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A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing. Container Closure Systems. Container closure systems are highly regulated by health agencies.
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.
From packaging errors and contaminants to serious adverse effects, there are many reasons why products in the lifesciences industry get recalled. Here’s a look at some of the latest drug and medical device recalls.
Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. Free Whitepaper Environmental monitoring for closed robotic workcells used in aseptic processing Recognising that human operators are a major potential source of contamination in aseptic processing, a global study was set up to examine the use of closed robotic workcells.
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.
Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. The pharmaceutical and lifesciences services provider recently revealed its latest partnership with Moderna, collaborating for renting of COD services across the US.
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Requirements relating to biologics’ starting and auxiliary materials, controlling the contamination of biologics, and biologics’ storage and transportation requirements would be replaced with more flexible conditions which apply more broadly. Manufacturing Controls. On-site Evaluations.
Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, lifesciences and pharmaceutical sectors. In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing.
It outlines the main touchpoints, including the earliest stages of technical transfer and new product introduction, through formulation development and scalable manufacture, and finally ensuring that these potent products are packaged in a safe environment before global distribution to clinic or market.
trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.
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