Professional Documents
Culture Documents
Juhani Kääriänen
Cyber-security enables more
intelligent automation solutions
page 18
Anita Vuorenmaa
Corrosion in district
cooling systems
page 26
Anna-Mari Hämäläinen
The new welding symbol
standard – something new,
something old
page 30
18
Engineering for sterile product manufacturing
facilities – A GMP overview 4
Markku Mäkinen
A practical approach to GMP cleanrooms
and cleanroom HVAC 10
26 Timo Rauma
Structural Analysis
– A brief history: 1980s to 2010s 23
Martin Brink
Investing in technology and personnel
Anna-Mari Hämäläinen development bears fruit
The new welding symbol standard – Case Cadmatic 34
– something new, something old
30 Elomatic has donated this year’s
Christmas gift funds to develop
the Tampere University Hospital’s
pediatric clinic in Tampere, Finland.
Processing of sterile medicinal inal products, with a particular focus quality systems (ICH Q10) should be in-
products is one of the most critical on engineering aspects. It should be troduced in the design and during pro-
operations in pharmaceutical remembered, however, that engineer- duction of pharmaceutical preparations.
ing is only the basis and that quality as- These concepts are already noted in the
manufacturing due to the highly
surance is vitally important. Manufac- Sterile Product Manufacturing Facilities
technique-driven processes turing must strictly follow the carefully guide (Volume 3, Sept. 2011, ref. 9) by
and the potential detrimental established and validated methods of ISPE (International Society for Pharma-
impact on patients. Since sterile preparation and prescribed procedures. ceutical Engineering) and are under
manufacturing is subject to An overview of the relevant regulato- preparation and discussion in the EU
inspections by different regulatory ry authorities and their publications is (Concept paper on the revision of An-
provided in the info box (see overleaf ). nex 1, February 2015) as well as in the
authorities, such as the US FDA, Sterile manufacturing processes re- Pharmaceutical Inspection Convention’s
WHO and EMA, it is imperative to quire close coordination and interac- co-operation scheme (PIC/S).
be thoroughly familiar with Good tion between personnel, equipment It needs to be kept in mind that the
Manufacturing Practice (GMP) systems, cleanroom and support facil- manufacture of sterile preparations
regulations and their application. ities, and sterilized components. should be carried out in clean areas,
Recommendations by the various and operations are divided into two
US Food and Drug Administration (FDA) good manufacturing practices for veterinary medicinal
products. Annex 1, Manufacture of Sterile Medicinal Prod-
The FDA publishes regulations and guidance documents. ucts, (Nov. 2008) of Volume 4 of European Good Manu-
Its Code of Federal Regulations (CFR) is a codification of facturing Practice Guidelines specifically explores sterile
the general and permanent rules published by the Federal medicinal product manufacturing.
Government, which is divided into 50 titles that represent
broad areas subject to federal regulation. World Health Organization (WHO)
Title 21 of the CFR is reserved for FDA rules and updated One of the WHO’s constitutional functions is to provide
annually on April 1. It contains general regulations for objective and reliable information and advice in the field
pharmaceuticals including manufacturing, processing, of human health, a responsibility that it fulfils in part
packing, or holding of a drug, and rules for design and through its extensive programme of publications. WHO ex-
construction features of buildings and facilities, ventila- pert committees have made numerous recommendations
tion, air filtration, as well as air heating and cooling and di- contained in annexes to several WHO Technical Report
rections regarding the use of defined areas and controlled Series (TRS). Today TRS 986 (2014) Annex 2 profiles the
conditions to prevent contamination (Part 210, and 211). WHO’s thinking with regards the main GMP principles for
It also covers general instructions for equipment selection pharmaceutical products.
with respect to equipment design, size and location, con-
struction, cleaning and maintenance, as well as guidelines The WHO Good Manufacturing Practices for Sterile Phar-
for automatic, mechanical and electronic equipment and maceutical Products (Annex 6, WHO Technical Report Series
filters. 961, 2011) describes its regulatory requirements for sterile
manufacturing.
The CFR delineates GMP for complete manufacturing
activities from raw material issuance to final product International Organization
dispatch from the facility. There are also special regulatory
for Standardization (ISO)
parts for Quality Systems (Part 820) and Electronic Records
(Part 11). The ISO has published a number of standards relevant to
pharmaceutical manufacturing, of which ISO 14644 for
The FDA’s guidance documents represent the agency’s
clean rooms and associated controlled environments is
current thinking on a particular subject and as non-
the most adhered to by industry.
