BS EN ISO 13408-4:2011 - Aseptic processing of health care products. Clean-in-place technologies
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BS EN ISO 13408-4:2011

Aseptic processing of health care products. Clean-in-place technologies

Status : Current   Published : October 2011
Conformity to regulation : Designated



ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

Standard NumberBS EN ISO 13408-4:2011
TitleAseptic processing of health care products. Clean-in-place technologies
Publication Date31 October 2011
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO/IEC 90003, ISO 13408-1
Informative References(Provided for Information)90/385/EEC, 98/79/EC, 93/42/EEC, ISO 14937, ISO 9000
ReplacesBS EN 13824:2004
International RelationshipsEN ISO 13408-4:2011
DescriptorsVerification, Personnel, Quality management, Medical equipment, Sterile equipment, Production, Sterilization (hygiene), Cleaning, Quality assurance systems, Environment (working), Cleaning materials
Title in FrenchTraitement aseptique des produits de santé. Technologies de nettoyage sur place
Title in GermanAseptische Herstellung von Produkten für die Gesundheitsfürsorge. Reinigung vor Ort
ISBN978 0 580 72609 5
File Size1.017 MB

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