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ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
Requirements for materials used in the cleanroom [10] Maintaining the cleanroom environment in a clean, usable condition conforming to design standards. [10] This part was published as an International Standard in 2004. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-5:2004 in the United ...
Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.
The goal of these standards is to help organizations (a) minimize how their operations (processes, etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land); (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above. The standards ...
ISO 11064-2:2000 Principles for the arrangement of control suites; ISO 11064-3:1999 Control room layout ISO 11064-3:1999/Cor 1:2002; ISO 11064-4:2013 Layout and dimensions of workstations; ISO 11064-5:2008 Displays and controls; ISO 11064-6:2005 Environmental requirements for control centres; ISO 11064-7:2006 Principles for the evaluation of ...
All guidelines follow a few basic principles: [2] [6] Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...