17.2 Hanser

Felix Hanser ,Sebastian Schöning and Gareth Alford
Research Paper
User research in pharma R&D: Contextual
inquiry for the elicitation of user needs in a
chemistry laboratory for analytical method
development within a corporate continuous
manufacturing organization
Felix Hanser *, Sebastian Schöning ** and Gareth Alford ***
* Felix Hanser, SAP SE, Walldorf, Germany; formerly Fraunhofer IPA, Project Group for
Automation in Medicine and Biotechnology, Mannheim, Germany, felix.hanser@sap.com.
** Sebastian Schöning, Fraunhofer IPA, Project Group for Automation in Medicine and
Biotechnology, Mannheim, Germany, sebastian.schoening@ipa.fraunhofer.de.
*** Gareth Alford, GlaxoSmithKline, Stevenage, Great Britain, gareth.l.alford@gsk.com.
DOI: 10.17879/91129602140 ; URN: urn:nbn:de:hbz:6-91129602389
Laboratories in the pharmaceutical industry see an ongoing transition towards

continuous manufacturing by means of tighter integration of novel and existing
technologies and, thus, the introduction of new work methodologies. However,
technological studies focusing novel manufacturing methodologies usually do not
address social aspects, while social sciences studies on the other hand rarely ad-
dress scientific and industrial aspects of manufacturing processes and therein in-
volved personnel. Hence, the scientific literature lacks systematic analyses of hu-
man and social factors in such continuous manufacturing environments. There-
fore, the study provides a literature review of social research of scientific laborato-
ries and lab work. Then, ethnographic field research is conducted in a laboratory
for continuous manufacturing. One by one a team of six lab workers are observed
and interviewed during a typical day shift (N=6). All sessions are recorded on video
(4h 47mins) and transcribed to enable a qualitative content analysis. The overall
work environment of a research and development chemistry laboratory of a big
multinational pharma company is described including the general laboratory
workflow. Finally, a list of 96 user needs as well as user role descriptions of the par-
ticipating lab workers are generated. One key finding of the study is that the work
culture in this lab follows a mode of constant debate trying to contain knowledge
transfer in teams top-down as well as bottom-up, e.g. during experimenting with
hardware setups trying not to compromise the chemical recipe following a re-
search hypothesis. In this regard, digitization efforts like introducing electronic lab
notebooks should prioritize to promote and support communication and collabo-
ration over features and technological enhancements. Specifically, learning can be
considered a shared responsibility to promote a common work process knowledge
that is needed to successfully act and react in the context of continuously chang-
ing experiment setups and team compilations. Based on these results, the authors
highlight the importance of holistic upfront user research to uncover underlying
human and social factors as determinants for the success of socio-technical sys-
tems. All in all, with this study the authors provide a data set, which may serve as a
foundation for future research and development projects in similar, industrial re-
search working conditions, following a human-centered design approach.
Journal of Business Chemistry 2020 (2) 151 © Journal of Business Chemistry

User research in pharma R&D: Contextual inquiry for the elicitation of user
needs in a chemistry laboratory for analytical method development within
a corporate continuous manufacturing organization
1 Introduction 1.1 Background: Working in pharma

R&D
Social research addressing the pharmaceuti-
cal industry or the life sciences is usually The pharmaceutical industry includes the
focused on high-level critical debates about manufacture, extraction, processing, purificati-
political regulation, consumption and consu- on, and packaging of chemical materials to be
merism, customer expectations and broader used as medications for humans or animals
innovations (Williams et al., 2008), while social (World Bank Group, 1998; Konstantinos et al.,
studies that address scientific and industrial 2011). Following Konstantinos and colleagues
aspects of manufacturing processes and the (2011), pharmaceutical manufacturing can be
therein involved people are rare. This assertion separated into two main phases: (a) the pro-
is true for processes in corporate research-and- duction of the active ingredient or drug
development (R&D) in industrial research (primary processing, or manufacture) and (b)
(Darrouzet et al., 2009; Jordan and Lambert, the secondary processing, the conversion of the
2009) and it is especially true for R&D in the active drugs into products suitable for admi-
pharmaceutical industry and the life sciences nistration.
industry. Typically, such R&D organizations are According to the European Federation of
focused on the creation of intellectual property Pharmaceutical Industries (EFPIA), turning a
(IP) as the output of all activities. Some phar- newly synthesized active substance into a mar-
maceutical researchers argue that this strict ketable medicinal product takes an average of
focus is the root of the “culture of secrecy” and 12-13 years. However, only three in ten of these
a cause for the massive duplication of effort. products will produce revenues that more than
Further, these researchers argue for the adopti- cover their research and development costs
on of open science approaches allowing orga- (EFIPIA 2010; Konstantinos et al., 2011). In additi-
nizations to experiment with new forms of col- on, the pharmaceutical manufacturing industry
laboration (Bountra et al., 2017). This is also produces therapeutic substance (human and
what makes this study unique, because social veterinary medicines, drugs, and related pro-
field research in many cases still lacks recogniti- ducts) in an increasingly concentrated set of
on of management and business stakeholders. mostly transnational company and sub-
As a result, social scientists, ethnographers and contracting facilities. The sector has five broad
user researchers in industry often find their areas of activity: (a) research and development,
efforts devalued, neglected, or not realized by (b) manufacturing, (c) sales and marketing, (d)
stakeholders (Amirebrahimi, 2015). distribution, and (e) administration
In this spirit of innovation by means of o- (Konstantinos et al., 2011).
penness and transparency this study aims to For the manufacturing of pharmaceutical
encourage a more deliberate discussion about products many facilities have multi product
laboratory processes. Specifically, these strict capability and the equipment may in some
R&D processes center around highly regulated cases be the same as are operating personnel.
laboratory workplaces, which are common Thus, in the same workplace different raw ma-
place in any pharmaceutical or life sciences or- terials are used, different processes are execut-
ganization (Osakwe, 2016). ed, and different waste streams are generated
However, there is a lack of research that (Gad, 2008; Konstantinos et al., 2011). These
offers insights into how these corporate labs facilities are considered highly maintained en-
are run, how people actually work there, what vironment wherein equipment must be
these people require to work efficiently, and cleaned, to avoid cross-contamination. This
what they might need in the future to enhance involves water, steam, detergents, as well as
their current workflows. organic solvents.
Now, this study aims to shed light on the Today, many steps are automated in these
field of corporate laboratory work by investiga- processes, with examples of employee tasks
ting the work performed in a research laborato- including: (a) weighing and dispensing solids
ry for continuous manufacturing of a big, mul- and liquids (using pumps or pouring), (b)
tinational pharma company. charging and discharging solids and liquids
from containers and process equipment, (c)
manual materials handling, (d) equipment

maintenance and repair, and (e) watching con- potential public health threat as failures within
trols and processes (Konstantinos et al., 2011). manufacturing facilities that result in poor pro-
Furthermore, as Konstantinos and collea- duct quality can lead to drug shortages
gues (2011) summarize, the employees working (Throckmorton, 2014; Myerson et al., 2015; Lee
in these environments of a manufacturing faci- et al., 2015). In this regard, the Food and Drug
lity may be exposed to all kinds of influences Administration (FDA) considers continuous ma-
like noise, heat, and humidity. Also, surfaces nufacturing the innovation that has great po-
can be hot and slippery, while some surfaces tential to improve the aforementioned level of
and floors may be covered with dust from the agility, flexibility, and robustness in the manu-
process. Moreover, employees may be exposed facturing of pharmaceuticals (Lee et al, 2015).
to hazards like moving machinery parts and In continuous manufacturing pharmaceuti-
pressurized pipes and vessels, and some work is cals are moved nonstop within the same facili-
done in confined spaces or with high-energy ty, which eliminates hold times between steps.
sources. In extreme circumstances involving Substances are fed through an assembly line of
large quantities of highly charged powder par- fully integrated components, which saves time,
ticles explosive atmospheres can exist, for exa- can reduce the likelihood for human error, and
mple, solvents can burn or explode, especially lab managers can respond more easily to mar-
in organic synthesis. To cover all these work- ket changes.
related risks, general manufacturing practice However, continuous manufacturing requi-
and other quality control rules set by regulatory res a different experimental approach. The im-
agencies, customers, and pharmaceutical orga- pact of the equipment used within drug develo-
nizations cover a number of these processes pment has a large impact of the industrializati-
and the equipment used. Health and safety on approach, which requires far greater under-
laws as well as good manufacturing practices standing of the impacts of the equipment on
(GMP) guidelines apply to all of them the synthesis of substances. Specifically, certain
(Konstantinos et al., 2011). equipment does not scale, especially those used
Overall, the pharmaceutical industry relies in early screening, such as microfluidics. There-
on highly-regulated work processes on the one fore, a complete understanding of the charac-
hand, while it relies on constant discovery of teristics of the equipment is needed to ensure
new recipes for drugs in R&D that may have that the processes are well understood to reali-
great impact on the health of consumers on the ze commercial requirements. Done right, the
other hand. The main goal of the laboratory is coupling of mechanistic process understanding
to gain a fundamental understanding of chemi- along with equipment models allows the deve-
cal synthesis through workflows of mechanistic lopment process to move rapidly from different
and statistical analysis, ultimately leading to scales of operation, without the need for exten-
increased knowledge of not just one process, ded development operations. To ensure that
but of common schemes. the required process data is captured to sup-
port the mechanistic model generation, stan-
1.2 Current developments: From batch dard platforms are needed to provide consis-
to continuous manufacturing tent data. These platforms have a high level of
automated control, data capture and data pro-
For several decades, pharmaceuticals have cessing. In this regard, debates about standards
been produced using a method known as of workflows, process models and data hand-
‘batch manufacturing’, a multi-step, lengthy ling are still ongoing, e.g. in international con-
process that involves the use of ungainly, large- sortiums like the Allotrope Foundation (see Fi-
scale equipment (see Figure 1). Recently, advan- gure 2). While continuous manufacturing is a
ces in manufacturing technology have encoura- general methodology, the investigation of a
ged the pharmaceutical industry to move from laboratory for so-called ‘analytical method de-
this traditional way of manufacturing to a fas- velopment’ following this methodology builds
ter, more efficient process known as the center of this study. Therefore, this study
‘continuous manufacturing’ (FDA, 2004; Lee et aims to investigate the people and their work in
al., 2015). Some authors even argue that the pharmaceutical research and development la-
lack of agility, flexibility, and robustness in the boratories for continuous manufacturing.
pharmaceutical manufacturing sector poses a

Figure 1 A conceptual fully integrated continuous manufacturing process versus a typical batch
manufacturing process for tablets (source: Lee et al., 2015).
1.3 Literature review Academic Social Sciences Literature about Lab

Work
In order to research people working in phar- The academic social science studies of scien-
maceutical research and development labora- tific laboratories go back to the 1970s and is
tories for continuous manufacturing a litera- called ‘Science and Technology Studies’ (STS).
ture review is conducted. Its goal is to review Typically, the main aim of laboratory studies in
current literature that studies cultural, social STS addresses broader concerns of epistemolo-
and psychological factors in laboratory work. gy of science and technology demonstrating
The review applies the following two major the local accomplishment and social construc-
literature categories: Academic Social Sciences tion of scientific knowledge (Harrington, 2013;
literature originating in anthropology, sociolo- Sormani, 2014; Stephens and Lewis, 2017;
gy, and general psychology; and Applied Sci- Friberg, 2017). The research perspective in these
ences Literature originating in (a) education studies is committed to the interactionist tradi-
and instructional psychology, (b) human fac- tion of ethnographic work that focuses on the
tors, and (c) user experience design. interactive practice and detailed observation of
how scientific work is accomplished through
social interaction (Atkinson et al., 2008; Atkin-
son, 2015; Stephens and Lewis, 2017). Other ap-
proaches to laboratory studies are rooted in

