Global Sterile Powder Filling Machine Market – Restraints
Some disadvantages associated with filling of powdered drugs aseptically as well as use of sterile powdered drugs is expected to hamper the growth of global sterile powder filling machine market. For instance, according to National Center for Biotechnology Information (NCBI): 2018, every year, patients are exposed to contaminated pharmaceutical products, with a mortality rate as high as 15%. Most of the contaminations occur in hospitals and pharmacies as a result of user error, but around 20% of contaminations in sterile products occur as a result of the manufacturing process, including mistakes in aseptic filling. Because of the very real and present danger associated with contaminated products, sterile filling requires a complex and time-consuming quality control process to ensure product efficacy and patient safety. Furthermore, according to the International Society for Pharmacoepidemiology, there is more risk in aseptic filling processes. Filling must be accomplished in a sterile environment (cleanroom, isolator, RABS), and greater levels of testing are required. All components used in the aseptic fill-finish process must be sterilized/sanitized before use. Sterilization with pressurized steam, irradiation or hydrogen peroxide must also be performed in a manner that does not impact the quality and stability of the drug product.
Sterile Powder Filling Machine Market Report Snapshots
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