1. INTRA REPORT
Darragh Gillick – 12376651
Environmental Science and Health – ESH 3
Company: LEO Pharma
Address: LEO Laboratories Ltd
285 Cashel Road,
Crumlin,
Dublin 12
Tel: +353 1 4908924
Fax: +353 1 4901606
http://www.leo-pharma.ie
18/05/15 18/09/15
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CONTENTS
Abstract
Introduction
Company Structure
Duties Performed
Knowledge Gained
Theory V Practice
Conclusion
Images
Appendices
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ABSTRACT
LEO Pharma is a pharmaceutical industrial company whose main aim is to help people
achieve healthy skin. LEO continues to grow from strength to strength with new
dermatological products and innovative new ways to improve patients’ lives all over the
world.
As with any major company in the world there are a number of departments working together
on a day-to-day basis. For the duration of my placement I would be involved with the
Environmental Health and Safety (EHS) Department in LEO Pharma which relates directly to
my course of study – Environmental Science & Health.
The EHS Director and Executives are responsible for the company’s compliance with
National and International Health & Safety and Environmental Protection standards. Two
policies have been put in place by the CEO in Denmark in order to ensure full compliance
within each production site. There are sites in Denmark, Ireland, France and Australia.
The INTRA placement exposed me to the world of Health & Safety procedures; protocols,
training programmes; emergency drills/planning; auditing; reviews; both Corrective and
Preventative actions and general issue solving. On top of that, the protection of the
environment and efficient use of energy within the company demands strict regulations as
well as compliance with Dublin City Council licences for effluent, all of which I experienced
first-hand.
My main duties included presenting Site Safety inductions for new contractors coming on to
the Site; Environmental Analysis and Control of both water and effluent; sampling; use of IT
systems such as TREND, IPL and MAI; working with Environmental, Health & Safety and
Energy Management Systems and various campaigns which promoted health, safety or the
environmental protection.
Having been involved with the EHS Department, not only has my knowledge been greatly
increased but also my skills and attitude towards my course. I now understand a completely
different side to my degree, one which I was previously unaware of and the presentation, IT
and organisation skills I have gained with that will stand to me for any future career prospects.
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I would highly recommend any student with an interest in Environment Health and Safety or
Environmental Analysis to apply for a position at LEO Pharma. It is a fantastic company with
very friendly and welcoming people. It also provides the perfect environment to learn and
enhance both your knowledge and skills, not to mention to meet new people. Overall the
experience has been thoroughly enjoyable and tremendously beneficial not only for my
academic future but also for my personal development.
INTRODUCTION
Having been employed by LEO Pharma Dublin as an Intern in the EHS Department
(Environment Health & Safety), a variety of roles, responsibilities and training were available
for me over the 4 month period. The purpose of this placement was to learn and experience as
much as possible associated with the Environmental aspects of a successful pharmaceutical
company as well as the various Health and Safety procedures, policies and laws that are
relevant in companies world-wide.
The EHS Department coordinates overall environment, and health and safety management at
LEO Pharma Dublin. The EHS department structure is shown below.
LEO Pharma has Health and Safety and Environment and Energy policies in place which
commit the company to achieving standards which provide a safe and healthy workplace and
Michael Whooley
Kevin Reid Ger Craven
EHS Intern
Darragh Gillick
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the protection of the environment by preventing pollution and the efficient use of energy.
The Environment Health & Safety Director is responsible for ensuring the environmental
safety and health standards are met; the appropriate management systems are implemented
correctly on the LEO Pharma Dublin site and ensuring compliance throughout the company
with environmental legislation. The EHS Director supervises the EHS Executives and is
responsible for reviewing and approving policies and procedures generated to support both
the Environment Management System, and the Health & Safety Management System.
The EHS Executives are responsible for the day to day activities of the EHS Department and
they work to sustain the Environment and Health &
Safety Management Systems through maintenance,
support and training activities including:
Contractor Site Safety Inductions
Preparation of environmental/health & safety
policies and procedures
Development and delivery of training programmes in health and safety, and on the
environment
Carrying out or over-seeing the monitoring and analytical requirements of site licenses and
permits
Submitting data to Global EHS for monthly reporting in the LEO Group.
Preparing reports and environmental information including the Annual Environmental
Report, to assist in management review and to conform to regulatory and group
requirements
Assisting in waste reduction programmes and awareness-raising initiatives.
