Determining the criticality of equipment. Identification of critical equipment to make a decision to change the repair interval

Before defining the essential characteristics of such terms as "critical technology" and "production technology", let's define the concept of "technology".

The term "technology" was first introduced in 1772 by I. Beckman, a professor at the University of Göttingen, to designate handicraft art, which includes professional skills and empirical ideas about tools and labor operations.

The Encyclopedic Dictionary provides the following interpretation of this term:

"Technology(from Greek. techne art, craftsmanship, skill and logos - word) - a set of methods of processing, manufacturing, changing the state, properties, form of raw materials, material or semi-finished products, carried out in the process of manufacturing products; a scientific discipline that teaches physical, chemical, mechanical and other regularities that operate in technological processes. Technology is also called the operations of extraction, processing, transportation, storage, control, which are part of the overall production process.

Most people view technology as something to do with inventions and machines, such as semiconductors and computers. Charles Perrow, who has written extensively on the impact of technology on organizations and societies, describes technology as a means of transforming raw materials—whether people, information, or physical materials—into desired products and services. Lewis Davies, writing on works design, offers a similar broad description: "Technology is the combination of skills, equipment, infrastructure, tools, and related technical knowledge necessary to bring about desired transformations in materials, information, or people."

Tasks and technology are closely related. Completing the task involves using a particular technology as a means of converting the input material into the output form. According to Wieland and Ulrich, "machinery, equipment and raw materials can of course be considered as components of technology, but the most significant component is undoubtedly the process by which raw materials (raw materials) are transformed into a desired product. At its core, technology is a method which allows such a transformation to be carried out.

The high importance of technology was largely determined by three major revolutions in technology: the industrial revolution; standardization and mechanization; using conveyor assembly lines.

Critical Technologies represent scientific and technical areas to ensure the country's defense capability, the security of the population and various facilities. Among them, for example, the safety of nuclear energy, biological means of protecting plants and animals, the rapid construction and transformation of housing, etc.

The term "critical technologies" ( critical technologies ) originates from the so-called critical materials - 15 in the middle of the 20th century. the so-called strategic materials not produced in the USA, but necessary for the effective functioning of the economy, a five-year supply of which was to be available in the country in case of possible military conflicts. Literal translation from the English word critica - extremely necessary, scarce. However, in many other languages, including Russian, it has a negative connotation. Therefore, in a number of countries the term "key technologies" is used: for example, in France - technology cles, in Germany - Schlusseltechnologien .

The list of critical technologies in Russia is one of the main instruments of the country's state policy in the development of domestic science and technology. Its formation is provided for by such a document as the Decree of the President of the Russian Federation of March 30, 2002 No. Pr-576 "Fundamentals of the policy of the Russian Federation in the field of science and technology development for the period up to 2010 and beyond." The list of critical technologies of the country is approved in accordance with the order of the President of the Russian Federation dated April 17, 2003 No. Pr-655 on the adjustment of priority areas for the development of science, technology and technology in the Russian Federation and the list of critical technologies of the Russian Federation by decisions of the President on the proposal of the Government at least once every four of the year. At the same time, the Priority Directions for the Development of Science, Technology and Engineering in the Russian Federation are being approved.

In accordance with Decree of the President of the Russian Federation of July 7, 2011 No. 899 "On approval of priority areas for the development of science, technology and technology in the Russian Federation and the list of critical technologies of the Russian Federation", the following critical technologies and priority areas are distinguished.

I. Priority directions for the development of science, technology and technology

• 1. Security and counter-terrorism.
• 2. Industry of nanosystems.
• 3. Information and telecommunication systems.
• 4. Life sciences.
• 5. Promising types of weapons, military and special equipment.
• 6. Rational nature management.
• 7. Transport and space systems.
• 8. Energy efficiency, energy saving, nuclear power.

II. Critical Technologies

• 1. Basic and critical military and industrial technologies for the creation of promising types of weapons, military and special equipment.
• 2. Basic technologies of power electrical engineering.
• 3. Biocatalytic, biosynthetic and biosensor technologies.
• 4. Biomedical and veterinary technologies.
• 5. Genomic, proteomic and postgenomic technologies.
• 6. Cellular technologies.
• 7. Computer modeling of nanomaterials, nanodevices and nanotechnologies.
• 8. Nano-, bio-, information, cognitive technologies.
• 9. Technologies of nuclear power engineering, nuclear fuel cycle, safe handling of radioactive waste and spent nuclear fuel.
• 10. Bioengineering technologies.
• 11. Technologies for diagnosing nanomaterials and nanodevices.
• 12. Technologies of access to broadband multimedia services.
• 13. Technologies of information, control, navigation systems.
• 14. Technologies of nanodevices and microsystem technology.
• 15. Technologies of new and renewable energy sources, including hydrogen energy.
• 16. Technologies for obtaining and processing structural nanomaterials.
• 17. Technologies for obtaining and processing functional nanomaterials.
• 18. Technologies and software for distributed and high-performance computing systems.
• 19. Technologies for monitoring and predicting the state of the environment, preventing and eliminating its pollution.
• 20. Technologies of search, exploration, development of mineral deposits and their extraction.
• 21. Technologies for the prevention and elimination of natural and man-made emergencies.
• 22. Technologies to reduce losses from socially significant diseases.
• 23. Technologies for creating high-speed vehicles and intelligent control systems for new modes of transport.
• 24. Technologies for the creation of rocket-space and transport equipment of a new generation.
• 25. Technologies for creating an electronic component base and energy-efficient lighting devices.
• 26. Technologies for creating energy-saving systems for the transportation, distribution and use of energy.
• 27. Technologies of energy efficient production and conversion of energy on organic fuel.

