British Pharmacopoeia Environmental Sustainability Information Pack v1 1 March 2024
British Pharmacopoeia Environmental Sustainability Information Pack v1 1 March 2024
Information Pack
An overview of key resources and case studies on how to
improve the environmental impact of your laboratory and quality
control testing.
Published March 2024
Contents
Case study list ..................................................................................................................... 3
Terminology ......................................................................................................................... 4
1. Introduction ...................................................................................................................... 5
1.1 Purpose of the information pack ................................................................................. 5
1.2 Reasons to act on sustainability ................................................................................. 6
1.3 Wider Agency and BP sustainability action ................................................................ 7
1.4 Disclaimers................................................................................................................. 8
1.5 What the information pack covers .............................................................................. 8
2. Chapter 1: Laboratory facilities and management ......................................................... 10
2.1 Collaboration, culture, and advocacy ....................................................................... 10
2.2 Reducing energy consumption ................................................................................. 11
2.3 Water usage ............................................................................................................. 14
2.4 Waste ....................................................................................................................... 16
2.5 Procurement ............................................................................................................. 20
3. Chapter 2: Testing methods and solvents ..................................................................... 22
3.1 Regulatory guidelines ........................................................................................... 22
3.2 Research design ...................................................................................................... 22
3.3 Testing methods ....................................................................................................... 25
3.4 Solvents ................................................................................................................... 28
4. Chapter 3: Monitoring and measuring ‘greenness’ ........................................................ 30
4.1 Laboratories ............................................................................................................. 30
4.2 Testing methods ....................................................................................................... 30
Where to start .................................................................................................................... 32
Next steps ......................................................................................................................... 33
References ........................................................................................................................ 34
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Case study list
Case studies have been collated from an open call for contributions that went up on the BP
website. Case studies on internal practices have also been included. We would welcome
receiving further case studies to incorporate into future iterations of this document. Please
see our page on how to provide case studies.
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Terminology
Definition of emission scopes1:
Scope 1: Direct emissions such as from refrigerants, on-site electricity generation and
gas consumption for heating.
Scope 2: Indirect emissions from energy directly consumed such as from electricity
purchased from an off-site generator.
Scope 3: Indirect emissions across an organisation’s whole value chain (for example,
travel, laboratory equipment, chemicals, materials and waste).
GWP – ‘Global Warming Potential’, which is a measure of how much energy the emissions
of 1 tonne of a gas will absorb over a given period of time, relative to the emission of 1 tonne
of CO2. GWPs provide a common unit of measure to allow comparisons of the global
warming impacts of different gases2.
CO2e – 'Carbon Dioxide Equivalent', which is used to measure and compare emissions from
greenhouse gases based on how severely they contribute to global warming3.
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1. Introduction
In 2019, the UK Government committed to net zero greenhouse gas emissions by 2050 and
healthcare contributes approximately 5% of the UK’s emissions4,5. Recent reports, such as
from the Office of Health Economics, highlight the joint action that needs to be undertaken
by the UK government, the NHS and industry, in order to tackle healthcare’s carbon
footprint. In the 2022 Annual Report, the Medicines and Healthcare products Regulatory
Agency (MHRA) committed to reducing its carbon emissions and adopted several Net Zero
ambitions to meet targets set in the 2021 Greening Government Commitments. These
ambitions span from achieving a net zero building estate to reducing water consumption and
minimising waste by embracing a ‘circular economy’. Whilst these ambitions are internally
focused, following initial consultation with interested stakeholders, the British
Pharmacopoeia (BP) Secretariat has developed this environmental sustainability information
pack as a starting point, for BP users and other relevant professionals, to encourage and
support the adoption of more sustainable practices where appropriate.
As detailed in section 2.1, collaboration, culture, and advocacy are important actions to drive
forward sustainability alongside more practical measures. This information pack is the BP’s
initial step in outwardly advocating for sustainable changes where possible. This information
pack aims to support industry’s efforts in reducing environmental impacts through:
Uniting the sector’s action and ambition behind sustainability.
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1.2 Reasons to act on sustainability
Paris Agreement
Many global biotechnology and pharmaceutical companies are setting targets according to
the Science Based Targets Initiative. This provides companies with a clearly-defined path to
reduce emissions in line with the Paris Agreement goals – which are limiting global warming
to well-below 2°C above pre-industrial levels and pursuing efforts to limit warming to 1.5°C6.
Figure 1. Number of companies that have targets aligned with different warming scenarios (3-5°C, 2-3°C, 1.5-
2°C and 0-1.5°C scenarios). Taken from ‘The Carbon Impact of Biotech & Pharma’ report.
Supplier requirements
From January 2021, all new procurements from UK Government ‘in-scope organisations’
had to apply the social value model laid out in Procurement Policy Note (PPN) 06/20, which
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includes ‘fighting climate change’8. Following this, from September 2021, prospective
suppliers bidding for UK government contracts above £5million a year from these ‘in-scope
organisations’ needed to have committed to the government’s target of net zero by 2050 and
to have published a carbon reduction plan, as outlined in PPN 06/219.
