Rapid Sterility Testing uses the latest in bioburden scanning and detection technology in order to accurately predict the growth of bacterium, debris and other microorganisms over the course of time. If there is an issue with bacterial colonies growing on a sample or product, rapid sterility testing will quickly detect that the process used to sterilize that product is in fact, not efficient enough for the FDA to accept and authorize said product for public consumption. The FDA is only half of your problem though, the other half falls upon the integrity and respect of your patients, doctors and clientele. Effective sterilization services protect your business, protect your patients and protect your reputation; getting approval from the FDA is an added bonus.
When do we think Rapid Sterility Testing is necessary? Well, any time when something is going to be in direct contact with a sensitive part of your body or inside your body, we believe that sterility testing should be done rapidly to further curb the development of bioburden and debris on any medical or pharmaceutical device or product. With that being said, let’s focus on some things that we think rapid sterility testing is perfect for. You might just agree with us.
Water for Injection (WFI)
WFI gets overlooked by many, but not us. When you make water for injection, that water is going to be infused with some kind of medicine at some point in time. Some kind of vaccination or medication, sometimes with a biological product within will be used in that product, and and presence of microorganisms will greatly hinder that process. If someone’s immune system is already compromised and they need injectable medication, it’s of utmost importance that medical professionals eliminate any bioburden from that WFI.
WFI is quite clean and can be perfect for microorganisms to grow. For that reason, rapid sterility testing is more important than ever. WFI should be bought by medical facilities, used as quickly as possible and then disposed of. Prolonging the sterility testing and shipping processes just decreases the amount of time that product is actually good to be used for.
Liquid Parenteral Products
Liquid parenteral products such as dextrose solution, sodium chloride solution, etc. are among the most frequently used medicines in the acute and post-acute care settings. These products can be released to the marketplace much faster when rapid sterility testing and bioburden testing are performed.
These are just a few items that our rapid sterility testing greatly benefits. Rapid sterility testing provides a great return on investment for anyone investing within the medical and pharmaceutical industries. At Gibraltar Labs we provide comprehensive contract research services from the ground up, working transparently every step of the way