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...

1 Abstract We present work in progress on creating and using a novel audiovisual database that contains a diverse set of conversational expressions. The database is currently undergoing cleaning, annotation and validation to make it useful for the research community. While our main focus is on conversational expressions, we believe that the audio data is of use for the language community. We ai...

The suitability of micellar electrokinetic chromatography for the simultaneous trace determination of several compounds (sulfamethoxazole, trimethoprim, sulfanilic acid, sulfanilamide, 3,4,5-trimethoxybenzoic acid and nonoxynol-9) was assessed. The mixture was separated within 14min at an applied voltage of 22kV by using 30mM phosphate electrolyte, containing 10mM SDS, adjusted to pH 7.8. Under...

Introduction Disposable bioreactors are increasingly gaining acceptance for cell culture applications due to a number of advantages including ease of use and reduced labour costs, less requirements for utilities such as steam and purified water. In addition, the system requires no cleaning or cleaning validation and only a reduced clean room footprint. Integrated ready to use pre-sterilised dis...

Cleaning validation, a requirement of the current Good Manufacturing Practices (cGMP) for Drugs, consists of documented evidence that cleaning procedures are capable of removing residues to predetermined acceptance levels. This report describes a strategy for the selection of the worst case product for the production of lyophilized reagents (LRs) for labeling with 99mTc from the Instituto de Pe...

An ultra performance liquid chromatographic (UPLC) method was developed for simultaneous determination of seven steroid (dienogest, finasteride, gestodene, levonorgestrel, estradiol, ethinylestradiol, and norethisterone acetate) active pharmaceutical ingredient (API) residues. A new, generic method is presented, with which it is possible to verify the cleaning process of a steroid producing equ...

The problems associated to data quality is an increasingly growing concern. Throughout this document we will focus on a specific data quality problem: the existence of approximate duplicate records. Data cleaning aims at correcting data quality problems that can be found in various situations. There are some data cleaning tools that address these data quality problems. One of the tasks of a dat...

The handling of increasing amounts of data creates the need to deal with redundant and/or complementary repositories which are disparate in their data models and/or their data structures. Current data cleaning techniques developed to tackle data quality problems are just suitable for scenarios were all repositories share the same model and structure. Recently, a novel methodology was proposed t...