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IFPMA Supports Plastic Materials And
Components For Safe And
Effective Medical Production Along With Circular Economy
The International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) supports the UN Global Plastics
“Instrument” because it could help create globally harmonized plastic
regulations. The IFPMA believes that these regulations are important for driving
innovative change while also ensuring that plastic materials and components are
safe and effective for medical production.
The innovative pharmaceutical industry is
proactively addressing its environmental footprint and embracing sustainable
initiatives. For instance, several leading pharmaceutical companies are
committed to reducing the impact of plastic waste through the adoption of
recyclable and biodegradable packaging materials
Importance of medical and medicinal products for
Human Health:
Medical and medicinal products are pivotal in
maintaining public health and well-being, driving healthcare outcomes, and
supporting economic growth. They prevent disease, alleviate symptoms, cure
illnesses, and enhance the quality of life for billions worldwide. From
antibiotics and innovative biologics to the COVID-19 vaccines and cutting-edge
medical devices, medical and medicinal products represent the pinnacle of
scientific achievement and medical progress.
Access to medical and medicinal products underpins
global health equity and social justice and, therefore, any requirements related
to use and disposal of plastics must not jeopardize the uninterrupted
availability of medical and medicinal products even considering the laudable
objective of minimizing the negative impact of plastics on planetary and human
health. The best way to do so under the Instrument is to establish targeted
extended compliance periods for medical and medicinal products to assure the
availability of appropriate alternatives that meet the quality, safety and
access requirements needed by our patients while alternatives are developed and
implemented. Exceptions to limitations on plastic use in healthcare applications
must be permitted when no safe or effective alternatives are available.
Throughout this process, engagement of regulators will be critical as most
changes to manufacturing processes and packaging will need to be approved before
being allowed to be marketed.
Plastics1 in medical product
manufacturing and packaging:
Plastic materials and components are indispensable
in every stage of the pharmaceutical lifecycle, and are crucial for medicine
production, quality, and safety. The use of plastics, like any material employed
in drug development and manufacturing processes, follows comprehensive and
intensive benefit-risk analyses, which are reviewed by experts at health
authorities worldwide. Currently, plastic materials and components cannot easily
be replaced by other materials while ensuring the same levels of patient and
healthcare practitioner safety. For example,
• In drug development, plastics facilitate the
synthesis, purification, and formulation of active pharmaceutical ingredients
(APIs), enabling precise dosing and controlled release mechanisms.
• Plastics are used in lieu of fiber based materials to minimize contamination
due to fiber particulate in pharmaceutical operations.
• Plastics play a crucial role in the healthcare sector due to their unique
properties such as versatility, durability, transparency, sterilizability and
biocompatibility. In addition, they enable
aseptic and sterile environments during manufacturing of biologics and sterile
injectables (for example biobags, tubing, and filters).
• Plastic packaging ensures the integrity, stability, and sterility of
medicines, safeguarding their potency and safety during storage and
transportation. Whether in the form of vials, blister packs, or infusion bags,
plastics offer versatility, reliability, and cost-effectiveness in
pharmaceutical packaging that is not easily replicable with other materials.
Broadly speaking, the use of plastics in
manufacturing provides a number of important benefits:
.(I) facilitates installation and qualification of
equipment, especially in low-income countries; (ii) reduces the amount of
electricity and water needed; (iii) increases productivity and scalability; and,
(iv) facilitates production in more diverse locations, especially in
lower-income countries.
Conscious of the negative impacts that plastic use
has on the environment and human health, many companies committed to and are
already working to reduce or eliminate the amount of plastic waste as well as
supporting more sustainable alternatives, such as recycling and longterm
circularity (see
Annex).
Positive efforts by the pharmaceutical industry
towards environmental sustainability
The innovative pharmaceutical industry is
proactively addressing its environmental footprint and embracing sustainable
initiatives. For instance, several leading pharmaceutical companies are
committed to reducing the impact of plastic waste through the adoption of
recyclable and biodegradable packaging materials. Furthermore, innovative
technologies such as green chemistry and continuous manufacturing hold promise
for reducing plastic usage and minimizing environmental impact throughout the
pharmaceutical supply chain.
However, as mentioned above, plastics are used for a
number of different purposes and at different points in the manufacture,
distribution and use of medical and medicinal products. The specific function
and point at which plastics are used strongly influences the feasibility of
replacement of these materials. Specifically, the different quality and safety
requirements between primary packaging, secondary packaging and plastics used in
production processes affect the ability of manufacturers to replace or
reformulate such plastics.
Case studies
Plastic materials which have been in contact with
certain drug product process streams present some unique challenges from a waste
management standpoint as they can be considered regulated medical waste. Some
pharmaceutical companies have been working with waste and materials vendors who
are able to treat and recycle this material to produce plastic lumber.
