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Beamex - Book - Ultimate Calibration 2nd Edition
Beamex - Book - Ultimate Calibration 2nd Edition
2
nd
Edition
Ultimate Calibration
2
nd
Edition
Beamex is a technology and service company that develops, manufactures and
markets high-quality calibration equipment, software, systems and services for the
calibration and maintenance of process instruments. The company is a leading
worldwide provider of integrated calibration solutions that meet even the most demanding
requirements. Beamex offers a comprehensive range of products and services-from portable
calibrators to workstations, calibration accessories, calibration software, industry-specific
solutions and professional services. Through Beamexs global and competent partner network,
their products and services are available in more than 60 countries. As a proof of Beamexs
success, there are more than 10,000 companies worldwide utilizing their calibration solutions.
Several companies have been Beamexs customer since the establishment of the company
over 30 years ago. For more information about Beamex and its products and services,
visit www.beamex.com
Beamex has used reasonable efforts to ensure that this book contains both accurate
and comprehensive information. Notwithstanding the foregoing, the content of this book is
provided as is without any representations, warranties or guarantees of any kind, whether
express or implied, in relation to the accuracy, completeness, adequacy, currency, quality,
timeliness or fitness for a particular purpose of the content and information provided on this
book. The contents of this book are for general informational purposes only. Furthermore, this
book provides examples of some of the laws, regulations and standards related to calibration and
is not intended to be definitive. It is the responsibility of a company to determine which laws,
regulations and standards apply in specific circumstances.
Ultimate Calibration 2
nd
Edition
Copyright 20092012 by Beamex Oy Ab. All rights reserved.
No part of this publication may be reproduced or distributed in
any form or by any means, or stored in a database or retrieval
system, without the prior written permission of Beamex Oy Ab.
Requests should be directed to info@beamex.com.
Beamex is a trademark of Beamex Oy Ab.
All other trademarks or trade names mentioned in this book
are the property of their respective holders.
Graphic design: Studio PAP
Photos: Mats Sandstrm and image bank
Printed by: Fram in Vaasa 2012, Finland
Preface by the CEO of Beamex Group 7
QUALITY, REGULATIONS AND TRACEABILITY
Quality standards and industry regulations 11
A basic quality calibration program 35
Traceable and efcient calibrations in the process industry 57
CALIBRATION MANAGEMENT AND MAINTENANCE
Why Calibrate? What is the risk of not calibrating? 73
Why use software for calibration management? 79
How often should instruments be calibrated? 89
How often should calibrators be calibrated? 97
Paperless calibration improves quality and cuts costs 101
Intelligent commissioning 107
Successfully executing a system integration project 115
CALIBRATION IN INDUSTRIAL APPLICATIONS
The benets of using a documenting calibrator 125
Calibration of weighing instruments Part 1 131
Calibration of weighing instruments Part 2 137
Calibrating temperature instruments 143
Calculating total uncertainty of temperature calibration with a dry block 149
Fieldbus transmitters must also be calibrated 157
Conguring and calibrating smart instruments 163
Calibration in hazardous environments 169
The safest way to calibrate to calibrate Fieldbus instruments 175
APPENDIX: Calibration terminology A to Z 181
Contents
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C
alibrators, calibration software and other related equipment
have developed significantly during the past few decades in
spite of the fact that calibration of measurement devices as
such has existed for several thousands of years.
Presently, the primary challenges of industrial metrology and
calibration include how to simplify and streamline the entire
calibration process, how to eliminate double work, how to reduce
production down-time, and how to lower the risk of human errors. All
of these challenges can be tackled by improving the level of system
integration and automation.
Calibration and calibrators can no longer be considered as isolated,
stand-alone devices, systems or work processes within a company or
production plant. Just like any other business function, calibration
procedures need to be automated to a higher degree and integrated to
achieve improvements in quality and efficiency. In this area, Beamex
aims to be the benchmark in the industry.
This book is the 2
nd
edition of Ultimate Calibration. The main
changes to this edition include numerous new articles and a new
grouping of the articles to make it easier to find related topics. The
new topics covered in the edition mainly discuss paperless calibration,
intelligent commissioning, temperature calibration and configuring,
and calibration of smart instruments.
This book is the result of work that has taken place between 2006
and 2012. A team of experts in industry and calibration worldwide has
put forth effort to its creation.
On behalf of Beamex, I would like to thank all of the people who
have contributed to this book. I want to express my special thanks to
Pamela at Beamex Marketing, who was the key person in organizing
and leading the project for the 2
nd
edition. I hope this book will assist
you in learning new things and in providing fresh, new ideas. Enjoy
your reading!
raimo ahola, ceo, beamex group
Preface
Quality,
Regulations and
Traceability
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B
efore going into what the current standards and regulations
actually state, here is a reminder from times past about
measurement practices and how important they really are.
Immersion in water makes the straight seem bent; but reason, thus
confused by false appearance, is beautifully restored by measuring,
numbering and weighing; these drive vague notions of greater or less
or more or heavier right out of the minds of the surveyor, the computer,
and the clerk of the scales. Surely it is the better part of thought that
relies on measurement and calculation. (Plato, The Republic, 360 B.C.)
There shall be standard measures of wine, beer, and corn
throughout the whole of our kingdom, and a standard width of dyed
russet and cloth; and there shall be standard weights also. (Clause 35,
Magna Carta, 1215)
When you can measure what you are speaking about and express
it in numbers, you know something about it; but when you cannot
express it in numbers, your knowledge is of a meager and unsatisfactory
kind. It may be the beginning of knowledge, but you have scarcely, in
your thoughts, advanced to the stage of science. (William Thomson,
1st Baron Kelvin, GCVO, OM, PC, PRS, 26 June 182417 December
1907; A.K.A. Lord Kelvin).
1
One of the earliest records of precise measurement is from Egypt.
The Egyptians studied the science of geometry to assist them in the
construction of the Pyramids. It is believed that about 3000 years B.C.,
the Egyptian unit of length came into being.
The Royal Egyptian Cubit was decreed to be equal to the length
of the forearm from the bent elbow to the tip of the extended middle
Calibration requirements
according to quality standards
and industry regulations
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finger plus the width of the palm of the hand of the Pharaoh or King
ruling at that time.
2
The Royal Cubit Master was carved out of a block of granite to
endure for all times. Workers engaged in building tombs, temples,
pyramids, etc. were supplied with cubits made of wood or granite. The
Royal Architect or Foreman of the construction site was responsible for
maintaining & transferring the unit of length to workers instruments.
They were required to bring back their cubit sticks at each full moon
to be compared to the Royal Cubit Master.
Failure to do so was punishable by death. Though the punishment
prescribed was severe, the Egyptians had anticipated the spirit of the
present day system of legal metrology, standards, traceability and
calibration recall.
With this standardization and uniformity of length, the Egyptians
achieved surprising accuracy. Thousands of workers were engaged in
building the Great Pyramid of Giza. Through the use of cubit sticks,
they achieved an accuracy of 0.05%. In roughly 756 feet or 230.36276
meters, they were within 4.5 inches or 11.43 centimeters.
The need for calibration has been around for at least 5000 years.
In todays calibration environment, there are basically two types of
requirements: ISO standards and regulatory requirements. The biggest
difference between the two is simple ISO standards are voluntary, and
regulatory requirements are mandatory. If an organization volunteers
to meet ISO 9000 standards, they pay a company to audit them to that
standard to ensure they are following their quality manual and are
within compliance. On the other hand, if a company is manufacturing
a drug that must meet regulatory requirements, they are inspected
by government inspectors for compliance to federal regulations. In
the case of ISO standards, a set of guidelines are used to write their
quality manual and other standard operating procedures (SOPs) and
they show how they comply with the standard. However, the federal
regulations specify in greater detail what a company must do to meet
the requirements set forth in the Code of Federal Regulations (CFRs).
In Europe, detailed information for achieving regulatory compliance
is provided in Eudralex - Volume 4 of The rules governing medicinal
products in the European Union.
