ASTM E3106-22

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

SIGNIFICANCE AND USE
4.1 Application of the approach described within this guide applies risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for cleaning should also be commensurate with the level of risk.  
4.2 Application of the approach described within this guide applies many of the science-based, risk-based, and statistical concepts and principles introduced in the FDA’s Guidance for Industry Process Validation: General Principles and Practices   (3) and Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement.  
4.3 This guide supports, and is consistent with, elements from ICH Q8, ICH Q9, ICH Q10, ICH Q11, and ICH Q12.  
4.4 This guide supports and is consistent with the content and intent of ISO 14971.  
4.5 Key Concepts—This guide applies the following key concepts: (1) quality risk management, (2) science-based approach, (3) statistics-based approach, (4) process understanding, (5) continued improvement, and (6) life-cycle management as described in the ICH Q series.
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 , 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.

General Information

• Status: Published
• Publication Date: 31-Oct-2022
• ICS: 13.020.60 - Product life-cycles
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.13 - Process Evaluation and Control

Relations

• Refers: ASTM E2614-15(2020)e1 - Standard Guide for Evaluation of Cleanroom Disinfectants
• Effective Date: 01-Apr-2020

Standards Content (Sample)

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.
Designation: E3106 − 22
Standard Guide for
Science-Based and Risk-Based Cleaning Process
1
Development and Validation
This standard is issued under the fixed designation E3106; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
3
1.1 This guide applies the life-cycle approach to cleaning 2.1 ASTM Standards:
process validation, which includes the development, E1325 Terminology Relating to Design of Experiments
qualification, and verification of cleaning processes. It is E2281 Practice for Process Capability and Performance
applicable to pharmaceuticals (including active pharmaceutical Measurement
ingredients (APIs)); all dosage forms; over-the-counter medici- E2476 Guide for Risk Assessment and Risk Control as it
nal and neutraceutical products, veterinary products, biologics, Impacts the Design, Development, and Operation of PAT
clinical supplies, advanced therapy medicinal products Processes for Pharmaceutical Manufacture
(ATPM), medical device manufacturing; and is also applicable E2500 Guide for Specification, Design, and Verification of
to other health, cosmetics, and consumer products. Pharmaceutical and Biopharmaceutical Manufacturing
Systems and Equipment
1.2 This guide is focused only on the cleaning of equipment
E2614 Guide for Evaluation of Cleanroom Disinfectants
product contact surfaces and medical device surfaces and does
E3219 Guide for Derivation of Health-Based Exposure Lim-
not cover disinfection, sterilization, or non-product contact
its (HBELs)
surfaces (which are covered under other existing guides: Ref
2
E3263 Practice for Qualification of Visual Inspection of
(1), USP <1072>, Guide E2614, ISO 14698, and ISO 14937).
Pharmaceutical Manufacturing Equipment and Medical
1.3 The values stated in SI units are to be regarded as
Devices for Residues
standard. No other units of measurement are included in this
F3127 Guide for Validating Cleaning Processes Used During
standard.
the Manufacture of Medical Devices
1.4 This standard does not purport to address all of the
F3357 Guide for Designing Reusable Medical Devices for
safety concerns, if any, associated with its use. It is the Cleanability
responsibility of the user of this standard to establish appro-
G121 Practice for Preparation of Contaminated Test Cou-
priate safety, health, and environmental practices and deter- pons for the Evaluation of Cleaning Agents
mine the applicability of regulatory limitations prior to use.
G122 Test Method for Evaluating the Effectiveness of
1.5 This international standard was developed in accor- Cleaning Agents and Processes
4
dance with internationally recognized principles on standard-
2.2 ICH Guidelines:
ization established in the Decision on Principles for the
Q8 Pharmaceutical Development
Development of International Standards, Guides and Recom-
Q9 Quality Risk Management
mendations issued by the World Trade Organization Technical
Q10 Pharmaceutical Quality System
Barriers to Trade (TBT) Committee.
Q11 Development and Manufacture of Drug Substances
1 3
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture For referenced ASTM standards, visit the ASTM website, www.astm.org, or
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Subcommittee E55.13 on Process Evaluation and Control. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 1, 2022. Published December 2022. Originally the ASTM website.
ɛ1
4
approved in 2017. Last previous edition approved in 2018 as E3106 – 18 . DOI: Available from International Conference on Harmonisation of Technical
10.1520/E3106-22. Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
2
The boldface numbers in parentheses refer to a list of references at the end of Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,
this standard. http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E3106 − 22
Q12 Implementation Considerations for FDA-Regulated 3.1.4.1 Discussion—COP systems can range from elaborate
Products washing cabinets with automatic control systems to simple
5
2.3 ISO Standards: dishwasher type units. Many medical
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: E3106 − 18 E3106 − 22
Standard Guide for
Science-Based and Risk-Based Cleaning Process
1
Development and Validation
This standard is issued under the fixed designation E3106; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Corrections were made editorially to 3.1.13 in October 2018.
1. 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); (APIs));
all dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) 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 disinfection, sterilization, or non-product contact surfaces (which are covered under other existing guides: Ref
2
(1), USP <1072>, Guide E2614, ISO 14698, and ISO 14698).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.
2. Referenced Documents
3
2.1 ASTM Standards:
E1325 Terminology Relating to Design of Experiments
E2281 Practice for Process Capability and Performance Measurement
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes
for Pharmaceutical Manufacture
E2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and
Equipment
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.03 on General Pharmaceutical Standards.
Current edition approved Sept. 1, 2018Nov. 1, 2022. Published September 2018December 2022. Originally approved in 2017. Last previous edition approved in 20172018
ɛ1
as E3106 – 17.18 . DOI: 10.1520/E3106-18E01.10.1520/E3106-22.
2
The boldface numbers in parentheses refer to a list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E3106 − 22
E2614 Guide for Evaluation of Cleanroom Disinfectants
E3219 Guide for Derivation of Health-Based Exposure Limits (HBELs)
E3263 Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for
Residues
F3127 Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
F3357 Guide for Designing Reusable Medical Devices for Cleanability
G121 Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents
G122 Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes
4
2.2 ICH Standards:Guidelines:
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q12 Implementation Considerations for FDA-Regulated Products
5
2.3 ISO Standards:
ISO 9000 Quality Management Systems—Funda
...