The point-of-use disposable bag testing is a procedure equipped to validate reliability and reproducibility of methodology used in pressure decay. The high growth in terms of value for media and time interval required to perform a cell culture process that demands a strict examination during the test. In a GMP facility bioreactor leakage may generate economic loss and affect the scheduled production. The point-in-use disposable bag testing is useful to quantify the risk in single-use production facilities.
In a bioreactor including the tubing system for detecting leakages that have been introduced by the operator the pre-use disposable bag testing can be used. Numerous testing methods are proposed to detect any leakage that are based on various techniques such as sniffers, which is used for special gases that work as leak testing agents, flow measurement, thermal imaging, and change in pressure. Risk assessment favor the examination of a leak test prediction for single-use bioreactors that should be performed pre-use but after installation. This is because the process of test is usually done in a separate device for testing a single use bioreactor bag during the application of sniffer technology and then installing it into bag holder, this in turn will minimize the operating errors.Point-of-use disposable bag testing Market: Drivers & Restraints
Point-of-use disposable bag testing is a novel and an important technique due to which it is getting widely accepted to determine leakage in biopharmaceutical processes. The Point-of-use disposable bag testing market is expected to gain traction on the backdrop of rise in demand for biopharmaceutical products globally. There are many factors that are responsible for the wide acceptance of the point-of-use disposable bag testing techniques such as accuracy and reproducibility, rest time, handling aspects, condition of the bags after testing, possibility of testing connections, investment costs for equipment and cost per test. However, there are few risks in using the technique as potential handling errors may erupt while installing single-use bioreactors into their holders. These factors are projected to hinder the market for the point-of-use disposable bag testing over the forecast period.Although, low competition due to strict entry barriers creates an opportunity for the existing players in the market, which in turn is expected to favor the monopolistic approach for market expansion in terms of market share in the near future.
Single-use bags drastically reduce requirements for sterilization and validation as compared to glass material or stainless steel that saves time and other vital resources. Bags are pre sterilized and validated till they are introduced into the process train. After the initiation of the utilization of single use bags in biopharmaceutical industry has promoted the growth in the market and the other end users has become more confident for the adoption of single-use technologies. Geographically point-of-use disposable bag testing market is segregated into seven key regions: North America, Latin America, Eastern Europe, Western Europe, Asia Pacific and Middle East & Africa.
North America point-of-use disposable bag testing market is projected to expand with significant CAGR in the near future on the back drop of increasing demand for more biopharmaceutical products. Eastern and Western Europe point-of-use disposable bag testing market is expected to witness promising growth in the near future due to large demand radiopharmaceuticals. With rise in health care spending on economic manufacturing in Asia Pacific countries is projected to favour the market for point-of-use disposable bag testing.
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Dechema, Pall Corporation, Biosan, Cellab GmbH, GE Healthcare Life Sciences,Integra Biosciences AG, Merck Millipore, Sartorius Group, are some of the participating global players in Point-of-use disposable bag testing market.