This article explores redundancy stability storage: What it is, how it works, what level of redundancy do you require and the benefits.
The loss of samples that have been in stability storage due to a chamber breakdown or emergency in your sample storage process could represent a critical loss to your company, disrupt development activities and potentially impact a product launch.
Any kind of downtime is bad for business. Since internal chamber failures can happen at any time, it is important to have redundancy space or back-up equipment available to avoid any interruptions to your stability studies.
In an emergency you can quickly recover any samples in stability by having redundancy space reserved at Q1 Scientific. Here we talk you through the process for managing redundancy space.
What is redundancy stability storage?
Redundancy stability storage is having space available at your conditions, which you can make use of in an emergency. Having redundancy storage space is a back-up protection method for your samples.
For example, by reserving redundancy space at Q1 Scientific you can ship your samples to us in an emergency if anything goes wrong with one of your own chambers.
How does it work?
Back-up redundancy is a must in such a critical process as stability storage. This can be achieved in many ways.
- Your own standby system: The first option is to include your own duty-standby system where all controlling equipment is installed in duplicate. This allows one system to control the chamber and in the event of a malfunction, control can be swapped over to the second unit, while the first is investigated/maintained. This system works well but greatly increases the cost of chamber install, validation and maintenance.
- Using the same equipment: Another option is to decide on a type or model of equipment and use the same format for all chambers. With this in place it is possible to store all required replacement parts on site without needing a multiple of different models of pumps or heaters etc. This system works well and will keep costs down, but it can be difficult to keep to one model as different needs arise over the varied nature of samples and storage conditions. An on-call maintenance team must also be in place to facilitate this system, as time is of the essence in the event of a failure.
- Spare onsite chambers: The third option is to have a spare chamber available for all conditions currently in use. This will only work with certain conditions, a chamber that provides chill conditions such as 5⁰C, is unlikely to be able to also provide up to 40⁰C or humidity control. There are also challenges around return-to-use protocols, and whether a chamber may need temperature-mapping before being used, which would add a large time delay.
The final option is to reserve redundancy space at Q1 Scientific across your environmental conditions.
If there is an emergency, problems in your facility or with your chambers you can transfer your stability samples to Q1 Scientific. Through moving your samples to our fully ICH and cGMP compliant storage facility you will avoid any further interruption to your sample storage process. Q1 Scientific offer:
- Disaster recovery capabilities to cover any emergency transfer of samples from individual batches to entire chambers
- The full range of ICH and non-ICH storage conditions to meet the specific storage requirements of any emergency with options from -80⁰C storage up to +50⁰C with full range of humidity control.
- Flexible storage capacity which can adjust with your requirements along with no pressure to take your samples back
- Temperature-controlled transport from frozen or chilled to ambient transport, and even -80⁰C shipments. We can provide transport solutions in an emergency to meet your requirements.
What level of redundancy storage is right for you?
Having additional redundancy storage requires space. If you are planning to incorporate redundancy onsite then first you need make sure that you have enough capacity. Through identifying your own storage needs you can calculate your onsite capacity to see if you have enough redundancy space at each environmental condition onsite or if you need to outsource.
Many of our clients reserve redundancy space with us for their range of environmental conditions. Having redundancy space available which is close to onsite storage capacity is usually more than enough to ensure you are covered.
What are the benefits of reserving redundancy space at Q1 Scientific?
- Protecting your samples: The biggest and most obvious virtue of having redundancy stability storage in place is that it protects the loss of samples. For companies who perform stability studies the risks associated with stability storage will reduce through working with Q1 Scientific. Our large stability storage capacity and service provide a responsive redundancy storage solution in the event of a disaster.
- Space to meet your environmental and capacity requirements: With a range of ICH and non-ICH stability storage conditions, Q1 Scientific can reserve stability storage space across all your environmental conditions. In addition, Q1 Scientific has the capacity for a range of sample sizes and volume. For example, the manufacture of vials or other small products typically do not require a huge storage chamber. However, if your product requires a large package, a small space fills up quickly and more chamber space will be reserved.
- A business continuity solution: In the event of an emergency or disaster at your site, Q1 Scientific offer a business continuity solution. When reserving redundancy space, we will work with you to develop a responsive contingency plan for transferring samples to avoid significant interruption to your stability studies.
Contact us to find out more about reserving stability storage space
Reserving redundancy stability storage space at Q1 Scientific costs about one third of the price of normal storage.
To find out more contact our team today.