The National Health Service (NHS) has committed to reaching net zero by 2045 for the
emissions they influence; through the goods and services they buy from partners and
suppliers10. Aligning with PPN 06/20 and 06/21, in 2021, the NHS England Public Board
approved a roadmap to help suppliers align with this net zero ambition between now and
2030. The initial stages of the roadmap include10:
From April 2022, all NHS procurements will include a minimum 10% net zero and social
value weighting (building on PPN 06/20).
As of April 2023, for all contracts above £5 million per annum, the NHS will require
suppliers to publish a carbon reduction plan (CRP) for their UK Scope 1 and 2 emissions
and a subset of scope 3 emissions as a minimum (aligning with PPN 06/21).
From April 2024, the NHS will extend the requirement for a CRP to cover all
procurements.
Cost savings
Adopting environmentally sustainable practices has the potential for cost savings. By
reducing energy consumption, water usage and waste generation, operational costs can be
lowered. Examples of financial savings have been outlined in case study boxes throughout
this information pack.
Staff at the BP laboratory have also already begun to implement sustainability into their ways
of working. These include several laboratory management practices from re-using packaging
where appropriate to actively avoiding over-ordering laboratory consumables. It further
includes steps to reduce chemical consumption such as through harmonising and adjusting
methods prior to starting monograph development (see case study 5). Moreover, the BP
Laboratory have recently taken action to reduce the environmental impact of the packaging
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used to send our BP chemical reference substances (see case study 2) and have
successfully trialled recirculating solvents for isocratic assays (see case study 7).
Going forward, the BP team are aiming to accelerate efforts to reduce the environmental
impact of the standards it produces and will be considering ways to make future content, as
well as revisions to existing content, more environmentally sustainable where possible. In
terms of more widely across the Agency, in the 2023 to 2026 Corporate plan, MHRA has
committed to deliver, by the end of March 2025, a sustainability strategy for medical
products in conjunction with international regulators, which contributes to addressing the
climate change emergency.
1.4 Disclaimers
The BP secretariat has not independently assessed the case studies BP users have
contributed to this information pack. However, they are a valuable means of sharing sector-
wide sustainability actions being taken and provide examples of changes that can be made
to encourage others to adopt similar approaches.
There are already many resources and initiatives aimed at improving the sustainability of
laboratories. The purpose of this information pack is not to duplicate this work but to use the
BP platform to raise awareness and encourage engagement with these materials. This
information pack is a starting point and will be iterated over time to accommodate more
useful sustainability practices. As such, we would greatly welcome your feedback and
contributions for the next iteration of this information pack.
Lastly, in examples where certain providers are specified, these are for information and are
not endorsements of these providers over others who may offer similar services.
This information pack has been divided into three chapters. The first chapter outlines
suggestions for how to manage the running of your laboratory and its facilities more
sustainably. The second chapter brings in more specific information around quality control
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testing methods and solvents, with the third chapter summarising key resources and current
work underway on measuring ‘greenness’.
Engagement with industry in shaping the development of this information pack suggested
the need for a key focus area to be on reducing CO2 emissions. Ways to reduce the energy
consumption (scope 1 and 2 emissions) of laboratory facilities and through testing methods
have been suggested. However, it is important to note that ‘The Carbon Impact of Biotech &
Pharma’ report found scope 3 emissions of biotechnology and pharmaceutical companies to
be 3.3 - 4.3 times higher than scope 1 and 2 emissions combined, with much of these scope
3 emissions coming from purchased goods and services. As such, the section on
procurement within the first chapter of the information pack highlights suggestions for
making greener purchases.
The Royal Society of Chemistry (RSC) undertook research to find out what scientists were
already doing in terms of sustainability in their laboratories. These actions have been
included in the chapters below alongside suggestions from other sources. However, as
cautioned in the RSC’s report, these actions1:
May not be the best option, a good option, or even an option, in every context.
May come with challenges and trade-offs in everything from health and safety or
research quality, to cost, culture, and lack of data to enable decision-making.
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2. Chapter 1: Laboratory facilities and management
The RSC has published several suggested ways to enhance ‘collaboration, culture and
advocacy’ in their ‘Sustainable Laboratories’ report. These findings are based on a survey
with 700 respondents as well as discussions with their expert member groups on what they
are currently doing to drive forward sustainability. Their suggestions, which have been
reproduced below, are to1:
Establish a laboratory culture where considering environmental sustainability is expected
and normalised.
Draw on the skills and interests of new recruits to bring more sustainable approaches to
laboratory culture and practice.
Seek certification and awards, for example: LEAF, LEAN, My Green Lab.
• Many of these programmes will help you to ‘score’ how sustainable your laboratory
is currently and provide suggestions for how to improve.