As an EHS Intern, I experienced each of these roles and provided assistance to both the
EHS Director and Executives in the day to day running of the EHS Department within
LEO Pharma Dublin.
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COMPANY STRUCTURE
Since beginning in 1908 in the basement of a Copenhagen pharmacy, LEO Pharma has grown
into one of the leading pharmaceutical companies in the world which strives to help people
enjoy a better quality of life. LEO is stronger than ever with a growing global presence, a
dedicated workforce of more than 4,500 and a strong pipeline of unrivalled pharmaceutical
products within dermatology and critical care.
Being headquartered in Denmark, LEO opened in Dublin in 1958 and adapted the site for
pharmaceutical manufacturing. Since then the Dublin site has been developing and investing
in new facilities and ideas to drive the company forward in the extremely competitive markets
that exist today. In the Irish healthcare market, LEO Pharma is now an established leader in a
number of key therapeutic areas and also has a network of manufacturing sites in Denmark,
Ireland, France and Australia.
Unlike most Pharmaceutical industries, the LEO Foundation is an independent, private
institution with the aim to ensure the continuation of the LEO Group. This means that there
are no external shareholders i.e. the company owns itself, which ensures LEO can truly
commit to the long-term research goals necessary to continue the development as a
successful, efficient, responsible and professional research-based company. The various
sectors and departments can be seen clearly by the following diagram:
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Manufacture on the site is dedicated to the formulation, filling and packaging of LEO Pharma
dermatology products for topical use such as ointments, creams and gels in different formats,
mainly tubes. LEO Pharma in Dublin supplies cost-effective medicines to patients suffering
from skin infections and diseases such as psoriasis and eczema. Examples of LEO products
include Daivobet®, Dovonex®, Fucidin®, Xamiol® and Picato®.
The bulk manufacturing facility has mixing and homogenising plants in clean rooms with
batch volume capacity ranging from 10 litres to 4000kg along with all the associated support
systems. Filling of the finished goods is also carried out in clean rooms. The facility has a
total of seven tube filling and packing lines, one bottle filling line and one web processing
line. It also contains a sterile plant which is dedicated to the production of an ophthalmic eye
gel product.
In the Irish market there are two main rivals to LEO – Pfizer and Johnson & Johnson. Pfizer is
the world’s largest research-based pharmaceuticals firm which produces medicines for
ailments in fields such as cardiovascular health, metabolism, immunology and neurology.
Some of their products include pain management drugs Celebrex and Lyrica, pneumonia
vaccine Prevnar as well as arthritis drug Enbrel. Similarly Johnson & Johnson are a huge
manufacturer of medical devices such as surgical equipment; monitoring devices along with
drugs for an array of ailments e.g. blood disorders, neurological conditions and autoimmune
diseases.
DUTIES PERFORMED
As an EHS Intern, I assisted the EHS Director and Executives in various tasks related to the
Health and Safety within the company as well as any Environmental issues.
A big part of my role in assisting the EHS Executives was to provide Site Safety Induction
LEO Mission We help people achieve healthy skin.
LEO Vision We are the preferred dermatology care partner
improving people’s lives around the world.
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training to contractors coming in to complete a certain job. Whether it was electricians,
builders, inspectors, engineers, fire management system personnel etc. – everyone had to
receive a safety induction before they were allowed to be on site. The induction covered the
general rules and regulations within LEO Pharma and what was expected of each individual
in order to achieve total compliance with both the Health and Safety and the Environment and
Energy Policies. This included the various permits which are required to work on site, the
waste management systems we have in place (e.g. colour coded bins); the correct use of
Personal Protective Equipment (PPE); procedures for entering confined spaces with low
oxygen levels; fire alarm evacuations and general safety information which all personnel must
be aware of. The inductions were carried out every morning at 8.30 and lasted for 30 minutes.
In addition, each year there is a two week shutdown period where production stops. This two
week gap is essential for contractors coming in to complete certain jobs. Due to the high
numbers of workers on site the likelihood of an accident increases in that period and therefore
hour-long Shutdown Inductions were presented each morning for the two weeks.