Manufacturing technologies– this is a certain set and sequence of various kinds of actions of a person and machines to create the most economical ways of producing raw materials, materials, products or providing services(repair of equipment and tools, transportation of goods and passengers, collection and processing of information ).

Working for a long time with world leaders in the production of industrial equipment components, we came to the conclusion that not only the quality and cost of spare parts affect the cost of the enterprise and the life of the equipment. Important factors are also: the qualifications and knowledge of maintenance personnel, the frequency, speed, quality of repairs, the reliability of suppliers, control of work in overhaul intervals, and a number of others. With all this in mind, we have created a program to optimize the operating costs of production assets. This program aims to reduce production costs for our partners, increase equipment productivity and maximize profits without incurring significant additional costs.

This program consists of four stages and leads to an excellent and often necessary result for many managers.

Stage number 1. Determining the degree of criticality of equipment.

First of all, we must jointly determine the degree of criticality of the equipment. The focus should be on critical equipment.

An example of a criticality matrix:

Stage number 2. Monitoring of critical equipment, analysis of existing outage.

Critical equipment must be regularly monitored by non-destructive testing methods, such as equipment surface temperature measurements, thermal imaging, noise analysis and vibration diagnostics. Together with the people operating this equipment at your enterprise, we will determine the scope and duration of observations, the purpose of which will be to evaluate the scheduled preventive maintenance (PPR) schedules for equipment adopted at this enterprise in order to increase the overhaul intervals and / or eliminate unplanned downtime.

The implementation of this stage will significantly save on outage, as well as reduce (or nullify) the cost of forced equipment downtime.

Stage number 3. Analysis of the causes of frequent failure of non-critical equipment.

Frequent failures of non-critical equipment can become a significant cost item. They include the cost of spare parts and staff salaries. As a rule, the enterprise incurs additional costs for maintaining a warehouse of spare parts for such equipment. At this stage, we find solutions to eliminate the causes of frequent equipment breakdowns and reduce maintenance costs.

Stage number 4. Training of personnel operating the equipment.

On the basis of our own training center, which includes classrooms for both theoretical materials and practical exercises, we can audit current knowledge and train your technical staff. The classrooms of our center are equipped with the most modern tools, with the help of which repair and diagnostics of industrial equipment can be carried out today. We regularly train specialists from such companies as PJSC KVZ, PJSC NKNK, PJSC TAIF-NK, JSC Generating Company and others.

As a result of the work carried out at all stages, you get:

• Increase in productivity. Better use of resources. Improved reliability and efficient maintenance. Reliable results. Competent staff.
• Reducing the cost of PPR. Reducing unplanned downtime. Increase machine durability by reducing vibration and wear. Overall cost reduction.
• Increased mean time between failures. Extending the intervals between scheduled repairs.
• No capital costs.

To implement the program of optimization of operating costs of production assets at your enterprise, please contact us and we will advise you in detail on the implementation of each of its stages.

Methods for organizing a system of maintenance and repair of equipment in order to ensure its trouble-free operation.

Methods of eguipment maintenance and repair organization to ensure its failure-free operation.

Goncharov A.B. Doctor of Technical Sciences, Tulinov A.B. Doctor of Technical Sciences, prof., Perepechai B.A., Goncharov A.A. (CJSC MMK Mosintrast).

Goncharov Alexander B., Tulinov Andrey B., Perepechai Bohdan A., Goncharov Andrey A.

Address: 143405, Moscow region, Krasnogorsk, Ilyinskoye highway, 2nd km, territory of the Becema plant

annotation

The article deals with the issues of complex maintenance of equipment of industrial enterprises in order to ensure their trouble-free operation. The requirements for the reliability of mining equipment while ensuring the highest possible level of efficiency through the formation of a maintenance and repair program are proposed. The main indicators of reliability and the methodology for determining functional failures and their causes are considered. This will allow timely decisions to be made about possible impacts on the equipment in use. For these purposes, it is proposed to use the "Decision Diagram, which provides a significant extension of the life cycle of the equipment."

The article includes the questions of complex service of the equipment of the industrial enterprises for ensuring their accident-free operation. Offering requirements to reliability of the mountain equipment when ensuring the greatest possible level of efficiency due to the formation of the program of maintenance and repair. Considered the main indicators of reliability and technique of definition of functional refusals and their causes. It will allow to make in due time decisions on potential impacts on the equipment used. For these purposes it is offered to use "The chart of decision-making that provides essential extension of life cycle of work of the equipment".

