PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 20 , Issue 1
Showing 1-3 articles out of 3 articles from the selected issue
Topics Review
  • Minoru Takeuchi, Hiromasa Ookawa, Matteo Falgari
    2018 Volume 20 Issue 1 Pages 1-4
    Published: 2018
    Released: June 22, 2018
     Ready-to-use (RTU) sterile syringes account for approximately 80% of the global consumption of these primary containers. The remaining 20% are bulk ones which still need to be washed, siliconized, assembled and sterilized before they can be processed on a fill and finish line. Although there are still firms sourcing the latter, there is a clear trend toward switching to RTU syringes and, therefore, outsourcing operations to primary packaging suppliers.
     There are several reasons why these activities are contracted to external partners. When comparing RTU primary packaging to traditional bulk containers, the advantages are clear: lower investment costs and smaller footprint equipment for fill and finish upstream processes such as syringe washing, drying, siliconization and assembly. They can also reduce the complexity of the overall process which, in turn, yields superior quality performances. All of this enables organizations to focus and deploy resources on their core business activity: developing and manufacturing innovative, safe and effective drug products to treat patients.
     With this outsourcing trend comes a growing reliance on primary packaging suppliers to address increasingly stringent regulations for safer drug products. Since 2006, nearly 50 medications have had glass breakage or particulate issues serious enough for FDA recalls, impacting over 100 million units of mediation. While the risk to human health is paramount, glass particulates contribute to other global healthcare issues like drug shortages. The formulation of parental drugs is highly demanding and complex. It is crucial to guarantee the sterility of the product and the container closure integrity (CCI) at every step. To comply with the expectations of companies and regulators, manufacturers must invest in state-of-the-art production and inspection technologies, which enable the fulfilment of such high-end requirements. Like with other obstacles, there is almost always a way to overcome it. Perhaps laser-assisted cutting technology system, which leads to the improvement of final products' dimensional accuracy, mechanical property and/or reduction of glass particles, is the answer.
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  • Alessandro Morandotti, Daniele Zuccato
    2018 Volume 20 Issue 1 Pages 5-10
    Published: 2018
    Released: June 22, 2018
     High-end biotech products continue to enter the market posing new technical and regulatory challenges for the development of injection systems. Primary packaging for parenteral drugs is exploring new materials and new technologies around all the typical topics involved with these systems: mechanical resistance, surface quality, gliding performances, optional formats, etc.
     In these development syringes and cartridges are playing an increasingly important role thanks to their superior performances of an injection system, as a replacement of the legacy reconstitution procedures for vials. New manufacturing process and advanced technology have been developed and making available a new range of primary packaging. This paper describes glass manufacturing process with improved mechanical resistance and their relative cost/benefits.
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  • Daikichiro Murakami
    2018 Volume 20 Issue 1 Pages 11-17
    Published: 2018
    Released: June 22, 2018
     Although there are laws to enable the transition to the electronic original of the record document on paper in Japan, safekeeping stands still on the paper originals in large quantities, and the reality in its transitional progress to computerization in Japan is so slow as compared with the situation in the Western countries.
    This subject has been discussed in the ES (e-signature) group of the Japan PDA ERES committee more than one year and the main issue was “need of the computerization” and “a risk when domestic electronic extension was late”.
    Also, we have examined pros and cons focused on some methods of concrete computerization, that we paid attention to electronization from paper-oriented system.
    The committee delivered the presentation that featured the subject of “the computerization of the paper original” in the committee session in Japan PDA Annual meeting held in Kobe-city in the end of November, 2017, so some essential points are hereunder described for future subjects.
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