A huge amount of water is used in LEO every day for the washing of equipment; in the
laboratories and for the actual manufacture of products. The water used for washing is then
brought to a Neutralisation chamber where acids and bases are injected in order to stabilise
the solution so that it can be discharged safely where it is treated further. The Control room
contained instrumentation which kept track of the flow rate of effluent being discharged as
well as the pH of the effluent and chamber and finally the temperature of the effluent. Certain
limitations were put in place by Dublin City Council for LEO to abide by (e.g. maximum
discharge volume of 250m3
per day and a maximum temperature of 44o
C). Each morning at
8:00 I checked the flow meter in the neutralisation chamber, ensured the sampling machine
was emptied and finally checked the chart readings for compliance before recording my
findings in the log book. Any issues had to be reported and followed up on for example, an
unusually high temperature or a reoccurrence of baseline noise on the flow meter. A system
known as TREND was used to record various sets of data to ensure total compliance with the
Dublin City Council Licence. In the absence of one of the executives in July I had to compile
a report of effluent information for Quarter 2 of the year. This report contained information
and data for Chemical Oxygen Demand (COD), Grease & Oils, Suspended Solids,
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Temperature and Volume of the effluent, and had to be submitted to Dublin City Council as
part of the terms of the licence.
The protection of the environment is something which LEO Pharma takes extremely serious
and with the local River Poddle located just meters away, certain controls are in place to
minimise the risk of pollution. Every Wednesday it was my responsibility to take a sample of
water from the drain leading to the river for analytical testing in the analysis lab. This
involved the use of a powerful magnetic tool for lifting the heavy metal drain cover. A certain
amount of spillage kits are also situated around the yard, generally near drainage systems,
should a spill occur. Similarly all major tanks containing oil, paraffin or any harmful chemical
have a bund constructed underneath to contain spillages.
On top of the desire to protect the environment from pollution, LEO Pharma also works hard
in the efficient use of energy which is environmentally friendly and cost effective. Over the
course of the placement I examined various ways in which the company could enhance their
environmental and energy savings. This consisted of surveys of electrical use on lights across
the entire site (e.g. how many were energy saving LEDs, solar powered etc.), as well as
surveys on water use in toilets, sinks, showers, emergency wash stations in each building.
Possible corrective actions were then proposed like replacing each light for energy saving
LEDs or reducing the duration of water flow in taps. The use of pallets in the pharmaceutical
industry can also be a major environmental factor to consider – are these wooden pallets
recycled correctly for example. This was another idea examined in terms of improving the
company’s environmental footprint and saving money which can be invested in new energy
efficient projects.
From a Health & Safety point of view one of the most important factors to consider in the
Pharmaceutical industry or in any company is the risk of a fire and the emergency evacuation
procedure should a fire occur. The importance of fire exits and escape route plans around the
site cannot be underestimated. It was my responsibility to go around each building and ensure
the emergency escape plans were up-to-date and portrayed the exact layout of the
room/building where it was located. Road Safety awareness was also raised through the
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distribution of posters and emails. An issue regarding eye safety was raised during July and
the importance of eye protection across the site was highlighted. I was instrumental in
purchasing a large dispenser for safety glasses to ensure a pair of safety glasses was always
present for each worker before they entered a potentially harmful environment.
LEO maintains a strong relationship with the Dublin Fire Brigade (DFB) through regular
drills and meetings which help both parties to remain fresh and ready should an accident
occur on the pharmaceutical site. For example, in July there was a Confined Space
Emergency Evacuation drill which aimed to deploy DFB crews in a simulated emergency
scenario and work effectively with LEO Pharma Emergency Response Team (ERT). This
exercise evaluated the DFB Confined Space Rescue capabilities; provided data for
performance gap analysis; and also tested the LEO ERT. I had the responsibility of taking
photos for the performance report and got to experience the drill first hand. Similarly over the
summer there were a number of fire evacuation drills to test the employee and contractor
response to a fire. The EHS team are responsible for the planning and execution of these drills
and are a vital part of the continued safety and training of everyone on site.
As LEO Pharma is a major manufacturer of medicinal ointments, gels and creams for topical
use, there are a huge variety of chemicals and solvents on site. One of my tasks included
formulating an Excel spread sheet of the Chemical Store stock with the appropriate hazards
associated with each solvent. This spread sheet must be updated every year and each chemical
in store must have an up-to-date Safety Data Sheet.
KNOWLEDGE GAINED
Over the course of my placement I have been exposed to various areas and departments
within the LEO group; as a result of this I have gained valuable experience and knowledge
which will be extremely beneficial for future career prospects.
I had the opportunity to provide training to contractors each morning which greatly enhanced
my presentation skills and public speaking – something which is essential in everyday
working life in the modern world. These induction presentations introduced the hired
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contractors to the rules and regulations of LEO and covered the main risk assessment
procedures to be taken before completing any task. The appropriate permits relevant to each
contractor were also discussed as without the appropriate permits, no task can be undertaken.
