Andrea Wagner, PhD, SVP, Business Development, BSM
Less than 10 years ago you needed different filling equipment for vials, syringes, and cartridges. The ability to buy and install isolators for each of these separate operations in a CMO was cost prohibitive. Companies that had high volume production of one product with one type of container would invest in this technology and it remained out of reach for others, thereby labeling it unavailable and impractical.
As advancements in filling technology, cleanrooms, and isolators have occurred over the past 10 years it is now possible to perform small scale filling – clinical fills in isolators for a variety of different containers. Though isolators offer huge advantages on the microbial side of manufacturing they have been used primarily as a means to provide containment of products that have high risk to personnel. The use of isolators for highly potent or cytotoxic products requires isolators that have sealed environments that have very limited access (complete containment during operations) and in some cases decontamination ports. Access ports cannot or should not exist when dealing with these types of products.
Isolators provide some of the highest sterility assurance to surround your product with. Finding no microbial counts inside of isolators while conducting filling operations is not uncommon. The entire chamber is sterilized and the only way to introduce microbial contamination into the process is through the items that enter the isolator. Having a RABS system that is attached to these systems is critical to ensuring that you are able to manufacture in this high sterility state.
Once a client or company sees the advantages and now flexibility of an isolator based CMO, will they ever go back to the “open-air” processing again? The answer will most likely be no. It’s addictive to have extremely clean micro readings. With such a reduced risk to a batch of highly valuable products the temptation to say, “once you use isolators, you will never go back” – becomes a real challenge.