ASTM E3106-22
Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

Standard No.

ASTM E3106-22

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E3106-22

Scope

1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs)); all dosage forms; over-the-counter medicinal and neutraceutical products, veterinary products, biologics, clinical supplies, advanced therapy medicinal products (ATPM), medical device manufacturing; and is also applicable to other health, cosmetics, and consumer products. 1.2 This guide is focused only on the cleaning of equipment product contact surfaces and medical device surfaces and does not cover disinfection, sterilization, or non-product contact surfaces (which are covered under other existing guides: Ref (1),2 USP <1072>, Guide E2614, ISO 14698, and ISO 14937). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM E3106-22 Referenced Document

• ASTM E1325 Standard Terminology Relating to Design of Experiments
• ASTM E2281 Standard Practice for Process Capability and Performance Measurement
• ASTM E2476 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
• ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• ASTM E2614 Standard Guide for Evaluation of Cleanroom Disinfectants
• ASTM E3219 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
• ASTM E3263 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• ASTM F3127 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• ASTM F3357 Standard Guide for Designing Reusable Medical Devices for Cleanability
• ASTM G121 Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
• ASTM G122 Standard Test Method for Evaluating the Effectiveness of Cleaning Agents
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14698 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data; Technical Corrigendum 1
• ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
• ISO 9000 Quality management systems - Fundamentals and vocabulary [French version]

ASTM E3106-22 history

• 2022 ASTM E3106-22 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• 2018 ASTM E3106-18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• 2018 ASTM E3106-18 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• 2017 ASTM E3106-17 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation