gowith the flow
Low Viscosity Epoxy
Resin System
Two Part EP30Med
Adhesive, sealant, coating,
potting compound
ì;Superb optical clarity
ì;Meets USP Class VI specifications
154 Hobart Street, Hackensack, NJ 07601 USA
;;;;;;;;;;;;;;;;ì; main@masterbond.com
www.masterbond.com
Emphasis On Package Testing
interest during an audit may include:
• Quality controls (quality program, statistical process controls, validations pro-
gram)
• Calibration/preventative maintenance program
• Receiving/storage/shipping controls
• Adherence to GDP/GLP standards
• Employee training/records controls
3. Evaluate the cost vs. value
Cost versus value is somewhat cliché, but this relationship should not be overlooked. Consider what value-added services the prospective lab offers. A good
lab will provide guidance in the form of test protocol development, explanation
of the test standards and methods, and assistance with failure analysis. This can
be especially helpful for smaller organizations or start-ups lacking the resources
to develop their own test plans, or the experience to evaluate failures. If a company is having an issue with a specific package or material, chances are that the
folks at the test laboratory have seen identical or similar issues; they should be
willing and able to help.
The personnel employed should also be taken into account as well. Does the
lab have packaging or materials engineers on staff? What level of experience do
they have? Keeping abreast of changes within a dynamic, tightly regulated industry
requires involvement in technical committees and organizations, such as AAMI,
ASTM, IoPP, and ISTA. The lab should be have involvement with these, or similar, organizations.
4. The location of the lab
The proximity of the lab, in relation to the medical device OEM’s manufacturing
or R&D facility, should be considered. The logistics of working with a local lab
can be easier and more cost efficient. Getting samples to and from the lab using a
courier service is often less expensive and faster than typical FedEx/UPS delivery.
And many of the environmental hazards that samples would be exposed to during
shipping can be eliminated when using a local courier service. Being near the test
lab will make vendor audits easier to schedule and perform, and will allow for lab
visits to observe critical testing. While important, locality should not be the only
deciding factor in choosing a lab. Many medical device OEMs do not have a lab
that will meet their requirements within their metro area. If working with a lab
out-of-state or across the country, make sure to send samples in protective packaging in an effort to minimize the stresses seen during shipping.
5. Vendor lead times
The lead times of vendors will always be important when bringing a product to
market on time. Labs often experience fluctuations in the volume of testing, but
should be able to provide a reasonable lead time. Does the lab have the facilities
and staff necessary to meet the company’s demands? In pinch situations, the lab
should be able to work with an OEM to provide priority testing services. With
certain large-scale projects, some deviation from the standard lead time may be
necessary; the staff should be willing to develop a test schedule in advance of the
project’s initiation.
Conclusion
In addition to these considerations, soliciting recommendations from peers in the
medical device industry could be beneficial. Due to non-disclosure agreements, the
lab itself may not be able to provide references, but it can’t hurt to ask.