Keywords: Diagnostics, maintenance, reliability, indicators, efficiency, impact, critical failure, equipment.

keywords: Diagnostics, maintenance, reliability, indicators, efficiency, influence, critical refusal, equipment.

Over the past 25 years, the approach to equipment maintenance and repair (MRO) has changed more than any other management discipline. The changes are driven by a huge increase in the number and variety of equipment, with much more complex designs. New methods of service have emerged and views of service organizations and their responsibilities have changed. This forced large companies to reconsider their approaches to MRO solutions. In order to exclude unscheduled downtime of equipment, accompanied by production losses, maintenance systems have been developed abroad, aimed at improving the reliability of equipment operation. One such system is RCM (Reliability-Centered Maintenance) methodology, which allows to determine the necessary measures to ensure that each production system and its elements perform their assigned function within the production process.

Similar tasks are facing our industry, as evidenced by recent publications. So in the work for mining enterprises it is proposed to create an intelligent system for monitoring the state of mining equipment in order to ensure the reliability of its operation. However, this requires the creation of structured statistical information. The paper sets the task of creating for domestic enterprises a system for ensuring trouble-free operation of equipment at optimal costs. The monograph presents an information retrieval system for analyzing defects in products in the field of industrial production and housing and communal services. This system can also be used to analyze defects in production equipment.

Today, the task of ensuring the reliability of production equipment at optimal costs is relevant for both foreign and domestic enterprises.

Historically, starting from the 20s of the last century, MRO characterizes 3 main stages. The first stage covers the period before the Second World War. In those days, industry was not highly mechanized and preventing equipment failure was not a priority. Maintenance was limited to simple adjustments, lubrication, etc. Only failed equipment was restored.

In the next phase, the demand for goods of all kinds increased, while the demand for labor fell sharply, this led to an increase in mechanization. In the 1950s, machines and mechanisms become more complex, large-scale industry begins to depend on them. With the growth of this dependence came the understanding that equipment failures can and should be prevented. In the 1960s, maintenance and repair consisted primarily of overhauls of equipment at a fixed time interval. Maintenance costs also began to rise sharply in relation to other operating costs. Finally, the increase in capital investment in fixed assets, together with a sharp increase in the cost of capital, forced companies to start looking for ways in which they could maximize the life of production assets.

In the mid-1970s, maintenance and repair programs were based on the assumption that the life cycle of any asset depends only on the time of its operation. Therefore, periodic overhauls are necessary to ensure performance and reliability. However, the established frequency of overhauls did not contribute to the increase in productivity. In the future, in order to increase the productivity of equipment, the frequency of overhauls in the US industry was reduced, but, as was noted, the shortening of the intervals between overhauls increased the cost of repairs, and too early replacement of parts led to underutilization of the resource. The number of early failures immediately after overhauls also increased.

This situation was the impetus for many US companies to create a new MRO ideology. The most widely used, mentioned earlier, is the RCM methodology, which is focused on ensuring the reliable operation of equipment. Today, the RCM methodology is used in aviation (MSG3), nuclear power plants, NASA, and large manufacturing companies.

The goal of RCM is to meet the requirements of equipment reliability and safety while ensuring the highest possible level of efficiency through the formation of an optimal equipment maintenance and repair program. The objective of an RCM analysis is to create an equipment maintenance and repair program that ensures that any production facility continues to perform the functions required by the owner under current operating conditions.

Based on the results of RCM analysis, reliability indicators are calculated that characterize the operation of equipment, including: technical readiness factor, time between failures, recovery time, time between failures, etc.

When conducting an RCM analysis, answers to the following questions should be obtained:

• what equipment is critical for production;
• under what conditions the equipment may cease to perform its function;
• what causes functional failure;
• what happens when a failure occurs;
• how critical each failure is;
• what can be done to prevent rejection;
• what to do if failure cannot be prevented;

When determining the conditions for the operation of equipment a list of equipment is compiled with a detailed description of its characteristics and operating conditions. The need to describe the operating conditions is due to the fact that under different operating conditions, even for objects that are identical from a technical point of view, they can differ significantly:

• features and performance requirements;
• types of failures and the results of their consequences;
• operational measures to be taken in case of failure.

When determining the functions of the equipment a complete list of functions is compiled, indicating performance requirements, and the definition of primary and secondary functions. For each function, performance requirements are defined. The initial capacity of the equipment, set by the manufacturer, must always be greater than the level set by the performance requirements. Performance requirements are not always absolute values, but may have upper and lower limits. The boundaries in this case are set in accordance with the current norm, as well as the documentation of the equipment manufacturer. In some cases, performance requirements are variable, such as when performance depends on load or external factors.

The functions of protective devices should also be described, although they do not perform any function under normal conditions of the production process, they serve to prevent failures, mitigate or eliminate the consequences of a failure.

Definition of critical equipment. The equipment is considered critical, the downtime of which incurs the greatest production losses and the cost of refurbishment. A number of factors are taken into account when determining the critical condition of equipment, including:

• equipment repair costs;
• loss of products due to reduced quality;
• time between failures;
• impact on safety and the environment.