The inductions took about 30 minutes each morning in the EHS Training room.
A huge exposure to Environmental, Energy and Health & Safety Management systems
provided me with a fantastic insight into how companies in the pharmaceutical industry
operate. These systems contain various policies, objectives, controls, auditing and monitoring
aspects necessary in order to comply with laws that ensure all workers and employees are safe
and a contribution to environmental protection and efficient use of energy is achieved. In
order to achieve full compliance, each sector with the company must work together –
Utilities, Automation, Projects, Facilities, Operational Excellence, Reliability and EHS –
which gave me a better knowledge of how LEO Pharma Dublin is run.
Various training modules were provided to me such as Good Manufacturing Practice (GMP),
Cardiac First Responder (CFR), Manual Handling, Risk Assessment and training in software
programmes such as IPL, MAI, eQuality and TREND.
Good Manufacturing Practice refers to the part of Quality Management which ensures that
products are consistently produced and controlled to the quality standard appropriate to their
intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or
product specification. Some key topics covered by GMP are good hygiene and hand-washing
in order to prevent contamination of product; good housekeeping (i.e. a clean workplace
which prevents harm to the employee and product) and finally Quality Control, which is
concerned with the testing and sampling of product to ensure the highest quality for
customers.
The Cardiac First Responder training course was an extremely beneficial experience not only
for my time in LEO but for life. The course is approved the Pre Hospital Emergency Care
Council (PHECC) and covers the procedure in the event of a sudden collapse with cardiac
arrest. This procedure deals with the appropriate steps when dealing with a victim and the
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correct techniques for chest compressions. Test dummies were provided to practice on and
training in the use of Automated External Defibrillators (AED) was provided. The course also
covered how to deal with incidents such as Choking for Conscious Adult; CFR for Children
and Infant; Choking for Conscious Child and Infant; Heart Attack; Stroke; and the appropriate
technique for The Recovery Position. This was hugely beneficial course provided for me by
LEO.
The Manual Handling and Risk Assessment training taught me the importance of assessing
every task I am doing before going ahead with it and how the simplest of tasks can cause
serious injury. An outside trainer was brought in to show the techniques involved with lifting
heavy items and how to assess the ergonomics of your working environment. For example
sitting at an office desk for prolonged lengths of time can cause a strain on your eyes or if
your chair is not adjusted can cause damage to your spinal cord without you thinking.
LEO uses various software systems for the day-to-day running of the company. For example
the IPL system is used to identify any accidents, environmental hazards, near misses, safety
hazards or injuries that occur on site in the form of tickets. These tickets are then given a
provisional date for a corrective action to be completed to ensure this incident will not happen
again so that no one will be hurt, the environment will not be effected or production will not
stop. MAI is new type software programme that will be replacing IPL which also contains risk
assessments, reporting, auditing, statistics, problems, corrective and preventative actions etc.
The eQuality software programme brings all the Management systems and procedures
together in one place and I learned a lot about how to use and implement these programmes in
a huge pharmaceutical company.
As environmental analysis was one of my main duties during the placement, I gained
invaluable experiences working with Excel spread sheets, Microsoft word, PowerPoint and in
particular a system known as ‘TREND’ which records a huge range of data needed to compile
reports for DCC, and ensure full compliance with their licence requirements. I gathered
information on various water meters, effluent discharge readings, pH, temperature and flow
rates from TREND and used the data to produce graphs which are used for performance
evaluation and reviewing. My IT skills were enhanced remarkably through the use of these
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programmes and systems.
Through the organisation of fire drills with the Dublin Fire Brigade I received first-hand
experience of emergency planning and map work while also being able to witness the step by
step procedures put in place in the event of a fire or incident. Similarly by updating the fire
escape routes across the site I learned more about blueprints for buildings and how to go
about changing layouts using different software systems.
THEORY V PRACTICE
Having studied Environmental Science and Health in DCU for two years I have gained a basic
knowledge of Biology, Chemistry and Physics. From these three sciences, modules such as
epidemiology, organic chemistry, genetics, cell biology, meteorology, society/health & illness,
pollution & biosphere and environmental geophysics have been made available to me. These
modules have further enhanced my knowledge of the scientific background associated with
the environment. Similarly I have participated in laboratory sessions each week over the
course of the two years on subjects such as Environmental Chemistry, Biotechnology and
Physics Laboratories. These modules provided the skills and techniques needed for various
forms of laboratory analysis whether it is from a biotechnological background (e.g. sampling
water for micro-organisms using agar plate) s or a chemical background (e.g. using one of
many chemical separation techniques for analysing compounds such as spectrophotometry,
gas or liquid chromatography using High Performance Liquid Chromatography), among
dozens of other experimental procedures.
