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Oetiker ear clamp selection guidelines
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...
Regulatory Update - FDA Classification of Cell and Gene Therapy
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.
Regulatory Update - Supply interruptions: steps you can take to reduce the risk of component shortages
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.
Regulatory Update - Connectors for liquids and gases
Connectors are used in many types of medical and diagnostic devices. Learn strategies for development and testing connections to help reduce verification and validation burden, mitigate the risks associated with misconnections and supply interruptions, and ensure predicable performance for these connections...
Key considerations and options for sample collection in process sampling
Process monitoring and control of critical process parameters are required to ensure product quality. The most common methods for process monitoring are linked to sampling...
Force majeure on Zytel® 101F nylon drives use of high-performance Vydyne® 21SPF
Nylon is used in the manufacture of many single-use components for medical device and bioprocessing applications. With surging customer demand, lead times for nylon have extended beyond explanation, causing significant disruptions in the global supply chain and unprecedented shortages...
Gamma Irradiation Part 2 - Using a risk-based approach to sterility requirements for single-use systems
Ionizing irradiation, typically gamma, has been the most used method of sterilization and bioburden control for single-use bioprocess systems for more than 20 years. Still, there remains some confusion around the need for sterile or bioburden-controlled systems and how to achieve it...
Gamma Irradiation Part 1 - Gamma, E-beam or X-ray? The future of radiation sterilization
Gamma irradiation is a key technology for the sterilization and bioburden control of medical devices and single-use bioprocess systems...
Five key benefits of genderless aseptic connectors
This blog outlines five key benefits of genderless aseptic connectors and how they can lead to more flexibility, reduced risk and lower costs for your organization.
Polybutylene terephthalate (PBT) offers alternative to nylon in components for single-use systems
The global supply chains for many raw materials and finished goods are experiencing unprecedented shortages and supply interruptions, in particular, the supply of plastic resins...
Everything You Need to Know about Creating a Secure Hose Barb Connection
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...
5 Key Considerations to Supplier Risk Evaluation
The Covid-19 pandemic exposed major vulnerabilities in global supply chains, causing uncertainty, shortages and long lead times. These events challenged supplier relationships, with status quo partnerships in...
Five ways Qosina can help speed your time to market when designing medical devices
It’s no secret getting your medical device to market in a timely fashion gives you a competitive advantage. Being the first to debut a cutting-edge product can help you bring in new customers who are eager to...
Error Proofing Single-Use Systems: Adopting Three Strategies from the Medical Device Industry
In a typical hospital setting, patients often have numerous lines connected to them to deliver a variety of medicines, gases and nutrients, as well as suction and drainage lines. Many of those devices and systems utilize universal luer lock connectors...
How to Minimize Supply Chain Disruption in Regulated Industries
The challenges of managing supply chain disruption are complicated and can have serious consequences. When news about sea freight and shipping containers...