binding guides they act as the reference for inspectors and
manufacturers. The most relevant guidelines for the manu- ISO 14644
facturing of sterile products are contained in Guidance for Cleanrooms and associated controlled environments
Industry: Sterile Drug Products Produced by Aseptic Process- Part 1: Classification of air cleanliness
ing — Current Good Manufacturing Practice (Sep 2004), and
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Part 2: Specifications for testing and monitoring to
Preventing Cross-Contamination (April 2013). prove continued compliance with ISO 14644-1
Part 3: Test methods
European Union GMP (EU GMP)
Part 4: Design, construction and start-up
The rules governing medicinal products in the EU are
published in various EudraLex volumes containing EU leg- Part 5: Operations
islation and guidelines that support the basic legislation. Part 7: Separative devices (clean air hoods, glove boxes,
Volume 4 of the European publication contains guidance isolators and mini-environments)
for the interpretation of the principles and guidelines of
good manufacturing practices for human and veterinary Part 8: Classification of air cleanliness by chemical con-
medicinal products specified in EU directives. centration (ACC)
Directive 2003/94/EC (8 Oct 2003) lays down the principles Part 9: Classification of surface cleanliness by Particle
and guidelines of good manufacturing practice in respect Concentration
of medicinal products for human use and investigational Part 10: Classification of Surface Cleanliness by Chemical
medicinal products for human use while Directive 91/412/ Concentration
EEC (23 Jul 1991) covers the principles and guidelines of
Table 2 presents selected airborne Table 1a: Operations in various grades for terminally sterilized products
particulate cleanliness classes and the – EU GMP (ref. 3)
corresponding particle concentrations
Terminally Sterilized Products
for particles equal to and larger than
Grade Operations
the considered sizes shown.
The US FDA defined area classifica- A ■■ Filling of ‘unusually at risk’ products
tion is provided in Table 3. USFDA con- ■■ Filling of Products
C
siders only In-operation condition and ■■ Solution preparation of ‘unusually at risk’ products
for 0.5 µm particle size only. ■■ Solution preparation
D
The EU GMP & WHO defined area ■■ Components preparation for subsequent filling
classification is provided in Table 4. EU
GMP & WHO considers limits ‘at rest’ as Table 1b: Operations in various grades for aseptic preparations – EU GMP
well as ‘in operation’. Also, these regula- (ref. 3)
tions consider 5 µm particle size along
Aseptically Processed Products
with 0.5 µm particle size. These regu-
lations don’t define ‘in operation’ lim- Grade Operations
its for Grade-D; the company should ■■ Aseptic Preparations
A
establish in operation limits based on ■■ Product Filling
a risk analysis and on historical data C ■■ Preparation of solution to be filtered
where applicable. D ■■ Component handling after washing
During operation the manufacturer
should monitor airborne particles and Table 2: Area Classification – ISO (ref. 8)
microbiological contamination. In this ISO Classifica- Maximum concentration limits (particles/m³ of air) for particles equal
context FDA accepts the use of settle tion Number, to and larger than the considered sizes shown below
plates only as optional for continuous N 0.1µm 0.2µm 0.3µm 0.5µm 1µm 5µm
air sample measurements (Table 5a); ISO Class 1 10 2
while for WHO / EU GMP, the use of
ISO Class 2 100 24 10 4
settle plates and glove prints are com-
ISO Class 3 1000 237 102 35 8
pulsory (Table 5b).
ISO Class 4 10000 2370 1020 352 83
A new version of EU GMP Annex 15
ISO Class 5 100000 23700 10200 3520 832 29
(Qualification and Validation) has been
ISO Class 6 1000000 237000 102000 35200 8320 293
published describing the principles of
ISO Class 7 352000 83200 2930
qualification and validation for facili-
ISO Class 8 3520000 832000 29300
ties, equipment, utilities and processes.
ISO Class 9 35200000 8320000 293000
Annex 15 takes into account current
changes to other sections of EudraLex,
Volume 4, Part I, the relationship to Part Table 3: Area Classification – US FDA (ref. 1)
II, Annex 11, ICH Q8, Q9, Q10 and Q11, Clean Area Classification
ISO Designation ≥0.5 µm Particles /Cu. m
QWP guidance on process validation, (0.5 µm particles/Cu.ft)
and changes in manufacturing tech- 100 5 3,520
nology. This version has been opera- 1000 6 35,200
tional from 1 October 2015. 10000 7 352,000
100000 8 3,520,000
sterilized after maintenance work (ex- (ref. 9). It is a valuable book offering References
cept when the cleanliness and asep- consistent interpretation of facility de- 1. Guidance for Industry: Sterile Drug Products
sis is maintained during maintenance sign, construction, commissioning and Produced by Aseptic Processing — Current
work). The WHO recommends using qualification. It takes into account the Good Manufacturing Practice (Sep 2004), FDA
2. Non-Penicillin Beta-Lactam Drugs: A CGMP
dry heat/moist heat to sterilize the guidelines referred in this article and
Framework for Preventing Cross-Contami-
equipment as far as possible. provides practical and illustrated ex- nation (April 2013), FDA
It is further recommended that WFI amples of the implementation of good 3. Annex 1, Manufacture of Sterile Medicinal
be kept at temperatures (>70 °C or NMT engineering practice. Products, (Nov. 2008), Eudralex Volume 4, EMA
4 °C) that prevent microbial growth and It should be kept in mind that oth- 4. Annex 2, Main principles of good manufactur-
ing practice for pharmaceutical products. Tech-
that planned maintenance and valida- er standards and guidelines are availa- nical Report Series (TRS) 986 (2014), WHO
tion of critical process equipment be ble in this subject area. One of these is 5. Annex 6, Good Manufacturing Practices for
conducted. Processing equipment and the ISO 13408-1 standard “Aseptic Pro- Sterile Pharmaceutical Products, Technical Re-
systems should be equipped with sani- cessing of Healthcare Products”, which port Series (TRS) 961 (2011), WHO
tary fittings and valves. The WHO also adds value in the design of aseptic pro- 6. Q9, Quality Risk Management, ICH
7. Q10, Pharmaceutical Quality System, ICH
indicates that threaded pipe connec- cesses. 8. ISO 14644-1. Clean rooms and associated
tions should be avoided. Careful and systematic adherence to controlled environments. Part 1: Classification
the guidelines described in this article of airborne particles. Geneva, International
and others is key in delivering facilities Organization for Standardization.