Figure 2 General Workflow Process in Analytical Chemistry (source: Allotrope Foundation, 2018).
sociology which treated scientific practice as a reflect the state and status of bioscientific inno-
strange and alien culture (Latour and Woolgar, vation (Thrift, 2006). Other researchers argue
1986). This is in contrast to other research focu- for shifting focus of STS studies towards the
sing on understanding the scientific work from private sector (Penders et al., 2009).
the individual perspective of the scientists
(Knorr, 1977). But all authors utilized the detai- Applied Sciences Literature
led ethnographic observation of day-to-day The body of research coming from applied
work to document how normal scientific know- sciences, industries, and corporations aims to
ledge is accomplished (Knorr, 1977; Latour and investigate and optimize the work experience
Woolgar, 1986; Lynch, 1985; Traweek, 1988). So- for employees (e.g., training and ergonomics),
mehow connected to this research are orga- workflows, technical processes, management,
nizational studies investigating the every-day and businesses.
life, skills, knowledge, identities, and attitudes
of technicians as a general working type Education and Instructional Psychology
(Barley, 1996; Barley et al., 2016). One branch of research coming from the
Another body of laboratory ethnography disciplines of education and instructional psy-
specifically investigates scientific laboratories chology discusses current challenges like lifel-
as spatial arrangements and work environ- ong learning on the job or mental stress in
ments for the social construction of knowledge. knowledge work (Boreham and Morgan, 2004;
This research also borrows from social research Fischer, 2005; Grundgeiger et al., 2017; Bahl and
of architecture design (Gieryn, 2002). Here, the Dietzen, 2019). Here, some research is focused
laboratories are treated as special work spaces on learning at work in general (Maclean et al.,
focusing on rhythms of day-to-day work, move- 2009; Fischer et al., 2004) as well as learning
ments, materials, transitions, boundaries, and and teaching in specific domains of work
barriers as labs come in different shapes and (Boreham et al., 2002; Fischer, 2005). Some stu-
sizes. Some are large and spacious, others small dies include learning in laboratory work en-
and confined, some are busy and heavily popu- vironments with respect to the generation and
lated, others quiet and conspicuous by the ab- appropriation of ‘work process knowledge’ of
sence of workers (Stephens and Lewis, 2017). chemical laboratory assistants in particular
Many labs are gated communities, others are (Talanquer, 2006; Fischer and Röben, 2002a;
linked closely to hospitals and clinics. Some are Fischer and Röben, 1997; Storz et al., 1997;
distant from highly populated regions e.g., the Kruse, 1986). Following Boreham (2002) the
UK Stem Cell Bank (Stephens et al., 2008), and concept of ‘work process knowledge’ goes back
some are transient spaces that pop-up as to Kruse (1986) who originally defined the term
“portable packages” (Lewis et al., 2014; Ste- as ‘labour process knowledge’, meaning:
phens and Lewis, 2017). In this regard, some
authors argue for a radical redesign of scientific
space speculating that new life science buil-
dings following these redesigns are designed
not only to intentionally produce intense social
action between scientists but are also built to

 an expanded understanding of work roles They always say that they need a research cent-
in parts of the organization other than the re that is three times bigger. But when the R&D
employee’s own; starts, we find that the eighty percent of the
new ideas originate from everyday activities on
 an awareness of the interdependency of the the basis of local insights. (Excerpt from an in-
activities in different departments, including terview with the person responsible for Plan-
characteristics of the system as a whole, ning and Control)” (Mariani, 2002)
such as the flow of work through the orga-
nization, both upstream and downstream of The employees of the chemical company
the worker’s own station; and argue for flexibility of workflows within a strict
ruleset of controls for scientific discovery and
 participation in a workplace culture which safety regulations. Therefore, Mariani (2002)
provides a service to colleagues in support concludes that successful R&D depends critical-
of a high quality of service to the actual ly on two preconditions: The capacity to per-
customer. form a large number of experiments and the
capacity to rapidly modify or adjust production
The concept of work process knowledge was programs so that, whenever a line of research
developed to define the knowledge that work- produces promising results, processes in the
ers, whether hotel employees, machinists or plant focus on producing the chemical in ques-
laboratory assistants, need in order to cope tion. Interestingly, the call for flexibility and
with more organic and knowledge-creating increased rate of experimentation over regula-
working environments. Developing work pro- tions to foster scientific discovery is also de-
cess knowledge helped them to adjust to more monstrated by changes in attitudes towards
flexible processes (Boreham and Fischer, 2009; confidentiality. During the evolution of this
Fischer and Boreham, 2004). chemical company’s laboratory work culture
However, only a few studies investigate the employee’s focus shifted from covering all
learning processes inside scientific laboratories site installations with opaque steel shielding to
of companies (Torz and Eichhorn, 2001; Röben get rid of everything that slows down the who-
et al., 1998). Mariani (2002) as an exception le process, including expenditure for hiding
conducts an in-depth investigation of the R&D their work. Employees summarized this shift in
practices of a major Italian chemical company philosophy by stating that if they are first, it
that has been in existence for 40 years and would not matter who might copy them. Regar-
employs about 1000 people. The study is ding the organization of the company’s lab
focused on investigating the claimed competi- work both the pilot plants and the laboratories
tive advantage of this company by looking into started to operate on a 24-hour cycle in order to
team work and the respective work process maximize the rate of experimentation. Also, on
knowledge of individual team members, while the basis of a very small increase in personnel,
including organizational factors of short-term activity in the pilot plants was increased from
contracts for learning and group dynamics. In one experiment per month at the beginning of
this study the site management of the com- the 1980s to the present rate of two per week.
pany is convinced that innovation and especial- And by introducing a continuous work cycle,
ly the invention of new products are a function the output of the laboratories was increased
of the number of tests and experiments that from two or three tests per day to 20 to 25 per
are run. Research processes, in contrast to pro- day.
duction processes, have very uncertain outco- These intense boundaries for teamwork
mes and it can be very difficult to make a ratio- seem to be especially effective in the pilot
nal selection of trials. Hereby, one comment plants of the company. Work in these pilot
stands out pointing towards the special circum- plants consists mainly of running investigati-
stances and social dynamic of laboratory team- ons to discover new products and develop new
work: production technologies. As Mariani (2002) ob-
serves, this work is managed by two types of
“When the R&D project is planned, mana- teams, one performing on a technical level and
gers of the different customer areas and resear- one on an operational level. The technical
chers are asked their ‘wish list’ of activities. teams are responsible for setting up and mo-

difying the program in each pilot plant. They as very positive alone (Mariani, 2002). It re-
consist of three people with different responsi- presents a step back to the tradition of appren-
bilities: ticeship that has been undermined by industri-
al change or as one experienced lab worker
 a plant manager who takes responsibility commented during the study (Mariani, 2002):
for the overall functioning of the plant (this
role was created in the early 1970s), “It also . . . increases our professionalism. For
example, if we did not have to teach some of
 a process engineer, responsible for desig- our plant schemes to newcomers, we would
ning the test which is to be run (this role not look at those schemes for four-to-five mon-
was created in the mid 1980’s), ths. In this way, we have got to continuously
refresh our knowledge in order to be able to
 a technologist responsible for the technolo- transmit it. (Excerpt from an interview with a
gy needed to perform the test (this role was skilled worker)”
created in 1990). Its rationale is that, to ad-
just activities as a function of progressively However, the informative corporate study of
emerging findings, it is critical that the tech- Mariani (2002) does not offer concrete descrip-
nological configuration of the scaled down tions of the actual lab work (workflows) nor
chemical installations can be altered very does it offer insights into the specific needs of
rapidly. lab workers (user needs) to work in a team and
to perform respective everyday tasks. So far it
In order to investigate the lab work in teams can be noted that laboratory workers possess a
of such chemical companies it is important to specific kind of work process knowledge that is
be aware of technical constraints in contrast to quite different from academic knowledge of
the adaptability of chemical formulas. For exa- chemistry and that dynamic team work in some
mple, while the time required by the investiga- laboratories has high demands of situational
tion itself might be fixed, the time needed for adaptability. Nevertheless, their work is similar
installation set up could be shortened as a to work in any scientific lab: Variations are int-
function of team efficiency (Mariani, 2002). In roduced in existing substances by a (synthetic)
this regard, team members of this chemical chemist, which are subjected to standardized
company’s operational team rotate between tests to determine their chemical properties.
roles to secure efficient teamwork even if one Now, complementary to Mariani (2002),
team member drops out. This way the lab team Fischer and Röben (2002a) investigate the actu-
is flexible enough to react on changing circum- al work of laboratory assistants inside analytic
stances. In addition, this kind of rotation exists laboratories. Analytic laboratories are involved
for technical employees, too. Before a new in both the development of new drug sub-
employee, such as an area technologist, beco- stances eventually becoming medicines and
mes fully operational, he or she is asked to work the translation of the chemical reaction from
for a period in the operational teams as an ordi- the laboratory standard to the production stan-
nary team member. As Mariani (2002) conclu- dard. For example, such labs are responsible for
des, this eliminates the familiar problem of en- determining the structure, purity, and content
gineers and researchers who are very know- of substances produced by means of synthetic
ledgeable theoretically, but whose knowledge chemists. They develop the first procedure for
of plant structure and organization is almost ascertaining the identity, purity, and content of
nil. Within both teams, therefore, everybody screening substances. Also, these laboratories
comes to know everybody else’s job and to offer advice with regard to possible ways of
compensate each other’s lack of experience. In synthesizing substances. In addition, standard
this way, the different phases of the work pro- operating procedures for determining the iden-
cess become well known to all members of the tity, purity, and contents of the byproducts of
team, making it possible to develop a common these syntheses are elaborated and stability
language that allows a tight coupling of activi- tests, in particular, are carried out. Regarding
ties. Beyond this idea of sharing work process the work environment and workflows, the au-
knowledge to ensure efficiency, having experts thors investigate the organizational structure
to teach their work to novices can be regarded of labs. They postulate that the fundamental

principle of the organization of a chemical labo- compromised by any treatment carried out be-
ratory is the established division of labor fore the computer-controlled measurement.
between a chemist and a laboratory assistant, Thus, meeting these conditions requires work-
wherein, traditionally the latter is considered ing closely to the instructions and regulations,
the former’s helper (Fischer and Röben, 2001). which represent the context of the analysis.
Specifically, in the companies the authors The authors stress the fact that, for example,
surveyed, the employees of the laboratory work scientific procedures given for an analysis
in teams mostly made up of one chemist and might specify that a sample should be crushed
several laboratory assistants. These teams work with a pestle and mortar, dissolved in a soluti-
on one or more analytical procedures while the on and then filtered. But these procedures do
number of people working in a team depends not say anything about the method of filtering,
on the amount of work needed for the analyti- which is not a trivial issue. Therefore, it is ar-
cal methods used, and also on the complexity gued again that laboratory assistants need a
of these methods (Fischer and Röben, 2002a; kind of work process knowledge to successfully
Röben, 2002b). Furthermore, the authors interpret and follow laboratory instructions
describe the different responsibilities of scien- (Fischer and Röben, 2002a). Here, the authors
tists (e.g. chemists or pharmacists) and as- rely on two psychological constructs: Context
sistants. Work of scientists is based on their awareness and context comprehension. The
scientific knowledge about the structures, reac- authors describe work process knowledge as a
tions and properties of chemical substances construct that connects the requirements of a
(Schmauderer, 1973). Sometimes scientists are task with the company-specific conditions un-
acting as heads of a laboratory and manage der which a task is to be carried out (Boreham
teams which usually consist of two to five labo- et al., 2002). Such knowledge is acquired from
ratory employees. More often scientists are ta- the experience gained by working in a specific
king charge of research projects, which includes work environment. This is important, because it
that they discuss and collaboratively decide is often the case that for example an instruc-
what is to be measured, in what form and with tion refers to a five minutes treatment of a
which methods (Fischer and Röben, 2002a; sample, while practical experience tells that
2002b). This academic laboratory staff is occu- this treatment might require eight minutes
pied with planning and carrying out analysis as with a particular device. Another example are
well as evaluating and controlling validity of process drawings or specifications, which are
results. usually made by someone other than the as-
The work of laboratory assistants on the sistant worker who uses it. Here, the lab as-
other hand is focused on determining the quali- sistant needs to learn and understand the spe-
ty and the quantity of substances (Ciommer, cifications before he or she uses it in the work
1996; Fischer and Röben, 2002a). While a che- process. This insight then follows the argument
mical analysis in its entirety goes through the that if a laboratory assistant lacks the relevant
stages of taking samples, preparing samples, scientific understanding, it is not possible to
analysis and evaluation, the job of laboratory develop adequate work process knowledge
assistants consists mainly of the preparation of (Fischer and Röben, 2002a). Successful lab work
samples and then the process of taking measu- relies on subject matter expertise, practical ex-
rements (Mohler, 1970). Generally speaking, pertise as much as it relies on the actual work
they work in the context of the work of scien- community and the division of labor. Therefore,
tists, that is, cleaning components and the lab like Mariani (2002) the authors conclude that it
environment, maintenance, calibration, quality seems to be very important that lab assistants
control, buying equipment, taking samples, or are able to make mistakes within the rule set of
providing and documenting measurements at strict organizational regulations, in order to
the end of an analysis. Of course, this assisting educate themselves in a pragmatic learning-by-
work is critical to the quality of the measure- doing manner within a scientific laboratory
ment, which is – in most cases – done automa- environment to progressively combine their
tically by computer-controlled instruments practical knowledge with the feedback and sci-
(Fischer and Röben, 2002a). But this does not entific knowledge of their colleagues (Fischer
relieve the lab assistant’s work, because the and Röben, 2002a).
representativeness of samples must not be