The Pharmaceutical Inspection Convention and Pharmaceutical
Inspection Co-operation Scheme (PIC/S) aims to improve
harmonisation of Good Manufacturing Practice (GMP) standards
and guidance documents.
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Calibration requirements according to the U. S. Food and Drug
Administration (FDA)
Following are examples of some of the regulations required by
the FDA, and what they say about calibration and what must be
accomplished to meet the CFRs. Please note that European standards
are similar to FDA requirements. Listed below are several different
parts of 21CFR, that relate to the calibration of test equipment in
different situations and environments.
TITLE 21 FOOD AND DRUGS
CHAPTER I FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H MEDICAL DEVICES
PART 820 QUALITY SYSTEM REGULATION 22
Subpart A General Provisions
820.1 Scope.
820.3 Definitions.
820.5 Quality system.
Subpart B Quality System Requirements
820.20 Management responsibility.
820.22 Quality audit.
820.25 Personnel.
Subpart C Design Controls
820.30 Design controls.
Subpart D Document Controls
820.40 Document controls.
Subpart E Purchasing Controls
820.50 Purchasing controls.
Subpart F Identification and Traceability
820.60 Identification.
820.65 Traceability.
Subpart G Production and Process Controls
820.70 Production and process controls.
820.72 Inspection, measuring, and test equipment.
820.75 Process validation.
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Subpart H Acceptance Activities
820.80 Receiving, in-process, and finished device acceptance.
820.86 Acceptance status.
Subpart I Nonconforming Product
820.90 Nonconforming product.
Subpart J Corrective and Preventive Action
820.100 Corrective and preventive action.
Subpart K Labeling and Packaging Control
820.120 Device labeling.
820.130 Device packaging.
Subpart L Handling, Storage, Distribution, and Installation
820.140 Handling.
820.150 Storage.
820.160 Distribution.
820.170 Installation.
Subpart M Records
820.180 General requirements.
820.181 Device master record.
820.184 Device history record.
820.186 Quality system record.
820.198 Complaint files.
Subpart N Servicing
820.200 Servicing.
Subpart O Statistical Techniques
820.250 Statistical techniques.
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR820.72]
TITLE 2 FOOD AND DRUGS
CHAPTER I FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H MEDICAL DEVICES
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PART 820QUALITY SYSTEM REGULATION
Subpart GProduction and Process Controls
Sec. 820.72 Inspection, measuring, and test equipment.
(a) Control of inspection, measuring, and test equipment. Each
manufacturer shall ensure that all inspection, measuring, and
test equipment, including mechanical, automated, or electronic
inspection and test equipment, is suitable for its intended purposes
and is capable of producing valid results. Each manufacturer shall
establish and maintain procedures to ensure that equipment is
routinely calibrated, inspected, checked, and maintained. The
procedures shall include provisions for handling, preservation,
and storage of equipment, so that its accuracy and fitness for use
are maintained. These activities shall be documented.
(b) Calibration. Calibration procedures shall include specific directions
and limits for accuracy and precision. When accuracy and precision
limits are not met, there shall be provisions for remedial action to
reestablish the limits and to evaluate whether there was any adverse
effect on the devices quality. These activities shall be documented.
(1) Calibration standards. Calibration standards used for
inspection, measuring, and test equipment shall be traceable to
national or international standards. If national or international
standards are not practical or available, the manufacturer shall
use an independent reproducible standard. If no applicable
standard exists, the manufacturer shall establish and maintain
an in-house standard.
(2) Calibration records. The equipment identification, calibration
dates, the individual performing each calibration, and the
next calibration date shall be documented. These records shall
be displayed on or near each piece of equipment or shall be
readily available to the personnel using such equipment and
to the individuals responsible for calibrating the equipment.
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[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2012]
[CITE: 21CFR211]
TITLE 21 FOOD AND DRUGS
CHAPTER I FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C DRUGS: GENERAL
PART 211
CURRENT GOOD MANUFACTURING PRACTICE FOR
FINISHED PHARMACEUTICALS
Subpart D Equipment
Sec. 211.68 Automatic, mechanical, and electronic equipment.
(a) Automatic, mechanical, or electronic equipment or other types
of equipment, including computers, or related systems that will
perform a function satisfactorily, may be used in the manufacture,
processing, packing, and holding of a drug product. If such
equipment is so used, it shall be routinely calibrated, inspected, or
checked according to a written program designed to assure proper
performance. Written records of those calibration checks and
inspections shall be maintained.
Sec. 211.160 General requirements.
(b) Laboratory controls shall include the establishment of scientifically
sound and appropriate specifications, standards, sampling plans,
and test procedures designed to assure that components, drug
product containers, closures, in-process materials, labeling, and
drug products conform to appropriate standards of identity,
strength, quality, and purity. Laboratory controls shall include:
(1) Determination of conformity to applicable written
specifications for the acceptance of each lot within each
shipment of components, drug product containers, closures,
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and labeling used in the manufacture, processing, packing,
or holding of drug products. The specifications shall include
a description of the sampling and testing procedures used.
Samples shall be representative and adequately identified.
Such procedures shall also require appropriate retesting of any
component, drug product container, or closure that is subject
to deterioration.
(2) Determination of conformance to written specifications and a
description of sampling and testing procedures for in-process
materials. Such samples shall be representative and properly
identified.
(3) Determination of conformance to written descriptions of
sampling procedures and appropriate specifications for drug
products. Such samples shall be representative and properly
identified.
(4) The calibration of instruments, apparatus, gauges, and
recording devices at suitable intervals in accordance with an
established written program containing specific directions,
schedules, limits for accuracy and precision, and provisions for
remedial action in the event accuracy and/or precision limits
are not met. Instruments, apparatus, gauges, and recording
devices not meeting established specifications shall not be
used.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932,
Sept. 8, 2008]
Sec. 211.194 Laboratory records.
(d) Complete records shall be maintained of the periodic calibration
of laboratory instruments, apparatus, gauges, and recording
devices required by 211.160(b)(4).
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TITLE 2 FOOD AND DRUGS
CHAPTER I FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A GENERAL
PART 11
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart A General Provisions
Sec. 11.1 Scope.
(a) The regulations in this part set forth the criteria under which
the agency considers electronic records, electronic signatures,
and handwritten signatures executed to electronic records to be
trustworthy, reliable, and generally equivalent to paper records
and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted, under
any records requirements set forth in agency regulations. This
part also applies to electronic records submitted to the agency
under requirements of the Federal Food, Drug, and Cosmetic Act
and the Public Health Service Act, even if such records are not
specifically identified in agency regulations. However, this part
does not apply to paper records that are, or have been, transmitted
by electronic means.
(c) Where electronic signatures and their associated electronic records
meet the requirements of this part, the agency will consider
the electronic signatures to be equivalent to full handwritten
signatures, initials, and other general signings as required by
agency regulations, unless specifically excepted by regulation(s)
effective on or after August 20, 1997.
(d) Electronic records that meet the requirements of this part may be
used in lieu of paper records, in accordance with 11.2, unless paper
records are specifically required.
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(e) Computer systems (including hardware and software), controls, and
attendant documentation maintained under this part shall be readily
available for, and subject to, FDA inspection.
(f ) This part does not apply to records required to be established or
maintained by 1.326 through 1.368 of this chapter. Records that
satisfy the requirements of part 1, subpart J of this chapter, but that
also are required under other applicable statutory provisions or
regulations, remain subject to this part.
[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655,
Dec. 9, 2004]
Sec. 11.2 Implementation.
(a) For records required to be maintained but not submitted to the
agency, persons may use electronic records in lieu of paper records
or electronic signatures in lieu of traditional signatures, in whole or
in part, provided that the requirements of this part are met.
