Quality Featured Articles
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Why It's Vital To Choose The Right Inspection Technology For Different Drug Products
2/3/2021
With patient safety and product quality as top priorities, the need for efficient, technologically advanced and highly accurate automatic inspection systems is greater than ever. Explore the advancements in inspection machines and case studies on turbid vaccine suspension, lyophilized drugs and biotech products.
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A New Way Of Looking At De-Nesting And Re-Nesting Solutions
2/3/2021
Systems that process drug containers must prioritize container integrity and gentle handling to prevent breakages and product losses. We have developed the innovative, automatic handling unit Nestor to process ready-to-use containers, such as syringes, to and from nests and tubs.
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Unlocking The Power Of Artificial Intelligence For Pharma Inspection
1/20/2021
Rapid progress is being made using artificial intelligence (AI) in visual inspection in the pharmaceutical manufacturing process. Ensuring that glass vials, syringes and other primary containers are free of splinters, particles and other defects is crucial – but traditionally, in automated equipment there has been a trade-off between detection rate and false rejection rate (FRR). AI is proving to be a game changer when it comes to this delicate balance.
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Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues
1/8/2021
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.
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Six Serialization Mistakes Pharmaceutical Companies Make
12/21/2020
This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project and proposes a solution to avoid each of these issues.
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Implementing Improved Analytical Methods To Support Vaccine Quality
12/18/2020
Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.
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Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices
3/2/2020
This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.
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Experimental Methods For Microorganism Challenges On OWBA
2/17/2020
While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.
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USP <1207> Updates Leak Testing Recommendations For Pharma Companies
10/2/2018
Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
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Materials Characterization In Pharma
9/5/2018
Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.