Life Cycle Analysis Problem Statements
Problem 1 – Life Cycle Inventories and Assessments of Excipients
and Other materials Used in Secondary Manufacture
Problem Statement
There is very limited life cycle inventory (LCI) information for secondary operations,
including technology profile, LCI data for excipients, and energy requirements.
Exemplification of Problem
Secondary operations, the next step after API manufacture, combines the API
into formulations and its final product form. GSK currently has information on the
life cycle inventories for solvents and have used this information for tools to help
chemists and engineers select “greener” solvents. However, LCI information of
excipients used in the product formulations is generally not available. In addition,
gate-to-gate life cycle inventory information of processes to manufacture the
formulations is not available. Some of these materials contribute significantly to
the GSK-wide environmental footprint, so
Examples of these excipients include:
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Magnesium stearate
Avicel
Povidone
Lactose
Hard gel capsules
Sorbitol
Glucamate
Expected Output of Research
Life cycle inventories for a list of excipients and typical secondary manufacturing
processes. GSK can provide a fuller list of excipients upon request.
Problem 2: Life cycle assessment of renewable and vaccine
materials
There is very limited Life Cycle Inventory (LCI) information for materials used in
bioprocesses, vaccines, and materials coming from agricultural and animal sources.
Problem Statement
There is very limited Life cycle inventories of materials from renewable sources,
materials used in bioprocesses and vaccines and LCIs of biotransformations.
Exemplification of Problem
GSK currently has life cycle inventory information on some materials from
renewable sources, has used this information to develop tools to help chemists
and engineers select “greener” solvents and other materials. A recent GSK-wide
carbon footprint has highlighted the gaps on LCI information needed for
renewable materials, materials used in bioprocesses, agricultural materials used
in vaccine production, and gate-to-gate or cradle-to-gate assessments of the
typical biotransformations used in GSK.\
Example of these materials include:
 Solvents that may be derived from renewable sources
 Ethyl Acetate
 Butanol
 Methanol
 Acetone
 Acetic acid
 Isopropyl acetate
 Agricultural materials used in vaccines and products
o Eggs
o Barley
o Malted barley
o Malt extract
o Milk powders
o Citric Acid
Expected Output of Research
Life cycle inventories for selected materials from renewable sources, materials
used in bioprocesses and vaccines and LCIs for biotransformations.
Problem 3: Blister Packaging Sustainability Problem Statement
Currently GSK Pharmaceutical solid oral dose blister packaging materials utilize a
significant amount of Polyvinylchloride (PVC). PVC reduction is identified as key to
improving our corporate sustainability profile and a replacement for PVC needs to be
identified.
Exemplification of Problem
The table below describes the current first intent blister forming materials as well as their
relative barrier to moisture. Since new product development trends seem to favor the
need for higher barrier materials we often utilize the PVC/PVdC or Foil option.
PVC/Aclar is typically only used for larger tablets (product foot print reasons). Any PVC
replacement evaluation must take into account product moisture barrier requirements.
First Intent Blister Forming Material Description
PVC Mono Layer
PVC/PVdC
PVC/Aclar/PVC
OPA/Foil/PVC
Relative Moisture Vapor
Barrier Property
Poor
Good
Very Good
Excellent
In addition to the forming material every blister pack has foil lidding material. The
current first intent lidding material utilizes a vinyl acrylic heat seal lacquer capable of
sealing to PVC and PVdC. Any PVC replacement material considered must also be able
to seal properly to the lidding material and may require reformulation of the heat seal
coating.
For several years polypropylene (PP) has been considered as a replacement for PVC
blister films. We have a lot of information relating to sustainability of PP however there
are blister processing concerns that have kept PP from being widely accepted. More
recently, COC blister films have been promoted as a more sustainable blister film
alternative. Cost and limited manufacturing capacity are potential concerns. The desire of
this proposal is to evaluate sustainable, non-PVC materials currently on the market and
novel sustainable materials that may be developed for the market.
Expected Output of Research
Identification of potential alternatives to PVC including the following:
- Environmental life cycle assessment
- Commercial viability and supply chain assessment
- Comparable processing conditions and efficiency to current films utilizing existing
blister packaging technology.
- Moisture barrier properties providing a range of performance, as above at ICH
conditions.
- Ability to seal to lidding material and pass leak / peel adhesion tests evaluated
- Test methods for evaluation of new material identified
Problem 4 - New technologies to replace electronic addons to inhalation devices
In order to improve patient compliance with the use of inhalation devices, electronic addons are sometimes requested, e.g. dose counters and other forms of patient information
display. These add-ons often include printed circuit boards and display screens which
require an energy supply, provided by a battery. More sustainable ways of providing
energy are required, through new technologies.
Exemplification of Problem
Electronic display screens providing patient information need to be permanently visible,
thus consuming energy. A system is required which requires energy only when there is a
need to change the display, e.g. through actuation of the device by the patient.
Expected Output of Research
Assessment of new technologies, which are more energy efficient for inhalation device
add-ons.
Problem 5. - Sustainable materials of construction for
Multiple Dose Inhalation devices
Inhalation devices typically consist of multiple components of precision moulded
polymers. New materials of construction are required which are more sustainable.
Exemplification of Problem
The Diskus inhalation device consists of 14 polymer components assembled as a circular
device containing a drive mechanism which, when actuated by the patient, accurately and
reproducibly advances a foil laminate strip to present a dose of API to a mouthpiece for
inhalation by patient.
Currently the best materials for this purpose are polymers, e.g. polypropylene, acetal,
polycarbonate and ABS.
Expected Output of Research
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New materials of construction which match the performance of current materials.
These materials should be from polymer produced from renewable sources.
Alternative approaches to the design of multidose inhalation devices which enable
manufacture using more sustainable materials such as the incorporation of cardboard.