Human Factors Literature knowledge from work on medical devices, mili-

In contrast to this body of applied research tary systems, and aviation safety systems (e.g.
about scientific laboratories focusing on educa- Endsley and Robertson, 1996) to the lab work
tion, training and instructional psychology, the- (Konstantinos et al., 2011).
re is another prominent field of applied rese- Nevertheless, it is argued that HFE research
arch focusing on optimizing work processes. could provide sustainable mechanisms to sup-
The Human Factors and Ergonomics (HFE) stu- port innovation at a ‘‘grassroots-level’’; i.e.,
dies conducted on scientific research laboratori- from ‘‘bottom-up” (Kant and Burns, 2016).
es as a work domain are minimal (Jones, 2005; Another limiting aspect of these initial HFE stu-
Jones and Nemeth, 2004). This is probably be- dies is the fact that they typically aim to study
cause historically HFE as a discipline has em- laboratory processes exclusively addressing
phasized naturalistic studies of real-life “in the scientific laboratory work within government
wild”, in order to contextualize laboratory- research facilities or universities. Access to cor-
based experimental results (Kant and Burns, porate research facilities seems to be an issue.
2016). Besides the interdisciplinary nature of However, in this regard the study of Konstanti-
HFE that as a discipline proposes a holistic view nos et al. (2011) can be highlighted as a re-
regarding product strategy, field research, re- sourceful source of insights. The study is
quirements engineering, and usability enginee- focused on Human Factors, that is, any factor
ring (Privitera, 2019), another general theme in that affects human performance and increases
HFE research is the strong focus on human er- the probability of errors in the workplace. Theo-
ror (see Figure 3; e.g. false identification of a retically, the authors base their work on a mo-
component) in contrast to equipment error (e.g. del created to represent the human factors in
insufficient sample or a broken container), and aviation maintenance. This model was named
safety issues (e.g. individual attitude damage or Safety Training for the Aircraft Maintenance
hygiene regulations). This is also true for HFE Industry. The study of Konstantinos and collea-
studies about laboratory work environments gues (2011) contains a literature review of legis-
(Ala and Bagot, 1994; Bonini et al., 2002; Ho- lation surrounding the manufacturing process
ckey, 2005; Ross, 2008; Haile and Hussen, 2012; of pharmaceuticals (Good Manufacturing Prac-
Kuselman et al., 2013; Perry, 2018). Here, HFE tice, GMP; Occupational Safety and Health,
researchers try to transfer their experience and OSH), so as to reveal if human factors were in-
Figure 3 Steps in measurement process and types of human errors (source: Kuselman et al., 2013).

corporated in the various laws, directives or partments.
guidelines produced by the legislative bodies. The final results contain an overview of
Secondly, the authors conducted research at a “skills/competencies required” in the daily work
large commercial biopharmaceutical manufac- of the study participants, which represent
turing facility and a small pharmaceutical ma- “factors that can lead to errors/events in BPM”
nufacturer. from the authors Human Factors perspective.
Overall, the results of their literature review For example:
show that the compliance with the legislation
regarding the GMP regulations are the main (a) Task-related skills include “Preserving at-
requirement for pharmaceutical production. tention to detail”, “set up and clean processes”,
This does not directly emphasize the human “responding to time/operational/production
factors aspect. On the other hand, the authors pressures”;
conclude that the researched OSH legislation (b) Individual-related skills include “Physical,
gives more attention to human factors, alt- cognitive capabilities and limitations on job
hough indirectly, and could be used as performance (dealing with fatigue, interrupti-
guidance towards effective organizational plan- ons, distractions, complacency, etc.)”,
ning that incorporates more of these aspects. “identifying the preconditions/precursors for
Here, the authors conclude that if an orga- errors”, “Patience: resistance to rushing; main-
nization uses both GMP and OSH legislation to taining vigilance”, “Professionalism: sense of
their full effect, it will provide the foundations ownership in task/process/product-outcome”;
for a safe, dynamic working environment that (c) Team-related skills include “Teamwork
has as the production of safe pharmaceutical (benefits, challenges)”, “Danger of diffusion of
products of high quality as main priority, but responsibility”, “Communication (effective, fre-
also respects the individual needs and abilities quent, different types of, as a function of level,
of the worker. Thus, the likelihood for errors of time of day, limitations of)”, “Hand-over/
produced from human factors will be reduced shift changes: ensuring situation awareness/
and their effect on manufacturing minimized. common operational picture quality support
Furthermore, the authors mention the future needed on shifts, transfer of responsibility,
trends in pharmaceutical manufacturing and in planning activities near hand-over”;
industry as a whole, that reinforce the need of a (d) Organization-related skills including
stronger utilization of human factors aspects, “Management of unscheduled-tasks”,
as many issues of concern can be avoided or “Monitoring (without losing focus)”, “Cross trai-
their effect minimized (Konstantinos et al., ning (advantages, disadvantages)”,
2011). “Introduction of new technologies/equipment”,
In addition to the literature review, the au- or “Time-Management” for example
thors conducted observations in the field (what (Konstantinos et al., 2011).
they call “walk-arounds”) to identify cognitive In addition, the survey results contain sever-
demands, physical demands, verbal communi- al issues regarding risks for human error. Spe-
cation requirements, non-verbal communicati- cifically, as far as task factors are concerned, the
on requirements (e.g. paperwork), interaction primary human factors-related issues that
with automation and equipment, potential hu- employees generally agree are potentially error
man errors, potential machine errors, potential -inducing and threaten safety: (a) Time Pres-
human-machine interaction error, and general sure, (b) Distractions, and (c) Interruptions.
workload issues. Also, they conducted informal Furthermore, “Unclear procedures” was re-
one hour interviews to investigate responsibili- ported as an issue that appeared to specifically
ties, priorities, rules, staff, working hours, concern employees, perhaps due to a large ran-
sources of pressures and constraints, and work- ge of activities which require detailed proce-
arounds. In addition, the authors conducted a dures. Konstantinos and colleagues (2011) see a
survey to gather perceptions, opinions and trend for employees to believe that the human
further comments regarding factors that in- factors issues ranking high on the list of con-
fluence human performance and endanger cerns are also those for which employees are
worker safety, reliability, and pose a risk to the not well-equipped or trained to effectively
product. The survey was made available at lar- address them. Regarding individual factors, the
ge scale to employees at all levels and all de- respectively same issues seemed to concern

employees: “Stress,” “Fatigue,” and “Personal 2008), the quite younger discipline of User Ex-
problems”. The authors mention that some perience Research goes back to the human-
employees reported that they had some type of centered design methodologies co-developed
training on how to handle fatigue, while all by psychological researchers and design practi-
respondents appear to believe that “Stress” is tioners within the fields of Human-Computer
an issue for which they require more assistance Interaction (Stuart et al., 1983; Norman, 1988;
in dealing with. In addition, survey participants Preece et al., 2007; Grudin, 2017) and Product
from the larger facility placed emphasis on the Design (Holtzblatt and Beyer, 2017) hereby the
issues of “Lack of motivation” and “Personal authors include the fields of industrial design,
problems” (Konstantinos et al., 2011). On the media design, user interface design, graphics
other hand, both team and organizational fac- design, and visual design). Although there are a
tors appeared to generate more consensus re- lot of studies of industrial environments and
garding their potential to induce errors. Half of systems (Lee et al., 2017; Jakl et al., 2018; Aro-
the listed team and organizational issues gene- maa et al., 2018; Karim and Tretten, 2014; Terzic
rated agreement that they are potentially error- et al., 2009) and some exclusively focus on user
inducing, compared to only a third of the listed research to explore user needs (Palviainen and
task-related issues and individual issues. Leskinen, 2006; Sørensen et al., 2008), techno-
Within team factors, specifically, the issue that logy adoption (Singh, 2019) or evaluation of
appeared to concern all participants the most user acceptance (Gavish et al., 2015), there
were unclear roles and responsibilities. Another seems to be not one study regarding the user
issue the study showed was a general unwil- needs within scientific laboratory work environ-
lingness to ask for help from colleagues. All in ments.
all, the top-issue from all target groups and
facilities indicated not having been trained on Conclusion and Research Question
how to deal with this lack of communication Social research addressing the pharmaceuti-
among team members. Lastly, within Organiza- cal industry or the life sciences is usually
tional factors, respondents from different facili- focused on high-level critical debates about
ties responded differently about issues that political regulation, consumption and consu-
may lead to errors. At the smaller facility res- merism, customer expectations and broader
pondents selected: (a) Lack of effective respon- innovations (Williams et al., 2008), while social
se from Supervisors and Management regar- studies that address scientific and industrial
ding reported safety issues, while respondents aspects of manufacturing processes and the
from the larger facility selected, (b) Insufficient therein involved people are rare. This assertion
workforce, (c) Inadequate tools and equipment, is true for processes in corporate R&D in indust-
(d) Poor documentation as issues which may rial manufacturing (Darrouzet et al., 2009; Jor-
lead to error. In terms of knowing how to hand- dan and Lambert, 2009) and it is especially true
le issues, the interesting finding has to do with for R&D in the pharmaceutical industry and the
the larger facility response, which highlights life sciences industry.
the need for training regarding a clear lea- Currently, social research of laboratory work
dership structure (Konstantinos et al., 2011). All lacks systematization from an interdisciplinary
in all, the study from Konstantinos and collea- point of view. Studies aiming for an academic
gues (2011) follows the tradition of HFE research audience of social scientists have a diverse and
focusing on the specification of human errors broad set of topics and are very specific in their
in specific situations, while concrete workflows theoretical perspective, e.g. investigating the
and observations are not described in detail. spatial arrangements of laboratories. The Ap-
plied Sciences literature on the contrary seems
User-Experience Design Literature to have a limited set of topics that share gene-
Following, the literature coming from User ral themes of process optimization and effi-
Experience Research is discussed (UXR; formerly ciency, e.g. focusing on identifying the potenti-
called User Research or Usability Engineering). al for human error in general laboratory work-
UXR is another field of disciplines that is in rela- flows. Another aspect is the clear lack of studies
tionship with Human Factors and Ergonomics. on lab work coming from the human-centered
But, while HFE is rooted in occupational and design community, although comparable stu-
engineering psychology (Badke-Schaub et al., dies investigating work inside of other indust-