(b) For records submitted to the agency, persons may use electronic
records in lieu of paper records or electronic signatures in lieu of
traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been
identified in public docket No. 92S-0251 as being the type of
submission the agency accepts in electronic form. This docket
will identify specifically what types of documents or parts of
documents are acceptable for submission in electronic form
without paper records and the agency receiving unit(s) (e.g.,
specific center, office, division, branch) to which such submissions
may be made. Documents to agency receiving unit(s) not specified
in the public docket will not be considered as official if they are
submitted in electronic form; paper forms of such documents
will be considered as official and must accompany any electronic
records. Persons are expected to consult with the intended agency
receiving unit for details on how (e.g., method of transmission,
media, file formats, and technical protocols) and whether to
proceed with the electronic submission.
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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 11
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart C Electronic Signatures
Sec. 11.100 General requirements.
(a) Each electronic signature shall be unique to one individual and
shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or otherwise
sanctions an individual`s electronic signature, or any element of
such electronic signature, the organization shall verify the identity
of the individual.
(c) Persons using electronic signatures shall, prior to or at the time
of such use, certify to the agency that the electronic signatures
in their system, used on or after August 20, 1997, are intended
to be the legally binding equivalent of traditional handwritten
signatures.
(1) The certification shall be submitted in paper form and signed
with a traditional handwritten signature, to the Office of
Regional Operations (HFC-100), 12420 Parklawn Drive, RM
3007 Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request,
provide additional certification or testimony that a specific
electronic signature is the legally binding equivalent of the
signer`s handwritten signature.
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Calibration requirements according to the European Medicines
Agency (EMA)
Following are examples of some of the regulatory requirements of
the EMA, and what they say about calibration and what must be
accomplished to meet the GMPs.
Eudralex Volume 4
Chapter 3: Premises and Equipment
Equipment
3.41 Measuring, weighing, recording and control equipment should be
calibrated and checked at defined intervals by appropriate methods.
Adequate records of such tests should be maintained.
Chapter 4: Documentation
Manufacturing Formula and Processing Instructions
Approved, written Manufacturing Formula and Processing
Instructions should exist for each product and batch size to be
manufactured.
4.18 The Processing Instructions should include:
a) A statement of the processing location and the principal equipment
to be used; b) The methods, or reference to the methods, to be used for
preparing the critical equipment (e.g. cleaning, assembling, calibrating,
sterilising); c) Checks that the equipment and work station are clear
of previous products, documents or materials not required for the
planned process, and that equipment is clean and suitable for use; d)
Detailed stepwise processing instructions [e.g. checks on materials,
pre-treatments, sequence for adding materials, critical process
parameters (time, temp etc)]; e) The instructions for any in-process
controls with their limits; f ) Where necessary, the requirements for
bulk storage of the products; including the container, labeling and
special storage conditions where applicable; g) Any special precautions
to be observed.
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Procedures and records
Other
4.29 There should be written policies, procedures, protocols, reports
and the associated records of actions taken or conclusions reached,
where appropriate, for the following examples:
Validation and qualification of processes, equipment and systems;
Equipment assembly and calibration;
Technology transfer;
Maintenance, cleaning and sanitation;
Personnel matters including signature lists, training in GMP and
technical matters, clothing and hygiene and verification of the
effectiveness of training.
Environmental monitoring;
Pest control;
Complaints;
Recalls;
Returns;
Change control;
Investigations into deviations and non-conformances;
Internal quality/GMP compliance audits;
Summaries of records where appropriate
(e.g. product quality review);
Supplier audits.
4.31 Logbooks should be kept for major or critical analytical testing,
production equipment, and areas where product has been processed.
They should be used to record in chronological order, as appropriate,
any use of the area, equipment/method, calibrations, maintenance,
cleaning or repair operations, including the dates and identity of
people who carried these operations out.
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Chapter 6 Quality Control
Good Quality Control Laboratory Practice
Documentation
6.7 Laboratory documentation should follow the principles given
in Chapter 4. An important part of this documentation deals with
Quality Control and the following details should be readily available
to the Quality Control Department:
specifications;
sampling procedures;
testing procedures and records (including analytical worksheets and/
or laboratory notebooks);
analytical reports and/or certificates;
data from environmental monitoring, where required;
validation records of test methods, where applicable;
procedures for and records of the calibration of instruments and
maintenance of equipment.
Annex 15 to the EU Guide to Good Manufacturing Practice
Title: Qualification and validation
QUALIFICATION
Installation qualification
11. Installation qualification (IQ) should be performed on new or
modified facilities, systems and equipment.
12. IQ should include, but not be limited to the following:
(a) installation of equipment, piping, services and instrumentation
checked to current engineering drawings and specifications;
(b) icollection and collation of supplier operating and working
instructions and maintenance requirements;
(c) icalibration requirements;
(d) verification of materials of construction.
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24
Operational qualification
15. The completion of a successful Operational qualification
should allow the finalisation of calibration, operating and cleaning
procedures, operator training and preventative maintenance
requirements. It should permit a formal release of the facilities,
systems and equipment.
Qualification of established (in-use) facilities, systems and equipment
19. Evidence should be available to support and verify the operating
parameters and limits for the critical variables of the operating
equipment. Additionally, the calibration, cleaning, preventative
maintenance, operating procedures and operator training procedures
and records should be documented.
PROCESS VALIDATION
Prospective validation
24. Prospective validation should include, but not be limited to the
following:
(a) short description of the process;
(b) summary of the critical processing steps to be investigated;
(c) list of the equipment/facilities to be used (including measuring/
monitoring/recording equipment) together with its calibration
status
(d) finished product specifications for release;
(e) list of analytical methods, as appropriate;
(f ) proposed in-process controls with acceptance criteria;
(g) additional testing to be carried out, with acceptance criteria and
analytical validation, as appropriate;
(h) sampling plan;
(i) methods for recording and evaluating results
(j) functions and responsibilities;
(k) proposed timetable.
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EU GMP Annex 11
The EU GMP Annex 11 defines EU requirements for computerised
systems, and applies to all forms of computerised systems used as part
of GMP regulated activities.
Main page for the EudraLex - Volume 4 Good manufacturing practice
(GMP) Guidelines:
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
PDF of Annex 11:
http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_
en.pdf
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Public Health and Risk Assessment
Pharmaceuticals
Brussels,
SANCO/C8/AM/sl/ares(2010)1064599
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Annex 11: Computerised Systems
Legal basis for publishing the detailed guidelines: Article 47 of Directive
2001/83/EC on the Community code relating to medicinal products
for human use and Article 51 of Directive 2001/82/EC on the
Community code relating to veterinary medicinal products. This
document provides guidance for the interpretation of the principles
qutiifv sftotnos to iousfnv nicuitfios
26
and guidelines of good manufacturing practice (GMP) for medicinal
products as laid down in Directive 2003/94/EC for medicinal products
for human use and Directive 91/412/EEC for veterinary use. Status of
the document: revision 1
Reasons for changes: the Annex has been revised in response to the
increased use of computerised systems and the increased complexity
of these systems. Consequential amendments are also proposed for
Chapter 4 of the GMP Guide.
Deadline for coming into operation: 30 June 2011
Commission Europenne, B-1049 Bruxelles / Europese Commissie,
B-1049 Brussel - Belgium
Telephone: (32-2) 299 11 11
Principle
This annex applies to all forms of computerised systems used as
part of a GMP regulated activities. A computerised system is a set
of software and hardware components which together fulfill certain
functionalities.
The application should be validated; IT infrastructure should be
qualified.
Where a computerised system replaces a manual operation, there
should be no resultant decrease in product quality, process control or
quality assurance. There should be no increase in the overall risk of
the process.
PIC/S
The abbreviation PIC/S describes both the Pharmaceutical Inspection
Convention (PIC) and the Pharmaceutical Inspection Co-operation
Scheme (PIC Scheme) which operate together. It aims to promote
harmonisation of global regulations for the pharmaceutical industry.
Further information can be found at the PIC/S Web site (http://www.
picscheme.org/.).
qutiifv sftotnos to iousfnv nicuitfios
27
GAMP
GAMP
COP
aims to provide guidance and understanding concerning GxP
computerized systems. COPs provide networking opportunities
for people interested in similar topics. The GAMP
COP organizes
discussion forums for its members and ISPE organises GAMP
related
training courses and educational seminars.
