As I have worked in the industry for many years, the main excitement around single use technology when it was first being introduced into the Biotech industry was the flexibility of the design, mitigation of cleaning validation, higher production efficiency due to optimized production schedule turnover and the ability to manufacture easily within a multiproduct facility. These were all welcome benefits to biotech manufacturing.
As the industry has matured however companies are more focused on lowering the cost of the single use consumables and minimizing the lead time of single use assemblies. One interesting fact about the majority of single use suppliers that may not be as well known is that the final step of the manufacturing process has been typically a bottleneck. Almost all the major single use suppliers to the Biotechnology utilize one main company for gamma irradiation and that company is called Steris. There of course other players in the contract gamma irradiation services market however Steris is a name that is synonymous with gamma irradiation in the biotech industry. The only problem with this is that Steris handles almost the entire flow of gamma irradiation of single use assemblies which means there can be often times a long wait for manufacturers to sterilize the product. This means the long wait for customers to receive there product!
Depending on the wait in line this could add 1-2 weeks or more to the lead time of the single use assembly being produced. In addition, it should be noted that each individual manufacturer does not maintain control in house of one of the most important processing steps which is to ensure the sterility of the product - it is mainly by all the major suppliers contracted out and not under their direct control.
In order to minimize lead times for single use assembly and reduce this bottleneck MDI has recently completed validation of their Gamma Irradiation which allows them to gamma irradiate their single use assemblies within 1 day. This gives MDI full control of the irradiation process, minimizing cross contamination risk and also reducing the overall lead time for production of custom single use assemblies.
The gamma irradiation facility is built as per AERB guidelines
The gamma irradiation facility meets ISO 1137-1
The plant uses radioactive Cobalt-60 as gamma radiation source
Site area is approximately 80900 Sq. meter
Total built up area is 1725 Sq. meter
Continuous type of irradiation facility with a floor mounted conveyor system
As far as we know MDI is the only single use supplier on the market that has in house control of the sterilization process and we think that is a significant advantage. We are excited to share the news regarding this milestone achievement for MDI and we are proud to represent MDI here in the San Francisco Bay Area