5.1 Under well-controlled conditions, the quantitative evaluation of morphological features of a cell population can be used to identify changes in cellular behavior or state. Cell morphology changes may be expected when, for example, there is a response to changes in cellular cytoskeleton organization (1), a response of cells to toxic compounds, changes in differentiation state, and changes in adhesion properties of cells to a substrate by either chemical or mechanical-induced extracellular matrix-based (ECM-based) signaling pathways (2, 3). Typically, populations of cells exhibit a range of morphologies even when the cells are genetically identical and are in a homogeneous environment (4). This biological variation in cell response is due to both cell-cycle variations and stochasticity in the cellular reactions that control adhesion and spreading in cells. By using cell-by-cell, microscopy-based measurements and appropriate statistical sampling procedures, the distribution of cell morphologies such as cell spreading area per cell can be measured. This distribution is highly characteristic of the culture and conditions being examined.5.2 It is important to note that the use of this technique for cells on or in a 3-D scaffold materials can complicate the interpretation of the data. The topographic transforms of the cells on a 3-D material may require full volumetric imaging and not just wide-field fluorescence imaging as described here.5.3 the following are several examples of how this measurement can be used in a laboratory:—5.3.1 Quantify Cellular Response to a Biomaterial—The measurement of cell spread area can be used to characterize the response of cells to biomaterials. For example, spreading of most cell types is extremely sensitive to the stiffness of the culture substrate (5), (6). It is important to note that cell response to an ECM may be dependent on the preparation of the matrix. For example, the same ECM proteins prepared in a fibrillar or non-fibrillar surface coating can result in different morphology response5.3.2 Quality Control Metric for General Cell Culture Conditions—Cell spread area may be a useful metric for monitoring a change in cell culture conditions (that is, due to a serum component, pH, passage number, confluence, etc.). Cell morphology is often altered when cells are stressed and proceeding through cell-death related processes (that is, apotoposis).5.3.3 Quality Control Metric for Biomaterial Fabrication—Cell spread area measurements may be useful for generating specifications for a biomaterial. These specifications may stipulate how a particular cell line responds to a fabricated biomaterial.5.3.4 Quality Control Metric for Cell Line Integrity and Morphology Benchmarking—The morphology characteristic of a cell line grown under specified conditions should ideally be the same over time and in different laboratories. Thus, cell spread area measurements may be useful for validating that no significant changes in the cell cultures have occurred. This measurement provides a benchmark that is useful for establishing the current state of the cell culture and a metric that can be charted to increased confidence for within and between laboratory comparisons of cellular measurements (7).1.1 This guide describes several measurement and technical issues involved in quantifying the spread area of fixed cells. Cell spreading and the distribution of cell spread areas of a population of cells are the result of a biological response that is dependent on intracellular signaling mechanisms and the characteristics of cell adhesion to a surface. Cell spread area is a morphological feature that can be responsive to alteration in the metabolic state or the state of stress of the cells. Changes in cell spread area can also indicate an alteration in the adhesion substrate that may be due to differences in manufacturing of the substrate material or be in response to extracellular matrix secretions. High quality measurement of cell spread area can serve as a useful metric for benchmarking and detecting changes cell behavior under experimental conditions.1.2 The measurement described in this document is based on the use of fluorescence microscopy imaging of fixed cells and the use of image analysis algorithms to extract relevant data from the images. To produce robust cell spread area measurements, technical details involved in sample preparation, cell staining, microscopy imaging, image analysis and statistical analysis should be considered. Several of these issues are discussed within this document.1.3 This standard is meant to serve as a guide for developing methods to reliably measure the area to which cells spread at a surface. This surface can be conventional tissue culture polystyrene or sophisticated engineered biomaterial surfaces. An example of a detailed procedure to measure the spreading area of cells on a tissue culture polystyrene surface is provided in the appendix section.1.4 Cell morphology features such as cell spreading area and perimeter are generally reported in units of length. For example, spreading area per cell (that is, cell spread area) is likely reported in units of µm2. A spatial calibration standard is required to convert between numbers of pixels in a CCD camera image to µm2 as an SI unit.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 and health practices and determine the applicability of regulatory limitations prior to use.1.5.1 Sodium azide is used as a anti-bacterial reagent in the slide mounting media. This preserves the integrity of the mounting media. The toxicity of this reagent (for example, MSDS) should be considered before use of this reagent in large scale slide mounting procedures.

