Pharmaceuticals storage conditions are not something to be taken for granted. They should be viewed as an integral component of any pharmaceutical operation. Even if there is a 2 degree Celsius variation in temperature, a pharmaceutical product can be completely ruined. That can put your customers, and your business, at risk.
However, there is much more to properly managing pharmaceuticals storage conditions than just keeping the temperature right. This article will discuss not just temperature-related considerations but also some equally important factors that often get overlooked.
Matching the Appropriate Guidelines
The cGMP guidelines are a helpful resource when figuring out the best way to manage pharmaceuticals storage conditions. Any pharmaceutical samples need to be kept according to these guidelines, and using them as a starting point can be helpful when choosing the right pharmaceutical storage facility for your needs. But the guidelines are only the beginning. Each drug needs to be evaluated as to the types of conditions it can handle.
Tailoring the pharmaceuticals storage conditions to the needs of each drug is critical in the operation of an adequate facility focused on pharmaceuticals storage conditions. The data provided by stability studies must be analyzed carefully as the storage conditions are designed. When choosing a pharmaceutical storage company, you need to ask if they have access to the appropriate studies and, more importantly, what they do with the data they receive. They need to incorporate it into their storage parameters. You should ask how they go about doing this until you’re satisfied that the approach is both thoughtful and thorough.
Pharmaceuticals storage conditions also need to be specifically tailored to a company’s needs. What works for one company may not be best for another, even if the drugs they produce have similar characteristics. For example, if DNA is used in conjunction with a drug, the temperature at which it can be stored depends on a few different factors. Long-term storage for DNA requires the DNA sample be brought to -40 degrees Celsius. Conversely, if pure DNA is being used in conjunction with a buffer solution, it can be stored for extended periods of time at 4 degrees Celsius. The same variations can be found with the storage temperatures of other common components like stem cells and proteins. A good pharmaceutical storage company will enhance their sample management with the proper cold storage solutions—all based on the materials being stored.
You May Need Cryogenics
The storage of certain materials is going to require cryogenics. The facility you choose should, therefore, have the ability to engage in cryogenic freezing. This is critical because cryogenic freezing is a critical aspect of many pharmaceutical development programs. The cryogenic freezing process involves freezing something until all life-related reactions are stopped. In addition, the biochemical reactions that lead to cell death are also halted. This results in cells that can be preserved for future use.
However, if not done correctly, cryogenic freezing can damage the cells involved. A vitrification solution needs to be used in order to make sure the cell biology isn’t permanently damaged during the cryogenic freezing process. If this solution is not properly administered, the freezing will often do more harm than good. It takes a special body of knowledge to understand how this works. In addition, there is a specific skill involved in administering this type of freezing. Pharmaceuticals storage conditions need to carefully take this into consideration in order to fully satisfy your storage needs.
There is a lot involved in providing the right pharmaceuticals storage conditions. Doing it properly can be extremely time-consuming. In addition, it is costly. Not only does the room setup, along with the acquisition of the proper equipment require significant capital, but the cost of keeping the stored materials at the proper temperature represents a significant recurring cost. For these reasons, discerning companies choose to outsource their pharmaceuticals storage process.
If you are interviewing a company regarding this service, feel free to also inquire about cold shipping solutions. Getting the material from point A to point B may be as important as what happens to it once it arrives. You should ask about the details of the process until you are satisfied with the answers. In the end, the most important thing is to know that your materials are going to be stored professionally and carefully.