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ASTM E3263-20

(Practice)

Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.  
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6).  
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15 (2).  
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).  
4.5 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.  
4.6 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance on Process Analytical Technology Initiative (3).  
4.7 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based approach, (4) statistics-based approach, and (5) process knowledge and understanding.
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.  
1.2 This practice applies to pharmaceuticals [including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies] and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.  
1.3 This practice applies to all types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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
Historical
Publication Date
30-Sep-2020
ICS
11.020.01 - Quality and environmental management in health care
11.120.01 - Pharmaceutics in general
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.03 - General Pharmaceutical Standards
Current Stage
Ref Project

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ASTM E3263-20 - Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for ResiduesASTM E3263-20 - Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
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ASTM E3263-20 - Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E3263 −20
Standard Practice for
Qualification of Visual Inspection of Pharmaceutical
Manufacturing Equipment and Medical Devices for
1
Residues
This standard is issued under the fixed designation E3263; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber 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
2
1.1 This practice provides statistically valid procedures for 2.1 ASTM Standards:
determining the visual detection limit of residues and the E2782Guide for Measurement Systems Analysis (MSA)
qualification of inspectors to perform the visual inspection of E3106Guide for Science-Based and Risk-Based Cleaning
pharmaceuticalmanufacturingequipmentsurfacesandmedical Process Development and Validation
devices for residues. E3219GuideforDerivationofHealth-BasedExposureLim-
its (HBELs)
1.2 This practice applies to pharmaceuticals [including ac-
G121Practice for Preparation of Contaminated Test Cou-
tive pharmaceutical ingredients (APIs); dosage forms; and
pons for the Evaluation of Cleaning Agents
over-the-counter, veterinary, biologics, and clinical supplies]
3
2.2 ICH Guidance:
andmedicaldevicesfollowingallmanufacturingandcleaning.
ICH Q9Quality Risk Management
This practice is also applicable to other health, cosmetics, and
4
2.3 ISO Standard:
consumer products.
EN 12464Light and lighting—Lighting of workplaces—
1.3 This practice applies to all types of chemical residues
Indoor workplaces
(including APIs, intermediates, cleaning agents, processing
2.4 Federal Regulation:
5
aids, machining oils, and so forth) that could remain on
21 CFR 211.67Equipment Cleaning and Maintenance
manufacturing equipment surfaces or medical devices that
2.5 European Regulation:
have undergone all manufacturing steps including cleaning.
EudraLex Volume 4Guidelines for Good Manufacturing
Practices for Medicinal Products for Human and Veteri-
1.4 The values stated in SI units are to be regarded as
6
standard. No other units of measurement are included in this nary Use, Annex 15: Qualification and Validation
7
2.6 FDA Standard:
standard.
Guidance for Industry PATA Framework for Innovative
1.5 This standard does not purport to address all of the
Pharmaceutical Development, Manufacturing, and Qual-
safety concerns, if any, associated with its use. It is the
ity Assurance
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mine the applicability of regulatory limitations prior to use.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1.6 This international standard was developed in accor-
Standards volume information, refer to the standard’s Document Summary page on
dance with internationally recognized principles on standard-
the ASTM website.
3
ization established in the Decision on Principles for the Available from International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
Development of International Standards, Guides and Recom-
Secretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,
mendations issued by the World Trade Organization Technical
http://www.ich.org.
4
Barriers to Trade (TBT) Committee.
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
5
Available from U.S. Government Printing Office, Superintendent of
1
This practice is under the jurisdiction of ASTM Committee E55 on Manufac- Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
ture of Pharmaceutical and Biopharmaceutical Products and is the direct responsi- www.access.gpo.gov.
6
bility of Subcommittee E55.03 on General Pharmaceutical Standards. Available from https://ec.europa.eu/health/documents/eudralex/vol-4_en
7
Current edition approved Oct. 1, 2020. Published November 2020. DOI: Available from U.S. Food and Drug Administration (FDA), 10903 New
10.1520/E3263-20. Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3263−20
3. Terminology 3.1.10 maximum safe surface residue, MSSR, n—maximum
amount of residual process residue (API, cleaning agent,
3.1 Definitions:
degradant, and so forth) that may remain on manufacturing
3.1.1 cleaning process residue, n—any residue, including,
equipment or medical device surfaces without presenting an
but not l
...

