Since January 1995, medical devices to be marketed in the European Union (EU) have been required to comply with EU Medical Devices Directive (MDD), which specified requirements for safety assessment issues. The initial purpose of the directive was to promote a single European market for trade in medical devices, while ensuring that users and patients were not exposed to unnecessary risks. In 2008, due to several high-profile medical device scandals, and increasing public concern to strengthen the existing regulatory system, an effort was made to overhaul the medical device directive. As such, in 2017, the Medical Device Regulation directive was published to address such issues (MDR 2017/745), and reinforce the confidence in the EU medical device regulation system...

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Since January 1995, medical devices to be marketed in the European Union (EU) have been required to comply with EU Medical Devices Directive (MDD), which specified requirements for safety assessment issues. The initial purpose of the directive was to promote a single European market for trade in medical devices, while ensuring that users and patients were not exposed to unnecessary risks. In 2008, due to several high-profile medical device scandals, and increasing public concern to strengthen the existing regulatory system, an effort was made to overhaul the medical device directive. As such, in 2017, the Medical Device Regulation directive was published to address such issues (MDR 2017/745), and reinforce the confidence in the EU medical device regulation system...

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Risk assessment is a key component in the approval process for a new medical device. The International Organization for Standardization (ISO) 10993 series of standards is recognized by regulatory bodies throughout the world and applies when a medical device comes into contact with the body directly or indirectly. Both ISO 10993-17/18 should be considered in the context of the ISO 10993-1: evaluation and testing within a risk management process. ISO 10993 guides the assessment of medical devices on tissues in a general way. For a complete biological safety evaluation, it classifies medical devices according to the nature and duration of their use and indicates the data sets that are relevant. This white paper discuses ISO 10993-17/18, how they relate, and considerations for industry.

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Choosing the ideal IBC system to meet your needs can difficult. Whilst you want to ensure that your provider understands your requirements, you also need to adhere to the highest industry standards. To help you ask the correct questions of your IBC provider, we've developed the Ideal IBC System Checklist. Use our guide to help you solve your powder handling problems and validate your equipment procurement process. Discover how you can increase production capacity and improve profitability by using an IBC system.

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Embracing and investing in new technologies is one way to get ahead, and adopting lean, efficient manufacturing procedures is another. At a fundamental level, achieving efficiency can start at the outset of a project by considering the very design of a production facility. Careful planning can cut costs and reduce waste at all stages, while at the same time ensuring the production of quality products.

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Still handling tablets in drums?

It is common to find Intermediate Bulk Containers (IBCs) being used for handling powders and granules in solid dosage manufacturing processes, from initial Dispensing through to Tablet Compression or Capsule Filling. The benefits of using IBCs for efficient and flexible materials handling at this stage of the process are widely appreciated and applied in modern facilities.

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MedImmune wanted to respond to the voice of the customer who was requesting a new unit of sales – Single Unit Dose package. This new package format for a nasal administration live virus fl u vaccine must be stored at sub-zero temperatures (-25 deg C) and shipped at - 80 deg C. The costs to maintain the infrastructure to store product at these freezing temperatures is very expensive.

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Flu vaccines are a high volume commodity product, in which price, availability, and Time-to-Market are key factors for success. The entire production for the flu season takes place within a 3-4 month period. Production operates on 24/7 basis. In addition, vaccines are shipped and stored in a cold-chain. This requires cold storage within the facility and the warehouses in the distribution channel. Refrigerated trucks are also required for intermediate transport. Dispensing pharmacies and clinics must also store the vaccine in a refrigerator.

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