Necessary components are often shipped to
pharmaceutical manufacturers in plastic boxes instead of fiber-based boxes to
reduce potential contamination of pharmaceutical operations due to particulate.
While the material (i.e. polypropylene) typically used is recyclable, suppliers
servicing our industry are starting to change the material to 100% recycled
polypropylene which reduces greenhouse gas emissions, contributes to demand of
recycled material and is also recyclable.
 Industry
efforts at reducing plastic waste and working towards a circular economy
ASTRAZENECA
From single use to reusable thermal packaging
Each year, Astra Zeneca sends 60,000 products to
hospitals and clinics for clinical trial distribution. It involves a huge amount
of packaging. The original process used a box the size of a small table, each
containing 15kg of packaging that had to be thrown away after delivery with
recipients being responsible for its disposal. AstraZeneca decided to work with
its distribution partner to develop a new approach involving a returns process
and make it workable. Some simple ideas like using the brightest coloured paper
for returns instructions – a pink envelope gets more attention than just a white
sheet of paper. After a pilot, the initiative was rolled-out across 35
countries. The results: 98% return rate and reduced packaging waste
equivalent to the weight of a 747-jumbo jets.
 SANOFI
Eco-design – Plastic-free packaging for Vaxigrip®
vaccine
The new Vaxigrip® packaging has been designed to be
plasticfree, thanks to a complete cardboard packaging. This new packaging halves
the size of the box, which optimizes its storage and reduce its environmental
footprint: - 30% reduction of the number of transportations needed (air, sea and
road) - 50% reduction of CO2 per box - 25 to 50% reduction of environmental
impacts according to the indicator
BOEHRINGER INGELHEIM
Eco-design - Switch from single use to re-usable
inhaler
Respimat® re-usable is the result of patient
feedback, providing an inhaler with enhancements such as simplified handling and
an easy-to-read dose indicator, and significantly reduced impact on the
environment. It reduces waste and product carbon footprint (PCF) can be used
with up to six medication cartridges before needing replacement. Respimat® is
also propellant-free, meaning its CO2 emissions are 20 times lower than those of
commonly used pressurized metered-dose inhalers. By 2025, it is expected that
776 tons of plastic waste and 14,300 tons of CO2 emissions will be prevented as
a result. 776 tons of plastic waste equals more than 77.6 million 0.5-liter
PET bottles.
GSK
Complete the Cycle
73 million respiratory inhalers are prescribed every
year in the UK and not disposing of them correctly can be harmful to our
environment. GSK created an inhaler recycling scheme, Complete the Cycle, which
was the first of its kind for respiratory inhalers in the UK. 2 million inhalers
had been collected by 2019 and the scheme led to a wider discussion on how a
national inhaler return scheme could be created in conjunction with the wider
health care system. By working together with patients, pharmacies and healthcare
professionals, we can all help to reduce waste and greenhouse gases, moving
towards a more environmentally sustainable treatment of respiratory disease.
CHIESI
Take back pilot - Take Action for Inhaler
Recycling
Chiesi launched the Leicestershire Take AIR (Take
Action for Inhaler Recycling) pilot scheme in January 2021, to enable inhaler
users to recycle their empty, unwanted or out of date inhalers safely and
effectively through the post. Any inhaler, brand and type, is accepted. The
pre-paid, pre-addressed envelopes are provided by community pharmacies within
the area.
The scheme is funded by Chiesi and supported by
University Hospitals of Leicester NHS Trust and Leicestershire and Rutland Local
Pharmaceutical Committee (LPC).
Inhalers are sent through the postal system,
directly to a waste management company, where the component parts of pressurized
metered dose inhalers are recycled, and nonrecyclable inhalers are disposed of
using the most environmentally appropriate process. Through the scheme, the
aluminum canisters are crushed and recycled. The plastic components are recycled
into the plastic supply chain and any remaining propellant gas is extracted and
reused in the refrigeration and air conditioning industry. Non-recyclable
materials are converted into energy through a process called energy-from-waste
by high temperature incineration.
Scheme data as of 11th April 2022:
• 147 pharmacies and 3 hospitals participated
• Patients have returned 6,491 envelopes, containing 24,469 inhalers and
• 144 tons of CO2e have been captured
The results from the pilot are being evaluated
including quantitative and qualitative analysis, lessons learnt and
recommendations for potential upscale through system-wide collaboration. This
enables the findings to be shared with relevant stakeholders to support the
development of a future sustainable recovery and recycling process for inhalers
( Abstracted from : https://www.ifpma.org/publications/ourposition-on-the-global-plasticsinstrument/#:~:text=Ahead%20of%20negotiations%20on%20a,creates%20globally%20harmonized%20plastic%20regulations.
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