When determining functional failures and their causes all possible failures, failure causes, type of failure probability distribution are identified. Only those failures that can occur under given operating conditions with a sufficiently high probability should be described. The description includes the following failures, which:

• have happened before with this equipment. Such failures are determined from the analysis of the log of equipment defects, statistics of technological violations, etc.;
• currently prevented by existing maintenance and repair programs;
• did not appear, but are considered possible (analysis of statistics for other stations, statistics from open sources, manufacturer's data, etc.)

The reasons for the occurrence of each failure should be recorded and replenished with information arrays for possible use in the event of repeated failures.

The probability of failures can have several types of distribution from random failure to a high degree of occurrence and is determined based on the analysis of information on defect statistics, reliability indicators, and expert opinion.

When determining the possible consequences of failures the consequences of failures and their types are identified and described. The result of each failure must be described on the assumption that no action was taken to prevent it. When describing the consequences of a failure, the following should be defined:

• signs indicating the fact of a failure;
• the conditions under which the failure occurs;
• the impact of the failure on the safety of people or the environment;
• impact of failure on production (production volumes, product quality, customer service and production costs);
• assessment of damages due to failure;
• actions necessary to bring the system into working condition and the time required for their implementation.

Making decisions about possible impacts provides for determining the type of impact that must be applied to prevent the occurrence of failure, determining the signs by which it is possible to determine the imminent onset of failure, determining the frequency of impacts. To select the desired effect, use "Decision Diagram" , which works in the logic of "Yes" and "No". Horizontally, the scheme is divided into groups of failures. These can be failures: hidden, affecting the safety of people and the environment, affecting the production process.

The groups of failures in the "Decision Diagram" are arranged in order of importance, from left to right. In RCM, latent failures are considered the most important, so work on the scheme must begin with them. First, based on the results of describing the possible consequences of failures and from the criteria specified in the scheme, the type of failure is determined. After determining the type of failure, the actions that can be applied to reduce the probability of failure to an acceptable level are considered. Consideration of impacts is carried out in a strictly defined order. To make a decision on the application of influence, it must be feasible or expedient.

The feasibility of servicing equipment according to its technical condition is determined based on the existence of signs by which it is possible to determine the imminent onset of failure, as well as taking into account the "Equipment Condition Diagram".

The expediency of applying the impact should ensure that the probability of failure is reduced to an acceptable level so that the costs of performing this impact are justified.

When forming maintenance and repair schedules, it should be taken into account that the frequency of exposure should not contradict the existing regulatory and technical documentation (NTD). If the time intervals between impacts are longer than those specified in the NTD, then the latter should be taken as the basis.

Based on the study of RCM analysis and experience in its use, the Moscow International Corporation (MMC) Mosintrast implements such systems at industrial enterprises, including the pulp and paper and mining industries, that contribute to the trouble-free operation of production equipment and increase its productivity. At the same time, MMK Mosintrast not only assesses the technical condition of the equipment, but also promptly performs all types of repair and restoration work with further monitoring of the technical condition of the equipment. For industrial enterprises, the implementation of this project is proposed. The implementation period is 12 months. In doing so, the following is carried out:

• collection of basic data, audit and assessment of the technical condition of equipment (3 months);
• carrying out repair and restoration work of equipment (in the agreed time frame);
• organizing a maintenance and repair program for equipment based on the principles of reliability;

In the course of the work and upon its completion, the implementation of technical means of monitoring the condition of the equipment and its components is carried out, as well as daily monitoring and control of equipment parameters.

As a result of these works, the main indicators for assessing the reliability of equipment are calculated, an optimal maintenance and repair program is formed, and an effective system for monitoring the condition of equipment is created. This reduces production losses, improves equipment availability, reduces repair time and maintenance costs.

Bibliography.

1. Ostrovsky M.S., Verzhansky A.P., Taltykin V.S. Intelligent system for monitoring the state of mining equipment. Scientific and technical journal "Mining Engineer", No. 1, 2013, p. 126-137.
2. Birger I.A. Technical diagnostics. M., Mashinostroenie, 1978, p. 340.
3. Popov G.V., Ignatiev E.B., Vinogradova L.V., Rogozhnikov Yu.Yu. Expert system for assessing the state of electrical equipment "Diagnostics". Power stations, No. 5, 2011. - p. 36-45.
4. Sulin A. Rapid victories of reforming the maintenance and repair function. “Downtime is NOT”, No. 3, 2015, pp. 2-8.
5. Emphasis on MRO “Pulp. Paper. Cardboard, No. 10, 2015, p. 47-49.
6. Skvortsov D. Organization of maintenance in the XXI century. “Downtime is NOT”, No. 3, 2015, p. 25-31.
7. Tulinov A.B. The system for analyzing defects in manufacturing products and the housing and communal services sector: Monograph, FGUVPO "RGUTiS" .- M., 2008, p. 112.
8. Sutyagin A. technological providing of surface layer wear resistance of machine components. "Tribology" Romania, 2011 - p.15-18
9. SAE LA1012, A Guide to the Reliability - Centered Maintenance Standard Up to date of August 19, 2010
10. Nowlan F.S. and Heap, H.F., "Reliability-Centered Maintenance", DoD report AD - A066579, December 1978
11. NAVAIR Manual 00-25-403, Guidelines for the Naval Aviation Reliability-Centered Maintenance Process. March 2003
12. Echeverry, J.A. and Leverette J.C., NAVAIR Reliability-Centered Maintenance Compliance with SAE JA1011, July 2004

