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In recent years, there has been increasing use of single-use bags in a broad range of fields, with remarkable advances in the development and manufacture of biopharmaceuticals, vaccines, and other medical products. On the other hand, single-use bags are at risk of pinholes and other defects during manufacturing processes, and there is currently no practical equipment that enables product testing to be performed conveniently and quickly. Given this situation, the authors have developed a new method of pinhole detection for single-use bags. A composite film comprising two conductive layers is used as the primary material, and may be checked easily for damage or pinholes in terms of insulation by applying a voltage directly on the film before and after use of the bag. Characterized by the idea that the bag constitutes part of the testing system, this method involves changing only the material, without changing the current bag design (shape, size) or attachments, such as nozzles. Various advantages are thus offered, and it is believed to be highly practical. In this paper, the authors report the principle of this method and the results of some investigations, with mention of future prospects. [ABSTRACT FROM AUTHOR]

Currently, risk management based on a scientific approach is becoming required in the establishment of cleaning validation limits for pharmaceutical manufacturing equipment, as the acceptable daily exposure (ADE), which is set based on pharmacological and toxicological evaluation, is increasingly applied. At the early stage of development, ADE values may be set using the threshold of toxicological concern (TTC) approach due to lack of human data on toxicity. However, TTC values are estimates, so their application requires careful consideration. Especially in biopharmaceuticals (mainly proteins), whether or not the target product item is inactivated and degraded after cleaning is an important issue in evaluating the cleaning process. Therefore, a study was conducted by carrying out "CIP (clean in place) + SIP (steam in place)" and "CI (caustic immersion: alkaline treatment over a certain period of time)", which are usually processes used in the cleaning of antibody drug manufacturing equipment. The inactivation and degradation of antibody drug was evaluated from the molecular structure and physiological activity point of view, using sodium dodecyl sulfate-polyacrylamide gel electrophoresis and surface plasmon resonance. This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. [ABSTRACT FROM AUTHOR]

The article discusses the statistical evaluation of cleaning process using process capability in Pharmaceutical Industry and electronic manufacturing. Topics discussed includes Good manufacturing practice (GMP), quality engineering methods and guidelines issued by International Council for Harmonization (ICH).

The article discusses the ways to quantify protein degradation and how this information can be used to develop a customized, cost-efficient and science-based cleaning process to support cleaning validation. Topics include the potentials for Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS-PAGE) to be easily used as a tool for quantifying the degree of protein degradation.