October 1, 2018
7 steps to 100% secure logistics for liquids in biopharmaReading time: 4 minutes
It is a well-known fact that the logistics process for liquids in the biopharma industry poses a bottleneck. Before the substances, which are generally of very high quality, reach the Fill & Finish Process they usually have to travel a long way; it is not uncommon that they travel halfway around the globe. For instance not every substance that is produced in Switzerland is filled and packaged there.
At SUSupport we have been dealing with the optimization of this process for a long time now. We are confronted with the same question every day: How can we support the biopharma industry in optimizing the shipping of so-called “drug substances” as well as the “Freeze/Thaw & logistics process of drug substances” for single use bags? How can we eliminate the bottleneck and offer helpful support in the form of tools, developments and process optimizations?
This is why we have compiled a list of 7 tips that should be considered by anyone in charge of drug substance logistics:
1. The right container choice: Bottle, single use bag or stainless steel container?
Dealing with the complete logistics process for biopharma substances, which are mostly shipped frozen, made it clear that “single use containers” are the future. They allow for a clear reduction of shipping costs for the return trip, cleaning, warehousing and general logistical costs. Thinking further, it becomes evident that single use bottles have a clear disadvantage: They require a lot of storage space even before they are filled. This is different with the single use bag.
The storage space amounts to close to 0; furthermore, it constitutes an industry standard, it is compatible with a broad range of different connectors, and it already is a feature of the production chain in many pharmaceutical companies.
2. Testing of the chosen container: Well tested is half the battle won.
Based on the advantages as described in paragraph 1, we chose the single use bag. Across all manufacturers and filling volumes, single use bags can exhibit deficiencies in material than can cause high-quality substances to leak or to be penetrated with bacteria, which leads to so-called bio contamination. At this point we recommend a systemic testing of all single use bags prior to the filling process. MITS.2D® constitutes a patented tool specifically developed for this process. Single use bags with a volume of up 50 liters can be tested in less than a minute with regards to their integrity.
3. Protection for the container: Creating a crush zone.
With all the advantages of the single use bag – we have not yet mentioned its flexibility, which allows its content to expand during the freezing process – the skin of the single use bag is highly sensitive. To date, the containers available for more protected packaging of single use bags, are insufficient. Polystyrene and cardboard are a valid approach but they do not offer a satisfactory solution. This is why we recommend the RoSS® Shell System.
In the RoSS® Shell, the single use bag is embedded in high-quality foam, which in turn is carried by a robust frame of high-density plastic. The RoSS® top and bottom are made of stainless steel elements, which are in direct contact with the bag and its content. This allows for effective cooling and thawing.
RoSS® Shell also offers space for connectors, hoses and appliances for sampling. Furthermore, the RoSS® System is compatible with all established filling volumes and brands.
4. Sterile and lossless filling of the container.
The filling respectively the transfer of liquids poses another hurdle in the process. Readily prepared single use bags in the RoSS® Shell System racks can be filled via RoSS.Fill – an appliance developed for the fully automated filling of single use bags. Single use bags that are embedded in the RoSS® Shell System can be filled with up to 200 liters of liquid per hour.
5. Secure preparation for shipping of large batches.
The amount of single use bags to be shipped in the RoSS® Systems needs to be evaluated before the mostly cooled or frozen “drug substances” start their journey. In case of shipping several Shell Systems respectively single use bags we recommend the use of the RoSS.Ship Container System, which is an extension of the RoSS® System.
This specially isolated and highly robust stainless steel container allows for storing the RoSS® Shells with the smallest footprint possible. No matter whether you prefer it as a storage option for palette standards or as a single- or multiple-use shipping container, there is no safer way to ship highest-quality and highly sensitive biopharma substances.
6. Monitoring of temperature and tracking.
The sensitive goods are on their way. Optionally, RoSS.Ship can be equipped with GPS/Gforce. The status of the container’s inside temperature – which can be cooled actively or passively – can be monitored constantly.
Safety, transparency, controlling – what more could one ask for?
7. Minimizing risks during the draining process.
RoSS.FILL cannot only fill Ross® Systems respectively single use bags; it can also drain them once they have reached their final destination, be it individually or in batches/racks made up of up to 20 RoSS® units. Again, it can move up to 200 liters per hour.
Anyone responsible for the logistics process for liquids will help their company in increasing control and safety in drug substance logistics by following these rules. Not only will they be able to sleep better at night but they will actively contribute to higher yields by minimizing drug substance losses.