ries seem promising, especially in view of hedo- ses, workflows, habits, and people’s attitudes in
nic qualities of actual working experience (see: place.
User Experience Design). However, many stu- Therefore, methodologies like requirements
dies of human-centered design are performed engineering, ethnography, as well as user rese-
privately as part of contract work and may not arch and user needs analysis as the rather tech-
be published respectively. nology-oriented social research methodologies,
In sum, the current literature either explores aim to describe and clarify these as-is situations
fundamental themes like the social construc- to derive meaning and offer insights for opti-
tion of scientific knowledge or identifies and mization and management. The explorative
discusses specific human factors in an explana- nature of the qualitative research methodology
tory way trying to understand cause and effect offers opportunities to explore contextual de-
of errors and respective risks in manufacturing. pendencies, both for individuals and in groups,
While individual studies are exploring proces- and to question assumptions that are taken for
ses of learning and knowledge sharing of teams granted (Bednar and Welch, 2014). This study
working in laboratories, they do not explicitly follows a qualitative user research methodolo-
describe the actual workflows, tasks, responsi- gy to explore workflows and derive user needs
bilities, expectations and respective needs of of people working in a research lab. While user
people. requirements refer to potential system quali-
In addition, there seems to be a general sel- ties that need to be met for some kind of user
ection bias in the actual access to laboratory satisfaction, User needs refer both to the diffe-
facilities that limits the scope of investigation, rence between users’ goals and the present
e.g. while the study of work in public labs of condition, which is manifested by user prob-
universities seems to be convenient, only a few lems and possibilities, and the context of use,
publications address the work in corporate la- which includes the characteristics of the inten-
boratories. ded use reflecting a users’ present tasks and
Therefore, the current literature not only environment (Lindgaard et al. 2006; Kujala et
lacks descriptive, exploratory research on peop- al., 2001). User needs also imply that resear-
le working in pharmaceutical research and de- chers focus on the underlying needs of partici-
velopment laboratories in general, but also pants and try to infer these broader needs on
lacks research on people working in corporate the basis of what participants are saying during
continuous manufacturing laboratories. Con- interviews. Thereby, the researcher deliberately
cluding, the authors aim to close this gap by separates the interviewee’s wishes (sometimes
addressing the following research question in called “user wants”; Yi, 2018; Hartson and Pyla,
this research article: 2019).
RQ: How do people work in corporate phar- In order to build an understanding of how
maceutical research and development labora- work in a modern pharma R&D laboratory is
tories for continuous manufacturing, what are conducted and what the individuals working in
their respective needs, and how can these this environment actually need to perform
needs be met? tasks and reach their goals, participating obser-
vations with live interviews are conducted.
2 Methodology This applied research method is also known
as Contextual Inquiry, which originates in eth-
nographic research traditions coming from
2.1 Contextual inquiry and content anthropology (Plowman, 2003; Stanton et al.,
analysis 2013; Ladner, 2014). In addition, a master-
apprentice approach is applied in which the
The nature of organizations as emergent researcher takes on the role of an apprentice
open systems, subsisting through on-going treating the interviewee as an expert in the
interactions of the individuals who act within current situation and tasks at hand (Downey et
them, means that it is necessary to ‘view them al., 2015). From a practitioner’s point of view,
as human activity systems’ (Checkland and such a Contextual Inquiry can be considered an
Poulter, 2006). In this regard, people often fail extremely well-prepared customer visit, site
to manage organizational change and innovati- visit, or field visit (Goodman et al., 2012) to ga-
on, because they are not able to articulate and ther insights of users within the context of use.
describe the current as-is situation of proces-

The core of contextual inquiry is to conduct study not only people in a special research faci-
focused observation and having a conversation lity for continuous manufacturing, but people
while a user is performing a task of interest. working within a big pharma company. There-
This includes gathering artifacts, taking field fore, recruiting lab managers for this study is a
notes, while at the same time conversing with challenge. While the recruitment process in-
the user in an informal manner. This requires cluded lab managers from several of the wor-
the researcher to be adequately prepared, tra- ld’s biggest pharmaceutical companies, only
vel to the workplace, follow the appropriate one company was interested to cooperate for
requirements for access, gain approvals for re- the study investigating human factors for con-
cording, and bring along all the necessary tinuous manufacturing. In addition, the scope
equipment. Having a plan to collect reliable of the cooperation for this study was limited to
data is necessary, especially in pharma labora- conduct research in one laboratory. Also, the
tories, where schedules are quite busy and at access to the laboratory was limited to one day,
times uninterruptible (Privitera, 2015; Werner which corresponds to participating in one day
and Kirsten, 2003). Analysis of contextual inqui- shift of lab work in this laboratory.
ries explore users’ experiences, aspirations, sen- All in all, five in-depth participating inter-
se-making processes, and surface their tacit views are conducted in situ during one day shift
understandings of contextual dependencies in and one 70 minutes expert interview with the
the context of their ‘problem space’ (Bednar respective lab manager to cover the bigger pic-
and Welch, 2014; Privitera, 2015). ture of the current organizational setup of the
In the following sections the results of a lab and its possible future direction. In detail,
contextual inquiry in a selected R&D chemistry the set of participants contains a team leader
laboratory focused on continuous manufac- for a group of technicians (called ‘Operations
turing are presented. Thereby, the authors aim Team Lead’), who reported eight months of
to describe the as-is situation and dependenci- experience in this laboratory, one Continuous
es of actual lab work including the elicitation of Processing Engineer (called ‘Engineer’) with one
user need. These insights shall build a body of year of experience in this lab, and three Conti-
knowledge to identify challenges and design nuous Processing Technicians (called
implications for chemistry laboratory work- ‘Technicians’) with many years of experience.
places. Laboratory staff is interviewed during
their daily work in the chemistry lab with a 3 Findings
focus on workflows and used tools. Additional-
ly, videos are recorded to optimize the work- Regarding the question, how people work -
flow analysis process, resulting in four hours and what they need to do so - in corporate
and 47 minutes (287 mins) of video documenta- pharmaceutical research and development la-
tion. On this data basis, transcripts of the inter- boratories for continuous manufacturing, the
views are created containing key images of the findings from the qualitative content analysis
video recordings to set up an ‘authentic’ set of are summarized and presented in four steps.
qualitative data (Ladner, 2014). Then an in- First, the laboratory setup is explained. Second,
detail content analysis is conducted, which is general observations are summarized descri-
an extensive, transparent, stepwise interpreta- bing the organizational setup. Third, the obser-
tion process applied to the qualitative data ga- ved workflow for analytical method develop-
thered (Mayring 2000). Here, a researcher sorts ment is described. Fourth, responsibilities, nee-
the text snippets of transcripts into groups and ded information, and needed intercommunion
assigns codes, e.g. values, roles, goals, tasks, and advocacy regarding the job roles of study
mental model, behaviors, pain points, or mista- participants are summarized. Finally, a summa-
kes (Goodman et al., 2012). ry of initially 96 elicited user needs (see appen-
dix) is presented in four overarching categories
2.2 Sample of people’s needs during lab work.
As the literature review illustrates, gaining

access to corporate research facilities for
conducting social research cannot be taken for
granted. In addition, the goal of this study is to

3.1 Laboratory setup the laboratory next door. This area is connected
to the overall office space of the building.
In order to understand the activities invol- The section B represents the actual research
ved in working in a laboratory focusing on con- laboratory where chemical experiments are set
tinuous manufacturing, the first step requires up in big sterile work benches to test chemical
highlighting the layout of the equipment besi- recipes in different scale, ranging from very
des the processes of teamwork and communi- small, microscopic experiment setups in the
cation, hardware and automation setup, and beginning to medium sized setups occupying
maintenance, as well as testing and data analy- the complete space of a big sterile work bench
sis. In the following section a rough scheme of in the end of a test series before a possible
the laboratory floor plan is presented, which hand over to other departments responsible to
does not include the actual setup of additional scaling the setup to big production plants. Here
sinks beside sterile work benches or safety rela- the chemistry is tested using pressure control-
ted equipment that is mandatory in such rese- lers and computer software for recording data.
arch facilities. Overall, the laboratory space can The workflows deal with chemicals as well as
be divided in three main regions A, B, and C (see specialized equipment. Some equipment and
Figure 4). chemicals are stored in a cabinet directly lo-
Section A constitutes the office space where cated inside the laboratory.
responsible scientists (chemists, pharmacists, But most of the equipment is placed in the
engineers) meet, plan, analyze data, and mana- hallway outside the laboratory, in section C, in a
ge their research projects that are conducted in manner that separates the hardware archive
while providing adequate safety. This hallway is
Figure 4 Schematic building plan of the laboratory investigated in this study (own representation).

connected to the suppliers input areas and technicians take a look at the current state of
other laboratories. Along with the above setup, the hardware setup they are assigned to. They
safety is a key concern in the laboratory. Techni- walk up to the sterile work bench they are as-
cians and scientists working in the laboratory signed to, visually inspect the experiment setup
have to undergo mandatory safety training. and read the process diagram poster that is
Everyone entering the laboratory uses glasses, attached onto the front of a sterile workbench.
gloves and laboratory coats to ensure precauti- The process diagram posters are prepared by
on during work hours. As mentioned above the- the assigned chemist. The technicians look for
re are additional sinks and eyewash stations as planned changes to the experiment setup and
well as steps outlined about what is to be done then check for additional hardware compo-
in case of an emergency. There are also nents that are needed to rearrange the setup
emergency contact numbers and a phone accordingly. Hardware components are stored
available in the laboratory. All employees invol- in a separated inventory. Technicians then coll-
ved take the utmost care during the setup as ect the needed components and iteratively
well as during the testing process. Typically, change the setup according to the process dia-
there are considerable safety risks involved in gram. During their lab work they are always in
this work. All handling of dangerous chemicals correspondence with the overall team and the
is done under the sterile work benches which assigned chemist or their lab manager to clarify
contain a ventilated fume hood. information or discuss issues like e.g. how to
document a specific abnormality or which com-
3.2 General observations ponent could be used alternatively in order to
optimize the overall experiment setup. In gene-
The overall goal of the investigated R&D ral, everyone involved is required to document
chemistry lab is the continuous design and eva- any changes they make, abnormalities as well
luation of chemical recipes for drug develop- as incidents they observe. Therefore, the lab
ment on a small scale. Validated recipes are management provide printout documentation
then scaled to a bigger development setup un- templates called “proforma” on a regular basis.
til they fit the needed outcome on the one hand These printouts cover specific sub-processes
and regulatory norms on the other hand. Usual- like cleaning a specific part of an experiment
ly, several recipes on diverse scale levels are setup and are stored in a specific cabinet inside
tested side by side in one lab environment. The the lab.
recipes are tested with specific setups under In addition, general paper lab notebooks are
controlled conditions in fume cupboards. As used for overall documentation, which are
sterile work benches have glass doors a lab covered in red color. These lab notebooks are
worker can easily have a look at the current then placed upon the work benches opposite to
hardware, which is the experiment setup for the sterile work benches.
testing a chemical recipe. The desks of the lab Besides these assets of pen and paper docu-
manager and responsible chemists are visibly mentation there are several laptops and desk-
placed in the glass office right next to the steri- top computers installed on top of every line of
le experiment laboratory. This spatial setup work benches to provide access to company
enables ad hoc discussions between the opera- internal IT systems. These IT systems include
tion teams, chemists, and lab management. for example: An Electronic Lab Notebook,
In the beginning of a shift, the team of engi- Electronic Ordering Systems, and Equipment
neers and lab technicians takes a look at the Booking Systems.
current project plan to clarify the current situa- Currently problems occur at the intersection
tion the last shift team ceased to work and in of several ongoing processes, that is, the syn-
what condition the respective experiment chronization of research design, management
setup is right now. Besides these daily check-in of employees, concrete project planning and
and check-out meetings, the operations teams resource management. This also includes the
meet with the chemists that are assigned to supply of expensive resources and equipment
their project on a regular basis. over long periods of time. Momentarily a cent-
In general, the team differentiates three ral problem in the laboratory is the finding of
overall workflow phases: (1) Inventory Manage- specific equipment. This is especially difficult
ment, (2) Setup, and (3) Risk Management. First, because equipment is shared amongst the