Draw on the knowledge and skills of research collaborators to identify and implement
more sustainable approaches.
Build skills and experience as part of research visits to laboratories with higher
‘sustainability credentials’.
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Collaborate with internal sustainability experts and professionals: technicians,
sustainability managers, sustainability officers, waste management experts, or
colleagues with expertise in specific areas (for example, chemical engineering or green
chemistry).
It’s estimated that laboratories use 3-10 times more energy per metre squared than a typical
office11, with approximately 20-25% of energy being used by laboratory equipment, 25% by
heating, 13% by lighting, 13% by cooling, and 22% by fans12. Of the equipment typically
found in a laboratory, fume hoods and Ultra-Low Temperature (ULT) freezers are among the
most energy intensive1.
Fume hoods
A single chemical fume hood can use as much energy as 3.5 households every day due to
the large volume of air that must be moved through the hood by the ventilation system12.
Additionally, in a VAV fume hood, lowering the sash reduces the volume of air being
exhausted by the ventilation system and can result in energy savings upwards of 40%12.
Lowering the sash also helps to ensure the safety of laboratory personnel.
• Try putting up stickers to remind laboratory personnel to lower the sash. Example
stickers to use can be found from various providers.
However, it is important to ensure that fume hoods operate safely and meet minimum
face velocities required. Additionally, given that many hoods have cupboards below to
store potentially harmful materials, they must operate at all times.
ULT freezers
A single ULT freezer uses as much energy as one household every day12. Good freezer
management will help to reduce energy usage and will make freezers less likely to fail.
The University of Edinburgh’s Social Responsibility and Sustainability Department
undertook some research into best practice for ULT freezer management. Below is their
list of recommended actions to take and associated potential financial savings per
freezer13:
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Save space by clearing out old samples save (up to £1,000/year for every ULT
freezer you can retire)
Clean freezer filters and fins (save up to £230/year per freezer compared to a freezer
with severely dusty filters and fins)
Run your freezers a little warmer (up to £300/year saving per freezer)
• Raising temperatures from -80°C to -70°C, can produce almost 30% plug-load
energy savings. There are several sources listed in the University of Edinburgh’s
guidance which show a variety of samples are stable at -70°C.
• Consider how best to validate increasing storage temperatures for products in the
most efficient way, and the longer-term benefits of scaling these changes across
multiple freezers against any short-term costs.
• Consider whole life costs when replacing freezers, in particular the longer-term
benefits against the short-term costs that include the impact of removing the old
freezer (see case study 1).
• Some fridges and freezers contain fluorinated greenhouse gas (or ‘F-gas’)15. F-
gases have a high Global Warming Potential (GWP). Before purchasing a new
freezer check the refrigerant and explore options to purchase freezers that use
alternative substances with a lower GWP. The European Commission provides
some suggestions for alternative substances to commonly used refrigerants for
industrial refrigeration.
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Case study 1:
MHRA replaces old freezers
The MHRA site in South Mimms recently replaced old freezers that had reached the end of
their working life with newer ones that consume almost 50% less energy, and as a result,
almost halve associated electricity costs and CO2e emissions (see Table 1).
Not only does the reduced energy consumption have a positive environmental impact, but
the refrigerants in the new freezers also contain no fluorinated hydrocarbons and have a
~99% lower GWP compared to the refrigerants in the old freezers.
Whilst newer freezers can be more expensive upfront, considering the lower operating costs
from reduced electricity consumption over the freezer’s lifetime, total cost savings can be
significant – in this case approx. £4,000 (based on a minimum freezer lifespan of 12 years).
Table 1: Comparison of the electricity consumption, associated costs, and emissions, as well as
refrigerants used in the old vs new freezer
Annual Annual
Average electricity Refrigerant (kg
Freezer Capacity electricity electricity
consumption CO2e per unit§)
cost* emissions**
Old freezer
13.2 kWh /day Approx. Approx. R404a (3922)
‘New Brunswick 535 L
4,818 kWh /year £1,000 1,000kg CO2e R508B (13396)
U535’
*Estimated using 20.86 pence per kWH as the average price of electricity for 2022 (for non-domestic
consumers in the UK, including the climate change levy), published: https://www.gov.uk/government/statistical-
data-sets/gas-and-electricity-prices-in-the-non-domestic-sector
**Estimated from UK Government Greenhouse Gas (GHG) Conversion Factors (see link below) for kg CO2e
associated with electricity generation, transmission, and distribution.
§
1 unit = 1 kg. Emissions taken from UK Government GHG Conversion Factors:
https://www.gov.uk/government/publications/greenhouse-gas-reporting-conversion-factors-2022
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Other ways to reduce ULT freezer energy consumption:
Use a clear inventory system to keep the freezer organised and reduce open door time.
Don’t store items on top of freezers as it reduces the air circulation that they need to
work efficiently.
