Package Inspection Featured Articles
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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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A Paradigm Shift In Container Closure Integrity Of Parenteral Drugs
7/25/2017
This latest evolution of HVLD aims to achieve a high level of closed container integrity (CCI) assurance across the entire range of parenteral products.
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How To Monitor The Performance Of Metered Dose Inhalers (MDIs)
10/21/2015
The use of metered-dose inhalers (MDIs) for the treatment of diseases such as asthma has become popular since their introduction in the late 1950s. MDIs come in the form of nasal or oral inhalers and are much appreciated by patients who depend on them for their treatment. MDIs are designed to deliver precise/accurate and reproducible doses of the drug to the lungs or nose. This is crucial as patients rely on their inhaler to deliver the required medication at often crucial times when physical strength may be very low.
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USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
10/1/2014
The US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.