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5.1 This document will be of use to forensic laboratory personnel who are involved in the analysis of GSR samples by SEM/EDS (5).5.2 SEM/EDS analysis of GSR is a non-destructive method that provides (6, 7) both morphological information and the constituent elements detected in individual particles.5.3 Particle analysis contrasts with bulk sample methods, such as atomic absorption spectrophotometry (AAS) (8), neutron activation analysis (NAA) (9), inductively coupled plasma atomic emission spectrometry (ICP-AES), and inductively coupled plasma mass spectrometry (ICP-MS), where the sampled material is dissolved or extracted prior to the determination of total element concentrations, thereby sacrificing size, shape, and individual particle identification.1.1 This practice covers the analysis of gunshot residue (GSR) by scanning electron microscopy/energy-dispersive X-ray spectrometry (SEM/EDS). The analysis is performed using automated software control of both the SEM and EDS systems, to screen the sample for candidate particles that could be associated with GSR. Manual control of the instrument is then used to perform confirmatory analysis and classification of the candidate particles. This practice refers solely to the analysis of electron microscopy stubs (1).21.2 Since software and hardware formats vary among commercial systems, guidelines will be offered in the most general terms possible. For proper terminology and operation, consult the SEM/EDS system manuals for each instrument.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 cannot replace knowledge, skills, or abilities acquired through education, training, and experience (Practice E2917), and is to be used in conjunction with professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.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.

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5.1 This practice is intended to be used by subject matter experts in the field of forensic pGSR analysis who have met their laboratory’s technical requirements to be assigned to the role of trainer in the category of testing that deals with the detection, analysis, and classification of pGSR particles.5.2 This practice is intended to be used in conjunction with Practice E2917, as well as the laboratory’s existing generalized training protocols, standard operating procedures, and quality practices, to develop a complete training-to-competency program in pGSR analysis by SEM/EDS. This practice provides the required additional, discipline-specific elements for pGSR analysis by SEM/EDS, in accordance with 5.3.2 of Practice E2917; it does not include the core specific elements covered in 5.3.1 of Practice E2917.5.3 The topics and procedures outlined in this practice are grounded in the body of scientific literature that exists in the field of pGSR examination.5.3.1 Additional sources of information on pGSR examination, not specifically mentioned in this document, should be considered, added, or substituted. A review of new sources of information on general forensic methods and pGSR examinations should be carried out on a regular basis (e.g. annually or biannually) to incorporate well-established current findings and methods into the training program and to replace any outdated methods.5.3.2 When possible, make additional training available to the trainee. Such training might include off-site short courses, short internships, and specialized training by experienced examiners.1.1 This practice describes the minimum requirements of a training program in primer gunshot residue (pGSR) analysis by scanning electron microscopy/energy dispersive X-ray spectroscopy (SEM/EDS). It describes lessons, practical exercises, and progress monitoring and evaluation that should be part of a laboratory’s training program.1.2 The primary purpose of this practice is to facilitate the development and implementation of training programs in crime laboratories or other such analytical entities that participate in the detection, analysis, and classification of pGSR particles.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.

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4.1 This guide is designed to be used by forensic service providers when issuing final reports on pGSR analyses by SEM/EDS.4.2 This guide is intended to be used in conjunction with Practice E1588, Practice E620, and the SWGGSR Guide.1.1 This guide describes the contents of a formal, written technical report expressing the results and interpretation of pGSR particle analysis by SEM/EDS by forensic service providers.1.2 This guide is intended for use by competent forensic science practitioners with the requisite formal education, discipline-specific training (see Practices E2917), and demonstrated proficiency to perform forensic casework.1.3 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.

