Ensuring Quality in Drug-Delivery Devices
By Hugh G. Willett
Developing a new drug-delivery device requires detailed knowledge about all components as well as device performance in different situations. Medical device development companies are using advanced characterization and testing of materials at the product development stage to ensure quality in design and high-volume manufacturing.
Becton, Dickinson and Company (Franklin Lakes, NJ) manufactures and sells medical devices, instrument systems, and reagents. BD was one of the first companies to sell U.S.-made glass syringes. The company was also a pioneer in the production of hypodermic needles. Today, BD is a leader in the development of a variety of infusion and injection devices.
As part of its new product development efforts, BD employs various mechanical testing routines that are designed to provide decision support to device design engineers, according to Dr. Roman Tunkel, staff engineer/research and development at BD in Billerica, MA.
“The information we collect in the R&D lab streamlines the design cycle and supports our design for manufacture process. The investments we make in testing at this stage enable us to deliver quality in the manufacture of our devices,” Tunkel says.
Devices tested in the lab are often compact, with specimens generally smaller than 50 mm (2 in.) in size, and are mainly constructed from biodegradable plastic. Because of the nature of the devices being tested, it is important to be able to perform very small motions with a high degree of precision.
“The motions occur in the micrometer range and the application requires the utmost in testing accuracy,” Tunkel says.
BD uses sophisticated test and measurement instruments in the R&D lab, including those provided by Zwick USA, a subsidiary of Zwick/Roell (Ulm, Germany). For more than a century, Zwick has developed and manufactured materials and component testing solutions for the medical industry. Zwick testing systems and software are designed to meet specific needs within the medical packaging industry, including those designed for testing primary packaging such as prefilled syringes, vials, and carpoules. They can also be used to perform peel testing of secondary packaging such as blister packages.
“Our zwicki-Line system performs tests that utilize a very small stroke at very low forces, and the results are outstanding. We can count on our Zwick system to deliver a high degree of accuracy from sample to sample, even at mere micrometers of travel,” Tunkel says. The data obtained with BD’s zwicki-Line system is fed back into the development process, he said.
“In our application, we manage a wide range of operations within each unique testflow—some purely manual, some highly automated that require feedback from sensors,” he says.
The BD lab performs tensile setup, compression setup, breaking material setups, and cycling setup for investigating material interactions.
In addition to delivering accuracy and convenience, the zwicki-Line system at BD provides the versatility needed to enable testing of a variety of device attributes, Tunkel explains.
Such versatility is enabled by Zwick’s testXpert II software. Programmability within testXpert II is intended to ease setup of new test routines and supports the evaluation of ergonomic parameters.
Sophistication in the processing of external signals enables the testXpert II measurement and control software to support automation of the test procedure by feeding back those signals from external sensors to deliver the next sequence in the test flow.
“The fact that our Zwick system is able to store the entire test environment, including all software and hardware control parameters and test conditions, maximizes test throughput and supports our objectives in product development,” he said.
According to Tunkel, BD also makes use of the unique electronic record keeping functions proprietary to the Zwick test environment.
Production of medical packaging and delivery products requires compliance with regulations including FDA CFR Part 11 and Annex 11 of the EU GMP directive when using electronic recordings and signatures in the regulated environment. Part 11 requires medical device manufacturers to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation. This data can be used to demonstrate compliance to FDA predicate rules.
“Zwick’s electronic records function permits tamper proof documentation of all actions and modifications performed in testXpert II,” said Erik Berndt, medical industry manager at Zwick.
The user defines the degree of actions to be logged and justified according to specifications, which can originate from the QM manual or external requirements. In a specific case this could involve recording every change in a parameter relevant to testing.
The capture of electronic signatures permits the assumption of responsibility to be documented and simultaneously allows the conversion to a “paperless laboratory” because the signature on a document can be replaced with a digital signature of the test series, Berndt said.
Hugh G. Willett. Bio is Technology journalist with 30 years experience writing for daily newspapers, technology journals and trade publications.