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ASTM E3263-22e1(Practice)
Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.  
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.  
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.  
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).  
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.  
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.  
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.  
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.  
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.  
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.  
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.  
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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 Recommend...

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ASTM E3263-22e1(Practice)
Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.  
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.  
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.  
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).  
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.  
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.  
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.  
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.  
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.  
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.  
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.  
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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 Recommend...

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This specification covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for high-temperature service. Chemical analysis shall be performed on the alloy and shall conform to the chemical composition requirement in carbon, manganese, silicon, phosphorus, sulfur, chromium, cobalt, molybdenum, columbium, tantalum, titanium, aluminum, zirconium, boron, iron, copper, and nickel. The material shall follow recommended annealing treatment, solution treatment, stabilizing treatment, and precipitation hardening treatment. Tension testing, hardness testing and stress-rupture testing shall be performed on the material and shall comply to the required tensile strength, yield strength, elongation, reduction in area, and Brinell hardness.
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4.1 This test method establishes a selected set of conditions of temperature, relative humidity and rate of evaporation of the environment to which a mortar specimen of stated composition shall be subjected for a specified period of time during which its change in length is determined and designated “drying shrinkage.”  
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1.1 This specification covers preformed expansion joint fillers made from closed-cell polypropylene foam materials having suitable compressibility, recovery from compression, nonextruding, and weather-resistant characteristics.  
1.1.1 Type I, closed-cell polypropylene foam.  
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5.1 This test method can be used to determine whether the amount of draindown measured for a given asphalt mixture is within specified acceptable levels. The test provides an evaluation of the draindown potential of an asphalt mixture during mixture design and/or during field production. This test is primarily used for mixtures with high coarse aggregate content such as porous asphalt (open-graded friction course) and stone matrix asphalt (SMA).
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SCOPE
1.1 This test method covers the determination of the amount of draindown in an uncompacted asphalt mixture sample when the sample is held at elevated temperatures comparable to those encountered during the production, storage, transport, and placement of the mixture. The test is particularly applicable to mixtures such as porous asphalt (open-graded friction course) and stone matrix asphalt (SMA).  
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ASTM D545-23(Test Method)
Standard Test Methods for Preformed Expansion Joint Fillers for Concrete Construction (Nonextruding and Resilient Types)

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3.1 The compression resistance perpendicular to the faces, the resistance to the extrusion during compression, and the ability to recover after release of the load are indicative of a joint filler's ability to continuously fill a concrete expansion joint and thereby prevent damage that might otherwise occur during thermal expansion. The asphalt content is a measure of the fiber-type joint filler's durability and life expectancy. In the case of cork-type fillers, the resistance to water absorption and resistance to boiling hydrochloric acid are relative measures of durability and life expectancy.
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SCOPE
1.1 These test methods cover the physical properties associated with preformed expansion joint fillers. The test methods include:    
Property  
Section  
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7.1  
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7.4  
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7.5  
Water Absorption  
7.6  
Density  
7.7
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ABSTRACT
This specification covers asphalt plank used for bridge decks as well as for industrial floors. Asphalt planks shall be classified according to usage: Type Ia; Type Ib; and Type II. Asphalt plank shall be formed from a mixture of asphalt, fibers, modifiers, or a combination thereof, and mineral filler in such a manner as to produce a uniformly dense mass. The following test methods shall be intended to measure those attributes necessary to measure the ability of asphalt plank to provide a reasonably long and satisfactory service: absorption; brittleness; dimensions; and hardness.
SCOPE
1.1 This specification covers asphalt plank used for bridge decks as well as for industrial floors.  
1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.3 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.  
1.4 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.

  • Technical specification
    3 pages
    English language
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  • Technical specification
    3 pages
    English language
    sale 15% off