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5.1 Users of this practice must determine for themselves whether the practices described meet the requirements of local or national authorities regulating asbestos or other fibrous hazards.5.2 Variations of this practice have been described by the Asbestos Research Council in Great Britain (8), the Asbestos International Association (AIA) (RTM 1) (9), NIOSH 7400, OSHA (Reference Method ID 160), and ISO 8672. Where the counting rules of these methods differ, this is noted in the text.5.3 Advantages5.3.1 The technique is specific for fibers. PCM is a fiber counting technique that excludes non-fibrous particles from the analysis.5.3.2 The technique is inexpensive, but requires specialized knowledge to carry out the analysis for total fiber counts, at least in so far as the analyst is often required under regulations to have taken a specific training course (for example, NIOSH 582, or equivalent).5.3.3 The analysis is quick and can be performed on-site for rapid determination of the concentrations of airborne fibers.5.3.4 The procedure provides for a discriminate counting technique that can be used to estimate the percentage of counted fibers that may be asbestos.5.4 Limitations5.4.1 The main limitation of PCM is that fibers are not identified. All fibers within the specified dimensional range are counted. Differential fiber counting may sometimes be used to discriminate between asbestos fibers and fibers of obviously different morphology, such as cellulose and glass fiber. In most situations, differential fiber counting cannot be used to adequately differentiate asbestos from non-asbestos fibers for purposes of compliance with regulations without additional positive identification. If positive identification of asbestos is required, this must be performed by polarized light or electron microscopy techniques, using a different portion of the filter.5.4.2 A further limitation is that the smallest fibers visible by PCM are about 0.2 µm in diameter, while the finest asbestos fibers may be as small as 0.02 µm in diameter.5.4.3 Where calculation of fiber concentration provides a result exceeding the regulatory standard, non-compliance is assumed unless it can be proven that the fibers counted do not belong to a member or members of the group of fibers regulated by that standard.1.1 This practice2 describes the determination of the concentration of fibers, expressed as the number of such fibers per millilitre of air, using phase contrast microscopy and optionally transmission electron microscopy to evaluate particulate material collected on a membrane filter in the breathing zone of an individual or by area sampling in a specific location. This practice is based on the core procedures provided in the International Organization for Standardization (ISO) Standard ISO 8672(1)3, the National Institute for Occupational and Health (NIOSH) Manual of Analytical Methods, NIOSH 7400 (2), and the Occupational Safety and Health Administration (OSHA) Method ID 160 (3). This practice indicates the important points where these methods differ, and provides information regarding the differences. However, selecting portions of procedures from different published methods generally requires a user to report that they have used a modification to a method rather than claim they have used the method as written. This practice further gives guidance on how differential counting techniques may be used to indicate where a population of fibers may be asbestos.1.2 The practice is used for routine determination of an index of occupational exposure to airborne fibers in mines, quarries, or other locations where ore may be processed or handled. The method gives an index of airborne fiber concentration. The method provides an estimate of the fraction of counted fibers that may be asbestos. This practice should be used in conjunction with electron microscopy (See Appendix X1) for assistance in identification of fibers.1.3 This practice specifies the equipment and procedures for sampling the atmosphere in the breathing zone of an individual and for determining the number of fibers accumulated on a filter membrane during the course of an appropriately-selected sampling period. The method may also be used to sample the atmosphere in a specific location in a mine or in a room of a building (area sampling).1.4 The ideal working range of this practice extends from 100 fibers/mm2 to 1300 fibers/mm2 of filter area. For a 1000-L air sample, this corresponds to a concentration range from approximately 0.04 to 0.5 fiber/mL (or fiber/cm3). Lower and higher ranges of fiber concentration can be measured by reducing or increasing the volume of air collected. However, when this practice is applied to personal sampling in mines and quarries, the level of total suspended particulate may impose an upper limit to the volume of air that can be sampled if the filters produced are to be of appropriate particulate loading for fiber counting.1.5 Users should determine their own limit of detection using the procedure in Practice D6620. For reference, the NIOSH 7400 method gives the limit of detection as 7 fibers/mm2 of filter area. For a 1000-L air sample, this corresponds to a limit of detection of 0.0027 fiber/mL (or fiber/cm3). For OSHA ID 160 the limit of detection is given as 5.5 fibers/mm2 of filter area. For a 1000-L air sample, this corresponds to a limit of detection of 0.0022 fiber/mL (or fiber/cm3).1.6 If this practice yields a fiber concentration that does not exceed one-half the permissible exposure limit or threshold limit value for the particular regulated fiber variety, no further action may be necessary. If the fiber concentration exceeds one-half of the regulated permissible exposure limit or threshold limit value for the particular regulated fiber variety, it is necessary to examine the data to determine if more than 50 % of the counted fibers are thinner than 1.0 μm, or thicker but with an appearance of asbestos (curvature, splayed ends, or the appearance of a bundle).1.7 The mounting medium used in this practice has a refractive index of approximately 1.45. Fibers with refractive indices in the range of 1.4 to 1.5 will exhibit reduced contrast, and may be difficult to detect.1.8 Fibers less than approximately 0.2 µm in diameter may not be detected by this practice. (4)1.9 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For specific precautionary statements, see Section 7.

