Page 33 - Plastics Nuews October 2017

FEATuRES
FEATuRES

Canada, and the EU's European Food Safety Authority. In diethyl hexyl phthalate (DEHP) in PET are false. These
its April 2015 ‘Food Safety: What you should know’ report, chemicals are not even a part of the PET manufacturing
WHO published monographs that endorse the safety of PET chain.
as a packaging material for Food and Pharmaceuticals.
Any reliable assessment on the test reports on PET,
Regardless of which material is used for pharma packaging, therefore, needs to involve experts in analytical chemistry,
it has to undergo stringent examination before it is finally polymer scientists and packaging professionals.PET also
accepted as a package as per ICH (WHO) guidelines. The saves resources and is more feasible due to its light weight
nature and ability to recycle and reuse. It is not fragile
in nature and can withstand constant weather changing
conditions and resist physical impacts. PET containers
are more portable and travel friendly. It is environment
friendly and is not biodegradable.

PET bottles are recycled for non-medical or non-food
contact applications such as textile fibers, fiberfill,
carpets. In India, the use of containers made from recycled
PET is prohibited for packaging food and pharmaceuticals.
Although, no such oversight is available for other
packaging materials.
On the other hand, traditional materials like glass and
metal have various disadvantages as packaging materials,
such as - fragility and weight, non-flexibility, high co-
selection of the packaging, is part of the drug development efficient of friction to withstand fluid flow and high cost.
process, during which time it is tested for leaching and Recycling glass bottles requires large amount of water and
extractability. washing chemicals, directly impacting energy consumption
and environment.
Compounds that can be extracted from the container
closure system when in the presence of a solvent are Not just packaging of pharmaceuticals, but these days,
called extractables. While leachables are compounds that PET is safely used in more critical and permanent human
leach out of the container closure system upon direct implants. Close to 400 PET-based products are in use in
contact with the drug formulation. PET is non-leaching medical field for several decades and about 100 PET-based
and non-extractable, thereby allowing the formulation to products in ophthalmic applications.PET being accepted
remain unchanged and safe. globally by governments and pharma industry, has become
the indispensable part of not just drug packaging but also
The packaging material should be functionally robust, not the overall healthcare industry.
interact with the drug and offer protection to the product
not only till it reaches the consumer, but also after it is Over the years, the materials used for packing drug
opened. The packaging regulations worldwide, including formulations like glass, aluminum and plastic, undergo
in India are so strict that even the ink on the seal is tested stringent processes to determine their safety and quality
on all criteria! assurance. Therefore, it is imperative that various industry
stakeholders like drug manufacturers and packaging
The safety of PET packaging is established further by companies align with each other right from the first phase
understanding its manufacturing process, which does not of drug development to ensure that packaging becomes
involve the use of any heavy metals like Lead, Cadmium, an integral part of the R&D process.
Chromium, Arsenic, Mercury, etc. Concerns regarding
the presence of bisphenol-A(BPA) and phthalates such as (Couretsy: The Economic Times)

33 Octob er 2017 | Plastics News