GOST R 52896-2007

Group R28

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

Production of medicines

TECHNOLOGICAL EQUIPMENT FOR PRODUCTION
SOLID DOSAGE FORMS

General requirements

Manufacturing of medicinal products.
Processing equipment for manufacturing of solid dosage forms.
General requirements

OKS 11.040.99
OKP 94 7000

Introduction date 2008-10-01

Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On Technical Regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions"

About the standard

1 DEVELOPED by the All-Russian public organization "Association of Engineers for the Control of Micropollution" (ASINCOM)

2 INTRODUCED by the Technical Committee for Standardization TC 458 "Production and quality control of medicines"

3 APPROVED AND PUT INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology dated December 27, 2007 N 616-st

4 INTRODUCED FOR THE FIRST TIME


Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notifications and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet

Introduction

Medicines are a special kind of product. They are subject to high requirements for safety and efficiency, provided at all stages of development, testing, production and sale.

Requirements for the production of medicines are established by the backbone standard GOST R 52249. This standard is included in the set of standards related to the production of medicines, and specifies the requirements for technological equipment for the production of solid dosage forms (tablets, capsules, granules, powders).

1 area of ​​use

1 area of ​​use

This standard establishes general requirements for process equipment for the production of solid dosage forms in accordance with GOST R 52249 (GMP rules).

The standard does not establish requirements for industrial and other types of safety.

The standard is recommended for use in the development, design, selection, certification and operation of equipment for the production of solid dosage forms intended for oral use (tablets, capsules, powders, etc.).

2 Normative references

This standard uses normative references to the following standards:

GOST R 51251-99 Air purification filters. Classification. Marking

GOST R 52249-2004 Rules for the production and quality control of medicines

GOST R 52537-2006 Production of medicines. Quality assurance system. General requirements

GOST ISO 14644-1-2002 Clean rooms and associated controlled environments. Part 1. Classification of air purity

Note - When using this standard, it is advisable to check the validity of reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or according to the annually published information index "National Standards", which was published as of January 1 of the current year , and according to the corresponding monthly published information signs published in the current year. If the reference standard is replaced (modified), then when using this standard, you should be guided by the replacing (modified) standard. If the referenced standard is canceled without replacement, the provision in which the reference to it is given applies to the extent that this reference is not affected.

3 Terms and definitions

In this standard, the following terms are used with their respective definitions:

3.1 certification: Evidence that a technique, process, equipment, material, operation or system meets specified requirements and that its use actually produces the expected results.

Notes

1 "Validation", "qualification", "verification" are deprecated terms.

2 For processes and equipment, it is allowed to use the term "testing" along with the term "certification".

3.2 pollution: Any inclusion in a medicinal product that is not intended by its composition.

3.3 closed process: A process performed on equipment, the working area of ​​which and the material (product) do not come into contact with the environment.

Notes

1 Along with the term "closed process", the terms "closed system" or "closed equipment" may be used, having the same meaning.

2 In open processes, contact of the working area and materials (products) with the environment is possible.

3.4 critical parameter: A parameter that affects the quality of a medicinal product.

3.5 product protection level: Symbol (classification) of a set of requirements and measures aimed at preventing contamination of the product.

4 General technical requirements

4.1 Technological equipment must ensure the release of products in accordance with the specified requirements (specification). This is achieved through the design of equipment, materials used, controls and a certain operating procedure in accordance with GOST R 52249.

4.2 The following general requirements are imposed on the technological processes and equipment used in the production of solid dosage forms (despite the differences in purpose and design):

- ensuring the required composition of the product;

- ensuring the homogeneity (homogeneity) of the product;

— protecting the product from the risk of contamination (eg by using an appropriate level of protection);

- prevention of cross-contamination;

- control of process parameters (products);

- the possibility of certification of critical equipment;

- stability of equipment parameters, ensuring the invariability of product performance within acceptable limits;

- ease of maintenance and operation, provision of relevant documents, instruments, materials, etc.

4.3 Depending on the requirements for protecting the product from environmental influences, processes (systems) can be open or closed. In closed systems, the physical separation of the internal volume of the equipment and the materials and product contained in it from the environment is ensured, which provides a higher level of protection.

4.4 The design of the equipment should ensure:

- conformity of the equipment to its purpose;

- the required level of protection of the product, depending on the degree of closeness of the equipment;

- the possibility and convenience of cleaning equipment surfaces in contact with materials and products;

- maximum protection against erroneous actions of personnel;

- the ability to control parameters;

- the possibility of maintenance;

- convenience and reliability of performance of production operations of the technological process;

- accessibility for inspection;

- exclusion of the risk of contamination of medicines with dust, gases, steam, etc., and the ingress of foreign materials, traces of corrosion, lubricants and other substances into the finished product, the source of which is the equipment.