different teams and there can be long time design is held electronically in an electronic lab
elapses during projects, e.g. it is possible that notebook, with appropriate experimentation
there are two years between the first and se- context to allow for indexing.
cond use of a component part. Thus, the corres- Once built and tested (baseline standards)
ponding need for a systematically processed the platform will run a number of transient and
storage system and dynamic scheduling tools steady state experiments to allow for efficient
becomes stronger. data collection with minimal material utilizati-
on. Operation of the platform, although auto-
3.3 Workflow for analytical method mated, still relies on human oversight, and this
development is carried out through a number of dashboards
that support both experimental and operation
aspects.
In analytical method development people
Each experiment is monitored and data ana-
are looking to build appropriate testing plat-
lyzed as close to real time as possible - depen-
forms that are able to meet the needs of the
dent on the complexity of the model - to ensure
process as well as provide a platform for consis-
that experimental requirements are met before
tent operation and data processing. The pro-
moving to the next run. Where experimental
cess starts off with a hypothesis of the mecha-
data is not in line with the hypothesis, the ope-
nism for the chemical transformation. This re-
rator is informed as a user response is required
sults in a number of potential experimental
to move the process forward.
designs that can be used to test this. An experi-
At the end of an experimental run, the sys-
mental design is always assessed against the
tem is automatically cleaned and inline sensors
equipment capabilities. There is a library of mo-
determine the end of the cleaning cycle. During
delled equipment that is available to be used to
the cleaning cycle the equipment performance
create the test conditions needed to explore
is again baselined to determine any impacts
the mechanistic hypothesis of how a chemical
from experimental processing. Then follows
recipe might be applied technically. Here, the
cleaning and an inspection is carried out, which
equipment is matched against the proposed
is then followed by disassembly (further inspec-
experimental requirements and the operational
tions at this time), and any observations made
recipe developed. Modular automation is used
to the experimental procedure is documented.
to apply standard automation controls to the
Components are then returned to stores and
assembled platform. All aspects of the platform
the electronic equipment tracking system is
configuration are captured in the design pro-
updated. The workflow comprises the following
cess to ensure that full context information of
steps in the given order (see Figure 5):
the experimental design is documented.
These details include all factors that could
impact the repeatability of the experimentati-
on, which in flow includes all aspects of the
wetted flow path, such as interconnecting pipe-
work geometry, ambient conditions, equipment
baseline characteristics. All the experimental
Figure 5 Workflow for analytical method development in the investigated pharma laboratory
(own representation).

(1) Design Experiment: Initially, experiments are motely in respective data silos (databases).
being designed by scientists based on previous- Operation of experiments is conducted accord-
ly conducted experiments or prior knowledge. ing to a manual called Process Guide.
The outcome of this step are recipes and instru- (7) Collect Data: Experiments that have been
mentations, which are filed in some repository run successfully for the desired amount of time
supporting versioning. The design phase inclu- require the collection of data that is not auto-
des an intensive negotiation between scientific matically transmitted to back-end data storage.
and technical staff that aims to obtain an im- (8) Finish Operation: Technicians shut down
plementable experiment design. Specifically, a experiment operation.
joined risk analysis is conducted and documen- (9) Clean Components: After experimentation,
ted, which is not covered in the above figure. equipment must be cleaned superficially by
(2) Match and Reserve: Components Given a technicians. The cleaning state is adapted ac-
recipe and instrumentation plan, requirements cordingly.
imposed by both are matched against specific (10) Inspect: Technicians inspect components
physical components represented in a compo- after cleaning of experimental setups in order
nent inventory database. The outcome of this to check their functionality. Component's func-
step is a bill of materials accounting for specific tional statuses are updated accordingly.
components that have been reserved for expe- (11) Disassemble: Technicians disassemble the
rimentation and that need to be collected. The experimentation setup and prepare individual
reservation status of components is updated components for their return to storage.
accordingly. If matching fails, experiments (12) Return Components: Individual compo-
need to be redesigned or rescheduled. This step nents are returned to the component inventory
usually also includes collecting of components. and their usage status is updated accordingly.
Here, technicians search and collect compo-
nents from physical inventories based on the 3.4 User roles
bill of materials, which is embedded into a re-
cord containing all information relevant to the This section contains results that summari-
experiment. If component can actually be ze (a) responsibilities (see table 1), (b) needed
found, their status is updated accordingly. If information (see table 2), and (c) needed inter-
components cannot be found because they are communion and advocacy (see table 2) regar-
either not available or obviously broken, other ding the job roles of study participants. The
components have to be found in another match authors consider this kind of job role descripti-
-and-reserve components step. ons a foundation for the creation of people’s
(3) Build: Technicians assemble the experiment role profiles that may help other researchers,
based on the mod-prep record. If components designers, software developers, engineers, and
turn out to be incompatible, technicians have manufacturers to initially specify and discuss
to go back and repeat the match-and-reserve the user requirements of respective workflows,
components step. lab instruments, and lab software. Such sum-
(4) Sign-off Components: After successful build- marizing role descriptions are considered highly
up of the experiments, all utilized components important in human-centered design methodo-
are signed-off in the component inventory logy, because they offer a set of information
database and, thus, made unavailable and lo- clarifying which type of user might need what
cked for further use. The usage status of com- information in which situation. Therefore, the-
ponents is updated accordingly. se role descriptions are referred to as ‘user ro-
(5) Test Experiment: Instrumentations are re- les’, sometimes also called ‘user profiles’ or
quired to be tested prior to ordinary operation. ‘personas’.
In case this step fails, technicians have to revert
to the match-and-reserve components step in
order to remedy failures. Testing involves run-
ning a system with proxy solvents as well as
with the target agents.
(6) Operate: Successfully tested experiment
instrumentations can be operated. Data obtai-
ned during operation is stored in locally or re-

Table 1 Responsibilities of participants sorted by job role (own representation).
Technicians Operations Team Leader Process Engineer
Responsibilities Setup of experi- Keep the workflows of the lab Discuss experiment process theory and
ments; running; Organize team meetings; proof feasibility of experiments; Relate
Maintenance of Set organizational priorities / information of operating conditions
experiments set- managing demands; Keep track of (e.g. temperature), challenges with
up; and maintain documentation operation limits, to operation capacities
Maintenance of offline (lab notebooks, workflow of the system (heat and cold); Write
equipment; proformas, notes) and online specification sheets for materials;
Focus on flexibil- (intranet wiki/platform, Tracking- Check suitability of equipment (e.g.
ity for trial and Spreadsheet); Optimizing overall limits listed in manufacturer manuals);
error as continu- lab workflow (e.g. working on Keep track of current stock spares and
ous iteration automation of equipment track- ordering of new equipment; Maintain
ing with barcodes), Broadcast key and share templates for process dia-
information for experiment set- grams; Plan processes and draw pro-
ups; Relate and share shift plans, cess diagrams; Maintain process dia-
lab status overview, project status, grams at the place of respective setups;
and template status for lab man- Discuss setup solutions; Keep track of
agement; Coordinate skills of special equipment (e.g. reactors, pres-
technicians to tasks; Check for sure sensors and temperature sensors);
training demand of team mem- Maintain settings of special equipment
bers; Broadcasting important (e.g. pressure reliefs); Documentation
information (e.g. safety issues);
Broadcasting the different work
requirements and rules between
GMP and Non-GMP.
3.5 User needs elicitation Therefore, the complete list is considered

‘first-order’ content regarding user needs inter-
Another result of the conducted content pretation. ‘First-order’ user need statements
analysis is an extensive list of 96 elicited user refer to concrete tasks, goals, or concepts like
needs referring to things, information, know- “checking pressure values”. The complete list is
ledge, or communication the observed and in- broadly grouped by the mentioned job roles
terviewed participants need in their work en- (scientist, lab technician, operations team lea-
vironment to perform tasks and reach their der, engineer) and - where possible - by applica-
respective goals. The complete list can be found tion context (design, setup, communication,
in in the appendix. It contains redundancies as documentation), while the actual user need
different users share the same tools and lab statements all follow a consistent syntax con-
space and report similar things respectively. taining (a) which job role a user has (b) what a
Therefore, it represents the complex mesh of user needs (c) as well as a contextual reason
everyday lab work that needs to be considered why a user needs it.
when discussing lab management, lab proces- On this basis, summarizing categories or
ses, workflow optimization, or the potential clusters of user needs are generated resulting
development of hardware and software for in two further levels of interpretation and
chemistry laboratories. But for reasons of respective coding: ‘Second-order’ concepts that
readability presenting the complete list would generalize the first-order statements, and a
be beyond the scope of this paper. However, final ‘third-order’ level, here called ‘aggregate
the authors consider the following summary to dimensions’, which represents the most gene-
be sufficient for understanding the main user ral interpretation of groups of statements
needs and their interdependencies that occur in across job roles. The following section high-
the flow of the studied lab work. lights some examples for this qualitative data
analysis and stepwise interpretation process.

Table 2 Needed intercommunion and information of participants sorted by job role

Technicians Operations Team Leader Process Engineer
Needed intercom- Receives initial process definition briefing; Requests information for Offer notes and in-
munion & advo- Receives ad hoc advice from every team documentation, manage- structions at the loca-
cacy member at any time in person and via ment, and planning; Re- tion of an experiment
online platform (wiki); Receives top-down source planning in discussion setup (e.g. need for
advocacy before reserving components with scientists; Offers profor- cleaning of compo-
(e.g. due to cleaning); External support mas & templates for work- nents); Offer prepara-
advocacy for facility operations (e.g. re- flows tion and instructions
starting operation system, earthing of for the team of the
setups); Receives ad hoc top-down direc- following lab shift
tion for changing priorities; Offers bottom
-up suggestions for optimization and
workarounds
Needed Planning for projects, shifts and job rota- Current status of everything Operating conditions;
information tions; Picture of process definition for in the lab (maintenance Flow rate; Volume of
setup; Changes in process definition, Re- status, equipment status, materials; Suitable
quired equipment and setup parts; Tech- time plans etc.); Overview of equipment; Equipment
nical interfaces of a setup (“Inlets” and requests and respective pri- location (e.g. archive);
“Outlets” as connectors); Consistency of orities (input via email, notes, Equipment status (e.g.
language, codes and symbols; Current whiteboard, in-person); ready to use); Equip-
setup performance status (by visual in- Equipment location (e.g. ment history (e.g. last
spection and by instrument data); Current archive); Equipment status time of cleaning, last
performance status of especially error- (e.g. ready to use); Setup user, project number);
prone equipment (e.g. pumps); Equipment categorization (GMP or Non- Equipment manufac-
location (e.g. archive); Equipment status GMP) turer manuals; Equip-
(e.g. ready to use); Equipment history (e.g. ment exchangeability/
last time of cleaning, last user, project compatibility
number); Equipment manufacturer manu- (compensating for
als; Equipment exchangeability/ missing components);
compatibility (compensating for missing Equipment capabilities
components); Equipment capabilities and and weaknesses
weaknesses (official and actual); Equip- (official and actual);
ment mail ordering periods; Rules for Equipment mail order-
processes and equipment documentation ing periods; Serial
(e.g. cleaning record), Rules for changing numbers of equipment
processes including documentation tem- and materials; Maxi-
plates; Current team setup (who) and mum pressure of a
responsibilities (what and when); Sum- pump compared to a
mary of the last shift event history includ- system’s pressure in-
ing respective directions (day shift and cluding flow rate; Ma-
night shift) terial risks/hazards
about chemicals; Ma-
terial and solvent com-
patibility (e.g. max. and
min. pressure, temper-
ature rating)

General Need for Information changes as well as iterations during the lab
The observations and interviews from the experimentation are collected (see examples in
contextual inquiry show a “general need for Figure 9).
information”. This category contains user need
items that reference needed types of informati-
on (see examples in Figure 6).
General Need for Efficient Collaboration

Another overarching category that contains
multiple user need statements is named
“general need for efficient collaboration”. Here,
user need items that address the need for effi-
cient communication, documentation, and acti-
ve information sharing are summarized (see
examples in Figure 7).
General Need for Control

The third category that contains multiple
user need statements is called “general need
for control”. This category addresses user need
items regarding preparation or being prepared,
reassurance or control checks, as well as au-
thentication or responsibility checks (see exa-
mples in Figure 8).
General Need for Flexibility

The last summarizing category is called
“general need for flexibility”. Here, user need
items that address issues regarding frustration
tolerance and openness to cope with constant
Figure 6 Illustration of coding (aggregation) of user needs into overarching category “need for
information” (own representation).