9. Sterile Product Manufacturing Facilities (Vol-
Other guides and processes that can pass the strict ume 3, 2nd Ed., Sept. 2011), ISPE (Internation-
Good Manufacturing Practice require- al Society for Pharmaceutical Engineering)
The International Society for Pharma- ments. Getting it right is crucial in gain-
ceutical Engineering (ISPE) has pre- ing access to markets and ensuring the
pared a guide for engineering Ster- safety of end users. About the author
ile Product Manufacturing Facilities
room HVAC systems include the EU The ISPE publication series includes Conceptual Design
GMP, PIC/S GMP, FDA cGMP, and WHO ISPE Baselines, ISPE GAMP Guidance ↓
GMP. documents, ISPE Guides and Good Basic Design (or Functional Design)
What is clean and how particle- Practice Guides, ISPE Investigational ↓
based cleanliness is specified depends Products Resources, and ISPE Regu- Detail Design
on what standards are applied. The latory. This excellent source of refer- ↓
world community of cleanroom de- ence information combined with en- Design Review and/or
signers mostly follows the ISO 14644 gineers’ practical experience allow Design Qualification
standard family for this purpose. Clean- most clients’ GMP related questions ↓
room designers and builders should to be solved. Local laws and codes Implementation (Construction)
concentrate on the first five parts of naturally have to be applied in every ↓
the standard family depicted in Table 1. aspect in order for project goals to be Installation Qualification
ISPE has provided a set of tools that fulfilled. Once a project has started the ↓
facilitates a clearer understanding of ISPE general V-model should be fol- Operational Qualification
the application of different GMP reg- lowed (see Figure 1) ↓
ulations, standards and guidelines in According to the V-model all GMP Performance Qualification
everyday work. Without these base- projects should start with a properly
lines it would be difficult to find suit- executed risk assessment based ap- Every phase has to be approved and
able solutions to GMP matters. ISPE proach which leads to the appropriate completed with documented confir-
creates a bridge between pharma- Validation Master Plan (VMP) and final- mation before proceeding to the next
ceutical engineers and regulative au- ly to project-specific User Requirement phase. It all starts from the user re-
thorities by writing baselines, good Specification (URS). All GMP cleanroom quirements and ends with the very
Project
Management Validation Plan User Performance Plan Validation Plan
Define Scope (VP) Requirements Qualification (PQ) Re-Qualification
Summary Report
Procure Budget Risk Assessment (URS) and CQ
Develop Timelines
Functional Operational
Requirements Qualification (OQ) Change Control
(FRS) and CQ
Commissioning
Design Installation and Qualification
Preventive
Specifications Qualification (IQ)
(DDS) and CQ Maintenance
Commissioning
Engineering Runs
Build Calibration
FAT/SAT
External Areas
Street, offices, restaurant
Transition Zone
Brings people, materials, etc. from external areas
to the manufacturing areas in a “controlled” manner
Supporting Clean Area
Provides a protective envelope to minimize
the challange to the Critical Areas
Critical Area Remove Raw
People Change Change e.g. Point of Fill Compounding outers materials
Sterilize
Remove
outers
15 Pa
“Building” areas (general) Cooling area (“Sterile corridor”)
Autoclave
Changing room/ loading room
airlock
Autoclave Packing hall
(measured Grade C (not directly
at rest) 30 Pa Aseptic processing room 1 pressure controlled)
45 Pa
Grade B
Final rinse Grade B
CNC
Pass thru
airlock
Grade C
30 Pa
Washing / sterilizing tunnel
“Critical” Areas
Airflow direction
Grade A
◄◄ A RePCI project meeting in Jyväskylä, nia during RePCI. The concept is based volved and elevated the cooperation
Finland. On the far left, Arto Sampo, on the use of pedagogical approach- from an operational level to a more
and on the far right, Pasi Ahonen. es used in HEI institutions in the de- strategic level. Both the HEIs and their
velopment of knowledge in partner partner companies will reap the bene-
companies. Staff from the HEIs worked fits of the deeper strategic cooperation
velopment, while action plans based as coaches in training projects inside over the long-term.
on the common areas of development partner companies. As a result the first In some countries legislation needs
were also agreed. competence matrix of job descriptions to be adjusted to make the coopera-
The RePCI project allowed all par- was created, which outlined what skills tion between educational institutions
ticipants to become more familiar with are required by industry players going and companies easier. Development
how other European HEIs cooperate forward. The industrial partners were work is also required to identify the op-
with industry players. This informa- also involved in ensuring that these timal interface and how to retain flex-
tion is extremely useful when plan- identified competences were included ibility in scheduling. It is clear, however,
ning new projects and cooperation as intended in the teaching programs. that precisely the kind of novel coop-
activities. The possibility to benchmark A key result of the project was that eration seen during the RePCI project is
teaching at HEIs in different countries it deepened the cooperation between what is needed on a much larger scale
and student competencies interna- the universities and companies in- to bolster European competitiveness.
tionally is important for international
companies and HEIs.
Another significant achievement of
the project was the acquisition of the About the authors
information and connections required
for international student exchange.
