Discover how USP <800> affects original equipment manufacturers (OEMs) in designing medical devices for hospitals. Ensure compliance and safety with facility requirements...
Sanitary fittings are known in the industry under several names. These include, but may not be limited to, sanitary flange, sanitary coupler, ferrule, tri-clamp, tri-clover, hygienic union, or sometimes just TC for short...
In vitro diagnostic (IVD) instrumentation is used in a variety of healthcare applications to detect many different human elements related to patient diagnosis and treatment. IVD instruments are used for sample preparation, blood chemistry, therapeutic drug monitoring, electrochemistry, urinalysis and disease detection...
There are many factors to consider when selecting an appropriate bag chamber for a single-use system to support your bioprocess. The task can seem overwhelming, so it is important to lean on stringent procedures to ensure a successful outcome...
When choosing a quick disconnect connector for a medical device, there are several important factors that should considered. Learn how compatibility, sterilization, durability and safety play a critical role in ensuring device functionality...
The proposed restriction of per- and polyfluoroalkyl substances (PFAS) is a growing topic of conversation in the bioprocess and biopharma industry. Regulatory bodies have concerns regarding the hazardous properties of these chemicals as they are increasingly detected as environmental pollutants, with some linked to negative effects on human health...
The development of a medical device is a complex and extensive process. Rigorous design planning and controls will mitigate risks that lead to failed verification testing or other delays in the project...
Bioreactors are commonly used in bioprocessing to cultivate cells, microorganisms or biological molecules for various applications such as the production of biopharmaceuticals, enzymes or biofuels.
The European Union (EU) is strengthening safety and security at customs for its citizens through a large-scale cargo information system called Import Control System 2 (ICS2)...
Changes to medical device components may be prompted by several causes: supply chain issues, design changes, inter-device compatibility or component manufacturer changes...
ISO/TS 23565 addresses an unmet need in the specification of cell processing systems. It describes the minimum requirements for the equipment, software and consumables used in the manufacturing and processing of cells for therapeutic use...
Regulatory, compliance and quality management system considerations may vary between medical devices, components and accessories. Understanding these differences helps organizations to better identify their roles and responsibilities related to sales...
Mechanical hose barb connections consist of a hose barb, flexible tubing and a retention device. Retention devices are generally placed closely behind the barb and are used to improve the connection’s pull-off strength and pressure resistance...
FDA regulation of health products must adapt to new and emerging technologies. This update reviews product classification for cell and gene therapy to help aid better-informed informed decisions on product development and planning.
Ensuring adequate supply chain of components used in medical devices and for the manufacture of drugs and biologics is more challenging and more critical than ever. Find out what steps you can take to reduce the risk of component shortages and their consequences.