Report any issues like heavy icing, broken seals, or dirty filters to the freezer manager.
Replace damaged seals as soon as possible.
Turn off equipment when not in use. Alternatively, fit timer plugs to programme certain
equipment to only be on during operational hours for suggested savings of around
10%/year on each item of equipment16. However, before implementing, it is important to
check that more frequent switching off is not going to cause any technical or data
integrity issues.
• Equipment with some of the larger energy usages, including estimated figures for
annual kWh/unit and annual cost/unit, has been tabulated by the University of
Edinburgh’s Social Responsibility and Sustainability Department. For example, a
10% energy saving with a timer plug on a mass spectrometer could save
£114/year16.
Turn off computers and monitors completely when not in use, instead of using
screensavers12.
• Ultraviolet (UV) sterilizers only need to be on for 30-minutes in tissue culture hoods.
Leaving them on for longer can lead to the breakdown of any plastics in the hood, as
well as affecting people working in the area12. As such, consider setting timers for a
30-minute sterilisation cycle where possible.
Monitor and report times for a reaction to complete to reduce resources used when the
reaction is repeated (for example, report ‘seven hours’ rather than ‘overnight’)1.
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heating water17. Some of the largest laboratory uses of water have been discussed below,
alongside wider suggestions for reducing water usage.
Use a recirculating water bath (better for reactions that are greater than 1 L)12.
Autoclaves
Autoclaves can use as much as 270 L of water per cycle, and if your autoclave is >10 years
old, it likely uses 1.5x more water per cycle12. Suggestions for ways to improve autoclave
practice and reduce associated water usage have been reproduced from My Green
Lab and include12:
Consolidate loads and use the right-size autoclave.
• Old autoclaves continuously discharge cold water, but water-saving devices enable
this cold water to be released only when needed.
Be sure you have the right kind of autoclave for the number of cycles you run. If it's
fewer than 5 per day, a non-jacketed autoclave is most appropriate.
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Establish efficient labware washing practices, by running dishwashers, autoclaves, and
cage washers only when full12.
• A common misconception is that glassware washers use more water than hand
washing, however, glassware washers are much more efficient and effective18.
Identify the minimum quality of water required and use treated water only when
necessary. The purification procedure, often by reverse osmosis (RO) systems,
produces huge volumes (25%-50%) of reject water to remove impurities which typically
goes to waste18.
• Explore opportunities for reject water to be reused for other processes e.g., toilet
flushing.
2.4 Waste
It has been estimated that laboratories are responsible for around 2% of global plastic
waste11. Adopting the reduce, reuse, recycle hierarchy can help to minimise your
laboratory’s waste generation.
Reduce
The best way to make a difference in the amount of waste your laboratory generates is to
reduce its production from the start. Ways to do this include:
Substitute single-use plastic for glass or other reusable materials, such as using glass
pipettes or reload systems instead of single-use pipette tips12. Another example is to
replace single-use plastic syringe filters with glass filter holders, where the filter papers
can be changed each time.
• A full list of effective substitutions can be found in guidance from the University of
Edinburgh’s Social Responsibility and Sustainability Department.
• Not only will this reduce the amount of waste the laboratory produces, but also
scope 3 emissions, as shown by UCL’s data on CO2e emissions for glass vs.
plastics across production and disposal14.
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Consolidate orders and only order what you need (bulk purchases are only a good deal if
you need that much)12 to reduce packaging waste.
Make conscious decisions to use smaller boxes and less (or no) polystyrene in
containers. Purchase from organisations that have sought to reduce their packaging12.
Case study 2:
BP Chemical Reference Substances Packaging Change
The BP Laboratory is responsible for the production of BP Chemical Reference
Substances (BPCRS) which are used to support the monographs of the BP. For this
service, the Laboratory dispatches BPCRS orders to customers.
In September 2023, the polystyrene BPCRS vial boxes were replaced with cardboard
packaging to reduce the environmental impact (see images below). Based on published
Government greenhouse gas reporting conversation factors, for the same weight of
material, the CO2 equivalent emissions associated with the production of cardboard are
77% lower than those for polystyrene.
The polystyrene BPCRS vial boxes were only able to hold up to 3 vials. Comparatively,
the cardboard boxes can hold up to 9 vials. Given that 3 polystyrene boxes would be
needed to store the equivalent 9 vials, the 1 cardboard box gives a weight saving and
therefore an even greater environmental impact reduction.
In addition, BPCRS customers can more easily reuse or recycle this cardboard
packaging.
Images: Polystyrene BPCRS vial box on the left and the cardboard packaging on the right.
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Reuse
The next best way to impact waste is to reuse consumables. Ways to do this include:
Consider washing and reusing single-use plastics and packaging, for example12:
• Conical tubes and even pipette tips can be washed and/or autoclaved and reused,
provided this gives a lower environmental impact than discarding.