When applying for various work placements across the country I noticed that a large
proportion were lab based roles involving water sampling and chemical analysis and I had the
impression that with a degree in science, these were the only roles that would be available to
me. However, LEO Pharma offered something different and something which I had not
expected. The areas of Health & Safety in the workplace; Environmental policies; laws;
compliance; training; risk assessing; waste management; Incident reporting; auditing;
monitoring etc. are areas I had not been exposed to before and I found these very interesting.
This exposure introduced me to a whole new range of career opportunities related to my
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studies.
From my INTRA experience with LEO Pharma Dublin, I have realised that the ESH course in
DCU does not deal with a huge part of the Health and Safety aspects involved in companies
worldwide. Modules such as Health Promotion and Society, Health & Illness are simply not
enough to prepare students for the range of topics and issues associated with Environmental
Health & Safety in companies all over the world today.
Although, looking forward to the final year of the ESH course in DCU there are a number of
modules dealing with Environmental Legislation; Ethics and Health & Safety, but perhaps
introducing them in the final year is not enough. Most of the issues and information presented
to me from the EHS Department of LEO has been completely new to me. I believe modules
dealing with Risk Assessments; Health & Safety regulations; and Environmental control
policies should be implemented earlier in the ESH course as this would provide students with
a solid foundation of knowledge before applying to companies for work experience, and this
in turn would provide an advantage over other students across the country.
CONCLUSION
Overall the INTRA work placement experience has been extremely worthwhile. LEO Pharma
has given me the opportunity to gain invaluable experience in a major pharmaceutical
manufacturing company. The skills and knowledge I have learned will not only be beneficial
to my area of study but also for my future career prospects and day-to-day life.
During my time with the Environment Health & Safety Department I have been exposed to a
huge amount of information which I had very little knowledge of prior to the placement.
Every company in the world has employees, and it is the duty of that company to ensure a
safe and healthy workplace for everyone. Certain Standard Operating Procedures (SOPs) and
Work Instructions (WIs) are put in place for this exact reason. As well as SOPs and WIs, there
are various training programmes, rules, regulations and other controls which help not only to
keep employees safe but to protect the environment and use energy efficiently across the site.
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This is a huge part of Environmental Science & Health that I was previously unaware of and
something I find very interesting. The efficient use of energy especially is something which is
only becoming more recognised worldwide as there are huge economic and environmental
benefits for the company. I had the opportunity to experience first-hand how a major
pharmaceutical company with branches all over the world works to achieve the optimum
standards for both Health & Safety and Environmental Protection which was extremely
beneficial for me.
As well as the vast knowledge gained I also enhanced numerous skills which are relevant to
any job in the Modern Age. Through the use of Microsoft Word, Excel and PowerPoint I have
become more comfortable with reviewing documentation, writing reports and making
presentations. Similarly through the day-to-day induction of contractors my presentation skills
and confidence have grown. I learned how to read maps correctly while working with the
blueprints of each building especially during organised Fire Drills with Dublin Fire Brigade
which also gave me an insight into emergency planning and organisation.
The opportunity to participate in training programmes like Good Manufacturing Practice and
Cardiac First Responder are something which will stand to me in the future and not just in the
workplace. The programmes were both enjoyable and extremely worth-while.
My knowledge of IT systems greatly improved working with the IPL, MAI and TREND
systems as well as the eQuality programme for control of documentation such as
Environmental, Energy and Safety Management Systems. These systems also provided me
with a huge amount of information on procedures such as Risk Assessments, Audits,
Environmental Analysis, Sampling, Compliance and Operation Control, to name a few.
Finally I got to experience a working environment and the people within it – the people who
make the business so successful. From day one I was welcomed and felt comfortable which is
extremely important. I would highly recommend this placement to other students as the
benefits you gain - whether its skills, knowledge or training - are outstanding and something
which will stand to you for the rest of your life.
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CONTENTS
Abstract
Introduction
Company Structure
Duties Performed
Knowledge Gained
Theory V Practice
Conclusion
Images
Appendices](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)