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4.1 A microscopical hair examination is conducted to determine if the item is a hair; from a human; from a particular somatic region; characteristic of a broad geographically-assigned ancestral group; characteristic of a particular growth phase; damaged; symptomatic of disease, condition, or disorder; forcibly removed; chemically altered (for example, dyed or bleached); suitable for microscopical comparison; suitable for DNA analysis; and similar to or different from a known sample (4-9).4.2 Most often, hairs from the head and pubic regions of the body are used for microscopical comparisons. There is usually more interpersonal variability in the characteristics of head and pubic hairs than in the hairs from other somatic regions. Head hairs usually show more interpersonal variation than pubic hairs. Hairs from other somatic regions may also be compared, but these comparisons are usually limited and less frequently conducted. Accordingly, this guide primarily considers human head and pubic hair comparisons.4.3 Microscopical hair comparisons are not a means of individualization (10). This limitation is to be stated in any communication (for example, reports, testimony) when an association is reported.4.4 Additional analyses can be performed on hairs that have been chemically altered (for example, dyed hair) or have trace materials on the surface (for example, glitter). Such techniques are beyond the scope of this document.1.1 This guide covers procedures used by forensic laboratory personnel in the forensic examination of hair by microscopy, including microscopical comparisons and classification of hair samples.1.2 This guide addresses instrument setup, hair collection, sample handling techniques, and the use of various microscopes in the examination and comparison of hair.1.3 This guide addresses the benefit of following microscopical examinations with DNA analysis.1.4 This standard is intended for use by competent forensic science practitioners with the requisite formal education, discipline-specific training (see Practice E2917), and demonstrated proficiency to perform forensic casework.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.

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5.1 Users of this practice must determine for themselves whether the practices described meet the requirements of local or national authorities regulating asbestos or other fibrous hazards. 5.2 Variations of this practice have been described by the Asbestos Research Council in Great Britain (8), the Asbestos International Association (AIA) RTM 1 (9), NIOSH 7400, OSHA ID 160, and ISO 8672. Where the counting rules of the latter three methods differ, this is noted in the text. 5.3 Advantages:  5.3.1 The technique is specific for fibers. PCM is a fiber counting technique that excludes non-fibrous particles from the analysis. 5.3.2 The technique is inexpensive, but requires specialized knowledge to carry out the analysis for total fiber counts, at least in so far as the analyst is often required under regulations to have taken a specific training course (for example, NIOSH 582, or equivalent). 5.3.3 The analysis is quick and can be performed on-site for rapid determination of the concentrations of airborne fibers. 5.4 Limitations:  5.4.1 The main limitation of PCM is that fibers are not identified. All fibers within the specified dimensional range are counted. Differential fiber counting may sometimes be used to discriminate between asbestos fibers and fibers of obviously different morphology, such as cellulose and glass fiber. In most situations, differential fiber counting cannot be used to adequately differentiate asbestos from non-asbestos fibers for purposes of compliance with regulations without additional positive identification. If positive identification of asbestos is required, this must be performed by polarized light or electron microscopy techniques, using a different portion of the filter. 5.4.2 A further limitation is that the smallest fibers visible by PCM are about 0.2 μm in diameter, while the finest asbestos fibers may be as small as 0.02 μm in diameter. 5.4.3 Where calculation of fiber concentration provides a result exceeding the regulatory standard, non-compliance is assumed unless it can be proven that the fibers counted do not belong to a member or members of the group of fibers regulated by that standard. 1.1 This practice2 describes the determination of the concentration of fibers, expressed as the number of such fibers per millilitre of air, using phase contrast microscopy and optionally transmission electron microscopy to evaluate particulate material collected on a membrane filter in the breathing zone of an individual or by area sampling in a specific location. This practice is based on the core procedures provided in the International Organization for Standardization (ISO) Standard ISO 8672 (1),3 the National Institute for Occupational and Health (NIOSH) Manual of Analytical Methods, NIOSH 7400 (2), and the Occupational Safety and Health Administration (OSHA) ID 160 (3). This practice indicates the important points where these methods differ, and provides information regarding the differences, which will allow the user to select the most appropriate procedure for a particular application. However, selecting portions of procedures from different published methods generally requires a user to report that they have used a modification to a method rather than claim they have used the method as written. 1.2 The practice is used for routine determination of an index of occupational exposure to airborne fibers in workplaces. Workplaces are considered those places where workers are exposed to airborne fibers including asbestos. Additional information on sampling strategies, sample collection (including calibration) and use of sample results for asbestos abatement projects is provided in a standard Practice for Air Monitoring for Management of Asbestos-Containing Materials (WK 8951) currently being considered by ASTM subcommittee E06.24. A further practice has been approved for the specific purpose of sampling and counting airborne fibers in mines and quarries (Practice D7200), although the practice herein may also be used for this purpose. The current practice may be used as a means of monitoring occupational exposure to asbestos fibers when asbestos fibers are known a priori to be present in the airborne dust. The practice gives an index of airborne fiber concentration. This practice may be used in conjunction with electron microscopy (see Appendix X1) for assistance in identification of fibers. This practice may be used for other materials such as fibrous glass, or man-made mineral fibers by using alternate counting rules (see Annex A4). 