Figure 7 Illustration of coding (aggregation) of user needs into overarching category “need for efficient
collaboration”.” (own representation).
Figure 8 Illustration of coding (aggregation) of user needs into overarching category “need for control”.

Figure 9: Illustration of coding (aggregation) of user needs into overarching category “need for flexibility”.
4 Discussion study these traditional rule sets and top-down

management activities do not support all as-
Employees working in pharmaceutical R&D pects of the employee’s experience. Overall,
for drug discovery and manufacturing prepara- aspects of team culture and communication
tion face diverse challenges in all aspects of seem to be as important as these traditional
everyday laboratory work. Against this back- approaches for safety and risk management.
ground, this study addresses the question of Therefore, based on the results of this study
how people work in corporate pharmaceutical several implications are discussed as general
research and development laboratories for con- findings.
tinuous manufacturing, what their needs are,
and how these needs could be met. Finding 1: Digitization efforts should prioriti-
The results of the current qualitative study ze communication and collaboration over
show their extensive and diverse set of interre- features.
lated (user) needs from their employee’s point The results of this study also show that the
of view. Typically, these needs are supposed to lab workers struggle with the currently not con-
be supported by e.g. rule sets like good manu- sistent digitization efforts regarding documen-
facturing practice (GMP), safety regulations, tation and organization of materials, solvents,
and trainings. Looking at the literature, the im- and setup components. Digital tools like an
portance of these ‘human factors’ has been Electronic Lab Notebook (ELN) or Wiki as know-
emphasized. ledge base are already in place in this research
For example, while Konstantinos and collea- laboratory, but are used to a less degree, becau-
gues (2011) on the one hand mention future se they either do have technical limitations or
trends in pharmaceutical manufacturing and in are limited in provided features – so they do
industrial manufacturing as a whole, which provide some benefits, however, are not com-
reinforce the need of a stronger utilization of prehensively deployed and thereby do not fit
human factors aspects, as many issues of con- the user needs for constant and consistent
cern can be avoided or their effect minimized. communication during collaboration identified
On the other hand, their results show that com- in the inquiry. Therefore, the support of effecti-
pliance with the legislation regarding GMP re- ve collaboration is identified as a major challen-
gulations still seems to be the main require- ge for the digitization of lab work, that is the
ment for pharmaceutical production, while hu- continuous transition between both the analog
man factors are not explicitly emphasized. and the digital world. For example, there is no
However, in the context of the results of this consistent electronic documentation system in

place and just specific workflows take advan- mentioned paper-based setup diagrams that
tage of specific features of such tools. So, on are currently pinned on the front of sterile work
the one hand it is still common practice to use benches. Thereby, research laboratories might
paper-based lab notebooks. On the other hand, benefit from the logistics of so-called ‘control
there are a lot of ELNs available on the market. rooms’ (Lischke et al., 2018).
This, however, seems to be common practice in
the majority of laboratories and evidence sug- Finding 2: Learning is considered a shared
gests that whilst scientists willingly make use responsibility to foster an agile work culture for
of generic software for note taking and docu- efficient in-team knowledge management.
mentation, spreadsheets, general office soft- In order for the lab team to collaborate effi-
ware, as well as special scientific software to ciently there needs to be constant dialogue of
aid their work, current ELNs are lacking the re- team members fostering knowledge sharing
quired functionality to meet the needs of the and thereby collaborative learning. This finding
researchers (Kanza et al., 2017). For example, relates to the general best practices in software
most of available ELNs offer basic cloud-based engineering that follow a lean project manage-
text functionality like Microsoft Word while ment approach called ‘agile’ (Cardozo et al.,
many of them fail to offer basic not to mention 2010). Agile is a project management system
convenient capabilities of data sharing fea- where so-called ‘sprints’ or iterations are
tures. Based on this study’s results it is argued utilized to complete allocated tasks and assign-
that such tools like ELNs should offer data and ments. Sprints or iterations are short spans of
knowledge sharing as a main feature next to time, usually two weeks, where a team meets
documentation for teams working in research up and discusses the cycle of a project. In these
laboratories. Data sharing thereby includes fea- meetings, tasks are assigned according to a
tures like transparent versioning of documents proper timeline. Also, team work plays a signifi-
and visualization of data wherever possible in cant role in the success of a project and there
order to enable respective knowledge sharing are frequent interactions between the client
and collaboration. Goal should be to not simply and the developers. Although there seems to be
replace existing solutions, e.g. replacing Micro- a common understanding, that agile develop-
soft Word or Excel by a process development ment methods conflict with the generally ac-
tool not just for the features or to digitize an cepted software development methods within
analogue process, but more so if the latter is the pharmaceutical industry (Hajou et al., 2014),
enabling better collaboration by fostering the it can be argued that the scientific lab work in
right organizational climate that persuades the investigated pharmaceutical R&D laborato-
people to create, reveal, share and use know- ry shares some key dynamics to agile team
ledge (Davenport et al., 1998; O’Dell and work, following an overall mindset of adapting
Grayson, 1998; Mariani, 2002). to change including trial and error for success-
Here, again, the fact can be highlighted that ful and constantly evolving collaboration. One
in the development of new lab workflows or key aspect of agile methodology is constant
refinement of current workflows there are pro- communication or focusing on relationships to
cess plans and instrumentation blueprints that foster team work and knowledge sharing. This
are communicated as diagrams, while the colla- finding is supported by the results from Mariani
boration happening with these diagrams is not (2002) who describes the working culture in a
yet digitized consistently. But this exactly very successful research laboratory in a way
might be one issue to enable better communi- that resembles the ideal type of agile develop-
cation and thereby avoid mistakes and work- ment methodology (Beck et al., 2001). In additi-
flow errors. In this regard, the current investiga- on, some application-oriented publications ar-
tion shows challenges in communication, e.g. gue that agile methodology is showing itself a
by means of ad-hoc documentation with print- promising way of working and moving beyond
outs and lab notebooks in correspondence with software development projects and soon will
partially available digital documentation and find its place in other industries like phar-
knowledge sharing possibilities. For example, maceuticals (Alaedini et al., 2014).
one technical solution addressing this finding Overall, the results of this study suggest to
may be to include interconnected large display lean more towards theories of human factors
covering live data, which could replace the and education in lab management to foster this

kind of sociocultural, organizational way of users, while these collaborative relationships
learning. For example, Boreham and Morgan are often neither made explicit nor are these
(2004) propose a sociocultural model which assumed relationships verified in the field
identifies ‘dialogue’ as the fundamental pro- (Sharit, 2006). Furthermore, the conduct of vali-
cess by which organizations learn, and relatio- dation and verification studies during product
nal practices as the social structure which em- development and after product release is usual-
beds the dialogue and makes it sustainable in a ly limited to the technical side of implementati-
potentially conflictual environment. They defi- ons, thus results may be informative but hardly
ne a pedagogy of organizational learning in about a combined view of social and technical
terms of participation that builds on relations- aspects. On the other hand, the potential to
hips between employees in addition to the tra- succeed or to fail of a system, once it has been
ditional focus on autonomy of individuals. This brought to the field, is strongly determined by
argument is also supported by Konstantinos the adaptation of both social and technical as-
and colleagues (2011) who state that lab work- pects (Dekker, 2005). In this regard, the reward
ers need to interact as to form social networks, structure of organizations usually emphasizes
interactions and teams that can facilitate group on rapid completion of projects and the insula-
identification and lead to more smooth coordi- tion of engineers to give less consideration to
nation and collective action, while the parame- factors related to ease of operation and even
ter of auditing can be an issue among the work- safety (Perrow, 1983). Here, the results of this
ers and again prohibit the teamwork study show the interdependencies between all
(Hutchinson and Zain, 2009). In addition, these individual employees working in the lab, their
authors generalize such issues stating that in need and constant effort to initiate and main-
many organizations, a major cultural shift is tain an efficient mode of communication and
required to change employee attitudes and collaboration as a foundation for the technical
behavior so that they willingly and consistently side of chemical research and recipe develop-
share their knowledge and insights and thus ment.
help management and control process. Another The most striking yet straightforward exa-
study supporting this argument showed that in mple for this interdependency of responsibili-
order to be successful in pharmaceutical R&D ties and respective communication routines is
teams depend on the capacity to perform a lar- found in the collaboration around the already
ge number of experiments and the capacity to mentioned process design drawings. Here, a
rapidly modify or adjust production programs scientist creates and proposes a process dra-
(Mariani, 2002). Here, the call for flexibility, wing which follows his current experimental
continuous learning and teaching of team hypothesis in order to discuss the technical fea-
members, coupled with an increased rate of sibility of a respective process setup in the lab.
experimentation challenging strict regulations The process engineers and technicians on the
including confidentiality is especially interes- other hand rely on this process drawing in order
ting. to understand what they are supposed to do
next, while also anticipating the broader rese-
Finding 3: Incorporating user research prac- arch idea of the scientist. In theory, this collabo-
tices is important to uncover underlying social ration seems like a top-down approach of rese-
systems as determinants for the success of arch design and management, but the results
socio-technological systems. show that it is rather a constant debate or ite-
One goal of this in-depth exploratory user rative collaboration for setup refinement to
study is to foster fundamental and interdiscipli- find technical solutions as a team, which need
nary debates about the design and implemen- to be feasible yet do not compromise the scien-
tation of applications based on novel hardware tific hypothesis. Surprisingly, interview partners
and software products in laboratory environ- also mentioned that technicians sometimes
ments. Such debates are considered very im- have more in-depth knowledge about
portant since the conceptualizations of mana- equipment and instrumentations than their
gers, engineers, developers, and designers are highly skilled scientist and engineering collea-
often based on initial hypotheses concerning gues. One interview partner even mentioned
the collaborative relationship between their that occasionally scientists first ask technicians
technological product and the potential end- to propose a setup instrumentation to iterate