During the RePCI project student
groups worked together on partner
company tasks.
more intelligent
solutions Cyber-security is becoming
increasingly prominent when
it comes to automation. It is
noteworthy that technical
solutions can only remove
33% of all security threats
and that two out of three
attacks originate from within
our own organizations.
Firewalls cannot prevent an
attack if malware is installed
directly to the target on-site.
How can and should cyber-
security be handled and
what does the future hold?
Illustration © tigerlily713
T he cyber-security mind-set com-
bines information security, conti-
nuity management and societal crisis
The operative level directs the strat-
egy towards real actions, and the tech-
nical level implements the technical
The creation of a new automation
network, or the expansion of an exist-
ing one, must proceed in phases so
preparation. As a concept, it covers the actions according to the strategy. It is, that cyber-security is observed. Work
so-called digital world, which is con- then, important that cyber-security is must always begin with a risk assess-
nected to physical world practices and managed and influenced by corpo- ment to determine the cyber-securi-
society as a whole where individual ac- rate management as a strategy. Man- ty risks of the automation system. Af-
tions and human error are an addition- agement needs to work closely with ter this, the company’s cyber-security
al challenge. the ICT department and ICT solutions strategy, if one exists, comes into play,
Cyber-security can be divided into must be based on management-de- along with how that strategy is taken
three different levels: strategic, opera- fined strategic goals. into account in the design or expan-
tive and technical. At the strategic lev- sion of the automation system.
el, the company creates a cyber-secu- For technical reasons, the network
rity strategy that defines the actions Taking cyber-security must be segmented correctly and sen-
that have a significant effect on per- into account in automation sibly (DMZ, isolated, etc.) while deter-
formance. Actions that are greatly cy- mining access to company and other
ber-dependent can then be identified. In automation, cyber-security is cre- (external) networks. Equipment secu-
Resources can thereafter be allocated ated through the chosen solutions. rity surveys are an important part of
to secure these critical actions and en- Equipment must be reliable, and from cyber-security. Inspections of equip-
sure that the residual risk is acceptable. known operators. Cyber-security con- ment with or without network connec-
It will then, for example, be possible to cerns all “intelligence” connected to the tions include their identifier, type and
insure the residual. network or channel. explanation in addition to passwords.
The passwords should be strong and user experience is poor, it is possible examples include actions related to
the equipment password list must be that it may be misused or used in a preventive maintenance, such as meas-
kept in a secure location. In addition, way that is less secure. An example of urements related to bearing heat or ab-
the possibility of upgrading old devices this would be writing down complicat- normal vibrations in a device.
with new ones must be investigated. ed, frequently-changed passwords on As the amount of data grows, more
In many cases, industrial networks a post-it note next to devices. attention will certainly have to be paid
are completely disconnected from the to data integrity and confidentiality. In
Internet, which means they can only the future data itself and refining “raw
be accessed on-site. Even in this case, Manufacturing execution data” into a useful format will become a
the risk of a virus being installed on an systems (MES) commodity. As this happens, it is para-
on-site computer remains, regardless mount that the information is correct
whether done on purpose or by acci- Manufacturing execution systems add and unmodified.
dent. This is where “hardening” a com- intelligence to manufacturing execu-
puter is helpful. tion and optimisation. Intelligent field
Not all automation networks are, devices that are connected to an in-
however, entirely disconnected from dustrial-grade system with remote ac-
the Internet. Inspecting firewall con- cess require a secure framework to
figurations is integral to finding out ensure their functionality. There is a
whether unnecessary traffic has been large amount of information that can
blocked and default settings changed be gathered from the manufacturing
appropriately. For example, in a worst- process and that creates the possibil-
case scenario, routers/firewalls may ity for, among other things, industrial
have been left in “nearly default” set- espionage.
tings, and the connections to removed When discussing mobile devices, About the author
devices unrevoked. the term “fleet management” is often
In many cases, it is necessary to ac- used. Workstations maintain a connec-
cess an automation system from the tion to a server that gathers a host of
outside. Remote access is provided information and creates reports on, for
with industrial-grade VPN equipment. example, working hours, machine loca-
The devices contain a firewall and a tion and its working condition.
VPN server. A static IP address or dy-
namic DNS is required and the use of Juhani Kääriäinen
an Industrial VPN Appliance rather than Storing information (Big Data)
a cloud-based remote connectivity ser- M.Sc. Eng. (Process Automation)
vice is recommended. As MES and Fleet Management solu- Juhani Kääriäinen holds a graduate
The design must also take physi- tions become more common, it will be degree in process automation from
cal information security into account, increasingly important to gather data. the Oulu University. After graduating
which entails limitations to access / Over 99% of data is stored in digital for- in 2000 he has worked in research
disposal of sensitive papers / locking mat and the amount of stored data is and training as well as in consulting
doors, etc. If necessary, a training ses- constantly growing. As the Internet of and engineering. He also has several
sion for proper use of the system can Things (IoT) expands, intelligence is dis- years’ experience in sales and market-
be held as a part of the delivery. tributed ever further and linked via the ing. Currently Juhani works at the Elo-
Usability is an integral part of cyber- Internet. Smart devices communicate matic Jyväskylä office as the Design
security and also connected to physi- with host machines, which increases Manager of the Electrical and Auto-
cal information security. If a device be- the amount of gathered information. mation Engineering Team.
comes overly difficult to use due to Raw data can be used to collect infor- juhani.kaariainen@elomatic.com
security concerns it can in itself consti- mation and draw conclusions on cost
tute a cyber-security risk. If a device’s efficiency, among other things. Some
The Elomatic Magazine · 22 | 23
22 | 23
Structural Analysis
– A brief history: 1980s to 2010s
Text: Timo Rauma
All consulting work comes with its tural analyses. At first, the work was retical slant was of little use for practi-
own challenges and responsibilities much like laying a foundation – fortu- cal purposes.