Consider alternative uses for otherwise waste items, such as using polystyrene boxes as
ice boxes or to fill empty spaces in cold storage, which will also help to keep freezers at
a constant temperature13.
Consider glove thickness. Where you need to change gloves more regularly, for example
when contamination concern is high, use thin gloves as these contain less plastic.
However, where you can wear gloves for multiple uses, use thicker gloves as thin gloves
will be more likely to break and harder to put back on13.
Recycle
Whilst it is better to reduce and reuse, recycling is still a great way to minimise the amount of
waste incinerated or sent to landfill and to save money as recycling streams are 5-10 times
cheaper13. The options for recycling in your laboratory are likely dictated by where you live
and regulations in your country, city, and organisation, so check with your local waste hauler,
organisation’s safety officers, facilities management, and building management about what
you can recycle12. Consumables to consider recycling and suggestions of specialist
providers for these waste streams (reproduced from My Green Lab)12:
Gloves (note this is a special waste stream - gloves can be recycled by Kimberly-
Clark or Terracycle)
Cardboard
Conical tubes
Centrifuge tubes
Pipette tips
Reagent and chemical bottles (ensure that these are clean per your organisation’s
guidelines)
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Glass bottles
Hazardous waste (note this is a specialised waste stream that may be handled
by Triumvirate)
Batteries
To note, where certain providers are specified, these are for information and are not
endorsements of these providers over others who may offer similar services. Other
laboratory equipment and consumables recycling service suggestions include:
LabCycle has created a circular economy for single-use plastic waste from safety level
1&2 laboratories.
Solvents can be recycled and recovered, or otherwise repurposed and sold back into the
industry, such as by Veolia (see case study 3).
Case study 3:
Solvent recycling and repurposing
AstraZeneca partners with Veolia for chemical waste management at their Macclesfield site.
Liquid solvent waste from analytical and process chemistry work is segregated into
halogenated and non-halogenated waste streams and transported to an off-site specialist
recycling facility. Where possible, solvent is recycled, but if not, the waste is blended to
produce a secondary liquid fuel which is incinerated, and the energy recovered to power
industrial units near the Veolia site. In 2021, approximately 11 tonnes of solvent were
recovered from the Macclesfield site for this purpose.
Take-back programmes
These are initiatives where the manufacturer or retailer collects used products or materials
from consumers and reintroduces them to the original processing and manufacturing cycle.
Participating in these programmes is one way to recycle your waste and improve the circular
economy of your laboratory. Where possible, collating laboratory waste with other local
laboratories is a good way to reach a critical volume to help make the recycling and take-
back more effective. Always enquire with suppliers if they have a take-back scheme. The
following take-back programmes are either free or relatively low cost and have been taken
from My Green Lab and UCL’s LEAF resources12,13:
Agilent (laboratory instruments)
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Corning (all packaging)
Promega Package Return (polystyrene boxes comes with a pre-paid address label to
post it back for recycling)
NEB Package Return (each shipping box comes with a FreePost label to send it back)
Thermofisher Mauser and Winchester return scheme (collection and recycling service for
used Fisher Chemical 2.5 L glass (Winchesters) and plastic-coated glass bottles)
Starlab Tip Box Scheme (returned tip boxes are mostly recycled, but some are reused)
Additionally, there are several trading markets for used laboratory equipment such as:
British Medical Auctions (to buy and sell used laboratory equipment)
Consider placing bins separately to denote use, for instance, don’t place clinical waste
bins next to recycling bins to avoid contamination.
Update standard operating procedures to cover all relevant materials, and how they
should be handled and disposed of.
2.5 Procurement
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Use databases that provide third-party, verified information about the environmental
impact of the product.
• My Green Lab has a sizeable database of environmental impact factor labels for
equipment, consumables, and chemicals & reagents. The Accountability,
Consistency, and Transparency (ACT) label process entails third-party verification of
the sustainable impacts of a product, its operations, and its end of life12. This allows
the environmental impact factor scores of products to be compared to inform
decision-making when purchasing but does not provide a calculated environmental
impact value for the product.
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3. Chapter 2: Testing methods and solvents
Monographs of the Ph. Eur. that are incorporated in the BP are governed by the general
notices of the Ph. Eur., for which the following statement applies: ‘The tests and assays
described are the official analytical procedures upon which the standards of the Ph. Eur.
are based. With the agreement of the competent authority, alternative analytical
procedures may be used for control purposes, provided that they enable an unequivocal
decision to be made as to whether compliance with the standards of the monographs
would be achieved if the official procedures were used. In the event of doubt or dispute,
the analytical procedures of the Ph. Eur. are alone authoritative.’
Improving the design of testing methods can help to lower your energy, water, and
consumables consumption, as well as waste generation. Things to consider when
designing your testing methods include:
Conduct risk assessments on environmental impact as part of project design1.
