A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
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Cover Story

Key Essentials For The Perfect Medical Device Packaging

Sanjay Y. Shah
Managing Director
Unikal Consultants
www.unikalindia.com

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

  • Prevention of contamination

  • Preservation for the entire device life time

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.

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