An interview with the Stability Storage Team at Source BioScience
This week, the marketing team take time out to interview the stability storage team, at Rochdale to focus on what they do and how they can assist clients with their storage requirements.
How can a client set up a trial with you?
A client would issue us with details of their storage trial. This can be through a formal storage protocol or can be a simple email with sufficient information. Either way, we need to know such details as:
- What product you are storing
- Whether the product is a controlled substance or hazardous
- The quantity which you wish to store
- The dimensions of those products
- Which conditions you wish to store at
- The length of the trial
- Details of the return time points
- Any other specific information
From this information, our Commercial Team would then generate a quotation against this. If the client wishes to proceed, a purchase order should be placed and then we can arrange for the product to be set down.
Our stability storage team will arrange with the client when the product can be sent. Along with the product, we would need to have the storage protocol and the Material Safety Data Sheets.
What happens when product arrives at Source BioScience?
We should have advance notice that the product will arrive to us. That way, we can schedule our work loads accordingly. When the product arrives to us, we undertake a visible check to ensure that the product has not been damaged during transit and we undertake a two-person check to verify that the number of samples sent, matches the numbers on the protocol.
We enter information from this protocol on to our LIMS system and will place the product into our storage baskets and will set these down into our stability storage rooms.
The client is then issued with a product receipt note and pull summary.
What types of product do you store?
We store a variety of products such as tablets, capsules, creams, liquids, gels, a variety of medical devices including inhalers. We have even stored 200 litre oil drums! We can pretty much store what ever you want us to!
What conditions do you have available?
At all of our sites, we have the ‘standard’ ICH conditions of 25°C/60%RH, 30°C/65%RH, 30°C/75%RH, 40°C/75%RH and 5°C.
We have low storage too at -20°C, -25°C, -40°C, -70°C and -80°C.
We also have a variety of non-standard conditions available too, which varies from site to site.
If clients have a specific test they want to run, can you help?
Of course. We have cabinets available that we can tailor to suit client’s specific needs. We also have a cycling cabinet too should you wish to set a particular ramping profile. You just need to ask us!
Where are your sites?
We have 4 sites. Our largest site is in Rochdale, England. We have other sites in Tramore, Southern Ireland, a site in Livingston, Scotland and one in the United States, Los Angeles.
Can clients look around your facility or audit you?
Yes, of course they can! We always welcome clients to come have a look at what we do and show you how we do things! We store for over 200 clients across our 4 sites, for many of the blue chip pharmaceutical, biopharmaceutical, medical devices companies and contract laboratories. We are used to being regularly audited. I think we are getting audited once a fortnight at the moment.
Can you offer photo-stability testing?
Yes, we have cabinets that can undertake photo-stability trials. This is tested in accordance with the ICH Q1B guidelines. This test typically takes less than one week to complete.
How are returns handled?
Returns are made via professional approved suppliers such as Biocair, UPS and TNT. As our customers have individual needs we can accommodate returns via a same day, overnight and various controlled conditions through these suppliers.
Can you store controlled drugs?
Yes, we have a controlled drugs licence which is issued to us by the home office after rigorous checks under the miss use of drugs regulations 2001.
How is data logged and maintained?
For all our customers who are storing stability samples with us, the data is treated with the strictest of confidence. All of the customers contact names, trial information, POS etc. is stored under an individual SS trial reference number on our validated, AutoScribe System which is password protected and only trained competent members of staff can access.
How are samples kept secure?
Samples are processed in our stability suite prior and after set down. The suite is under strict fob entry access and only selected members of staff can enter. When each trial is started it is given a unique ‘SS’ reference number and placed in the desired conditions. Each environmental chamber has a key lock entry and only trained members of the stability and our 24hour on-call team have keys to access.
Are the walk-in rooms monitored?
Every piece of our equipment has independent monitoring sensors for temperature and humidity (where applicable). These sensors are linked back to touch screen, 21 CFR part 11 complaint data loggers. This information is stored on the data logger’s hard-drive and is backed up through IT servers.
These data loggers are connected to our auto-dialler system which will alert the on-call team should a temperature/humidity excursion occur.
Why do companies choose to store with Source BioScience?
Companies choose to store with us for a variety of reasons! We have vast experience in what we do, and we have worked with many of the blue chip pharmaceutical, biopharmaceutical, medical devices companies and contract labs across the UK, Ireland and the US.
We have rigorous quality systems which we adhere to, which are demonstrated when clients audit us. We have a state of the art LIMS system to track client’s product. We employ state of the art data loggers to ensure equipment is continuously monitored. We have safety measures in place, which include back up power generators, in case of power failure to the building, on-call duty engineers to respond to equipment break downs both during normal office hours and out of hours. We hold critical spare parts on site, so if there are component failures, we can respond immediately. We validate all of our equipment on an annual basis to ensure optimum equipment performance. We manage the entire process of stability storage.
In a nut shell, we take away all the hassle, all the worry, all the stress that stability storage can bring to clients. We take full responsibility for the day to day management of stability storage and our customers have confidence in what we do. Its why they keep on coming back to us time after time.
For further information and prices please contact us or call +44(0) 115 973 9012