1.3 This practice specifies the equipment and procedures for sampling the atmosphere in the breathing zone of an individual and for determining the number of fibers accumulated on a filter membrane during the course of an appropriately-selected sampling period. The practice may also be used to sample the atmosphere in a specific location or room of a building (area sampling), where this may be helpful in assessing exposure to workers handling fiber-containing products. 1.4 The ideal working range of this test practice extends from 100 fibers/mm2 to 1300 fibers/mm2 of filter area. For a 1000-L air sample, this corresponds to a concentration range from approximately 0.04 to 0.5 fiber/mL (or fiber/cm3). Lower and higher ranges of fiber concentration can be measured by reducing or increasing the volume of air collected. However, when this practice is applied to sampling the presence of other, non-asbestos dust, the level of total suspended particulate may impose an upper limit to the volume of air that can be sampled if the filters produced are to be of appropriate fiber loading for fiber counting. 1.5 Users should determine their own limit of detection using the procedure in Practice D6620. For Reference the NIOSH 7400 method gives the limit of detection as 7 fibers/mm2 of filter area. For a 1000 L air sample, this corresponds to a limit of detection of 0.0027 fiber/mL (or fiber/cm3). For OSHA ID 160 the limit of detection is given as 5.5 fibers/mm2 of filter area. For a 1000 L air sample, this corresponds to a limit of detection of 0.0022 fiber/mL (or fiber/cm3). 1.6 If this practice yields a fiber concentration that does not exceed the occupational limit value for the particular regulated fiber variety, no further action may be necessary. If the fiber concentration exceeds the occupational limit value for a specific fiber variety, and there is reason to suspect that the specific fiber variety is mixed with other fibers not covered under the same standard or regulation, the optional method specified in Appendix X1 may be used to measure the concentration or proportion of the fibers counted that are of the regulated variety. 1.7 The mounting medium used in this practice has a refractive index of approximately 1.45. Fibers with refractive indices in the range of 1.4 to 1.5 will exhibit reduced contrast, and may be difficult to detect. 1.8 Fibers less than approximately 0.2 μm in diameter will not be detected by this practice (4). 1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.10 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. For specific precautionary statements, see Section 7. 1.11 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.

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4.1 This guide will encompass considerations for manufacturers regarding sources and potential causes of subvisible particles in biomanufacturing operations and the use of dynamic imaging particle analyzers as a suggested common method to monitor them. The guide will address the following components of particle analysis using dynamic imaging microscopy: fundamental principles, operation, image analysis methods, sample handling, instrument calibration, and data reporting.1.1 Biotherapeutic drugs and vaccines are susceptible to inherent protein aggregate formation which may change over the product shelf life. Intrinsic particles, including excipients, silicone oil, and other particles from the process, container/closures, equipment or delivery devices, and extrinsic particles which originate from sources outside of the contained process, may also be present. Monitoring and identifying the source of the subvisible particles throughout the product life cycle (from initial characterization and formulation through finished product expiry) can optimize product development, process design, improve process control, improve the manufacturing process, and ensure lot-to-lot consistency.1.2 Understanding the nature of particles and their source is a key to the ability to take actions to adjust the manufacturing process to ensure final product quality. Dynamic imaging microscopy (also known as flow imaging or flow microscopy) is a useful technique for particle analysis and characterization (proteinaceous and other types) during product development, in-process and commercial release with a sensitive detection and characterization of subvisible particles at ≥2 µm and ≤100 µm (although smaller and larger particles may also be reported if data are available). In this technique brightfield illumination is used to capture images either directly in a process stream, or as a continuous sample stream passes through a flow cell positioned in the field of view of an imaging system. An algorithm performs a particle detection routine. This process is a key step during dynamic imaging. The digital particle images in the sample are processed by image morphology analysis software that quantifies the particles in size, count, image intensity, and morphological parameters. Dynamic imaging particle analyzers can produce direct determinations of the particle count per unit volume (that is, particle concentration), as a function of particle size by dividing the particle count by the volume of imaged fluid (see Appendix X1).1.3 This guide will describe best practices and considerations in applying dynamic imaging to identification of potential sources and causes of particles during biomanufacturing. These results can be used to monitor these particles and where possible, to adjust the manufacturing process to avoid their formation. This guide will also address the fundamental principles of dynamic imaging analysis including image analysis methods, sample preparation, instrument calibration and verification and data reporting.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.

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