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The Importance of color coding in medical device design
Color coding is a crucial aspect of medical device design and application, particularly in ensuring the safe and effective delivery of treatments and medications...
How to Select the Correct Barbed Connector for your Single-Use System
Mechanical hose barb connections, which consist of the hose barb, tubing and retention device, are ubiquitous in single-use systems (SuS). They look deceptively simple, but the process of bringing all three elements...
Navigating the complexities of engagement qualifications in single-use assemblies
Single-use assemblies are designed with many connection points, or engagements. This refers to the places where two components are assembled, such as tubing on a hose barb, or two sanitary flanges connected with a gasket and clamp...
Breathing Innovation into Healthcare: My Extraordinary Journey
Picture a life that starts in Kiev, Ukraine, takes a detour through the Air Force, and arrives at the forefront of healthcare innovation in the USA. This is my story, and it's nothing short of extraordinary...
Will USP <800> have an impact on medical device engineering?
Discover how USP <800> affects original equipment manufacturers (OEMs) in designing medical devices for hospitals. Ensure compliance and safety with facility requirements...
Sanitary fittings overview and available options
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...
Guide to selecting the best tubing and connectors for In Vitro Diagnostics instrumentation
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...
Points to consider when specifying a bag chamber for your bioprocess application
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...
Connecting with ease: choosing a suitable quick disconnect connector
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...
Regulatory Update: Preserving critical materials in biopharma: Why fluoropolymers deserve a differentiation from PFAS
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...
Regulatory Update: Design Control Considerations for Medical Device Components
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...
Six considerations when creating large-diameter aseptic connections between bioreactors and Alternating Tangential Flow (ATF) systems
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.
Regulatory Update – New rules for air shipments to the EU, Norway, Switzerland and Northern Ireland
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)...
Regulatory Update - Change Control: Considerations for Medical Device Components
Changes to medical device components may be prompted by several causes: supply chain issues, design changes, inter-device compatibility or component manufacturer changes...
Regulatory Update - Bioprocessing: ISO/TS 23565 – Highlights and Interpretation
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...