Produce detailed documentation and reporting of results to ensure the wider community
can access and reproduce experiments. Recording and sharing data, including negative
results, supports a ‘right first time’ approach and helps to reduce the number of failed
experiments that result in 100% waste generation.
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• For example, Code Carbon is an open source software, compatible with Python, that
tracks emissions associated with code execution and Green Algorithms calculates
the carbon footprint associated with computations.
• Integration of analytical processes and operations saves energy and reduces the
use of reagents.
These are an adaptation of the 12 principles of green chemistry which were designed to
meet the needs of synthetic chemistry and as such aren’t fully suitable for their application to
analytical chemistry.
The first principle is to avoid sample treatment. However, for some samples this is difficult to
achieve. Instead of neglecting this principle, efforts should turn towards adopting a
framework for green sample preparation, such as the 10 principles of green sample
preparation published in a recent article in Trends in Analytical Chemistry. These principles
cover similar aspects to those found in the GAC approach but have been clearly adapted to
the requirements of sample preparation.
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Moreover, alternatives to the 12 principles of GAC exist, such as the 12 principles of White
Analytical Chemistry (WAC). In addition to green (environmental friendliness and safety)
aspects, WAC takes into account red (analytical efficiency) and blue (practical and
economic) aspects that affect the quality of the method. An algorithm (RGB 12) has been
developed to enable a quick evaluation of methods against the proposed 12 principles of
WAC, allowing the whiteness (i.e., degree of sustainability) of a method to be assessed.
Case study 4:
Digital tools in analytical method development
AstraZeneca has a focus on the use of digital tools to model and simulate experiments,
reducing the time taken and volume of waste generated during method development. For
example, for liquid chromatographic method development, by running as few as two
experiments (e.g., to simulate changes in chromatographic gradient), it is possible via
mechanistic equations to predict and optimise methods in-silico, often with experimental
accuracy of <2 seconds. It is estimated that this reduces the time it takes to develop the
method and volume of waste generated by approx. 50%.
Additionally, digital tools are used for accelerated predictive stability testing, whereby a small
number of accelerated degradation experiments at different temperatures and humidities are
used to extrapolate and predict shelf-life of a drug substance or product. This reduces the
need to perform multiple analyses to monitor degradation in real time over a much longer
time frame, and thus reduces experimental waste.
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Case study 5:
Harmonising analytical methods
Wherever possible, the BP laboratory seeks to harmonise related substances and assay
HPLC methods during monograph development. This reduces both the volume of solvent
and amount of standard used as solutions can be used for multiple purposes across the two
tests.
Cytarabine example: For the Cytarabine monograph it was determined that a single
method could be used for both the assay and related substances tests. This reduced the
overall number of chemicals consumed from 5 to just 2, and more than halved the volume of
methanol required (see Figure 2).
Sodium hydroxide (g)
Methanol (L)
Figure 2: Cytarabine monograph - comparison of the amount of reagent used for combined vs separate
methods.
Furthermore, where assay methods are based on related substances methods, discussions
are held prior to starting monograph development to reduce run times and change to
isocratic methods where possible, to avoid excessive use of solvents which then require
disposal.
Use analytical methods and instruments that require smaller sample sizes and reduce
the dead volume in solvent delivery systems such as HPLC.
Switch out inert gases as carriers in gas chromatography, such as helium which is non-
renewable, where feasible and safe to do so.
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• For example, previous research has indicated hydrogen to be a suitable replacement
to helium, with little or no change in chromatographic resolution, and that many
analytical laboratories are actively using hydrogen generators to supply hydrogen on
demand20.
During sample preparation, adjust diluent pH for ionisable analytes, instead of increasing
the volume of organic solvent in the sample.
Case study 6:
Scaling column dimensions
The Egyptian International Pharmaceutical Industries Company (EIPICO) has been using
the permitted adjustments of chromatographic conditions (Ph. Eur. method 2.2.46) to scale
the internal diameter of the column stated in the related substances method for the
Hydrocortisone Sodium Succinate Injection monograph, from 4.6 mm to 4.0 mm. This has
reduced the volume of solvent used by around 25%.
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Case study 7:
Recirculating solvents to reduce waste
The BP Laboratory have successfully trialled recirculating solvents for isocratic assays. For
this, the analysts recirculated the mobile phase back into the reservoir rather than running to
waste. The three trials that have been carried out so far have all been reverse phase
chromatography HPLC. This successfully reduced the amount of solvent used by an
average of 45%, saving a total of 1700 mL of mobile phase over the three analyses.
For one isocratic assay trial, the analysts also trialled not pre-mixing the solvents for the
mobile phase. The two solvents used were water and acetonitrile (as this needed to be a
non-phosphate buffer). The analysts made separate aqueous and organic portions of the
mobile phase and used the LC pumps to mix the correct proportions. Following completion
of the analysis, approximately 500 mL of acetonitrile remained, which could be used for
other projects in the laboratory instead of being wasted.