on a recipe experiment or that a recipe and its the adoption of new tools and solutions, which
experimentation setup is changed, because of a is often a challenge, because the benefits of
proposed technical solution from a technician. outdated yet established tools and solutions
Thereby, it can be concluded that the scientists usually predominate the adoption costs of new
include bottom-up experimentation in their tools and solutions that, however, may offer
research rationale. This statement also sup- more benefits in the long run (Rogers, 2003;
ports the finding regarding work culture in this Wang et al., 2010). For example, Schmitt (2019)
lab to follow a mode of constant debate that investigates the challenges regarding the adop-
tries to contain knowledge transfer in teams tion of B2B electronic marketplaces in the che-
top-down as well as bottom-up. mical industry and argues for a top-down ap-
In the end, the importance for lab manage- proval approach for introducing new solutions
ment to identify and clarify such aspects regar- through managers, because on the one hand
ding the flow of information for effective know- operative individuals in general show the ten-
ledge sharing in teams working in such fast- dency to stick to familiar processes and on the
paced and everchanging work environments other hand there is often a lack of incentives for
can be inferred. Hence, team leaders or lab ma- employees to take up the challenge of new di-
nagers should know and communicate which gital solutions bottom-up. However, as mentio-
team members need to know what information ned above, decision making for such top-down
in what kind of form and when in which point introduction of new solutions could be infor-
in time from whom to what effect. This finding med by bottom-up processes of cultural analy-
goes along with the research regarding the the- sis and knowledge management.
oretical construct of ‘work process knowledge’ This is considered highly important, because
from Fischer and Röben (2002a), which high- beyond the study of lab work, these circum-
lights a special type of shared knowledge that stances would appear to shift the attribution of
team members working in organizations need user errors from engineers, developers, and de-
to develop and continuously expand in order to signers to management in the development of
anticipate the organizational requirements and laboratory hardware and software products.
the needs of their colleagues. Thereby, it can be Following Reason (1990) and Sharit (2006),
concluded that it could be helpful and might such organizational ‘management errors’ re-
become important for pharmaceutical compa- present types of latent errors that are respon-
nies in the future to incorporate such kind of sible for creating preconditions of user errors in
user research or human-centered design prac- the end. Finally, this misaligned error attributi-
tices to uncover such underlying individual on problem created by poor engineering, deve-
needs and social interdependencies as determi- lopment, design, or management policies tradi-
nants for the success of the socio-technological tionally have been duped on training depart-
system that is the chemistry laboratory for rements to compensate for these problems
search and development. (Sharit, 2006). Respectively, it is argued that
Generally speaking, it is suggested to rese- one major deficiency in these development pro-
arch and analyze cultural and social aspects of cesses may be the hubris of decision makers
workflows in special environments like labora- underestimating the human factors in their
tories before designing and developing digital planning, as well as the inability of employees
solutions on the road to paperless work and management to appreciate human fallibili-
(Thimbleby, 2019). In addition, it is argued to ty by failing to take into account relevant infor-
respect and include bottom-up processes of mation. Overall, the step of developing a Hu-
collaboration that are based on experiential man Factors Engineering strategy or User Expe-
knowledge. Here, the increased cost of repetiti- rience strategy or Human-Centered Design
on (trial and error), e.g. by failed measurement, strategy is either not completed or it is accom-
has to be balanced against the contribution to plished by non-human factors personnel, which
the development of individual competence and can lead to poor results (Privitera, 2019). In this
quality assurance within an organization regard, Privitera (2019, p. 28) explicitly argues:
(Fischer and Röben, 2002a). “The reasons for this are varied; however
This ‘cultural approach’ to lab knowledge anecdotal evidence suggests that manufac-
management could also help organizations to turers often believe only a minimum of Human
specify opportunities and benefits regarding Factors input is required based upon what they

believe to be the agency requirements. Manu- sights. However, the most prominent limitation
facturers then provide a rationalization that is the small sample size due to limited access to
doing more is not necessary because they, in pharmaceutical companies as well as people
fact, “know their users”. In instances where ma- working in these companies. Here, different
nufacturers lack Human Factors analysis proce- modes and contract models of collaboration for
dure, they may rely on hearsay without an opti- co-innovation could be explored to get more
mized or documented approach. This becomes access to corporate research facilities
problematic in developing the required Human (Schneiderman, 2016), e.g. by supporting and
Factors submission documentation for agency fostering open innovation initiatives (Hunter
review. Lastly, personnel without additional and Stephens, 2010; Bianchi et al., 2011; Schuh-
education in Human Factors may not ask the macher et al, 2013) between social researchers
right questions necessary to determine approp- and corporations.
riate human factors strategies required to opti-
mize the device interface. Thus, developing a 5 Conclusion
Human Factors strategy at the onset of a device
program assures that all User Needs are met Scientists, engineers, and lab workers deve-
and that the manufacturer has a firm commit- loping chemical solutions in big pharmaceutical
ment to quality from the user’s viewpoint.” companies construct, engineer, monitor, and
Therefore, the notion of Ulbrich and Aggar- manage complex processes. Staff members
wal (2019) is supported that companies will have to follow strict regulations while making
need “translators-specialists” – the aforemen- system-relevant and sometimes safety-critical
tioned user researchers or human factors engi- decisions. Thereby they are supported by a lar-
neers – who are able to understand the functio- ge amount of information in form of lab note-
nality desired by e.g. lab workers and translate books, drawings, or diverse format templates
it into technical requirements that can be un- for documenting specific processes and in-
derstood and processed by the IT staff. In this cidents. This study provides an in-depth view
spirit, this exact concern is given serious into common work practices and aims to iden-
consideration in human-centered design prac- tify challenges for workflows, processes, decisi-
tices (Nielsen, 1995; Sharit, 2006; ISO/IEC 13407) ons, and actions in a chemistry research labora-
and this study represents a source of insight for tory for analytical method development in con-
user needs in the context of laboratory work- tinuous manufacturing.
flows in general. The findings show what people in this labo-
ratory need to work together and communicate
Limitations of this study effectively. On top, in comparison to current
Nevertheless, the aforementioned results psychological and social studies in the field of
and findings need to be reflected in context of laboratory work, e.g. from the human factors
the methodological limitations of this study. community, the results show that there is a
These limitations include a lack of prior rese- fundamental difference in research design
arch studies on the specific topic of lab work in focusing on human needs instead of human
continuous manufacturing labs of big phar- error. Thereby, the study follows the paradigm
maceutical companies. of positive psychology (Seligman and Czikzent-
Further research might also apply mixed- mihalyi, 2000) instead of a paradigm of econo-
methods research designs combining not only mic and mechanistic efficiency or technical
observation and interviews, but also surveys or functionality that typically considerers humans
longitudinal data collection approaches like as a source of risk and technical errors, hence,
diary methods for continuous experience samp- the traditional goal of such research initiatives
ling. In addition, reliability of qualitative data is is to optimize the human-machine system
always an issue due to the methods for data (sometimes even called ‘co-operation’) for redu-
collection relying on self-report data only. Here, cing the potential for human error. For examp-
it needs to be clarified that this study re- le, in comparison to these studies which offer
presents a first step in exploring the field of the overall identification and listing of risk fac-
corporate lab work in continuous manufac- tors like “stress” or “time pressure”, this current
turing and that more research is needed to ge- study investigates and identifies the constituti-
nerate more reliable data and respective in- onal employee needs as user needs in situ that

lead to such psychological and social phenome- Aromaa, S., Väätänen, A., Hakkarainen, M.,
na. Hereby, this study is in line with the overall and Kaasinen, E. (2018): User Experience and
goal of human-centered design including the User Acceptance of an Augmented Reality Ba-
user-research-led product development prac- sed Knowledge-Sharing Solution in Industrial
tice of user experience design, which are both Maintenance Work, in: Advances in Usability
fundamentally focused on human needs and and User Experience Proceedings of the AHFE
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Appendix (9) A Technician in this laboratory needs to be

able to understand the necessities of process
Complete list of elicited user needs: design iterations in order to avoid knowledge
Scientist: gaps and frustration.
(1) A scientist in this laboratory needs to proof (10) A Technician in this laboratory needs more
his thinking around a concrete set of chemistry. detailed and standardized process diagram
Therefore, he needs to produce an under- containing consistent symbols in order to be
standing of the process, that is, about the reac- more efficient.
tion time and the mixing characteristics of the
equipment. With these data a scientist in this
Setup Phase
laboratory needs to build a model to be able to
scale that in correlation to bigger setups for (11) A technician in this laboratory needs to visu-
mass production. ally control the setup flow in order to get a first
impression of its status.
(12) A technician in this laboratory needs to be

Continuous Processing Technician (Technician):
aware and constantly control setup equipment
Design Phase for errors, especially pumps, in order to be able
(2) A technician in this laboratory needs a dia- to change and thereby dispose the defective
gram of the setup in order to understand what equipment.
a scientist wants to do. (13) A technician in this laboratory needs to
(3) A technician in this laboratory needs to in- flush pumps with solvents in order to clean
terpret process design drawings in order to be setup parts.
able to start building the setup (14) A technician in this laboratory needs to be
(4) A technician in this laboratory needs to able to put a component aside for further
identify changed parts of the setup diagram (in cleaning when it is not clean and should be ab-
his proforma) in order to account for the ne- le to take a new (clean) component instead in
west version of the setup. order to continue a setup.
(5) A technician in this laboratory needs to read (15) A technician in this laboratory needs to
and understand the process design/drawing in identify errors on the operation system gathe-
order to know which parts he has to find for the ring data on the setup.
setup. (16) A technician in this laboratory needs to be
(6) A technician in this laboratory needs to able to build setups in iteration in order to coor-
know the “Inlets” and “Outlets” of a setup in dinate/compensate missing equipment.
order to know how special components are (17) A Technician in this laboratory needs to do
connected to the other parts of the setup. (besides visual check, a pressure check) a flow
(7) A technician in this laboratory needs to get rate check with equipment in order to assess if
as much information about the setup as pos- the pumps are delivering what their status
sible from different people in order to under- claims to be able to deliver.
stand their goals. (18) A Technician in this laboratory needs to be
(8) A technician in this laboratory needs to get able to work on basis of the process diagram
specific information on layers and details of without thinking of alternative setup possibili-
setup diagram in order to avoid iterations. ties including special components.

(19) A Technician in this laboratory needs to be discuss original setup designs/drawings/plans
able to work with a sorted and fully equipped at the very beginning in order to get a clear un-
(all in one) toolbox in order to be able work “out derstanding of the goals.
of the box” spontaneously.
(20) A Technician in this laboratory needs to be able to commit suggestions for setup changes
reassured about working rules for each compo- or adaptations in order to start a discussion
nent, with or without serial number, in order to with a scientist (e.g. about how the setup
know how to document/log them. might be more efficient).
(21) A Technician in this laboratory needs to be (31) A technician in this laboratory needs to be
able to help himself in terms of training, that is, aware of the intranet team-sites in order look
getting specific manufacturer manuals on the up suggestions from colleagues and share his
spot. own experiences with specific equipment or
setups.
(22) A Technician in this laboratory needs to
analyse the setup step by step with his boss or (32) A Technician in this laboratory needs to
a chemist before he is allowed to run the setup. communicate with his colleagues to share
knowledge about current status of a setup and
(23) A Technician in this laboratory needs to
what is to do next.
have an equipment-recipe attached to the pro-
cess design/drawing in order be more efficient. (33) A Technician in this laboratory needs to
know the current status of project setups, who
(24) A Technician in this laboratory needs to be
is working right now, who will be working in
aware of component capabilities and weaknes-
the next shift (am-shift & pm-shift) and when
ses that can unfold during instalment of diffe-
who will be on vacation.
rent components (e.g. the pressure or tension
of a screw that is fixing a tube that might lead (34) A Technician in this laboratory needs to
to a leak). anticipate support by colleagues in order to
know how to wrap up his shift or how to leave
a setup (turn off or leave it running).
Communication
(25) A technician in this laboratory needs to able to place orders for equipment sooner in
communicate to colleagues in order to seek and order to avoid the lack of equipment.
get advice or to find the right equipment.
(26) A technician in this laboratory needs to be able to share his current point of view of a part
able to talk to a chemist engineer in order to of the setup in order to get ‘hands-on’ feedback
start the cleaning of components. or advice from a colleague.
(27) A technician in this laboratory needs to or- (37) A Technician in this laboratory needs to be
der a specialist (e.g. from IT or facility manage- reassured about his role in order to manage
ment) to restart and fix the operation system in expectations regarding rotation of team mem-
order to keep the process running. bers and responsibilities.
(28) A technician in this laboratory needs to
react spontaneously to demands of scientists
Documentation
who are present in the lab and adapt his plans
or priorities. (38) A technician in this laboratory needs to get
a proforma to be able to focus on the required

