Packing material for both the non sterile packing.
Gesco has two approved non sterile packing materials the following summary provides the
purpose of the testing and demonstrates how the material were found to be complaint
Supplier 1 - Terramica
Material specification -
The Coa states the packing material is PET(56 um) - PE(12um) Laminate one side milky and the
other side is transparent. The material identification was confirmed by the third prty (SGS
report) report number ____. Wherein using FTIR as per ASTM E1252 - Standard Practice for
General Techniques for Obtaining Infrared Spectra for Qualitative Analysis. the materials were
identified to be PET and PE. In addition,the Differential Scanning Calorimetry (DSC) analysis
performed by SGS (third party report number ____) demonstrated endothermic melting peaks at
approximately 106.93°C, 124.82°C, and 253.60°C during the first heating cycle, and at
107.68°C, 123.16°C, and 247.14°C during the second heating cycle. These thermal transitions
correspond to the characteristic melting ranges of polyethylene (PE) (approximately 105–135°C)
and polyethylene terephthalate (PET) (approximately 245–260°C). Therefore, the DSC results
provide supporting evidence that the packaging material is a PET-PE laminate, consistent with
the declared material composition. The COA had specified the seal strength to have passed, i.e it
is greater than 1.5 N. These claims were found to align with the third party report (trustin report
number __) wherein all the four sides exhibited seal strength greater than 1.5 N. In addition we
tested the materials for heavy metals as per packing and waste directive (94/62/EC ) and the
values were found to be within acceptable limits ie The sum of concentration levels of lead,
cadmium, mercury and hexavalent chromium present in packaging or packaging components
shall not exceed 100 ppm . The Material Specification and Grade Doc No: GESCO/TF/02/01-
SIL , version 1 provides the specification of the approved primary non sterile packing material.
We have added both the approved nonsterile primary material. The primary packing material
selected was from a supplier with approved ISO ____. The non sterile packing materials are
materials typically utilized to make flexible gamma pouches.
Supplier 2 - SP Enterprises
Material Specification
The Certificate of Analysis (CoA) specifies that the primary packaging material is a 12 µm
polyethylene terephthalate (PET) / 100 µm low-density polyethylene (LDPE) laminate,
supplied as non-sterile reels, with one side transparent (natural) and the other side milky white.
The material is intended for the manufacture of packaging suitable for gamma sterilization
applications.
The laminate structure was independently verified by SGS (Report No. ______). Fourier
Transform Infrared Spectroscopy (FTIR), performed in accordance with ASTM E1252 -
Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative
Analysis. Identified the constituent polymers as polyethylene terephthalate (PET) and
polyethylene (PE), confirming the declared material composition.
Differential Scanning Calorimetry (DSC), also performed by SGS (Report No. ______),
demonstrated endothermic melting peaks at approximately 106.93°C, 124.82°C, and 253.60°C
during the first heating cycle, and 107.68°C, 123.16°C, and 247.14°C during the second heating
cycle. The thermal transitions observed at approximately 105–135°C are characteristic of
polyethylene (PE), while the transitions at approximately 245–260°C are characteristic of
polyethylene terephthalate (PET). These findings provide further confirmation that the packaging
material is a PET/PE laminate, consistent with the manufacturer's declared construction.
The laminate construction consists of an outer 12 µm PET layer and an inner 100 µm LDPE
(Natural Gamma Poly) layer, with the LDPE layer serving as the product-contact (sealant)
surface. The PET layer forms the outward-facing surface, providing mechanical strength and
dimensional stability. The milky variant has the same laminate construction, comprising 12 µm
PET laminated to 100 µm Milky Gamma Poly (LDPE).
The CoA specifies that the package seal strength complies with the acceptance criterion of
greater than 1.5 N. This claim was independently verified by Accuprec Research Labs
(Report No. ______), where seal strength testing demonstrated values exceeding 1.5 N on all
four sealed sides, confirming compliance with the specified acceptance criterion.
The packaging material was additionally evaluated for heavy metal content in accordance with
the Packaging and Packaging Waste Directive (94/62/EC). The measured concentrations of
the regulated heavy metals were within the specified regulatory limits, demonstrating compliance
with the applicable requirements.
The packaging material conforms to the approved specification defined in Material
Specification and Grade Document No. GESCO/TF/02/01-SIL, Version 1, which establishes
the requirements for the approved Non-sterile primary packaging Reels intended for the
manufacture of flexible packaging for gamma sterilization applications. The packaging materials
used in this study are included within the approved material specification.
The primary packaging material was procured from a supplier operating under an approved ISO
______ certified quality management system.