71.120.01 - Equipment for the chemical industry in general
ICS 71.120.01 Details
Equipment for the chemical industry in general
Ausrustungen fur die chemische Industrie im allgemeinen
Materiel pour l'industrie chimique en general
Oprema za kemijsko industrijo na splošno
General Information
Frequently Asked Questions
ICS 71.120.01 is a classification code in the International Classification for Standards (ICS) system. It covers "Equipment for the chemical industry in general". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 10 standards classified under ICS 71.120.01 (Equipment for the chemical industry in general). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
SIGNIFICANCE AND USE
5.1 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.
5.2 This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
SCOPE
1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.
1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both. The intention of this standard is to describe and support the implementation of a PAT enabled Control Strategy, as described in ICH Q8(R2).
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537, or for validation of PAT methods, which is covered in Guide E2898.
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for Industry—PAT and FDA Guidance for Industry—Process Validation, as well as EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and EU Guideline on Process Validation for Finished Products.
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 Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide7 pagesEnglish languagesale 15% off
- Guide7 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide is intended to provide a series of evaluations that will assist engineers dealing with chemical environments in selecting appropriate alloys (1-3). In chemical environments, an important issue for determining general corrosion resistance is the temperature at which an alloy transitions from corrosion at a low rate to corrosion at a much higher rate. Other important concerns include the tendency towards crevice corrosion and stress corrosion cracking resistance, especially in hot chloride-containing aqueous environments.
4.2 This guide is also intended for alloy developers to assist them in choosing environments and test methods that are of particular interest to the chemical process industries.
4.3 The use of this approach will allow direct comparisons to be made among alloys from various suppliers and, thereby, to assist engineers in selecting the most appropriate materials for further testing to determine suitability in their application.
SCOPE
1.1 This guide covers an evaluation approach that is designed to provide information on the corrosion properties of wrought iron- and nickel-based alloys for the chemical process industries. This guide incorporates test conditions for general corrosion measurements in a variety of environments, crevice corrosion resistance in chloride environments, and stress corrosion cracking resistance in chloride environments.
1.2 The values stated in SI units are to be regarded as 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 to 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.
- Guide6 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Application of this guidance should enable PAT method developers to design and implement reliable PAT applications that avoid many common sources of error around sampling. Sampling is a key element of method and process validation plans.
4.1.1 Many ASTM standards discuss sampling; however, almost all are very specific to a certain field or application. For example, the “Standard Practice for Automatic Sampling of Petroleum and Petroleum Products” (D4177) specifically covers information for the design, installation, testing, and operation of automated equipment for the extraction of representative samples of petroleum and petroleum products from a flowing stream and storing them in a sample receiver.
4.1.2 Other useful ASTM standards include: E105 (Practice for Probability Sampling of Materials), E122 (Standard Practice for Calculating Sample Size to Estimate, With a Specified Precision, the Average for a Characteristic of a Lot or Process), E1402 (Standard Guide for Sampling Design), and E456 (Terminology Relating to Quality and Statistics). These standards review similar considerations as those addressed in this guidance and can be consulted for additional insight on how to deal with specific sample types or situations. However, such standards should be carefully reviewed for relevance to pharmaceutical applications.
SCOPE
1.1 This document is to be used as a guide to Process Analytical Technology (PAT) instrument sampling, and covers both the sample from which PAT data is collected and the sample that is taken for reference assay. The ASTM definition of a guide is a compendium of information or series of options that does not recommend a specific course of action. The intention of a guide is to increases the awareness of information and approaches in a given subject area, as such this guide should serve as a collation of points to consider when determining a sample practice for PAT instruments. It is not intended to serve as a practice to be followed. As a first step, one should define the overall goal of the PAT measurement. Once defined, this guide describes various considerations as they relate to the specific requirements that must be met to achieve the overall PAT goal, including the attributes to be measured, impact of the scale of the process, and interfacing of the measurement system to manufacturing equipment (including sampling system reliability). Additionally, it discusses the estimation and validation of the effective sample size and the overall contribution to the measurement. Related aspects of data collection and data processing as well as the use of risk assessments to optimize sampling and to understand the impact of potential sampling errors are also covered. Furthermore, considerations for process control and aspects pertaining to sample withdrawal and retention are also included. Lastly, continuous manufacturing processes require special considerations due to the time dependency associated with continuous operations as compared to batch manufacturing and special considerations are needed for sampling of such processes.
1.2 This guide is limited to a high level overview of sampling considerations for PAT applied to any type of pharmaceutical manufacturing (for example, active pharmaceutical ingredient (API), solid oral dosage form, etc.). It is not intended to provide technology- or application-specific sampling guidance, or both. Instead, the intent is to evoke a thought process around sampling when developing a PAT application. While the focus is mainly on sampling considerations for on/in-line applications in solids, liquids, and gases (that is, in situ PAT measurements), many of the considerations also apply to at-line and off-line applications in which a sample is withdrawn from the process and subsequently presented for analysis.
1.3 This international standard was developed in accordance with internationally recognized principles on standardizatio...
- Guide6 pagesEnglish languagesale 15% off
IEC 62703:2013 specifies the general aspects in the terminology and definitions related to the performance of fluorometric oxygen analyzers used for the continuous determination of dissolved oxygen partial pressure or concentration in liquid media; unifies methods used in making and verifying statements on the functional performance of such analyzers; specifies which tests should be performed in order to determine the functional performance and how such tests should be carried out and provides basic documents to support the application of standards of quality assurance within ISO 9001.
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This standard specifies the essential requirements for compatibility and interchangeability of borosilicate glass plant, piping and fittings from DN 15 to DN 1000.
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