PACKAGING MATERIAL VENDOR EVALUATION FOR MEDICAL DEVICE MANUFACTURERS

Manufacturer needs to work in tandem with the packaging manufacturer during development Medical device packaging since it is not that one-size-fits-all.

Especially, if one is looking at a sterile medical device, packaging requirements need to be well understood by the packing manufacturer (vendor), as medical device manufacturer rarely manufactures packaging material and final package.

When the design of packaging for medical devices is left to the final hour, shortcuts often utilized to save time and money can increase the risk of noncompliance. Instead, during this process different sterile barrier systems can be evaluated and manufacturing methods evaluated to best meet the needs and characteristics of a particular device.

Every medical device is an unique product, both in terms of design and indications for use.

If that wasn’t enough, it’s also important to note that any changes made to existing products require revalidation and additional testing. These changes could be major, such as the intended use or an all-new design; they could also be internal directive shifts, like environmental sustainability initiatives. Thus, even a slight
change in raw materials for previously-validated packaging materials could result in further revalidation for years.

For any shot at long-lasting success, manufacturers need to thoroughly define the requirements of the unique device’s packaging system much earlier in the product development process. For good cause, too, as prequalification of these kinds of discussions around packaging validation will only save money, time, and labor in a variety of ways, such as:

• Early detection of design or manufacturing problems
• Gives ample time for revisions
• Identifies possible packaging test failures
• Prevents slowdowns in product release
• Improves overall quality and patient safety

These requirements are based on various requirements of

1. ISO 13485
2. MDR of EU
3. C-GMP
4. FDA
5. MDR India

Looking at the above we can understand the necessity of vendor, qualification, evaluation and regular planned audit is a necessity.

The packaging manufacturer approved as a vendor by the device manufacturer, like component suppliers; should be chosen with the same sense of careful considerations.

Earlier it was thought that at least ISO 9001 documentation system and certification was necessary, but as the regulations updated themselves and experience was gained, ISO 13485 compliance is the need of the day.

During audit of the packaging material vendor, following critical points should always be emphasized by the audit team.

A detailed check list will always be supportive, and records of the documents and personnel audit is mandatory.

Based on the packaging needs and the specifications of the medical device manufacturer, documentation, batch records, environment in which packaging material is manufactured as well as design specifications of the materials used should be verified. Any changes to the specifications should be looked in to.

Any design change should be pre-approved by the buyer (device manufacturer).

Apart from the above, during vendor audits, routine calibration of instruments, product process validation and design change should be verified.

A detailed supplier – vendor contract / agreement is a requirement.

Going through guidelines above, importance of packaging material supplier will be well understood. Their importance in the medical device manufacturer should not be undermined and, to reiterate, regular evaluation and audit of the vendor should be carried out.

Success of the device and their safety aspect depends on packaging as well.