Use independent laboratories to augment your own medical device expertise

Most plastics processors will never have the budget to purchase the full range of analytical instruments and equipment necessary to perform the many tests needed to successfully bring a new medical device to market, let alone the funds and time to hire and train employees to use them. Outsourcing testing to an independent laboratory can be a project-saving move in the medical world and serve as a force multiplier of a processor’s own staff.

It can also help a processor become more independent. For instance, one processor of polypropylene (PP) pill containers, keen to expand its supplier base for resin, knew it needed to learn if other resin suppliers were able to provide an equivalent material. In order to do this, the molder required baseline data for its current resin. Working with an independent laboratory, a proposal was developed for the processor that included differential scanning calorimetry (DSC) to characterize thermal properties; gel permeation chromatography (GPC) to measure the molecular weight distribution (MWD); extractable studies to determine what harmful chemicals might be present in the resin; and Fourier transform infrared (FTIR) spectroscopy for confirmation of chemical composition.

Then, as this processor expanded its operations, the lab-established data helped it evaluate potential new suppliers and reduce its risk of reliance on a single supplier. Plus, the same data could be used in the future to assist the laboratory with any causal investigation on the client’s behalf if there were an instance of a product failure.

Ideally, the independent laboratory performs like a virtual arm of its customer’s business. The process knowledge produced by the lab can provide the plastics processor with benchmark data for future products. It also can set the path for specifications for release testing, be used to establish substantial equivalence to a product already on the market (thereby reducing the amount of work necessary for FDA submission), or the data can be used when investigating a complaint or failure.

With the economic downturn’s effects, the possibility of $20 billion in fees on the device industry through proposed healthcare reform bills, and the anticipated tougher regulatory approvals under review for the 510(k) process, outsourcing to an independent lab can be cost effective and provide expertise that may not otherwise be available. A well-developed laboratory testing facility is equipped with a variety of equipment and analytical instruments with many method capabilities for a broad range of materials and applications. When the communication is strong and both sides understand each other, the independent lab can be a huge resource. Several factors are critical to a successful partnership with an independent laboratory: an aggressive supplier evaluation process, an active communication process, and a focus on quality assurance for each client’s project.

Only as good as your suppliers
Supplier evaluation has grown even more critical. The U.S. Food & Drug Administration (FDA) demands improved supplier management—including performing better supplier audits—at drug, device, and biologics companies as well as food processing companies. The reasons are clear: One does not easily forget the highly publicized cases in China where dog food, date rape drug precursors in children’s toys, and tainted pharmaceutical products caused injury, even death, due to changes in processes that were not documented or validated. There is great pressure on medical product manufacturers and food companies to ensure any outsourced partner meets applicable 21 CFR regulations, especially in the areas of validation and change control.

So, too, should processors invest time in their choice of an independent laboratory. The focus of an onsite audit of a laboratory follows the same 21 CFR regulations for GMP-regulated manufacturing facilities as they apply to the laboratory. Areas of focus during the onsite laboratory audit should include:
•    A Quality System in place based on ISO 17025, ISO 13485, and/or 21 CFR Parts 210, 211, and 820.
•    CAPA system, including an out-of-specification (OOS) procedure and a deviation procedure.
•    Validation of calculation and data sheets.
•    Equipment, including calibrations and preventive maintenance.
•    Purchasing controls.
•    Reference standards, reagents, and solutions procedures.
•    Training program, including yearly GMP training.
•    Internal auditing program, including technical audits of testing methods.
•    Data verification procedure.
•    Master validation plan for equipment, procedures, computers, and facilities.
•    Part 11 compliance of data.
•    Document and change control system.
•    Environmental controls.

Sending a technical person with some scientific knowledge of testing methodologies to the onsite audit gives a processor a bird’s-eye view of the type of testing, capabilities, and expertise that the independent testing laboratory is able to provide. In our experience, most onsite auditors with some laboratory testing knowledge realized during the tour of our laboratories that there are more capabilities that could be helpful during current or future projects than the processor had been aware of.

The work of the independent lab can be more productive and cost effective for the client when a good working relationship is in place between a lab liaison and a customer liaison. The customer doesn’t know what information might be critical to the materials science aspect of the issues, and the scientists do not understand the business implications and actions that may need to occur following the test results. The more information that is provided to the laboratory, the better opportunity those scientists will have to form their opinions on which tests should be run, how they should be run, and if they need to repeat any of these tests using different conditions. In our model, it is the project manager (PM) who is the liaison between the client and the laboratories. The PMs know how best to use the laboratories’ resources to get the work done and solve problems for their customers.

Documentation of the detailed verification of quality control in the laboratory provides added quality assurance for the specific project. This documentation is offered to the customer in addition to the laboratory testing in the form of a quality compliance report (QCR). The more critical the data in the product’s life cycle, the more relevant an additional QCR can be. The added QCR includes a quality verification of the following: sample handling, environmental controls, equipment calibration and qualification, methods and any associated validation, data control, approvals of data, validation of calculations, appropriate training, the project report, any CAPAs or deviations, and any additional information that could have an impact on the technical results.

The final factor that is critical to a long-term relationship between the plastics processor and its independent laboratory testing facility is a continuous QA verification that is project specific, especially when GMP regulations come into play. Quality systems require a followup process with customers to evaluate the overall customer satisfaction and to determine what can be done differently to better meet its needs. However, in the FDA-regulated world, a more detailed evaluation should be prepared with each project completion, and even multiple times during long-term projects. These evaluations provide a more in-depth QA evaluation of the quality control systems in place that give assurance that the data sets are both accurate and valid.

When communication is strong and both sides invest the time to know each other, the independent lab can be a huge strategic resource to the customer.

How a lab can help you get the job done
• Independent laboratories reinforce a processor’s ability to serve its medical device customers with services including:
• Raw material specification development and qualification.
• Identification and development of analytical methods.
• Specifications for process validation.
• Extractables and leachables testing.
• Real-time and accelerated aging and analysis of degradation products.
• Quality release testing.
• Process and material change validations.
• Failure analysis.

Cynthia Rancourt is director of quality at Polymer Solutions Inc. (Blacksburg, VA). Edited by Matt Defosse.