Material selection has significant implications on the design and cost of horizontal-form-fill-seal packaging machinery. To avoid excessive costs, machine redesigns and project delays, material selection must be reconciled early in the project and revisited throughout the construction of the machine.
To maintain a high standard of quality in the materials and components used in the container systems of orally inhaled and nasal drug products, manufacturers need to collaborate closely with all those in the supply chain. Best practices in information sharing, particularly in relation to change control, are outlined here.
European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quality system.
A novel cobalt-chromium (CoCr) based alloy, optimised for speciality needle applications, has been benchmarked against Type 304 stainless steel in a series of mechanical test and experimental needle trials. The results reported indicate that the CoCr alloy has the potential to overcome current limitations in endoscopic and minimally invasive surgery.
Fluorescence is a versatile technique with applications ranging from ultra-low-cost tests that are available over the counter via point of care instruments for use in the doctor's office to state-of-the-art clinical analysers. This article describes fluorescence, draws on a number of examples to illustrate its versatility and looks at what the future has in store for this powerful technique.
The 15th International Meeting on Radiation Processing was held in London, UK, on 21-25 September 2008. It provided a forum for researchers, academics, the radiation processing industry and its users and regulators to review progress. This report focuses on the developments relevant to medical device sterilisation in products, processes, technology and the regulatory environment that were examined at the event.
A permanent, molecular level layer, water based surface modification technology has been developed that can be applied to the external and internal polymer surfaces of high value catheters. Its characteristics, advantages and applications are discussed here.
Medical device companies need to meet European requirements designed to protect the environment.The deadlines for some of the requirements have already passed. This article discusses a European Regulation and two Directives, and a means for meeting environmental requirements in an effective manner.
Forty-four percent of hospital patients with indwelling catheters can develop significant bacteriuria within 72 hours of catheterisation. It is, therefore, critical that catheters are manufactured with perfectly smooth surfaces and apertures to reduce the potential for infection. An ultrasonic cutting technology is described here that produces smooth apertures and eliminates problems associated with debris.
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