GAMP
guidelines.
Three regional Steering Committees, GAMP
Japan, GAMP
Europe, and GAMP
Council which
oversee the operation of the COP and is the main link to ISPE.
Several local GAMP
Americas, GAMP
Nordic, GAMP
Francophone, GAMP
publication is GAMP
5 A Risk-
Based Approach to GxP Computerized Systems. This is the latest major
revision and was released in January 2008. There is also a series of
related GAMP
5
GAMP
CMX calibration
software.
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But plants can improve their efficiencies and reduce costs by
using calibration history trend analysis, a function available within
Beamex
CMX
to different customers across all industry sectors. He comments:
The largest savings from using the History Trend Option are in the
pharmaceuticals sector, without doubt, but all industry sectors can
benefit from using the software tool, which helps companies identify
the optimal calibration intervals for instruments.
The trick, says Mki, is determining which sensors should be re-
calibrated after a few days, weeks, or even years of operation and which
can be left for longer periods, without of course sacrificing the quality
of the product or process or the safety of the plant and its employees.
Doing this, he says, enables maintenance staff to concentrate their
efforts only where they are needed, therefore eliminating unnecessary
calibration effort and time.
But there are other, perhaps less obvious benefits of looking at the
historical drift over time of a particular sensor or set of measuring
instruments. As Mki explains: When an engineer buys a particular
sensor, the supplier provides a technical specification that includes details
on what the maximum drift of that sensor should be over a given time
period. With CMXs History Trend Option, the engineer can now verify
that the sensor he or she has purchased, actually performed within the
specified tolerance over a certain time period. If it hasnt, the engineer
now has data to present to the supplier to support his findings.
But thats not all. The History Trend function also means that a
plant can now compare the quality or performance of different sensors
from multiple manufacturers in a given location or set of process
conditions. This makes it an invaluable tool for maintenance or quality
personnel who, in setting up a new process line for example, can use
the functionality to compare different sensor types to see which one
best suits the new process.
Calibration software such as CMX can also help with the planning
of calibration operations. Calibration schedules take into account
the accuracy required for a particular sensor and the length of time
during which it has previously been able to maintain that degree of
accuracy. Sensors that are found to be highly stable do not need to be
re-calibrated as often as sensors that tend to drift.
The function enables
users to plan the optimal
calibration intervals for
their instruments.
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The History Trend function enables users to plan the optimal
calibration intervals for their instruments. Once implemented,
maintenance personnel, for example, can analyze an instruments drift
over a certain time period. History Trend displays the instruments
drift over a given period both numerically and graphically. Based on
this information, it is then possible to make decisions and conclusions
regarding the optimal calibration interval and the quality of the
instruments with respect to measurement performance.
The History Trend window enables users to view key figures of
several calibration events simultaneously, allowing to evaluate the
calibrations of a position or a device for a longer time period compared
to the normal calibration result view.
For example, the user can get an overview of how a particular device
drifts between calibrations and also whether the drift increases with
time. Also, the engineer can analyze how different devices are suited
for use in a particular area of the plant or process.
Reporting is straightforward and the user can even tailor the reports
to suit his or her individual needs, using the Report Design tool
option.
History Trend displays
the instruments drift
over a given period
both numerically
and graphically.
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Calibration history trend analysis allows you to analyze the
instruments drift over a certain time period.
The Beamex
CMX Calibration
Software.
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damage in transit or storage. There are also many other reasons why
instruments should be calibrated during the commissioning phase
before start-up.
Assuring transmitter quality
First of all, the fact that an instrument or transmitter is new does
not automatically mean that it is within required specifications.
Calibrating a new instrument before installing or using it is a quality
assurance task. You can check the overall quality of the instrument to
see if it is defective and to ensure it has the correct, specified settings.
Reconfiguring a transmitter
The new uninstalled instrument or transmitter may have the correct,
specified settings. However, it is possible that the original planned
settings are not valid anymore and they need to be changed. By
calibrating an instrument you can check the settings of the instrument.
After you have performed this task, it is possible to reconfigure
the transmitter, when the initial planned specifications have been
changed. Calibration is therefore a key element in the process of
reconfiguring an uninstalled transmitter.
Monitoring the quality and stability of a transmitter
When calibration procedures are performed for an uninstalled
instrument, the calibration serves also future purposes. By calibrating
the transmitter before installation and on a regular basis thereafter, it
is possible to monitor the stability of the transmitter.
Entering the necessary transmitter data into a calibration database
By calibrating an instrument before installation it is possible to
enter all the necessary instrument data into the calibration database,
as well as to monitor the instruments stability, as was explained in
the previous paragraph. The calibration database can be calibration
software designed specifically for managing calibration assets and
information, such as the Beamex
CMX Calibration
Software ensures that
calibration procedures are
carried out at the correct
time and that calibration
tasks do not get forgotten,
overlooked or become
overdue.
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therefore automatically produced when using the Beamex
Integrated
Calibration Solution. The quality and accuracy of calibration results
also improve, as there are fewer mistakes due to human error. The
calibration results are transferred automatically from the calibrators
memory to the computer/ database. This means that engineers do not
spend their time transferring the results from their notepad to final
storage on a computer; again, saving time and money.
Major time-savings can also be achieved by using Beamexs
documenting MC calibrators HART and/or Fieldbus functionality
to enter transmitter data into the calibrators memory where the data
can be populated to the CMX Calibration Software, instead of typing
the data manually into the calibration database.
SUMMARY
Calibration is beneficial during process plant commissioning
for various different reasons:
Transmitter quality assurance
Reconfiguring a transmitter
Monitoring the quality and stability of a transmitter
Entering the necessary transmitter data into a calibration
database and defining the optimal calibration interval
By using a documenting
calibrator, the calibration
results are stored
automatically in the
calibrators memory
during the calibration
process.
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F
or process manufacturers today, having a reliable, seamlessly
integrated set of IT systems across the plant, or across multiple
sites, is critical to business efficiency, profitability and growth.
Maintaining plant assets whether that includes production line
equipment, boilers, furnaces, special purpose machines, conveyor
systems or hydraulic pumps is equally critical for these companies.
Maintenance management has become an issue which deserves
enterprise-wide and perhaps multi-site attention, especially if the
company is part of an asset-intensive industry, where equipment and
plant infrastructure is large, complex and expensive. If stoppages
to production lines due to equipment breakdowns are costly,
implementing the latest computerized maintenance management
systems (CMMS) might save precious time and money.
In the process industries, a small, but critical part of a companys
asset management strategy should be the calibration of process
instrumentation. Manufacturing plants need to be sure that their
instrumentation products temperature sensors, pressure transducers,
flow meters and the like are performing and measuring to specified
tolerances. If sensors drift out of their specification range, the
consequences can be disastrous, perhaps resulting in costly production
downtime, safety issues or batches of inferior quality goods being
produced, which then have to be scrapped. For this, Beamexs
calibration management software, Beamex
CMX Professional
or Beamex
CMX
Professional or Beamex
CMX Enterprise software
can easily be integrated
to CMM systems,
whether it is a Maximo,
SAP or Datastream
CMM system or even a
companys own, in-house
software for maintenance
management.
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Project organization and resourcing
In order to have a successful integration, its important that the right
people and decision-makers are involved and participate right from
the beginning of the project. Its also essential that the main roles and
responsibilities of the parties are specified before the project evolves.
Moreover, a project organization should be established and include
members from both the suppliers and the customers organization,
as a successful project requires input from both parties. The role of
each member should be defined and project managers appointed. The
project manager is usually responsible for the operative management
of the project. In addition, a project steering group may need to be
established. The project steering group is responsible for making key
decisions during the project. The role, tasks and authority of the
project steering group must be defined as well as the decision-making
procedures.
Project phases
The integration project is divided into four main phases:
1. Scope of Work
2. Development and Implementation
3. Testing
4. Installation, Verification and Training
The four main phases are also often divided into sub-phases. A
schedule is usually defined for the completion of the entire project as
well as for the completion of each project phase. Each project phase
should be approved according to the acceptance procedures defined
in the offer, agreement, project plan or other document annexed to
the offer / agreement.
