ISO-13408-4-2005.pdf
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1、 Reference number ISO 13408-4:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products Part 4: Clean-in-place technologies Traitement aseptique des produits de sant Partie 4: Technologies de nettoyage sur place ISO 13408-4:2005(E) PDF di
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6、f the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reserved -,-,- ISO 13408-4:2005(E) ISO 2005 All rights reserved iii Contents Page Foreword iv I
7、ntroduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Quality system elements 2 4.1 General. 2 4.2 Management responsibility . 2 4.3 Design control. 2 4.4 Measuring instruments and measuring systems 2 5 Process and equipment characterization 3 5.1 General concepts 3 5.2 Ef
8、fectiveness of CIP . 3 5.3 Equipment . 4 6 Cleaning agent characterization . 5 6.1 Selection of cleaning agent(s). 5 6.2 Quality of cleaning agent(s). 5 6.3 Safety and the environment. 6 7 CIP process . 6 7.1 Process parameters 6 7.2 Process control. 6 7.3 Residues of cleaning agent(s). 8 8 Validati
9、on. 8 8.1 Validation protocol . 8 8.2 Evaluation of the CIP process. 8 8.3 Design qualification 8 8.4 Installation qualification. 8 8.5 Operational qualification 9 8.6 Performance qualification 9 8.7 Review and approval of validation 10 8.8 Requalification 10 9 Routine monitoring and control 10 9.1
10、CIP process control 10 9.2 Procedures 10 9.3 CIP process records. 11 9.4 Change control 11 9.5 Maintenance and calibration . 11 10 Personnel training 11 Annex A (informative) Description of sampling methods 12 Annex B (informative) Calculation examples for acceptance criteria. 13 Bibliography. 14 -,
11、-,- ISO 13408-4:2005(E) iv ISO 2005 All rights reserved 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
12、. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Intern
13、ational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Sta
14、ndards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subj
15、ect of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13408-4 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 13408 consists of the following parts, under the general title Aseptic processing of health ca
16、re products: Part 1: General requirements Part 2: Filtration Part 3: Lyophilization Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systems ISO 13408-4:2005(E) ISO 2005 All rights reserved v Introduction During the process of preparing ISO 13408-1 several items, e
17、.g. filtration, lyophilization drying and sterilization-in-place technologies, were found to be in need of supplementary information that was too voluminous to be given in corresponding annexes. This part of ISO 13408 includes requirements and guidance that are to be observed during clean-in-place p
18、rocesses. The purpose of this part of ISO 13408 is to achieve standardization in the field of validation and routine control of clean-in-place processes used in the manufacture of health care products. Clean-in-place processes allow parts of the equipment or an entire process system to be cleaned wi
19、thout being dismantled, reducing the need for disassembling and connections under clean conditions. For example, tanks, vessels, freeze-dryers piping and other processing equipment used for manufacture may be cleaned in place. The clean-in-place process is in most instances followed by sterilization
20、-in-place process (described in ISO 13408-5). While clean-in-place and sterilization-in-place methods differ considerably in technology, the concept of in situ treatment is similar. Design considerations of all systems are critical to ensure that clean-in-place technologies can be successfully appli
21、ed to clean manufacturing equipment to the desired level of cleanliness. -,-,- -,-,- INTERNATIONAL STANDARD ISO 13408-4:2005(E) ISO 2005 All rights reserved 1 Aseptic processing of health care products Part 4: Clean-in-place technologies 1 Scope This part of ISO 13408 specifies the general requireme
22、nts 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. This part of ISO 13408 is applicable to processes where clean
23、ing agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer. This part of ISO 13408 does not supersede or rep
24、lace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated
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