– fiscal for the company and moral nately no rocket science was required Those analytical solutions, while be-
in the beginning. ing theoretically accurate, could only
for the individual designer. In the
Changes in data transfer have turned be used for structures with a simple
field of structural analysis, this more than just my field upside down. and clear geometry. There are tables
is abundantly clear at all times. In the beginning, all we had were tel- for beams supported in different ways
Incorrect analysis can lead to ephones and the post, along with cus- that show the distribution deflections
personal injuries and significant tomer meetings, which we definitely and internal forces that the point load
economic ramifications. Structural had more of than we do now. Structur- or distributed loads can exert. Similar
al analysis, especially in the early days, calculations also exist for plates. Calcu-
analysis as a field of engineering was a challenging field for gaining cus- lation for more complicated structures
has gone through many changes in tomers’ and colleagues’ trust. was not, however, achievable with usu-
the past four decades. In this article al mathematics, so instead we had to
I take a closer look at these changes settle for near-solutions gained with
as I experienced them. Calculation methods and tools numerical methods. The most efficient
have seen many changes of those methods we’ve found is the
analysis with the same bewilderment. ture. Some well-informed customers tion-appropriate structural parts that
Elomatic had employed structural provided very helpful dimensioning are called elements. The elements are
analysts before, or at least so I under- guides. I also spent some time looking joined together with node points.
stood, but the company didn’t have for help in my study materials, but it The solution of node displacements
any material on any performed struc- soon became apparent that the theo- (translations and rotations) is, in fact,
a solution for an equation set with n Improved software
unknowns and n equations. The ele- user-friendliness
ment stresses can be calculated from in 80s and 90s
the displacements of the nodes re- ABAQUS thanks to their
lated to them. The figure n is called In the 1980s and 90s, the software start- wide feature-set.
the calculation model’s number of de- ed becoming more user-friendly. It was As personal computers have im-
grees of freedom, which indicates the called graphical interactivity: when cre- proved, they have become far more
magnitude of the solution. ating a calculation model, the analyst cost-effective solutions. The calculation
This simplified description of a fi- would be given immediate graphical software suites have become more us-
nite element method can be used as feedback, and the results were view- er-friendly. The geometry of a struc-
a bridge to our current level of pro- able in graphical form as well. As the ture can be transferred directly from
gress. Financially sensible computers development of personal computers 3D design software to the structural
and software in the 1980s were able kicked into full force in the 1990s, the analysis suite. Using different non-lin-
to calculate a solution with a few hun- finite element method started becom- ear analyses (large displacement, plas-
dred degrees of freedom, and today ing a more useful and efficient tool. ticity, stability, etc.) provides us with
we even use calculation models with We have used FEM calculations in more possibilities to use the finite ele-
millions of degrees of freedom. I re- structural analysis since the early 1980s. ment method.
member a calculation we did on a train At the time we performed our beam
sleeper carriage’s partition wall sup- calculations on HP computers, using
porting structure – it took two weeks Stafra software, which was made with Role and challenges
on a workstation machine (rough shell HP Basic. For shell and solid calculations of structural analysts
element model and non-linear large we used British software called Pafec
deflection calculation). Today, that (on a UNIX mainframe). Both of these Generally speaking, the role and chal-
would have taken no more than a few 1980s software programs were slow lenges of a structural analyst are de-
seconds. and labour-intensive to use. The scope pendent on the nature of their place
The finite element method came of the calculation models was extreme- of employment. In extreme situations,
into use in the 1950s in the USA. The ly limited. We had to simplify the struc- companies that focus on a specific
method improved along with comput- tural models and use symmetry and product or group of products can tai-
ers and a large amount of commercial asymmetry constraints whenever we lor the calculation methods to meet
software was already available in the could. Since the 1990s and the person- the needs of that specific product. The
1970s. The software ran on mainframes al computer “revolution”, we’ve had ac- calculation involves the development,
and was hard to use, as the inputs had cess to a wealth of financially sensible improvement and optimisation of a
to be made manually in numerical for- structural analysis software suites. Dur- product the company has extensive
mat. Even the results had to be read ing the DOS era, we used Beamex for experience in.
in numerical form in massive tables. beam structure calculations and ANSYS Engineering companies have a larg-
The analyst had to have an excellent for shell and solid element model cal- er portfolio when it comes to both en-
understanding of what the calculation culations. In Windows, we used Finnsap gineering and structural analysis – the
was, and confirmation of the results at first, and in the last few years our an- analytics bring variety and challenges
was necessary as well. alysts have been using both ANSYS and to our work.