The integration project
involves three main
parties: Beamex, the
customer and the CMM
system software partner.
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Scope of work
To ensure successful integration with a satisfied customer, defining
the correct scope of work (SOW) is crucial. The scope of work should
include a brief project description, services provided, main roles,
partner responsibilities and the desired outcome. The scope of work
is important to make sure that both the supplier and the customer
have understood the project in question and they have similar
expectations from it. The SOW is often developed through pre-studies
and workshops.
Defining what is not included in the scope of work is just as important
as defining what is included in it. This means that establishing some
framework and limitations for the project are also very important,
as the resourcing, scheduling and costs of the project depend greatly
on the scope of work. If the scope of work is not defined carefully,
questions or problems may appear later in the project, which will direct
the project back to phase one where a review of the scope is necessary.
This is an urgent but time-consuming matter and can be avoided if
the right people and decision-makers participate in the first project
phase. However, as changes to the original scope of work may be
necessary and required even in projects where the SOW phase has
been done carefully, it is important that the supplier and customer
agree on change management procedures as early as the starting phase
of the project.
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Development and implementation
When the scope of work has been defined and approved by both
parties, the integration can enter the next phase, which is the actual
development and implementation of the project deliverables.
Testing
Testing occurs both during the project after each partial delivery, in
order to be able to continue the development work to next phase, and
at the final stage of the project. The testing, approval procedures and
timelines should be defined when agreeing on the project.
Installation, verification and training
The final stage in the integration process is the installation and testing
at the customers facility and taking the system into production use.
The project manager at the buyers facility now plays a major role in
the success of the integration process. The supplier will, if required
and agreed, assist with informing, training and providing training
materials.
When the integration is finished, the customer has a system that
saves time, reduces costs and increases productivity by preventing
unnecessary double effort and re-keying of procedures in separate
When the integration is
finished, the customer
has a system that saves
time, reduces costs and
increases productivity by
preventing unnecessary
double effort and re-
keying of procedures in
separate systems.
INTEGRATION PROJECT PHASES
Specications
documentation
Purpose / needs
Target
Suppliers responsibilities
Customers responsibilities
Project management and
project steering group
Change management
Testing and acceptance
procedures
Final approval by customer
Implementation
documentation
Testing
documentation
Instructional
documentation
FOLLOW UP
CLOSURE OF INTEGRATION PROJECT
Scope of
work
(SOW)
Development
and
implementation
Testing
Ve n
Tr
Installation
ricatio
aining
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systems. When there is no need to manually re-key the data, typing
errors are eliminated. A CMMS integration will enable the customer
company to automate its management with smart calibrators. This
improves the quality of the entire system.
Integrating a CMM system with calibration management software
is an important step in the right direction when it comes to EAM,
Enterprise Asset Management. However, EAM is more than just
maintenance management software. Its about companies taking a
business-wide view of all their plant equipment and coordinating
maintenance activities and resources with other departments and
sites, particularly with production teams. Savings from EAM are
reasonably well-documented and come in various guises, the most
common benefits being: less equipment breakdowns (leading to a
reduction in overall plant downtime); a corresponding increase in
asset utilization or plant uptime; better management of spare parts
and equipment stocks; more efficient use of maintenance staff; and
optimized scheduling of maintenance tasks and resources. But the
key to success is really the quality of information you put in the
software, the data has to be as close to 100% accurate as possible to
get maximum benefit from the system.
Integrating a CMM
system with calibration
management software
is an important step in
the right direction when it
comes to EAM, Enterprise
Asset Management.
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Calibration
in Industrial
Applications
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F
or process manufacturers, regular calibration of instruments
throughout a manufacturing plant is common practice. In plant
areas where instrument accuracy is critical to ensure product
quality, safety or custody transfer, calibration every six months or
even more frequently is not unusual.
However, the key final step in any calibration process documentation
is often neglected or overlooked because of a lack of resources, time
constraints or the pressure of everyday activities. Indeed, many process
plants are under pressure to calibrate instruments quickly but accurately
and to ensure that the results are then documented for quality assurance
purposes and to provide full traceability.
The purpose of calibration itself is to determine how accurate an
instrument or sensor is. Although most instruments are very accurate
these days, regulatory bodies often need to know just how inaccurate a
particular instrument is and whether it drifts in and out of a specified
tolerance over time.
What is a documenting calibrator?
A documenting calibrator is a handheld electronic communication
device that is capable of calibrating many different process signals
such as pressure, temperature and electrical signals, including
frequency and pulses, and then automatically documenting the
calibration results by transferring them to a fully integrated calibration
management software. Some calibrators can read HART, Foundation
Fieldbus or Profibus output of the transmitters and can even be used
for configuring smart sensors.
The benefits of using
a documenting calibrator
Many process plants
are under pressure to
calibrate instruments
quickly but accurately and
to ensure that the results
are then documented
for quality assurance
purposes and to provide
full traceability.
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Heikki Laurila, Product Manager at Beamex in Finland comments,
I would define a documenting calibrator as a device that has the dual
functionality of being able to save and store calibration results in its
memory, but which also integrates and automatically transfers this
information to some sort of calibration management software.
A non-documenting calibrator is a device that does not store data,
or stores calibration data from instruments but is not integrated to a
calibration management system. Calibration results have to be keyed
manually into a separate database, spreadsheet or paper filling system.
Why use a documenting calibrator?
By using a documenting calibrator, the calibration results are stored
automatically in the calibrators memory during the calibration
process. The engineer does not have to write any results down on
paper, which makes the entire process much faster and consequently
reduces costs. The quality and accuracy of calibration results will also
improve, as there will be fewer mistakes due to human error.
The calibration results are automatically transferred from the
calibrators memory to the computer/database. This means the
engineer does not have to spend time transferring the results from his
notepad to final storage on a computer; again, saving time and money.
With instrument calibration, the calibration procedure itself is
critical. Performing the calibration procedure in the same way each
time is important for the consistency of results. With a documenting
calibrator, the calibration procedure can be automatically transferred
from the computer to the handheld calibrator before going out into
the field.
As Laurila states, Engineers, who are out in the field performing
instrument calibrations, receive instant pass or fail messages with a
documenting calibrator. The tolerances and limits for a sensor, as
well as detailed instructions on how to calibrate the transmitter, are
entered once into the calibration management software and then
downloaded to the calibrator. This means calibrations are carried out
in the same way every time because the calibrator tells the engineer
which test point he needs to measure next. Also, having an easy-to-
use documenting calibrator is definitely the way forward, especially
if calibration is one of the many tasks that the user has to carry out in
his daily maintenance routine.
With a multi-functioning documenting calibrator, such as the
The engineer does
not have to write any
results down on paper,
which makes the entire
process much faster and
consequently reduces
costs.
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Beamex
Integrated
Calibration Solution
concept is the
combination of calibrator,
calibration software and
PC for online calibration.
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T
his article will discuss the various uncertainty components related
to temperature calibration using a temperature dry-block. It will
also present how to calculate the total uncertainty of a calibration
performed with a dry block.
What is a temperature dry block?
A temperature dry block consists of a heatable and/or coolable metallic
block, controller, an internal control sensor and optional readout
for external reference sensor. This article will focus on models that
use interchangeable metallic multi-hole inserts. There are fast and
lightweight dry blocks for industrial field use as well as models that
deliver near bath-level stability in laboratory use. There are also some
work safety issues that favor dry blocks in preference to liquid baths.
For example, in temperatures above 200 C liquids can produce
undesirable fumes or there may be fire safety issues. If a drop of water
gets into hot silicon oil, it could even cause a small steam explosion
which may splash hot oil on the user. Dry blocks are almost without
exception meant to be used dry. Heat transfer fluids or pastes are
sometimes used around or inside the insert, but they dont necessarily
improve performance. They may actually even impede the dry blocks
performance and damage its internal components.