setup specifications. Operations Team Leader:
(39) A technician in this laboratory needs to (49) An Operations Team Leader in this labora-
know where specific parts of equipment are tory needs to organize and manage the storage
right now in order to collect them to be able to and maintenance of materials and equipment
start the setup process. in order to keep the workflow of the lab run-
ning.
document every adaptation of the setup dia- (50) An Operations Team Leader in this labora-
gram in the Proforma. tory needs to prioritize many different requests.
(41) A technician in this laboratory needs to be (51) An Operations Team Leader in this labora-
aware that there might be a lot of changes to tory needs to maintain the lab’s intranet team-
the setup and the Proforma in order to optimize site in order to track tasks and equipment, e.g.
the process that is to be developed. in combination with Proformas.
(42) A technician in this laboratory needs to (52) An Operations Team Leader in this labora-
understand protocols for lab notebooks and tory needs to document equipment status, that
discuss them with an engineer. is, where they are in use at the moment, their
current status as material and where it is
stored.
visually inspect components and take them
apart while documenting their status for (53) An Operations Team Leader in this labora-
cleaning. tory needs to combine information from lab
notebooks and Proformas in order to keep track
(44) A technician in this laboratory needs to fill
of equipment.
out a cleaning record that is a protocol within
the lab notebook that requires him to sign of (54) An Operations Team Leader in this labora-
single tasks, in order to be accountable for the tory needs to manage single requests, that is,
cleaning of components. assigning equipment to the request by che-
cking its status (e.g. via tracking-list or spread-
sheet).
know in which condition a component is before
he is allowed to use it. (55) An Operations Team Leader in this labora-
tory needs to think about ways to track
equipment with barcodes.
sign things correctly in the lab notebook, that
is, starting on the actual protocol and ending (56) An Operations Team Leader in this labora-
on the page of the lab notebook that contains tory needs to talk to scientists in order to dis-
the actual protocol. cuss the organization of resources for new ide-
as and significant setup changes.
aware of several projects, their status and cur- (57) An Operations Team Leader in this labora-
rent tasks. tory needs to prepare Proformas and assign
them to technicians.
gather and document all information regarding (58) An Operations Team Leader in this labora-
his current tasks in order to hand it over to col- tory needs to relate changes of shifts, the over-
leagues during the handover of a shift. view and current status information for each
project and the current status of individual Pro-
formas.

(59) An Operations Team Leader in this labora- Continuous Processing Engineer (Engineer):
tory needs to know if the setup is GMP or Not-
(68) An engineer in this laboratory needs to be
GMP and identify relevant implications.
able to proof the feasibility of experiments.
(60) An Operations Team Leader in this labora-
tory needs to be able to standardize resource
able to work and easily switch between the
management in order to plan and structure the
office work place and the laboratory in order to
expectations of team members.
discuss process theory and feasibility.
tory needs to be able to set requests ‘on hold/
aware of operating conditions, flow rate and
halt’ in order to avoid excessive demands by
volume of materials on the one side and suitab-
gathering more information and discussing
le equipment on the other side.
challenges.
(71) An engineer in this laboratory needs to wri-
te specification sheets for materials.
tory needs to organize requests in coordination
between email and demands that are (72) An engineer in this laboratory needs to be
broadcasted between team members and in able to check the suitability of equipment by
the lab, that is, e.g. on a whiteboard. reading manufacturer manuals and so-called
‘specification sheets’ which contains basic in-
formation of materials and limits.
tory needs to coordinate the skills of technici-
ans to tasks and further discuss demands for (73) An engineer in this laboratory needs to
training. check the Team-Sites/Spreadsheets to see
which equipment is available.
tory needs to be able to broadcast specific in- (74) An engineer in this laboratory needs shared
formation for safety issues, e.g. prior experi- templates for process drawings.
ences or highlight hazards working with a spe- (75) An engineer in this laboratory needs to plan
cific component. and draw process schematics on his office-PC
(65) An Operations Team Leader in this labora- and share these schematics with technicians at
tory needs to broadcast the following key infor- the place of the setup.
mation for setups: What equipment, what cap- (76) An engineer in this laboratory needs to be
abilities for the materials of construction (e.g. able to use small-scale experiment setups for
stainless steel), where is it going, what are the simulation in order to brainstorm and discuss
goals to aim for with this setup. possible setup solutions.
(66) An Operations Team Leader in this labora- (77) An engineer in this laboratory needs to
tory needs to be able to manage/coordinate know which special components are ready for
initial meetings including technicians in order setup and if not, what they need to become
to enable an ongoing knowledge transfer ready for use (e.g. pressure sensors and tempe-
between science and know-how. rature sensors require an interface with a con-
(67) An Operations Team Leader in this labora- trol and data logging system.
tory needs to be able to highlight and coordina- (78) An engineer in this laboratory needs to
te differences between the workstyles of GMP know and document the status of each compo-
and NON-GMP. nent before using it, that is, the history of it
including dates of use, project/experiment

number, name of the person who has signet (89) An engineer in this laboratory needs to be
out, specific logging codes for the component. sure about the documentation and specific sto-
rage of components.
(79) An engineer in this laboratory needs to
document smaller changes and adaptations in (90) An engineer in this laboratory needs to
the lab notebook (“logging”) using references know the last person responsible for a compo-
via logging codes (shortcuts) and specific serial nent of equipment.
numbers for specific components like pumps
that are enlisted in the lab notebook.
know compatibility of solvents, max. and min.
(80) An engineer in this laboratory needs to pressure and temperature rating for equipment
document events in detail during experiments in order to build a setup for experimentation.
or cleaning.
(81) An engineer in this laboratory needs to be know the last settings of components, e.g. of
able to simplify documentation habits, especi- pressure reliefs, and how to change the set-
ally in order to document group meetings. tings the right way (and when it was tested).
(82) An engineer in this laboratory needs to (93) An engineer in this laboratory needs to de-
know risks/hazards about chemicals as well as cide on which reactor to use, inlet-points and
compatibility data of the equipment (high tem- their class as well as the outlet-points in order
peratures & pressures) in order to get an idea to start modelling a small-scale simulation
about the process assessment. setup with the based on a rough idea for a pro-
cess.
(83) An engineer in this laboratory needs to get
a rough idea of what has to happen/to be done (94) An engineer in this laboratory needs to
in what order to document processes. combine the information of operation conditi-
ons (temperatures), what and where to opera-
te, problems with operation limits, operation
able to place short notes/instructions on the
capacities of the system (heat & cold), needed
setup in order to highlight simple tasks, e.g.
speed of mixer-components.
cleaning of a component.
know the maximum pressure of the pump
able to communicate instructions for the eve-
compared to the system pressure, also conside-
ning shifts in order to prepare things for the
ring flow rate.
next morning.
able to find the person to talk to in order to ga-
know the weak spots of a setup, that is, what is
ther information about new components.
the limiting bit of equipment and be able to
focus on the ‘delivery system’ and the ‘reactor’.

identify a component by serial number in order
to discriminate between logged equipment and
consumable materials.

know about the current stock spares and who is
involved in the ordering of new equipment.

Interview guideline for contextual inquiry in
continuous manufacturing lab
Introduction / Instruction
The goal of this document is to guide you

through the data gathering process during user
interviews on site. Overall, we aim to cover and
understand the sense making processes of pe-
ople during work within a specific work place
that comes with a specific culture, including
respective individual and social practices in
place (e.g. habits, routines, and rules).
The guideline document structure follows a

successive logic, beginning with easy to answer
questions for rapport to warm-up or break the
ice for having a relaxed and authentic discussi-
on. Interviewees shall know and understand
that this is not a test, that we are just curious
outsiders trying to understand the way they
think and work.
The overall structure is as follows:
1. Introduction / Instruction
2. Participant & his goals (“Me as a person &

employee”)
3. Working in a team („Me and the others in

the team”)
4. Tasks („What I do & my tools“)
5. General workflow („What I usually do, in

which order and why”)
6. Current workflow (Introduction to work

place)
7. Closing the interview

Table A1 Interview guideline for contextual inquiry in continuous manufacturing lab (own representation).
Project/Topic: __________________________ Date: ____.____._____
Participant: ____________________________ Time: _______ until ______o‘clock

No. Check Introduction / Instruction
column,
if topic
was men-
tioned
Summarize the reason for being here again & clarify the overall process and
next steps
Participant & his goals (“Me as a person & employee”)

Who are you and what is your job and your tasks here?
Since when do you work here?
What kind of education and training did you receive?
Who do you work with?
What do you like most about your work?
What is your first step?
What do you not like at all about your work?
Is there anything you wish you could just skip?
Is there anything you tend to postpone?
(short notes/keywords)
Working in a team („Me and the others in the team”)

How do you share your tasks within the team?
Who decides what?
Who is taking responsibility, if something goes wrong?
Do you have an example maybe?
What are the goals of your team?
What is your role for achieving these goals?
What do you consider as most important here?
What do you need for your work in this team?
What helps you make decisions in your work?
How does a great work day or workflow look like? How looks a bad day or run
in comparison?
Which activities currently waste your time?

Table A1 continued
Tasks („What I do & my tools“)

What do you do most often?
What or which parts do you use most often?
What do you like about it? Any favourits?
How do you help yourself when problems occur?
Which abbreviations or short cuts do you use?
General workflow („What I usually do in which order and why”)

What did you do first today when starting to work? What are your first
steps?
How often do you do these activities?
What do you do in addition or not that often, from time to time? Weekly or
monthly?
How does a typical day in your work life look like? Please describe!
What would be an extraordinary event or exceptional circumstances in your
work?
Current workflow (Introduction to work place)

(Think-aloud during demonstration: „What do I do exactly, when, how, where, and why?”
Why are you doing this right now? Why do you need to do that?
How often do you do this?
When is it necessary to do this task? What pushes you to do this in the first
place? Where is the task coming from?
What needs to be done before you can do this task?
What task follows on this task? What depends on this working step?
Are there special or especially difficult tasks/activities?
What happens, if something goes wrong there?
How do you usually deal with such a situation?
(check audio recording, if possible - short notes/keywords)
Closing the interview

Did we forget something that is important for you or your job?
Or is there something else on your mind you want to share?

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Felix Hanser ,Sebastian Schöning and Gareth Alford

DOI: 10.17879/91129602140 ; URN: urn:nbn:de:hbz:6-91129602389

Laboratories in the pharmaceutical industry see an ongoing transition towards

Journal of Business Chemistry 2020 (2) 151 © Journal of Business Chemistry

1 Introduction 1.1 Background: Working in pharma

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1.3 Literature review Academic Social Sciences Literature about Lab

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Journal of Business Chemistry 2020 (2) 158 © Journal of Business Chemistry

Human Factors Literature knowledge from work on medical devices, mili-

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As the literature review illustrates, gaining

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Table 1 Responsibilities of participants sorted by job role (own representation).

Technicians Operations Team Leader Process Engineer

3.5 User needs elicitation Therefore, the complete list is considered

Journal of Business Chemistry 2020 (2) 168 © Journal of Business Chemistry

Table 2 Needed intercommunion and information of participants sorted by job role

Technicians Operations Team Leader Process Engineer

Journal of Business Chemistry 2020 (2) 169 © Journal of Business Chemistry

General Need for Efficient Collaboration

General Need for Control

General Need for Flexibility

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Journal of Business Chemistry 2020 (2) 171 © Journal of Business Chemistry

4 Discussion study these traditional rule sets and top-down

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Appendix (9) A Technician in this laboratory needs to be

(12) A technician in this laboratory needs to be

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setup specifications. Operations Team Leader:

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(87) An engineer in this laboratory needs to

(88) An engineer in this laboratory needs to

Journal of Business Chemistry 2020 (2) 187 © Journal of Business Chemistry

The goal of this document is to guide you

The guideline document structure follows a

The overall structure is as follows:

2. Participant & his goals (“Me as a person &

3. Working in a team („Me and the others in

Project/Topic: ______________________ Date: .._

Participant: ________________________ Time: _ until ____o‘clock