In the beginning, when we had equipped to adapt to the current world 25 years ago. One nevertheless still has
one or two structural analysts, the cal- of calculation. to be able to look at results and use
culations mostly concerned our own As calculation capacity increas- your experience and common sense
engineering projects. Many assign- es and software develops, it has be- to question and verify results.
ments in the 1980s and 90s began with come possible to create very specific
brainstorming, preliminary design and calculation models for very significant
structural reviews. The analyst would structures. Even in real situations, a
take part in the project, if not as the structure’s points of discontinuity are
project lead, in a capacity that helped subject to peak tensions (or “hot spots”)
carry the project through. Analysts that are limited to the material’s yield
would in other cases fill the time be- strength. The hot spots shown by cal- About the author
tween calculation projects by taking culation models may also be caused by
part in engineering work. This helped an inappropriate element grid. It can
them understand how structures work be said that sometimes, the more you
and to become familiar with manufac- know, the more you suffer when inter-
turing requirements. preting the results.
Today, the structures under analysis The amount of norms and stand-
are often already engineered or even ards used in calculation is constantly
manufactured, when for some reason, growing, partly thanks to common EU Timo Rauma
a structural analysis is required (by an standards and the internationalisation
authority or an inspection body, or of work. M.Sc (Mechanical Engineering)
when the structure does not meet re- After working as an assistant for one
quirements for some reason, etc.). year at Oulu University, Timo joined
The “hand-in-hand” development of Balance between technology Elomatic in September1984. His expe-
information technology and structural and practical know-how rience covers strength calculations of
analysis software has, over the years, steel structures (e.g. cranes, harbour
ended up with us using different piec- Despite all the technological advance- equipment etc.).
es of software. The competition be- ments and changes we have witnessed
A standout project in his career was
tween analysis suite providers often in the field of structural analysis over the strengthening of the bow struc-
leads to an accelerating versioning cy- the years there are some things that tures and visors for all Viking Lines’
cle as they add features and correct haven’t changed. It is, for example, still car ferries. The work was based on rule
mistakes. Keeping up with their pace vitally important that analysts are con- modifications caused by the Estonia
while providing competitive structural vinced of the results of their work in catastrophe and consisted of preli-
analysis services poses its own chal- one way or another. The modern an- minary design, strength calculations,
lenge. Today, students become famil- alyst relies to a great extent on soft- applying for maritime class approval
iar with the use of FEM program pack- ware tools and the immense process- and leading the drawing design work.
ages while studying for their degrees. ing power of modern computers to
timo.rauma@elomatic.com
The youth are growing up using in- conduct analyses instantly. We could
formation technology and are better not even dream of such calculations
Corrosion
in district cooling
systems
Text: Anita Vuorenmaa
Info box
Basics of corrosion
When a metal corrodes it is oxidized and emits electrons (1). These electrons
are consumed in reduction reactions at the cathode. Usually reduction oc-
curs with oxygen or with water that contains oxygen (2) or with hydrogen
ions (3).
that galvanic corrosion is also a poten-
tial threat in cooling networks. Fe → Fe²+ + 2e- (1)
Moreover, pipelines in a cooling sys- O₂ + 2H₂O + 4e- → 4OH- (2)
tem can also be damaged by erosion + -
2H + 2e → H₂ (3)
corrosion. This is due to chemical cor-
rosion as well as mechanical wearing However, a corrosion cell will form and corrosion can occur only if all the fol-
caused by high velocity fluids in the sys- lowing conditions are met:
tem. Loose particles, such as solid cor-
rosion products, that are drifting in the 1. There is both an anode (a surface to be oxidized) and a cathode (a surface
where reduction takes place).
flow can accelerate the wearing effect.
2. There is an electric potential difference between the anode and cathode.
If a pipeline is exposed to residual or 3. There is a metallic path between the anode and cathode that allows the
applied stresses in a corrosive environ- transfer of electrons.
ment stress corrosion cracking (SCC) may 4. The anode and cathode are submerged in the same conductive solution
be induced. High pH levels and nitrite (electrolyte).
ion concentrations increase the risk of
SCC for carbon steel pipes.
◄◄ A scanning electron microscopy (SEM)
image of microbial growth on the in-
side surface of a carbon steel pipe.
Photo © VTT
The role of microbes tem, potentially creating a corrosive The two most critical factors in re-
in corrosion microenvironment. spect of the corrosion rate are the ox-
The role of microbes is made even ygen content and pH level. Oxygen
Corrosion that is induced or affected more complicated by the fact that they typically accelerates corrosion mark-
by microbes, i.e. microbiologically influ- can also inhibit corrosion. They can, edly, but the relation is not that sim-
enced corrosion (MIC), has often been for example, consume oxygen that is ple: a small amount of oxygen pro-
given too little attention. There is much needed for cathodic reaction, produce motes the formation of an oxide layer
evidence indicating that microbes can inhibitory metabolites, or stabilize the that can protect the metal surface
play a highly significant role in corro- protective film on the metal surface. from corrosion. This kind of protec-
sion attacks. Many microbes are toler- Some microbes can also produce an- tive or passivating film on the surface
ant of harsh conditions and can live in tibiotics that inhibit the growth of cor- of carbon steel usually consists mostly
unfriendly environments such as those rosion-inducing microbes. of magnetite Fe₃O₄ which – when con-
found in district cooling systems. How- A district cooling system is mostly ditions are favourable – forms a dense
ever, relating the observed corrosion an oxygen depleted environment. The layer that adheres tightly to the steel
attack to microbes can be difficult; find- most important microbes that cause surface.
ing microbes at the damaged site does MIC under anaerobic conditions are However, excess oxygen or destabi-
not necessarily prove that microbes are sulfate reducing bacteria (SRB). They lization or destruction of the magnetite
to blame. can promote corrosion in different layer can increase the corrosion rate.