EURAMET
The EURAMET guideline (EURAMET /cg-13/v.01, July 2007
[previously EA-10/13]):
The Euramet calibration guide defines a normative way to calibrate
Calculating total uncertainty
of temperature calibration
with a dry block
There are fast and
lightweight dry blocks for
industrial field use as well
as models that deliver
near bath-level stability in
laboratory use.
150
dry blocks. As most of the manufacturers nowadays publish their
product specifications including the main topics in the Euramet guide,
the products are easier to compare.
Main topics in the EURAMET guideline include:
Display accuracy
Axial uniformity
Radial uniformity
Loading
Stability over time
Hysteresis
Sufficient immersion (15 x diameter)
Stem loss for 6 mm or greater probes
Probe clearance
(<= 0,5 mm at 80660 C)
(<= 1,0 mm at +6601 300 C)
Related uncertainty components
Uncertainty components that are related to temperature calibration are
relevant to all manufacturers dry blocks. Some manufacturers specify
these components and some do not.
It is possible to use a dry block with the blocks internal measurement
as the reference (true value), or to use an external reference temperature
probe inserted in the block as a reference measurement.
Internal measurement as reference
When using a dry blocks internal measurement as reference, the
following uncertainty components should be taken into account:
Display accuracy (accuracy of the internal measurement)
It is important to remember that all of the thermometers based
on thermal contact measure their own temperature. With dry
blocks, the internal control sensor is typically located inside the
actual block, whereas the probes to be calibrated are immersed
in the insert. There is always thermal resistance between the
internal sensor and the probes inside the insert and other sources
of uncertainty need to be considered.
fofti ucinftifv oi fixiintfuni ctiinntfio
The Euramet calibration
guide defines a normative
way to calibrate dry
blocks.
151
Axial uniformity
Axial uniformity refers to the variation in temperature along
the vertical length of the insert. The Euramet calibration guide
states, dry wells should have a zone of sufficient temperature
homogeneity of at least 40 mm in length at the bottom of the
insert. The purpose of this homogenous measurement zone is to
cover various sensor constructions. The thermocouple typically
has its hot junction close to the tip of the probe whereas the PRT
sensing element may be 30 to 50 mm long. With this in mind, a
homogenous zone of at least 60 mm is recommended.
Radial uniformity
Radial uniformity refers to the variation in temperature between
the holes of the insert. Related uncertainty is caused, for example,
by the placement of the heaters, thermal properties of materials
and alignment of the insert holes. Non-symmetrical loading or
probes with significantly different thermal conductivity (for
example large diameter probes) may cause additional temperature
variation.
MAIN PARTS OF THE DRY BLOCK
Stem conductance
Sensor to be
calibrated
Reference sensor
Axial uniformity
Internal sersor
Radial uniformity
fofti ucinftifv oi fixiintfuni ctiinntfio
Uncertainty components
that are related to
temperature calibration
are relevant to all
manufacturers dry
blocks.
152
Loading effect
Every probe in the insert conducts heat either from or into the
insert. The more the load, the more the ambient temperature
will affect the measurements. Sufficient immersion depth and
dual zone control helps to reduce load-related uncertainties. The
loading effect is not visible in the control sensor indication and the
controller cannot completely compensate for this shift.
Stability over time
Stability describes how well the temperature remains the same
during a given time.
The Euramet calibration guide defines stability as a temperature
variation over a 30-minute period, when the system has reached
equilibrium.
Immersion
Sufficient immersion is important in any temperature measurement.
The Euramet calibration guide states that the immersion depth
should be at least 15 x the probes outer diameter. To minimize
the stem conduction error its recommended, as a rule of thumb,
to use immersion depth of 20 x the diameter, plus the length of
the sensing element. As the probe constructions vary greatly (sheet
material, wall thickness, lead wire thermal conductivity etc.), a test
for each individual probe type to be calibrated should be made.
If sufficient recommended immersion cannot be reached, then
the uncertainty caused by the insufficient immersion should be
estimated/ evaluated.
Hysteresis
Hysteresis causes the internal sensor to be dependent on its previous
exposure. This means that the temperature of the dry block may
be a bit different depending on the direction from which the set
point is approached. The hysteresis is greatest at the mid-point and
is proportional to the temperature range.
The specifications for the above uncertainty components should be in
the blocks specifications. If some component has not been specified, it
should be estimated or evaluated.
fofti ucinftifv oi fixiintfuni ctiinntfio
Stability describes how
well the temperature
remains the same during
a given time.
153
Using an external reference sensor as reference
Unlike using the dry blocks internal sensor as a reference, the external
reference sensor is inside the insert together with the probes to be
calibrated. Therefore, the external reference enables more accurate
measurement of the temperature of the probes to be calibrated. Using
an external reference sensor enables smaller total uncertainty of the
system. The internal sensor has to deal with quick temperature changes,
vibration and possible mechanical shocks so it has to be quite a robust
mechanically. Unfortunately, mechanical robustness is usually inversely
proportional to good performance: stability, hysteresis, etc.
The internal sensor is used just to adjust temperature close to the
desired calibration point and keep it stable. There are many advantages
to using a separate reference sensor. It helps to minimize calibration
uncertainty but also provides reliability in measurements. In the
case of using an external reference sensor, the following uncertainty
components should be taken into account:
Axial uniformity
Axial uniformity-related uncertainty can be minimized by aligning
the centers of the sensing elements. In many cases, the user can
reduce the axial uniformity well below specification. In case the
probe to be calibrated is short and wont reach the measurement
zone at the bottom of the insert, the reference probe can be drawn
out to match the immersion. Of course, the stem conductance has
to be taken into account. If the reference sensor and the sensor
to be calibrated are sufficiently similar in diameter and thermal
conductivity, the user may obtain good results.
Radial uniformity
Radial uniformity is still present when using an external reference
probe and should be taken into account as specified.
Loading effect
Since the internal sensor cannot completely compensate the load-
related temperature shift inside the insert, the external reference
sensor is within the same calibration volume as the sensors to be
calibrated. The loading effect is usually much less significant with
an external reference sensor.
fofti ucinftifv oi fixiintfuni ctiinntfio
Using an external
reference sensor
enables more accurate
measurement of the
temperature of the probes
to be calibrated.
154
Stability over time
The external reference sensor can be used to measure the actual
temperature deviation inside the insert, and it may often be smaller
than the specification. It also helps the user to see when the unit
has truly stabilized. Dry blocks usually have a stability indicator,
but depending on, for instance, the different loads, there may still
be some difference between the block and the insert temperatures
when the indicator shows the unit has stabilized.
External reference sensor
The external reference sensor (PRT) is typically much more capable
of producing accurate measurements than the internal sensor.
However, using an external reference does not automatically mean
better results. All of the previously mentioned uncertainty factors
need to be carefully considered.
Uncertainty related to the reference probe components includes the
probes calibration uncertainty, drift, hysteresis, stem conduction,
and the readout devices uncertainty.
Of course, the external reference sensor needs a unit that measures
the sensor. It can be the block or an external device.
fofti ucinftifv oi fixiintfuni ctiinntfio
The external reference
sensor can be used
to measure the actual
temperature deviation
inside the insert and it
also helps the user to see
when the unit has truly
stabilized.
155
CALCULATION EXAMPLES
MB155R with internal measurement @0 C
Component Specification (C) Standard Uncertainty (C)
Display Accuracy 0.10 0.058
Hysteresis 0.025 0.014
Axial Uniformity 0.02 0.012
Radial Uniformity 0.01 0.006
Stability 0.005 0.003
Loading Effect 0.05 0.029
Combined Uncertainty: 0.067
Expanded Uncertainty: 0.135
MB155R with external measurement @0 C
Component Specification (C) Standard Uncertainty (C)
Axial Uniformity 0.02 0.012
Radial Uniformity 0.01 0.006
Stability 0.005 0.003
Loading Effect 0.005 0.003
Ref sensor measurement 0.006 0.003
Combined Uncertainty: 0.014
Expanded Uncertainty: 0.028
Reference Sensor (Beamex RPRT-420)
Component Specification (C) Standard Uncertainty (C)
Short-term repeatability 0.007 0.004
Drift 0.007 0.004
Hysteresis 0.01 0.006
Calibration uncertainty 0.01 0.006
Combined Uncertainty: 0.010
Expanded Uncertainty: 0.020
MB155R and RPRT-420
Combined uncertainty: 0.017
Expanded Uncertainty: 0.034
All specifications have a rectangular probability distribution.