For all the trials carried out, the retention times, system suitability, resolution and baseline
noise were monitored throughout the sequence and no impact was observed. Based on
solvent prices quoted on suppliers’ websites, the trials so far represent an approximate total
saving of £87 (excluding waste disposal costs savings).
Regulatory Note:
Any changes to testing methods should be controlled and managed properly within the
GMP/quality system. Application of solvent recirculation, as trialled by the BP Laboratory
analysts, should only be used when the sample is not critical. The BP Laboratory has only
trialled recirculation on isocratic assays due to the lower risk of these methods being
affected by small changes in the sensitivity. However, examples of checks to assure that the
method still provides accurate results following such a change include:
- Baseline noise
- Signal to noise ratio
- Resolution between peaks
- Uncertainty of the measurement
- Retention times
- System suitability
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3.4 Solvents
Considering the solvents used is an important aspect of method design. In addition to their
carbon footprint and human health impacts, chemicals can – depending on how they are
produced, used, and disposed of – result in the pollution of air, water, and soil. Alongside
reducing the volume of solvent used through the method design, choosing greener
alternatives is essential to reducing the generation of hazardous waste as well as human
and environmental exposure to hazardous chemicals. There are several resources and
solvent or reagent selection guides to support the use of greener alternatives,
including:
The Green Chemistry journal has published a selection guide from ranking solvents
based on their safety, health, and environment impact scores.
The American Chemistry Society (ACS) Green Chemistry Institute has produced a
solvent selection guide that rates solvents against 5 categories: safety, health,
environment (air), environment (water), and environment (waste).
The ACS also has a solvent selection tool that provides the ability to interactively select
solvents based upon the principal component analysis of the solvent's physical
properties. Solvents mapped close together have similar physical and chemical
properties. The environmental impact rankings for each solvent can be overlaid as part
of the tool’s functionality. A similar tool is under development, focused on acids and
bases.
Avoiding excess preparation of mobile phase by calculating the exact amount of solvent
required through considering the number of injections and volume needed for dissolution
media preparation.
Case study 8:
Alternative solvents for liquid-liquid extraction
The Egyptian International Pharmaceutical Industries Company (EIPICO) has been
exploring solvent substitutions for liquid-liquid extraction. Specifically, in the BP monograph
for Hydrocortisone Acetate Ointment, n-hexane has been replaced with ethanol. Ethanol has
a much better safety, health and environmental score as ranked in the ACS solvent selection
guide. The extraction can also be performed at a lower temperature to avoid any
vaporization of the ethanol. This analytical method, whereby ethanol is used as the
extracting solvent, is fully validated, and approved by the Egyptian drug authority.
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Case study 9:
Modernisation and use of alternative solvents for chromatographic methods
AstraZeneca has been exploring the opportunity afforded by pharmacopoeia permitted
chromatographic changes, alongside the use of alternative solvents to both improve
performance and analytical method sustainability.
In one example, consolidation of two HPLC methods into a single UHPLC method whilst
simultaneously moving from acetonitrile eluent to ethanol, led to a step change reduction in
carbon footprint (88 kg to 1.6 kg) and water depletion (150 m3 to 3 m3) across the raw
material lifecycle per 100 batches analysed.
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4. Chapter 3: Monitoring and measuring ‘greenness’
4.1 Laboratories
To improve the sustainability and efficiency of your laboratory, monitoring resource use can
support decision-making on the most emissions-reducing and cost-effective changes to
implement. Suggested ways and resources to support monitoring and measuring
laboratory environmental impacts include:
Seek accreditation and/or certification from one of several programmes available.
• Many of these programmes will help you to “score” how sustainable your laboratory
is currently and provide suggestions for how to improve.
Conduct daily, weekly, or monthly audits and routines related to energy, water,
chemicals, and waste1.
• Given that most of the factors used to calculate emissions are based on CO2e per
monetary value of spend by product category, this can be used as a first
approximation to get a quick estimate of scope 3 emissions. However, where
possible, it is best to get primary data from suppliers.
To improve the environmental impacts and efficiency of your testing, ‘greenness’ metrics and
calculators allow the overall sustainability of methods to be evaluated. A recent critical
review in Analyst provides an overview on the most commonly used metrics for assessing
the environmental impact of analytical techniques24. However, some suggested metrics
with easy-to-use online interfaces include:
The American Chemistry Society Green Chemistry Institute has created the Analytical
Method Greenness Score (AGMS) calculator to compare methods during development.
It produces a score that factors the safety, health, and environmental assessment of the
solvents utilised, as well as solvent energy demand, instrument energy consumption,
and waste production to compare one method to another.
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The Analytical GREEnness calculator (AGREE) was created in 2020, based on the 12
principles of GAC. The tool is intended to evaluate the environmental and occupational
hazards associated with an analytical procedure.
The British Standards Institute is convening an ecosystem for exploring the development
of an industry standard to define environmental footprint measurements for “sustainable
product medicines”. This programme of standards will look at the lifecycle of medicines,
including analytical methods and testing.
