AAMI TIR100 2021

$99.32

AAMI TIR100:2021, End-to-end microbiological quality and sterility assurance

Published By	Publication Date	Number of Pages
AAMI	2021	27

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Category: AAMI

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This technical information report (TIR) provides guidance for a comprehensive framework that integrates and connects Microbiological Quality & Sterility Assurance (MQ&SA) into an organization’s end-to-end process for the development, validation, and routine control of sterile health care products.

PDF Catalog

PDF Pages	PDF Title
1	AAMI TIR100:2021; End-to-end microbiological quality and sterility assurance
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
6	Committee representation
10	Foreword
11	Introduction
13	1 Scope 2 Normative references 3 Terms and definitions
14	4 General
15	5 Research and Development (R&D) 5.1 Design inputs
16	5.2 Design process
17	5.3 Design outputs 5.4 Design verification
18	5.5 Design validation 5.6 Design transfer 6 Plan 6.1 Infrastructure
19	6.2 Work environment and microbiological control 6.3 Sourcing (purchasing)
20	6.4 Control of production 7 Source
21	7.1 Identification and selection of supplier for goods and services 7.2 Verification (i.e., inspection) of the goods and services 7.3 Monitoring and re-evaluation of the goods and services
22	8 Make 8.1 Infrastructure 8.2 Work environment and microbiological control 8.3 Sourcing (purchasing)
23	8.4 Control of production 9 Deliver
24	9.1 Maintenance of product conditions 9.2 Maintenance of the sterile barrier 10 Customer
25	Bibliography