel procedures .11
8.3 Gowning procedures .11
8.4 General employee health .11
9 Manufacture of product .12
9.1 General .12
9.2 Control of starting material .12
9.2.1 Cell-based starting material .12
9.2.2 Other starting materials .12
9.3 Manufacturing procedures .13
9.4 In-process controls and process monitoring .13
9.5 Virus elimination and inactivation .13
10 Process simulation and process confirmation .13
10.1 General .13
10.2 Process simulation .14
10.3 Process confirmation studies .14
10.4 Media selection and growth support .14
11 Finished product release: test for sterility .15
ISO 18362:2016(E)
11.1 General .15
11.2 Additional requirements .15
12 Finished product release: testing for biological contamination that cannot be
detected by the test for sterility .16
12.1 General .16
12.2 Extrinsic biological contamination .16
12.3 Intrinsic biological contamination .16
Annex A (informative) Examples of microbial risks for CBHP .17
Annex B (normative) Decision trees for application of risk assessment for cell-based
starting materials .18
Annex C (informative) Containment facilities .20
Annex D (normative) CBHP starting material .27
Annex E (normative) Containment requirements for procured, non-sterile starting
materials before entering the manufacturing area.29
Annex F (informative) Typical elements of a process definition .30
Bibliography .31
iv © ISO 2016 – All rights reserved

ISO 18362:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interes
...