The fill-finish stage of the production of pharmaceuticals has been plagued by a number of issues for a considerable amount of time, and one of the potential solutions to these issues is the utilization of single-use technology. Difficulties with capacity, such as when changeover periods slow down production, can also contribute to a number of these challenges. Aging facilities are another factor that can play a role.
On the other hand, it is essential to keep in mind that a single-use item is not a hammer, and that not every challenge you face is a nail. There will always be cases in which stainless steel, or even tanks encased with glass, will be a component of the best possible solution.
The question that has to be posed is as follows: Under what circumstances is it acceptable to contemplate single-use for fill-finish procedures? And besides, single-use is commonly utilized in upstream processes such as the creation of media and buffers. Follow the link if you want to find out more https://en.wikipedia.org/wiki/Fill_and_finish.
Therefore, why are upstream uses of technology designed for a specific use so popular? Since risks connected with upstream are lower when compared to those associated with downstream when leaks as well as leachables, the two biggest problems associated with single-use, are taken into consideration.
Because the value of the media and buffers is lower than that of the final output, an upstream leak that leads to the waste of the media or buffers is not a significant danger. In addition, the additional processing processes that will follow will eliminate the vast majority of any leachables that may migrate into the buffers or media.
When it comes to fill-finish applications utilizing single-use systems, you need to check that you are considering the appropriate risks. What potential hazards does your fill-finish procedure face? Why do batches sometimes turn out differently, or even worse, be rejected altogether? Have you considered the advantages and disadvantages of a single-use solution in comparison to your existing procedure?
Assessment of Risk for Aging Facilities
For many different kinds of factories, carrying out a risk assessment begins with factoring in the dangers that come with having an outdated or insufficiently equipped facility. It is essential to keep in mind that the phrase “aging facility” does not just refer to the age of the building or the equipment within it.
The rate at which systems deteriorate is frequently reliant on the level of effectiveness of the preventive maintenance program or on whether or not a predictive maintenance program has been implemented.
Furthermore, it is possible that a facility has become insufficient as a result of changes in the requirements set out by regulatory authorities (often as a result of the crisis experienced by another firm). Or, it’s possible that procedures weren’t strong to begin with because of the hasty introduction of a product without allowing enough time to optimize the product beforehand. Read more on this page.
A facility design that is inconsistent with the present process and/or people flows is an additional good illustration of a risk that is occasionally experienced. This can be the result of changes to the workflow in the building, or it can be the result of well-intentioned modifications to the current building, such as the addition of a new machinery entranceway in one wall or a staff airlock in another wall, both of which require requisite differential pressure changes.
When it comes to doing the risk assessment, the reasons that contributed to the formation of the conditions are irrelevant; what is important are the findings.
Benefits Of Single-Use Technology
The question therefore is: how might technology designed for a single application assist mitigate the dangers associated with old or insufficient facilities?
Flexibility is an important factor. We have all encountered marketing estimates that anticipate high sales for a new product; however, do we want to construct permanent capacity on forecasts that have not been proven? It may be possible for a solution designed for a single usage to satisfy the real requirements for launch, and subsequently to ramp up to sales stability without requiring significant financial investments or causing interruption to an existing facility.
However, scaling up to a sales estimate might not be the best risk management strategy for your plant. Furthermore, you need to ensure that the questions you ask are appropriate. What potential hazards does your fill finish procedure face? What factors contribute to the occurrence of batch variations or batch rejections?
Another circumstance that may provide a threat is when a product’s life cycle is drawing close to its conclusion. It’s possible that one of your rivals is getting ready to introduce a new therapeutic substance, which may hasten the demise of your product.
How can you quickly free up capacity for other products while simultaneously reducing production of that one? Would you be faced with the necessity to update validation for a procedure that is being discontinued? A single-use solution would not require cleaning or SIP certification because it would only be used once.
Additional benefits of a one-time usage include utilization of less water, reduction in the requirement for autoclaves, changeovers may be done more quickly since you don’t have to wait for the components to be cleaned and dried as well as the capability of autoclaving or incinerating items that pose a biohazard or high potential for contamination.
Risks Further Down the Line
Now that we’ve covered the benefits of the procedure, let’s speak about the potential dangers that single-use presents. To begin, there is the matter of what can be extracted and what can be leached. The worry that a regulatory inspector would ask questions regarding extractables and leachables and also that “enough might not have been done” is possibly the greatest danger.
The second concern is the possibility of leaks, which may not be a worry because there have really been leaks within the organization but rather because there have been reports of leaks. In the following parts, we will investigate each of these two dangers in deeper depth and compare them.