There are several ways microbes ways and cause severe corrosive dam- In district heating systems hydrazine
affect corrosion and not all of these age. It has to be remembered though, is used as a scavenger for residual oxy-
are fully understood. Microbes essen- that microbial communities consist of gen, but its reaction rate is very slow in
tially influence corrosion by changing many different microbes and there are cooling network temperatures, which
the electrochemical conditions at the numerous complicated biochemical re- means that it does not really work in
metal-solution interface. Micro-organ- actions and interactions involved. such conditions. There is still a lack of a
isms, of which the most abundant are simple and practical oxygen scavenger
bacteria, live on a pipe surface in the for district cooling systems.
form of a biofilm. Microbes can pro- Factors affecting the corrosion rate Typically fluid acidity speeds up cor-
duce organic or inorganic acids and rosion. A high hydrogen ion concen-
extracellular corrosive metabolites or The maintenance of proper water tration accelerates the cathodic reac-
concentrate chloride, oxygen, hydro- chemistry in piping systems is crucial tion, but a low pH also destabilizes the
gen or metal ions under the biofilm. in minimizing the corrosion risk. There magnetite layer which makes the metal
The biofilm can act as a barrier that are, however, many elements in water surface more susceptible to corrosion
blocks the free movement of mole- chemistry that interact, thereby mak- attacks. This is why water is kept alka-
cules and ions, thus affecting the con- ing the system highly complex. Opti- line in cooling systems. A very high pH
centrations of chemical substances. mal control over the corrosion rate in a can, however, also damage or destabi-
Consequently, the conditions under cooling network may still require some lize the oxide layer. Thus the optimal
a biofilm can differ significantly from fine-tuning of the conditions and dif- pH in respect of corrosion control is
the conditions elsewhere in the sys- ferent elements in the system. usually 9–10.
Water treatment is also used to gain Can plastic pipes are not usually a long-term solution in
low hardness and low conductivity. be a corrosion risk? MIC mitigation. A much more sustain-
Chloride and sulfate ions are examples able way is to control the habitat con-
of strongly corrosive elements, but In the future, high-density polyethyl- ditions of microbes.
some salts that affect conductivity can ene (HDPE) plastic pipes may be used
also be corrosion inhibitors. A tempera- in district cooling systems. HDPE pipes
ture rise is known to accelerate the cor- have many advantages compared to
rosion rate as it usually does for chemi- steel pipes: They are light and flexible
cal reaction rates. and therefore easy to install. They are
However, the final effect is a sum also not vulnerable to corrosion nor do
of several factors. As the temperature they erode easily. Moreover, the heat
rises the diffusion rate of oxygen in- conductivity of HDPE is much lower About the Author
creases, oxygen solubility decreases, than that of steel, which reduces the
pH falls, conductivity is enhanced and need for insulation.
the properties of corrosion products The problem with HDPE pipes in
can change. water systems is that plastic allows
The temperature also affects the some oxygen diffusion, which may
growth rate of microbes. In district lead to corrosion of steel parts. The lev-
cooling systems temperatures are rel- el of oxygen diffusion is dependent on
atively cool and the differences are not the material density, the wall thickness,
that large: the temperature is usually the size of the exposed area, tempera- Anita Vuorenmaa
about 8 °C in supply pipes and about ture, and whether the pipes are buried M.Sc. (Biology and Environmental
16 °C in return pipes. in soil or placed in tunnels or cellars. Sciences), B.Eng. (Energy Technology)
Other factors in the system that af- Studies indicate, however, that there Anita Vuorenmaa has worked at Elo-
fect the corrosion rate are e.g. the flow is only minor oxygen diffusion through matic since 2013. Her expertise covers
rate, materials and compounds that act HDPE pipes in district cooling systems. a wide range of biological, chemical
as nutrients for microbes, and different Oxygen leaks through pipe accessories and environmental issues, as well as
metals that can cause galvanic corro- during network operations in fact pose energy technology. In addition to bio-
sion. Loose particles such as magnetite a much larger corrosion risk. Oxygen energy she has previously worked in
deposits can induce corrosion through diffusion should not be a problem with ecotoxicological and microbiological
erosion and also by sedimentation – as HDPE pipes as long as there is sufficient research. At Elomatic her focus has,
particles deposit on the pipe surface steel in the network. among others, been corrosion cont-
they can form pockets that function as It is clear that corrosion control in rol and cleantech solutions such as
a suitable microenvironment for corro- district cooling systems requires careful ballast water treatment technologies.
sion to develop or microbes to grow. In water quality management, prevention anita.vuorenmaa@elomatic.com
addition, differences in altitudes in the of oxygen leaks, particle and sediment
network can affect the distribution of removal, and appropriate installation
gases, including oxygen. work to avoid contamination. Biocides
The new welding symbol standard
– something new, something old
Text: Anna-Mari Hämäläinen
Many years have passed since the welding symbol are the tail, as well as The Pacific Rim (AWS) system (system B
SFS-EN 22553 welding symbolic elementary and supplementary sym- in the standard) is based on a single ref-
representation was approved in bols. One of the most noteworthy ad- erence line where the arrow side is al-
ditions in the new standard is that it ways on the underside of the reference
1994. It has now come to its end
identifies welding symbols that are line, as shown in Figure 1.