That is why they are divided by the square root of three to get Standard Uncertainty.
Here are two examples
of total uncertainty
calculations. One is
done using the internal
temperature measurement
and the other with a
reference probe. In both
cases the MB155R is used
as the dry block.
The temperature in both
examples is 0 C.
Due to the rectangular
probability distribution of
the specifications, they
are divided by the square
root of three to get the
Standard Uncertainty. The
standard uncertainties
are combined as the root
sum of the squares. Finally
the combined uncertainty
has been multiplied by
two to get the expanded
uncertainty.
As can be seen in the
examples the total
expanded uncertainty
using the internal reference
sensor is 135 mK
(0.135 C). When using
an external reference
sensor the total expanded
uncertainty is 34 mK
(0.034 C).
The various uncertainty
components used in the
examples can be found in
the specifications in the
product brochures.
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F
ieldbus is becoming more and more common in todays
instrumentation. But what is fieldbus and how does it differ from
conventional instrumentation? Fieldbus transmitters must be
calibrated as well, but how can it be done?
Conventional transmitters can deliver only one simultaneous
parameter, one way. Each transmitter needs a dedicated pair of cables,
and I/O subsystems are required to convert the analog mA signal to a
digital format for a control system.
Fieldbus transmitters are able to deliver a huge amount of
information via the quick two-way bus. Several transmitters
can be connected to the same pair of wires. Conventional I/O
systems are no longer needed because segment controllers connect the
instrument segments to the quicker, higher-level fieldbus backbone.
Being an open standard, instruments from any manufacturer can
be connected to the same fieldbus as plug-and-play.
History of fieldbus
Back in the 1940s, instrumentation utilized mainly pneumatic signals
to transfer information from transmitters. During the 1960s, the mA
signal was introduced, making things much easier. In the 1970s,
computerized control systems began to make their arrival. The first
digital, smart transmitter was introduced in the 1980s, using first
proprietary protocols. The first fieldbus was introduced in 1988, and
throughout the 1990s a number of various fieldbuses were developed.
During the 1990s, manufacturers battled to see whose fieldbus
would be the one most commonly used. A standard was finally set
in the year 2000 when the IEC61158 standard was approved. The
Fieldbus transmitters
must also be calibrated
Fieldbus transmitters
must be calibrated as
well, but how can it be
done?
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Foundation Fieldbus H1 and the Profibus PA, both used in process
instrumentation, were chosen as standards.
For the most part, one can say that the Foundation Fieldbus is
dominating the North American markets and the Profibus is the
market leader in Europe. Other areas are more divided. There are also
certain applications that prefer certain fieldbus installations despite
the geographical location.
Future of fieldbus
Currently, a large number of fieldbus installations already exist and
the number is increasing at a huge rate. A large portion of new projects
is currently being carried out using fieldbus. Critical applications and
hazardous areas have also begun to adopt fieldbus.
The Foundation Fieldbus and Profibus have begun to clearly
dominate the fieldbus markets. Both Foundation Fieldbus and Profibus
have reached such a large market share that both buses will most likely
remain also in the future. The development of new fieldbuses has
slowed down and it is unlikely that new fieldbus standards will appear
in the near future to challenge the position of Foundation Fieldbus
or Profibus.
Recent co-operation between Foundation Fieldbus and Profibus
suppliers will further strengthen the position of these two standards.
Fieldbus benefits for industry
Obviously process plants would not start utilizing fieldbus, if it
would not offer them benefits compared to alternative systems.
One important reason is the better return on investment. Although
fieldbus hardware may cost the same as conventional, or even a little
bit more, the total installation costs for a fieldbus factory is far less
than conventional. This is caused by many reasons, such as reduction
in field wiring, lower installation labour cost, less planning/drawing
costs, and no need for conventional I/O subsystems.
Another big advantage is the on-line self-diagnostics that helps in
predictive maintenance and eventually reduces the downtime, offering
maintenance savings. Remote configuration also helps to support
reduced downtime. The improved system performance is important
criteria for some plants. There are also other advantages compared to
conventional instrumentation.
The Foundation Fieldbus
and Profibus have begun
to clearly dominate the
fieldbus market.
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Fieldbus transmitters must also be calibrated
The main difference between a fieldbus transmitter for pressure or
temperature and conventional or HART transmitters is that the output
signal is a fully digital fieldbus signal.
The other parts of a fieldbus transmitter are mainly comparable
to conventional or HART transmitters. Changing the output
signal does not change the need for periodic calibration. Although
modern fieldbus transmitters have been improved compared to older
transmitter models, it does not eliminate the need for calibration.
There are also many other reasons, such as quality systems and
regulations, that make the periodic calibrations compulsory.
Calibrating fieldbus transmitters
The word calibration is often misused in the fieldbus terminology
when comparing it to the meaning of the word in metrology. In fieldbus
terminology, calibration is often used to mean the configuration of
a transmitter. In terminology pertaining to metrology, calibration
means that you compare the transmitter to a traceable measurement
standard and document the results.
So it is not possible to calibrate a fieldbus transmitter using only
a configurator or configuration software. Also, it is not possible to
calibrate a fieldbus transmitter remotely.
Fieldbus transmitters are calibrated in very much the same way as
conventional transmitters you need to place a physical input into
the transmitter and simultaneously read the transmitter output to see
that it is measuring correctly. The input is measured with a traceable
calibrator, but you also need to have a way to read the output of the
fieldbus transmitter. Reading the digital output is not always an easy
thing to do.
When fieldbus is up and running, you can have one person in the
field to provide and measure the transmitter input while another
person is in the control room reading the output. Naturally these two
people need to communicate with each other in order to perform and
document the calibration.
While your fieldbus and process automation systems are idle, you
need to find other ways to read the transmitters output. In some cases
you can use a portable fieldbus communicator or a laptop computer
with dedicated software and hardware.
Although fieldbus
hardware may cost the
same as conventional,
or even a little bit more,
the total installation costs
for a fieldbus factory is
far less than conventional.
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Fieldbus instruments are increasing in popularity and calibration
can in many cases be cumbersome, time-consuming and may require
an abundance of resources.
The Beamex
MC6
can be used as a
communicator for the
configuration as well
as a calibrator for the
calibration of smart
instruments with the
supported protocols.
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S
o called smart instruments are ever more popular in the process
industry. The vast majority of delivered instruments today are
smart instruments. These new smart instruments bring new
challenges to the calibration and configuration processes. But what
are these smart instruments and what is the best way to configure and
calibrate them?
Beamex has recently introduced a new revolutionary tool, the
Beamex
MC6
Beamex
MC6,
the smart transmitters
input can be generated/
measured at the same
time as reading the digital
output.
167
documenting calibrator, data logger and Fieldbus communicator. In
addition, the MC6 communicates with Beamex
CMX Calibration
Software, enabling fully automated and paperless calibration and
documentation.
In conclusion, the MC6 is more than a calibrator.
A modern transmitter is advertised as being smart and extremely
accurate and sometimes sales people tell you they dont need
to be calibrated at all because they are so smart. So why
would you calibrate them? First of all, the output protocol of a
transmitter does not change the fundamental need for calibration.
There are numerous reasons to calibrate instruments initially and
periodically. A short summary of the main reasons include;
Even the best instruments and sensors drift over time,
especially when used in demanding process conditions.
Regulatory requirements, such as quality systems, safety
systems, environmental systems, standards, etc.
Economical reasons any measurement having direct
economical effect.
Safety reasons- employee safety as well as customer/patient
safety.
To achieve high and consistent product quality
and to optimize processes.