As another example, AstraZeneca identified that their uniformity of content methods being
used during development had high AMGS scores. This was due to typically non-optimised
long chromatographic methods combined with significant sample preparation (10 individual
tablets must be analysed) associated with this type of testing. Moving forward, wherever
possible, a uniformity of weight approach will be used instead which will completely remove
the chromatographic measurement.
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Where to start
Various organisations have put together ‘first steps’ guides or ‘how to get started lists’ to help
laboratories begin their sustainability journeys.
The RSC has developed a list of things to explore when starting to incorporate
sustainability in the laboratory. This slide neatly summarises a number of the sections
covered above and provides a useful direction for initial action.
Green Labs Austria have put together a ‘first steps toward sustainable lab work’ which
outlines their top actions to take to run your laboratory and machines more sustainably.
• For example, UCL’s LEAF guides users through sustainability actions to save
plastics, water, energy and other resources in their laboratory. In addition, it provides
online calculators to estimate how sustainable your laboratory is now and to track
improvements in terms of both financial and carbon impacts.
• Prior to launching online, LEAF was piloted across 23 different institutions in over
230 laboratory groups. On average each group reported 2.9 tCO2e was avoided and
£3,700 was saved25.
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Next steps
This information pack is a starting point and will be iterated over time to accommodate more
useful sustainability practices. As such, we would greatly welcome your feedback and
contributions for the next iteration. Your involvement will support greater collaboration in
developing this information pack further, helping to enable widespread, positive
environmental impacts across laboratory users and the quality control testing community.
Any feedback on the information pack or further sustainability practices to include are also
welcomed!
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References
1 - https://www.rsc.org/globalassets/22-new-perspectives/sustainability/sustainable-
labs/sustainable-laboratories-report.pdf
2 - Understanding Global Warming Potentials | Greenhouse Gas (GHG) Emissions | US EPA
3 - What is CO2e? Carbon Dioxide Equivalent Definition, Meaning & Impact | Inspire | Inspire
Clean Energy
4 - https://lordslibrary.parliament.uk/climate-change-targets-the-road-to-net-
zero/#:~:text=The%20Climate%20Change%20Act%2C%20as%20amended%20in%202019
%2C,gas%20emissions%20by%202050%2C%20compared%20to%201990%20levels.
5 - https://www.gov.uk/government/publications/life-sciences-vision
6 - https://sciencebasedtargets.org/
7 - https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_1840
8 - https://www.gov.uk/government/publications/procurement-policy-note-0620-taking-
account-of-social-value-in-the-award-of-central-government-contracts
9 - https://www.gov.uk/government/publications/procurement-policy-note-0621-taking-
account-of-carbon-reduction-plans-in-the-procurement-of-major-government-contracts
10 - https://www.england.nhs.uk/greenernhs/get-involved/suppliers/
11 - https://www.ucl.ac.uk/sustainable/leaf-laboratory-efficiency-assessment-framework
12 - https://www.mygreenlab.org/
13 - https://www.ed.ac.uk/sites/default/files/atoms/files/freezers_best_practice_guide.pdf
14 - https://www.ucl.ac.uk/sustainable/leaf/resources-and-materials
15 - https://www.gov.uk/f-gas-fridges-freezers
16 -
https://www.ed.ac.uk/sites/default/files/atoms/files/lab_equipment_best_practice_guide.pdf
17 - https://www.unwater.org/water-facts/water-and-climate-change
18 -
https://www.i2sl.org/documents/I2SLBestPractices_WaterEfficiencyinLaboratories_June202
2_v2.pdf
19 - https://www.sciencedirect.com/science/article/abs/pii/S0165993613001234
20 - https://www.sciencedirect.com/science/article/pii/S0731708518316649?via%3Dihub
21 - https://www.tandfonline.com/doi/full/10.1080/10826076.2017.1373672
22 - https://www.pharmacopoeia.com/bp-2024/appendices/appendix-03/appendix-iii-
chromatographic-separation-techniques.html?date=2024-01-01
• If the link above is not accessible, please see a stage 4 consultation draft of the text
on the ‘adjustment of chromatographic conditions’, available to the public to download
via the USP’s website here: https://www.usp.org/harmonization-
standards/pdg/excipients/chromatography
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23 -
https://www.waters.com/webassets/cms/library/docs/local_seminar_presentations/FI_USP_6
25_Stimuli_Article.pdf#:~:text=Analysis%20time%20decreases%20with%20both%20the%20
shorter%20columnlengthland,solvent%20per%20analysis%20isreduced%20with%20the%20
shorter%20column.
24 - https://pubs.rsc.org/en/content/articlelanding/2023/an/d3an00498h#!
25 -
https://www.sustainabilityexchange.ac.uk/leaf_a_new_approach_to_achieving_laboratory_s
us
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