Stability testing is done to determine how a medication or drug product reacts to being stored. During stability testing, the medication or drug products are exposed to different temperatures, humidity levels, and light conditions to determine their shelf life and how they should be stored by consumers. To complete stability testing, a laboratory needs to use a stability chamber or storage room. If you manage a laboratory, consider the following things when deciding to purchase equipment for a stability storage room or chamber or to rent stability storage space off-site:
Amount of Product that Requires Stability Testing
In many cases, the amount of product that needs to undergo stability testing will determine whether a laboratory is better off buying and setting up a stability storage room or chamber on-site or renting space at a dedicated stability storage facility. If your laboratory has a large number of products to require stability testing or is producing more than one type of drug product or medication that needs stability testing, space on-site may be at a premium. In this type of situation, many labs choose to rent stability storage space off-site.
How Long Products Will Be Stored
Before buying stability storage equipment or signing a lease for storage at an off-site facility, it is important to know exactly how long the product needs to be stored for. If your lab is running a stability test on medication or drug product that needs to be stored for an extended period of time, it may make more sense to invest in on-site stability storage equipment. Likewise, if your lab is planning on developing another product that will need stability storage testing in the future, purchasing the equipment needed may be the best option.
Back Up Power and Contingency Plans
In order for a stability test to be valid, specific conditions must be maintained at all times. This means that the stability storage room or chamber that your lab uses must have back up power and contingency plans in place in case the power ever goes out. If your lab is not able to provide a backup power system and develop the right contingency plans, an off-site stability storage facility that has these things in place may be the best bet.
Funding and the Bottom Line
Finances also come into play when deciding to do stability testing on-site or off-site. If you have the funding and can easily afford the upfront cost, purchasing stability storage equipment for your lab can be a very good investment. However, if money is tight, renting stability storage space may be better, since you can spread out the cost of the storage into monthly payments. and can easily afford the upfront costs.Share