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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

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.

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AvKARE Recall: Erectile Dysfunction Drug and Antidepressant Mistakenly Packaged Together

XTalks

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.

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FDA Recalls Catheter, Cardiac Devices and Meds Over Safety Issues

BioSpace

From packaging errors and contaminants to serious adverse effects, there are many reasons why products in the life sciences industry get recalled. Here’s a look at some of the latest drug and medical device recalls.

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AvKARE Recall: Erectile Dysfunction Drug and Antidepressant Mistakenly Packaged Together

XTalks

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.

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Cleanrooms-on-demand: a more efficient future for pharma?

pharmaphorum

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 life sciences services provider recently revealed its latest partnership with Moderna, collaborating for renting of COD services across the US.

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Digitalized HBSM: The Greatest Advantages

Cloudbyz

Advantages gained from digitalization are certainly not limited to Human Biosample Management (HBSM) or any other applied aspects of the Life Sciences. Relevant software packages may offer you options to track down a sample by project, origin, date of collection (or use), to name just a few options. Easier Data Matching.

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

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.