High-performance ion mobility spectrometry is an efficient technique for cleaning validation

Image courtesy of Covalent Bonds

The rigorous cleaning of manufacturing equipment via well-defined standard operating procedures (SOPs) is one of the pharmaceutical industry’s primary defenses against contamination and adulteration. Cleaning validation confirms the efficacy of such procedures but can present challenges, generating large numbers of samples for analysis and potentially keeping equipment offline for too long, compromising productivity.

This article examines high-performance ion mobility spectrometry (HPIMS) as a technique for cleaning validation, comparing it with conventional alternatives. Experimental data illustrate the linearity, reproducibility, and detection limits of HPIMS for relevant compounds, which offers rapid, inexpensive, high sensitivity, at-line measurement for cleaning validation.

Meeting regulatory requirements for cleaning validation

FDA regulations provide a clear and…

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Using RVI to prevent contamination and maintain purity of pharmaceuticals 

How remote visual inspection (RVI) can help pharma companies prevent contamination and maintain product-line purity requirements.

Drug manufacturers use a combination of indirect and direct quality control (QC) techniques to prevent contamination throughout the production line. Image courtesy of Olympus

Bacterial or foreign-particle contamination in production-line equipment can cause serious health issues for consumers and shake public confidence in the industry.

Strict purity and contamination control of pharmaceutical manufacturing facilities is required under various international standards, such as ASME (American Society of Mechanical Engineers), AWS (American Welding Society) and local regulatory authorities such as the U.S. Food and Drug Administration.

Get the full story from our sister site, Pharmaceutical Processing World. 

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Using RVI to prevent contamination and maintain purity of pharmaceuticals 

Image courtesy of Olympus.

Strict purity and contamination control of pharmaceutical manufacturing facilities is required under various international standards, such as ASME (American Society of Mechanical Engineers), AWS (American Welding Society) and local regulatory authorities such as the U.S. Food and Drug Administration.

Bacterial or foreign-particle contamination in production-line equipment can cause serious health issues for consumers and shake public confidence in the industry.

Preventing contamination in medication production lines is one of the main goals of good manufacturing practices (GMP). Following GMP is a prerequisite for the pharmaceutical industry to prevent poor quality or incorrect mixtures of elements from reaching the consumer. GMP requirements include implementing strict equipment maintenance and cleaning protocols supported by QC and QA inspections and audits, all backed by …

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