Gary Osborn and Steve Hansen
Pharmaceutical Technology JUNE 2002 ISO 9000 and FDA requirements mandate that any measurement be traceable to national standards. Calibration of equipment is necessary to ensure traceability, performance, and reliability.This article explains the proper method for the in situ, on-site, or off-site calibration of lyophilizer pressure gauges and offers some important guidelines to ensure the accuracy of a capacitance manometer.For full article Click Here
Sunday, February 24, 2008
Development of an In Situ Spectroscopic Method for Cleaning Validation
Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation
BioPharm International, May 2002 A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.
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Implementing Total Organic Carbon Analysis for Cleaning Validation
Pharmaceutical Technology, May 1, 2004
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
For full article Click Here
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
For full article Click Here
Pharmaceutical Cleaning Validation Method References
Alconox A cleaning validation involves testing for acceptable residues on pharmaceutical manufacturing or medical device surfaces. The validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues 3 or more times and then a rational monitoring program to maintain a validated state is put in place. If you are changing any part of your procedure or cleaner, first clean the new way, collect data and then clean the old way before using any equipment while you are in the process of validating the new procedure.
For more information Click Here
For more information Click Here
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufact
Karen A. Clark, Product Manager, Anatel Corporation
ISPE, October 2000 In the pharmaceutical industry, Good Manufacturing Practices (GMPs) require that the cleaning of drug manufacturing equipment be validated.1 Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents.Common analytical techniques in the validation process include HPLC, spectrophotometry (UV/Vis), and TOC. HPLC and UV/Vis are classified as specific methods that identify and measure appropriate active and substances. TOC is classified as a non-specific method and is ideal for detecting all carbon-containing compounds including active species, excipients, and cleaning agent(s). 2,3,4,5.
For full article Click Here
ISPE, October 2000 In the pharmaceutical industry, Good Manufacturing Practices (GMPs) require that the cleaning of drug manufacturing equipment be validated.1 Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents.Common analytical techniques in the validation process include HPLC, spectrophotometry (UV/Vis), and TOC. HPLC and UV/Vis are classified as specific methods that identify and measure appropriate active and substances. TOC is classified as a non-specific method and is ideal for detecting all carbon-containing compounds including active species, excipients, and cleaning agent(s). 2,3,4,5.
For full article Click Here
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