4.5 Materials used in the equipment:

- must not react with intermediate and finished products and starting materials;

- must not emit or absorb substances that affect the quality of the product;

- must be wear-resistant and ensure the preservation of the equipment's operability during its service life when performing the prescribed maintenance work;

- do not react with detergents and disinfectants, the types of which are recommended by the manufacturer or established by regulatory documents.

4.6 The error of instrumentation should correspond to the established values. The procedure for calibration (verification) of instrumentation and documentation of the results of calibration (verification) should be provided for.

4.7 Equipment with critical parameters is critical. Critical equipment includes:

- scales;

- grinders;

- mixers;

- granulators;

- dryers;

- tablet presses;

- capsule machines;

- on-site washing and cleaning systems;

- HEPA filters installed in the equipment;

- equipment for primary packaging of products;

- other types of equipment.

Critical are also clean rooms and clean zones, technological media in contact with products (compressed air, purified water, steam, vacuum, etc.).

4.8 For each type of critical equipment, the critical parameters to be qualified should be determined.

Examples of critical parameters are:

- drying temperature;

- accuracy of scales;

- cleanliness of equipment surfaces in contact with the product;

- cleanliness of the air inside the equipment;

- purity of compressed air, etc.

4.9 Certification is subject to:

- critical technological equipment (according to critical parameters);

- critical equipment for the preparation and distribution of process media in contact with the product.

5 Requirements for the protection of processes and equipment from contamination

5.1 For each critical piece of equipment, the risk of contamination of the product and materials included in the product should be assessed and protective measures should be provided.

The risk of contamination of the product due to foreign matter located in:

- in source materials;

- on the surface of the equipment;

- in technological environments (compressed air, water, steam, etc.);

- in lubricants;

- in the surrounding air;

- personnel, etc.

In preparation for production and during operation, it is necessary to analyze the causes of pollution, determine critical points, assess the risk of pollution, develop and implement measures to prevent pollution using the risk analysis method in accordance with GOST R 52537.

5.2 The risk of contamination depends on the duration of the process, the number of types of products produced by this equipment, the frequency of transition from the production of one product to another, the material from which the equipment is made, etc.

Closed processes are recommended to reduce the risk of contamination.

Special precautions should be taken in the manufacture of sensitizers, antibiotics, cytotoxins and potent drugs.

5.3 Surfaces of technological equipment are divided into three groups:

- in contact with the product;

- in contact with the materials that will be part of the product;

- not in contact with products and materials.

The component parts of the equipment in the working area must be smooth and made of non-toxic, corrosion-resistant material.

The use of materials containing heavy metals (copper, lead, etc.) for surfaces in contact with materials or products is not allowed.

The surfaces of the working area should not have blind "pockets", technologically unreasonable partitions, steps, edges, sharp narrowing of the cross section that impairs the processing or sterilization of these surfaces.

Hoppers, containers, trays, chutes, guides must be closed and have an easy-to-clean smooth surface without slots, gaps, protruding ends, rivets and other elements that impede sanitation.

All surfaces of the work area must be easily accessible for cleaning and control. Access to hidden places and their control must be provided with the possibility of dismantling. Structural elements in this case must be provided with easily detachable connections in order to ensure disassembly mainly without the use of metalwork tools.

5.4 In the production of solid forms, three levels of protection should be distinguished:

- level 1 - equipment and areas for which there are no special requirements;

- level 2 - equipment and areas in which measures should be taken to protect the open product and materials included in the product;

- level 3 - equipment and areas with special requirements for the environment and its controls to prevent contamination of the product and materials included in the product, as well as to prevent the loss of its properties.

Air filtration requirements for levels 2 and 3 are given in 5.7.

These requirements apply to the working areas of the equipment (where operations with the product are performed) or the premises where the equipment is located.

Protection of processes and product from contamination, including cross-contamination, is ensured through the use of:

- closed equipment;

- systems for washing in place (WIP - "Wash-in-Plact") or cleaning in place (CIP - "Clean-in-Place");

- filtering the air entering the equipment in accordance with the required level of protection (see 5.4);

- cleanliness of the room in which the equipment is located;

- purity of technological environments;

- parameter control, etc.

Washing and cleaning systems in place provide for automatic processing of equipment in a closed circuit, without contact of the treated surfaces with the environment and personnel.

5.5 The same type of equipment may require different levels of protection depending on the following factors:

- surface area of ​​materials (intermediate or finished product) in contact with the environment;

- specialization of equipment for a given product or use of equipment for different types of products;

- suitability of equipment for effective cleaning;

- the degree of hygroscopicity of the product and the influence of moisture on it.

5.7 Air filtration requirements

Level 1 equipment does not require air filtration.

The working area of ​​equipment with protection of the 2nd and 3rd levels must be supplied with air that has passed through high-performance filters (HEPA filters) of the following classes according to GOST R 51251:

- H11 - for protection of the 2nd level (not lower);

- H14 - for protection of the 3rd level.

For equipment with level 2 protection, the values ​​in Table 1 may apply to the air in the room in which the equipment is installed. The level 3 protected work area must be supplied with air directly through an appropriate filter.

When qualifying equipment before putting it into operation, the integrity of the HEPA filters should be checked. The same check should be carried out at least once a year or once a year or after changing the filters.

