Regulatory factors of modern injectable drug manufacturing
NNE’s latest article appearing on Pharmaceutical Online focuses on regulatory opinion around aseptic production technology, including VHP sterilization. Regulatory authorities are increasing the pressure to remove human intervention from biopharma aseptic filling, resulting in fully automated systems. Vanrx’s SA25 Aseptic Filling Workcell is the featured image in the article.
Pharmaceutical Online: The Rise In Aseptic Injection Drug Manufacturing Production
The goal of the article is to inform readers that “it is time to bring production to the speed and level of compliance your facility needs by integrating the right technologies.”
Recent inspection reports from the FDA demonstrate that ‘poor aseptic handling’ is one of the most frequent complaints. The requirement to minimize aseptic manipulations wherever technically possible, such as cleaning in place (CIP) and sterilization in place (SIP) for all product contacting parts. This clearly outlines the necessity to use advanced barrier technology for aseptic processes.
Many issues could be solved by implementing aseptic production that ends in isolators where cleanroom robots perform equipment setup before production and routine operations during production as well as conduct troubleshooting.
In effect, this will separate the product from the human operator, eliminating the biggest source of particulate and microbiological contamination in products.