of its shelf life and a new symbol used in most Pacific Rim countries. When using welding symbols these
standard has been introduced. A compromise solution between two systems should not to be used
Approved in 2014, the new welding the European system and Pacific Rim alongside each other and there should
symbol standard has brought new system could not be found in the new be a clear indication as to which sys-
symbols and methods of indicating standard and as such it includes two tem is in use. All the new welding sym-
different symbolic presentations. This bols are not available in the symbol
welds in more detail. means that there are two different sys- libraries of all 3D-modeling software
tems to designate the arrow side and programs. Most of the new elemen-
not start and stop at the same point ure 7). The symbol contains only the should be checked individually, not
can be marked with this new point- weld quality and the required pene- only for weld markings, but also for the
to-point symbol. The weld can con- trating depth, which means that the welding order and accessibility.
tinue around the corner and cover manufacturer can decide what prepa- The new standard has brought
more than one joint. The start and end ration to use to gain the desired qual- many useful improvements and ad-
points have to be clearly indicated in ity and dimensions. This symbol is very ditions to weld indications. The new
the drawing. new and it should not be assumed that elementary symbols are an especial-
everyone is familiar with it. It is recom- ly welcome addition. As manufactur-
mended that designers ensure that the ing continues becoming increasingly
Beneath the surface manufacturer knows the meaning of international the need for an interna-
the symbol. tional symbol standard has likewise
As with weld lengths butt welds are full grown. The new standard will ensure
penetrating unless otherwise dimen- that there are no longer diverging in-
sioned or if other information, such as Small circle, terpretations and misunderstandings
WPS, is referred to. The designer dimen- big meaning between designers and manufacturers.
sions the required minimum penetra-
tion after strength calculation without A supplementary symbol that has had
assuming that the penetration will ex- many interpretations over the years is
ceed the minimum measure. Manu- the all-around symbol. It is intended for
facturers can then produce joint weld- use in cases where the weld starts and
ing in the most practical way to attain ends at the same point and during the
the minimum demand for weld quality weld the dimensions and joint type do
About the author
and sizing. not change (see Figure 8). This doesn’t
The new standard contains guide- include circumferences of circular sec-
lines for the marking of dimensions for tions, holes or slots as they naturally
joint preparations, but implementa- start and end at the same point. In oth-
tion requires knowledge of the man- er words, all-around symbols can be
ufacturer and its WPS-documents. In used with profiles that have corners
cases where the preparations are di- that need to be welded all around.
mensioned it cannot be assumed that Sometimes the all-around symbol is
another manufacturer would have the used incorrectly. One of the most com- Anna-Mari Hämäläinen
same dimensions in their WPS-docu- mon situations is when the weld type is M.Sc. (Mechanical Engineering)
ments, and therefore the same pen- changed for a small part. The designer
etration with exactly the same prepa- might not even notice this or just feel Anna-Mari Hämäläinen has been wor-
ration. that it does not need a dedicated weld- king as a Special Designer at Eloma-
The same outcome can be achieved ing symbol. An example of this is when tic since 2012. She is specialized in
welding and has an IWS qualificati-
with different preparations. Small differ- a joint is marked with an all-around
on (International Welding Specialist).
ences in dimensioning are not crucial filled weld and some part of the joint
She has consulted on welding issu-
when manufacturers have approved is a bevelled weld. This may cause con-
es and provided welding training to
their WPS-documents with destruc- fusion regarding how bevelled welds
designers. She has also conducted
tive testing and the penetration is con- with fillet dimensions should be pro- mechanical design on a wide range
firmed. duced and how inspectors will deal of customer projects.
There is a new useful welding sym- with this.
bol that can be used if the manufac- This all-around symbol is not the anna-mari.hamalainen@elomatic.com
turers are not known when welding symbol for “weld everywhere”. When
drawings are being prepared (see Fig- planning welds every welded joint
Investing in technology
and personnel development
bears fruit
– Case Cadmatic
Investing in developing operations gy was, in fact, instrumental in gaining Cadmatic software in 55 countries and
and personnel most often has Elomatic’s first ship design contracts. since 1995 it has on average grown by
long-term positive business effects. The advent of laser scanning tech- 12,5% year on year.
nology at the end of the 1970s opened In case Cadmatic an investment in
A good example of this is a project
the door to visualising such plastic technology and personnel develop-
that was started in the early 1980s models on computers and led to ideas ment has born significant fruits. This
at Elomatic to take advantage of 3D of designing plants digitally. particular investment’s story contin-
technology to improve the design, In 1983 a project was launched to ues. One can naturally not foresee
visualization, distribution and develop a 3D plant design program how each development project will
total cost efficiency of engineering and by 1985 the first pilot project us- end, but at the very least they have a
ing the new 3D technology was com- very good chance of improving ways
projects. The spin-off from this pleted. The new technology proved working and/or creating new skills
development, Cadmatic, is today to be much more efficient than tradi- and know-how that increase com-
an independent company and 3D tional ways of working and compet- petitiveness.
design software used in marine and ing systems available on the market at
plant design projects all over the the time. As such it was decided in the
world. early 1990s not only to make use of Cadmatic and NCG combine
the software in engineering projects, business operations
but also to start marketing the soft-
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