The design of the filters should ensure the convenience of their replacement and, if necessary, cleaning.

6 Basic hardware requirements

6.1 General

The composition of the solid dosage form includes one or more active pharmaceutical ingredients using, if necessary, diluents, disintegrants, binders, lubricants, lubricants, coloring agents, flavoring agents, etc.

Technological equipment must ensure that the manufactured product complies with the established requirements, including the following parameters:

- homogeneity;

- dimensions;

- mass;

- cleanliness and other parameters.

Tablets must be free from defects in size, color, coating, lettering font and separation marks, including:

- protrusions (adhering powder particles);

- recesses (holes, crumbled parts of tablets);

- dust on tablets;

- uneven color, local color change (marbling);

- chips;

- adhesions;

- crumbling;

- deformations (violations of the roundness of the shape);

- scratches;

- coating defects, for example, uneven (different thickness) of the coating, its displacement relative to the core.

6.2 Parameter control

It is recommended to carry out continuous monitoring of the main parameters of the equipment (if necessary, according to the upper and lower limits), as well as to provide for diagnostics in case of equipment failure. If possible, it is advisable to provide for the operation of the equipment without the presence of an operator.

It is recommended to control the following units and parameters:

- operation of the main engine;

- tightness of the working area;



- feed rate of the source material;

- level of material in the initial loading bunker;

- operation of the WIP equipment washing system - "Wash-ln-Place" (washing in place of tablet presses, dedusters, etc.);

- compressed air pressure.

Equipment (product) parameters, alarms, fault data should be recorded (eg electronically).

The parameters recommended for the control of tablet presses are given in Appendix A.

The parameters recommended for the control of capsule filling machines are given in Appendix B.

6.3 Scope of delivery

6.3.1 The equipment delivery set shall include at least:

- equipment in the installed configuration;

- spare parts for the agreed period of operation;

- elements for connecting equipment with external communications;

— technical documents (see 6.3.2);

- instructions for installation, operation and maintenance, including cleaning of equipment;

— certification and testing documents (see 6.3.3).

All equipment and materials included in the delivery must be properly packed in the original packaging and shipping container.

6.3.2 Technical documents include:

- schematic diagram of the equipment;

- basic assembly drawings;

- drawings of the main units;

- specifications for equipment and units;

- electric circuit with specification;

- pneumatic diagram with specification;

- lubricant scheme and list of lubricants;

- technical documents of the manufacturer for the components of the equipment (for example, a vacuum cleaner, a machine for polishing and dedusting capsules, a control system, etc.);

- list of spare parts, etc.

6.3.3 Qualification and testing documents include:

- methods of certification in the built (installed), equipped and operated states;

- protocols of acceptance tests at the manufacturing plant;

- protocols of acceptance tests at the place of installation;

- certificates for materials in contact with the product;

- certificates of calibration of instrumentation installed on the equipment;

- declaration of conformity with the requirements of GOST R 52249 (GMP rules or a certificate of conformity (in the voluntary certification system).

7 Qualification (testing) of equipment

7.1 Certification (testing) of equipment is carried out, as a rule, in three stages (see GOST R 52537):

- in the built (installed) state;

- in equipped condition;

- in working order.

7.2 Procedures for certification (testing) of equipment are developed by the manufacturer or developer of equipment for various states: built (installed), equipped and operated.

The certification (testing) methodology includes:

- list of works in the order of their execution;

- technology for performing each work (if necessary);

- Applied devices, materials, etc.;

- admissible values ​​of parameters;

- forms of protocols (acts) of tests;

- requirements for performers.

7.3 The equipment certification (testing) program is drawn up by the user or the installation organization, taking into account the certification (testing) methodology.

The program includes a list of works and the sequence of their implementation during the certification (testing) of equipment.

7.4 The certification procedure should be included in the equipment delivery set. The methodology can be refined by the drug manufacturer, taking into account the conditions of use of the equipment (for example, taking into account the release of one or more products on one piece of equipment).

Annex A (informative). Control of parameters of tablet presses

Annex A
(reference)

Tablet presses are controlled by the following parameters:

- operation of the main engine;

- tightness of the working area;

- the position of the equipment windows and panels in the closed state;

- blocking of work in case of deviation of parameters or turning off the engine;



- feed rate of the tablet mass;

- the level of the tablet mass in the initial loading hopper;

- operation of the equipment washing system (WIP - "Wash-ln-Place");

- compressed air pressure;

- negative pressure in the tableting zone with the possibility of its regulation (in order to ensure safety);

- sticking of the tablet mass on the upper punch;

- mass of tablets;

- pressing force (in multilayer tablets - for each layer);

- tablet ejection force;

- filling depth of each layer;

- the appearance of congestion of tablets in the unloading device;

- punch break;

- the color of the tablets.

It should provide for the counting of tablets and the rejection of tablets in the presence of defects, foreign inclusions (metal and plastic).

Provision should also be made to prevent sticking of material to the punch (for example, by turning the punches in the opposite direction immediately after pressing the equipment with brushes to clean the surface of the punches, etc.). The option of a system for supplying lubricants to the inner walls of the die can be provided to facilitate ejection of tablets.