Environmental reasons.
Why calibrate?
coiicunic to ctiinntfic sxtnf isfnuxifs
The MC6 also contains a
full fieldbus communicator
for HART, Foundation
Fieldbus and Profibus PA
instruments.
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S
triking a match in an environment that contains combustible
gas is nothing short of dangerous personal injury and property
damage are likely consequences. Improperly calibrating an
instrument in this hazardous environment can be almost as dangerous.
The materials and fluids used in some processes can be hazardous in
the sense that they can ignite or explode. For example, hydrocarbons
in mines, oil refineries, and chemical plants are flammable and are
typically contained within vessels and pipes. If this were truly the case,
an external flame would not ignite the hydrocarbons. However, in
many locations, leaks, abnormal conditions, and fluid accumulation
may allow hydrocarbons to be present such that the flame could ignite
the hydrocarbons with disastrous results.
Hydrocarbons and other flammable fluids are not limited to the
petroleum and chemical industries. For example, combustible fuels,
such as natural gas, are used in all industries, including agriculture,
food, pharmaceuticals, power generation, pulp/paper, water/
wastewater, universities, retail, and in the home.
In addition, many materials and fluids used in seemingly safe
industries are themselves f lammable. Even seemingly safe water
treatment systems use combustible materials such as chlorine in their
processes. This means that certain areas of a water treatment plant
may well be considered hazardous. Similarly, certain areas of food
plants, such as reactors that hydrogenate oils, may pose hazards as
well. Therefore, it is important for plants to examine their processes
and identify hazardous locations so that the proper instruments are
Calibration in
hazardous environments
Many materials and fluids
used in seemingly safe
industries are themselves
flammable.
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selected, installed, and maintained in accordance with practices that
are appropriate for the hazard.
Equipment requirements in hazardous locations
Protection requirements for hazardous locations vary according to the
type of material present, frequency of the hazard, and the protection
concept applied.
The intensity with which various vapors can combust is generally
different. Groupings (IEC 60079-10) in order of decreasing ignition
energy (with an example of a gas in the group) are:
Group IIC Acetylene
Group IIB+H2 Hydrogen
Group IIB Ethylene
Group IIA Propane
The hazardous area classifications (IEC 60079-10) in order of
decreasing frequency are:
Zone 0 Flammable material present continuously
Zone 1 Flammable material present intermittently
Zone 2 Flammable material present abnormally
Intrinsic Safety (IS) is the most common protection concept applied
to calibrators that are used in hazardous locations. In general, the IS
concept is to design the calibrator such that it limits the amount of
energy available such that it cannot ignite a combustible gas mixture.
Adding the applicability of IS designs to various hazards in the
previous table yields:
Zone 0 ia Flammable material present continuously
Zone 1 ia, ib Flammable material present intermittently
Zone 2 ia, ib Flammable material present abnormally
In addition, a hot surface temperature on a device can cause ignition.
Temperature classes limit the maximum surface temperature between
450C (T1) and 85C (T6).
Intrinsic Safety (IS)
is the most common
protection concept
applied to calibrators
used in hazardous
locations.
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ctiinntfio i ntztnoous ivinoxifs
Beamex calibrators for hazardous locations are designed and certified
for Ex ia IIC T4 hazards per the ATEX Directive and are applicable to
all vapor hazards where a temperature class of 135C in a 50C ambient
is acceptable. As such, they can be used for the overwhelming majority
of applications where a vapor hazard is present.
Calibration solutions for hazardous locations
Instruments designed to measure flow, level, pressure, temperature,
and other variables designed in hazardous locations are generally used
to monitor and control the process. In some applications, it is practical
to remove these instruments and calibrate them on the workshop with
a calibration test bench. This is usually not the case, which means that
many instruments are calibrated in the field. Fortunately, there are
calibrators that are specifically designed to operate safely in rugged
environments and hazardous locations.
The Beamex multifunction IS-calibrators are portable and
intrinsically safe and have modules that can accommodate wide ranges
and many types of pressure, RTD, thermocouple, voltage, current,
pulse, and frequency measurements.
The Beamex modular calibration system is a test bench and
calibration system for workshops and laboratories that incorporates
the functionality of the MC5 multifunction calibrator and can
measure/generate additional parameters such as precision pressures.
The ergonomic design and modular construction allow the user to
select the necessary functions in a cost-effective manner.
The Beamex
CMX
software integrates
calibration management
by allowing efficient
planning and scheduling
of calibration work.
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A few points to remember
Improper actions in hazardous locations can result in property
damage and bodily injury.
Hazardous locations can exist in virtually all industries, stores, and
in the home.
Instruments should be specified, installed, operated, and maintained
in accordance with requirements for the hazardous location.
Portable Beamex calibrators for hazardous locations are designed to
be used in virtually all vapor hazards. Hazardous locations
can exist in virtually all
industries, stores,
and in the home.
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F
ieldbus transmitters must also be calibrated just like conventional
instruments. There are also industrial environments where the
calibration of fieldbus instruments should not only be made
accurately and efficiently, but also safely. When safety becomes a top
priority issue in calibration, intrinsically safe fieldbus calibrators enter
into the picture.
By definition, intrinsic safety (IS) is a protection technique for
safely operating electronic equipment in explosive environments.
The concept has been developed for safely operating process control
instrumentation in hazardous areas. The idea behind intrinsic safety
is to make sure that the available electrical and thermal energy in a
system is always low enough that ignition of the hazardous atmosphere
cannot occur. A hazardous atmosphere is an area that contains
elements that may cause an explosion: source of ignition, a flammable
substance and oxygen.
An intrinsically safe calibrator is therefore designed to be incapable
of causing ignition in the surrounding environment with flammable
materials, such as gases, mists, vapors or combustible dust. Intrinsically
safe calibrators are also often referred to being Ex calibrators,
calibrators for Ex Areas, or IS calibrators. An Ex Area also refers
to an explosive environment and an Ex calibrator is a device designed
for use in the type of environment in question.
Where is intrinsically safe calibration required?
Many industries require intrinsically safe calibration equipment.
Intrinsically safe calibrators are designed for potentially explosive
environments, such as oil refineries, rigs and processing plants, gas
The safest way to calibrate
fieldbus instruments
Hazardous area
classifications in IEC/
European countries are:
Zone 0: an explosive gas
& air mixture is continuously
present or present for a long
time.
Zone 1: an explosive gas &
air mixture is likely to occur
in normal operation.
Zone 2: an explosive gas
& air mixture is not likely to
occur in normal operation,
and if it occurs it will exist
only for a short time.
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pipelines and distribution centres, petrochemical and chemical plants,
as well as pharmaceutical plants. Basically, any potentially explosive
industrial environment can benefit from using intrinsically safe
calibrators.
What are the benefits of using intrinsically safe calibrators?
There are clear benefits in using intrinsically safe calibration
equipment. First of all, it is the safest possible technique. Secondly,
the calibrators provide performance and functionality.
Safest possible technique
Intrinsically safe calibrators are safe for employees, as they
can be safely used in environments where the risk of an
explosion exists. In addition, intrinsically safe calibrators
are the only technique permitted for Zone 0 environments
(explosive gas and air mixture is continuously present or
present for a long time).
Performance and functionality
Multifunctional intrinsically safe calibrators provide
the functionality and performance of regular industrial
calibration devices, but in a safe way. They can be used
for calibration of pressure, temperature and electrical
signals. A documenting intrinsically safe calibrator, such
as the Beamex
MC5-IS Intrinsically
Safe Multifunction Calibrator
The Beamex
calibrator. They are all delivered with
a traceable, accredited calibration
certificate.
Integrated calibration solutions
Beamex calibrators, workstations,
calibration software and professional
services form an integrated,
automated system.
Industry pioneer
with global presence
A forerunner in developing
high-quality calibration equipment
and software, with global customer
base and partner network.
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Constantly improving understanding
of customer needs and developing
solutions to meet them.
Support
Installation, training, validation,
system integration, database
conversion, Help Desk and
re-calibration services available.