Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particle, dust, lubricants, raw materials, intermediates. Mainly cleaning is performed to remove product and non-product contaminating material. Ineffective cleaning can lead to adulterated pr...

Selecting suitable cleaning agents and determining justifiable cleaning process parameters are critical prerequisites for cleaning validation. Proper selection of these cleaning agents and parameters could simplify cleaning validation efforts immensely. Process cleaners may range from a single component, such as an organic solvent, to multicomponent formulations that use multiple cleaning mecha...

*To whom all correspondence should be addressed. otal organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation in pharmaceutical manufacturing. This nonspecific method can be used to test for residues of previously manufactured products, cleaning detergents, chemicals, solvents, by-products, degradants, and microbial contaminants. However, many factors ...

A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision. ross contamination with active ingredients is a real concern. The...

Residue identification in a pharmaceutical manufacturing environment involves; the cleaner, primary ingredients, excipients, decomposition products, and preservatives. This document is intended to help with the cleaner residue identification. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatogra...

Introduction Total organic carbon (TOC) analysis provides a quick and efficient analytical process for cleaning validation in the pharmaceutical industry. When a single piece of equipment in a pharmaceutical manufacturing facility processes different active pharmaceutical ingredients (APIs), cross-contamination between products must be kept to an absolute minimum. Cleaning validation is the ove...

The manufacturing equipment in pharmaceutical industry, could be used in multiple and sharedproduction lines, therefore there is the possibility for the products components and active ingredients tointermix and pollute one another. In this purpose the cleaning methods are used, to reduce the residueslevels from the machinery surfaces and decrease the residues to acceptable level but these metho...

Introduction: Cleaning validation is an integral part of current good manufacturing practices in pharmaceutical industry. The main purpose of cleaning validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and adulteration of drug product with other active ingredient. Objective: A rapid, sensitive and sp...