Appendix B (informative). Parameter control of capsule filling machines

Annex B
(reference)

Capsule filling machines are controlled by the following parameters:

- operation of the main engine and engines of the main components (vacuum pump, vacuum cleaner, feeders, etc.);

- tightness of the working area;

- positions of equipment windows and panels in the closed state;

- blocking of work in case of deviation of parameters or turning off one of the drive units;

- blocking when opening the doors of protective structures;

- feed rate of powder or pellets and hard gelatin capsules;

- the level of powder or pellets and hard gelatin capsules in the hopper;

- operation of the equipment washing system (WIP - "Wash-In-Place");

- compressed air pressure;

- vacuum value;

- rejection of capsules (unopened empty capsules);

- filling level of capsules;

- the number of filled capsules.

It should also provide for the rejection of capsules in the presence of defects (dents, dust, etc.).

Bibliography

Equipment Decision Making for Condition Based Service Management (CMS)

Discussion of performance and reliability models for analysis, evaluation, and adoption of an MLA program is beyond the scope of this article. The scope of the article is deliberately limited to some of the main issues that need to be considered when deciding on the development of an MHI strategy for an industry.
The impact of any maintenance initiatives, including condition monitoring, should be predictable and measurable, and related to the performance and reliability of the production unit.
The most sensitive measure of productivity is production speed, or plant throughput. However, when analyzing performance and reliability, one should not forget the "random" nature of failures.
In addition, the industry must remember that condition monitoring systems, especially fully integrated technologies, are themselves subject to failure and failure and require attention (maintenance).

Various Factors Affecting CHI Implementation

For ease of understanding, Figure 2 presents in graphical form the various factors involved in effective and efficient CHI program planning.

Figure 2 - Factors influencing CHI

Equipment Criticality for Continuity

The first and foremost requirement is knowing how critical the manufacturing process is and how critical the electrical equipment (regardless of its rating) is used to ensure the continuity of the manufacturing process.
Usually, the decision on the criticality of equipment is made on the basis of the following considerations.
1. The definition of most critical equipment or system includes common plant services, such as connected power generators, engine-driven water-cooling pumps, electrical power supply systems, and safety systems, the failure of which could have a subsequent impact on the operation of the entire enterprise or a significant its parts
2. The next most critical elements are specific electrical equipment involved in the process, but not in a state of continuous readiness.
3. The category of critical (but not the most critical) equipment includes electrical equipment or systems that can have the greatest impact on mood and productivity.
4. The least critical are electrical equipment or systems that are used infrequently, or that are likely to have a negligible impact on the results of the enterprise.

For example, a power transformer installed to take power from the grid and convert it to the required voltage level is the most critical piece of equipment to maintain a continuous supply of power to continue production. The failure of such a transformer can lead to a general shutdown of critical production processes due to the loss of power supply for the entire enterprise. Therefore, it is important to consider this transformer in the condition monitoring mechanism, regardless of its rating.
The costs of the CHI system should be negligible compared to the financial losses in the event of an unplanned stoppage of production. If the OMC is deployed, then it is likely that an evolving condition capable of causing a failure will be detected early enough. This will allow you to initiate the necessary actions to quickly resolve the problem as planned in advance.

Downtime costs for electrical equipment

Taking transformer oil for analysis

Even if the cost of electrical equipment may not be very significant, but if its failure is capable of causing a complete shutdown of critical processes, this particular equipment should be taken into account in the MLA, regardless of the nominal characteristics of the equipment. If the production process takes a long time to restart and reach the required level, then electrical equipment becomes the most important equipment taken into account in the MLA.
The plant most likely has a number of small engines that are vital to the production process, and the failure of one of them can cause trouble for the entire process.

Impact of downtime on the environment and environment

In many industries, an unplanned shutdown of a production process can have a catastrophic effect on the environment or surroundings due to rapid changes in operating parameters such as increased pressures or temperatures in vessels and pipelines, releases of hazardous or toxic compounds due to a shutdown of a process, or loss of control. , etc.
For example, oil refinery and petrochemical industries are subject to such incidents. When implementing MLAs, such processes or systems must be taken into account.

Costs for new equipment vs. CHI costs

In a number of manufacturing processes, the cost of new spare equipment stored for immediate replacement of equipment that fails can be significantly lower than the cost of a CHI system. Where the replacement of failed equipment takes a long time, or the resumption of the process takes a long period of time, then such equipment or systems should be taken into account in the MLA.

Equipment service cycle

New and burnt switch

As far as practicable, critical electrical equipment whose operating time approaches its rated life should be taken into account in the implementation of the MLA. Live equipment monitoring complements the efforts of plant engineers to get early warning of an impending problem and enable them to take appropriate action without affecting production and greatly reducing production losses.

Availability of redundant equipment in a ready state

Many industries adopt the philosophy of installing redundant electrical equipment on standby as a precautionary measure. Standby power supplies are serviced like the main equipment, and in an emergency, power can be restored in a few seconds.
In such cases, plant engineers must make informed decisions depending on the other factors discussed above.