Inspection Featured Articles
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
How To Leverage Microcurrent High Voltage Leak Detection Technologies
7/16/2018
Using HVLD in the the pharmaceutical industry - leveraging test method development on some products to validate other products.
-
Innovative Robotic Handling For Pre-filled Syringes
7/12/2018
Addressing the challenge of implementing an inspection method to automate testing pre-filled syringes in a nested tray.
-
Maintaining Data Integrity With Inspection Software
2/23/2018
It may sound like just another pharma and life sciences industry buzzword, but “Data Integrity” is as important as computer system validation when products get released to market.