Non-specific methods for detecting residues of cleaning agents during cleaning validation
نویسندگان
چکیده
منابع مشابه
Analytical Methods for Cleaning Validation
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...
متن کاملDevelopment and Validation of RP-HPLC-UV Method for Determination of Diclofenac Sodium Residues on Surfaces for Cleaning Validation
In recent years, cleaning validation has achieved a position of increasing in the pharmaceutical industry. It provides assurance to the cleaning procedure that ensures equipment is consistently cleaned from the product, detergent and microbial residues to an acceptable level to avoid cross-contamination and adulteration of drug product with other active ingredients. The aim of this study was to...
متن کاملCleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
T wo previous articles in this series discussed acceptance limits for Active Pharmaceutical ingredients (APIs) and moving to a health-based approach. This article will discuss the currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, and emphasize the need to move to a health-based approach as was suggested for APIs. Thi...
متن کاملContinued process verification methods in cleaning validation
The U.S. FDA [1] process validation guidance document released in 2011 increased the emphasis on continued process verification: “ongoing assurance is gained during routine production that the process remains in a state of control”. Until recently, in a washing system, conductivity analysis was the only on-line method used to monitor the quality of the final rinse water. Now, developments in th...
متن کاملCleaning agents and asthma.
Although cleaners represent a significant part of the working population worldwide, they remain a relatively understudied occupational group. Epidemiological studies have shown an association between cleaning work and asthma, but the risk factors are uncertain. Cleaning workers are exposed to a large variety of cleaning products containing both irritants and sensitizers, as well as to common in...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Chemical Industry and Chemical Engineering Quarterly
سال: 2011
ISSN: 1451-9372,2217-7434
DOI: 10.2298/ciceq100524051m