Do you have a disaster recovery plan to cover a chamber breakdown or emergency failure in your stability storage process? What happens when unforeseen events interrupt your stability study?
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, disruption to development activities and potentially impact a product launch.
Stability storage disaster recovery
Q1 Scientific understand the importance of your samples and their value to your company.
We offer a simple and straightforward stability storage disaster recovery solution. In this post our expert team answer some of the common questions asked in a disaster recovery situation.
How do we mitigate stability storage risk?
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.
You can also manage risk by:
- Storing additional samples at Q1 Scientific for back-up in an emergency; or
- Reserving stability space across environmental conditions for immediate availability should an in-house condition fail.
How fast can you respond?
Q1 Scientific have disaster recovery capabilities to cover any emergency transfer of samples from individual batches to entire chambers.
Contact Q1 Scientific within 24 hours of a breakdown and we can take the affected samples to avoid significant interruption to your stability studies under ICH guidelines.
Do you have the right storage conditions?
Q1 Scientific offer custom conditions to meet the specific storage requirements of any emergency with options from -80oC storage up to +50oC with full range of humidity control.
Do you have the capacity to take our samples?
Yes, with 20,000sqft capacity, 30 walk in stability chambers and 15 reach in stability units, Q1 Scientific have the capacity to store your samples in an emergency.
In fact, we have recently expanded our storage facility and have added two new stability rooms to our facility this year.
Stability storage can flex with your requirements and you are under no pressure to take your samples back.
How will my samples be transported?
Q1 Scientific offer temperature-controlled transport from chilled to ambient transport, and even -80oC shipments. We can provide a number of transport solutions in an emergency to meet your requirements.
An independent monitoring datalogger is available within the transport unit to record the temperature for the duration of the journey. After a delivery/collection we can download the data from this unit and provide you with a report.
Sample delivery and collection is important and we handle transport with care to give you peace of mind.
Can you monitor my samples?
Q1 Scientific provides 24/7 monitoring with a 24/7 alarm system connected to each storage chamber to alert of any deviations in control parameters recorded by the monitoring system.
Temperature and humidity are continuously monitored and recorded using our monitoring system which is compliant with FDA (21 CFR Part 11), GMP & GAMP 5.
Our facility has an uninterrupted power supply and a backup generator with automatic cut over switch to cover any power outages or fluxes.
In the event of a network connection failure, the data storage and local alarm are not lost, and a notification is sent to inform of the connection failure. We store data at the facility for all chambers in real time and this data is backed up off site every day.
Can you facilitate quality audits?
At Q1 Scientific we maintain an extensive Quality Management System to control and manage every aspect of our sample storage and management service.
We will work with you to put Technical Agreements in place and facilitate quality audits so that the required documentation is in place to cover disaster recovery situations.
You will be provided with full visibility of actual monitoring data and details on all your samples on stability. Each Q1 Scientific client has their own secure website through which you can access documentation and view environmental conditions for your own study samples. In addition, you will have a dedicated Study Calendar which details all study events including ‘pull points’, duration and any special actions related to your stability study.
You can access and manage all your stability study data remotely as if the samples are on your own site.
Let us help you
The Q1 Scientific team have proven expertise in stability storage and the Irish pharmaceutical industry. We understand the complex and exact stability storage requirements for all our clients.
Due to our high-volume capacity and wide range of conditions we can respond to your disaster recovery storage needs for many types of pharmaceutical, medical device and food products.
Our stability storage facility is fully validated, fully compliant and fully secure. You can feel confident that in an emergency your samples will be stored to your specifications.
Interested in finding out more about our stability storage disaster recovery service?
To find out more about our stability storage services or to arrange a tour of our facility call +353 51 355 977 or email email@example.com
Contact us today.