Essential
Compliances
The
compliance mainly is for compatibility of the medical
packaging with the product and for the methodology
used for sterilization.
Sealing
integrity and packaging stability is also important
properties needing to comply with for acceptance.
There are many standards and guidelines of European
Agencies and US FDA for various types of packaging
material.
Availability of Industry Standards
There
are many industry standards and especially for medical
sterile packaging permeability, ability to with stand
steam or radiation etc. is evaluated.
Qualitative Standard rather than the Quantitative
Standard
The
criticality of maintaining sterile condition makes it
imperative to have best quality standards.
Physical, Thermal and Environmental Demands
This
will depend on the conditions and based on the
material of medical packaging.
Operational Qualification of the Equipment
It has
to follow CGMP guidelines on packaging. Sealing
process validation and packaging integrity testing is
critical.
Effective Test Methods for Evaluation
There
are many criteria. The packaging should make device
snuggly fit but not too tight to tear or rupture
during use or transportation. Depending on the design
of medical device the packaging needs to be designed
and formed. Device having sharp edges needs special
protection from tear.
Top
Priorities While Labeling
Of
course user ease is the most critical factor. The top
priority include label contents, information required,
clarity of printing, etc. are some of the
requirements.
Services Provided By Your Company
We have
been consulting and providing services to medical
device manufacturers throughout India for their
regulatory compliance need. We support in
documentation, training, plant layout, gap analysis
for existing plants as per the requirements of GMP /
MDD for CE / 510k and PMA for US FDA and other
international regulating agencies. We can support
within India and out of India as well. |
|
Arul Manickam
Systems & Services Certification
Product Manager (Medical Devices)
SGS India
www.sgsgroup.in |
Essential
Compliances
Availability of Industry Standards
Packaging material Companies follow their own
specifications. However, harmonized standards like EN
ISO 11607 gives the requirements & validation methods.
Qualitative Standard rather than the Quantitative
Standard
Quantitative evaluations always need lots of validated
data to compare. This becomes difficult where the
devices are new of its kind & also the data available
in public domain is very limited. Thus, qualitative
method are very handy & the manufacturer of the device
can make it very relevant.
Operational Qualification of the Equipment
If the
question either for the medical packaging manufacturer
of the user, in every case it is very crucial, because
inconsistency of packaging can ruin the reliability of
the device.
Top
Priorities While Labeling
-
Complete, correct &
accurate information to the user.
-
Information like ‘DOs &
DON’Ts’ should be present.
-
Guidelines for
preservation
-
More importantly,
information about the shelf life/ expiry
Services Provided By Your Company
SGS is into management system certification also. SGS
can provide QMS certificates to medical packaging
manufacturers as per ISO 15378 & also perform GMP
audits. |