What happens if you need more stability storage space? See our simple tips for increasing your stability storage space.
As with manufacturing capacity, the pressure on pharmaceutical and medical device companies to increase their development operations in recent years has created a demand for stability storage services that has possibly outstripped their long-term expansion plans for both facilities and staff.
Like Q1 Scientific, manufacturing sites are having to turn space into additional offices to allow for social distancing during Covid-19. Floor space comes at a premium and stability storage or warehousing space can be the first to go in this situation.
This extra demand combined with a variety of other reasons has led to pharmaceutical and medical device companies — even those with in-house storage facilities — to outsource their stability storage requirements to Q1 Scientific.
The process of increasing your stability storage space internally deserves a lot of thought and design. While the decision to outsource will depend on your site’s current resources and future needs.
In this article we have outlined some practical tips for:
- Identifying how much stability storage space you need
- Monitoring your stability storage capacity
- Freeing up on-site stability storage
- Reducing capital and time costs
How much stability storage space do I need?
From a planning perspective, the first point of investigation is ‘how much storage do I need, now or 3 years from now?’. This will have a big bearing on whether you decide to expand your stability storage in-house or outsource to a stability storage service provider like Q1 Scientific.
The required storage space is dictated by the number of samples that must be stored and the physical size of those samples. For example, the manufacture of vials or other small products typically do not require a huge storage chamber. However, if the product requires a large package, a small space will fill up quickly and more chamber space will be needed.
If your storage requirement is likely to be less than 1,000Litres, a reach-in style unit is probably a good option. Reach-in units typically range from 25L to 750L. Any program which will require above 3,000Litres storage is probably leaning towards justifying a walk-in chamber.
With walk-in chambers, the options are almost endless. A chamber can be designed and built to any size or shape. Capacity will typically range from 8,000Litres up to 200,000Litres. An important point to remember however, when installing a walk-in chamber, is all capacity may not be useable:
- While reach-in units are typically very efficient in their use of space, walk-in units will have ‘dead-space’ such as corridors, ducting areas or hard to reach shelving corners which reduce available storage space.
- Space must be allowed for air circulation and considered when designing the layout and shelving.
Q1 Scientific has recently expanded and added the 51st chamber to our cGMP site in Waterford.
Each year we typically add 4 to 8 new storage units to our facility. See our recent post on increasing your stability storage capacity for our expert advice on installing a new stability storage chamber.
How do you monitor stability storage capacity?
Keeping up with business demands and having stability storage available when required is vital. A good storage forecasting and capacity planning process will predict how much storage you will require so that either additional storage space can be purchased in time or you can outsource your requirements to a stability storage service provider like Q1 Scientific.
In addition to providing adequate storage levels, having a storage capacity plan enables you to forecast storage consumption and set budgets for storage acquisition. This reduces the risk of running out of stability storage space.
As part of your capacity monitoring process it is recommended to:
- Assess business growth, R&D and expansion plans
- Observe historical capacity trends to forecast future requirements and predict when your chambers will reach 80, 90 and 100% of their allocated storage
- Identify products requiring more space which may reduce on-site capacity
- Identify potential risks and keep a risk management plan
- Make allowances for contingency or redundancy space
This can be done through either utilising your site manufacturing capacity planning system or a simple Excel spreadsheet.
Making sure your stability storage strategy stays ahead of company R&D needs as well as watching out for sudden peak requirements can reduce the potential to overwhelm on-site stability storage capacity.
How can I easily free up on-site storage space?
You may be considering expanding your on-site stability storage, however there are some simple ways to free up on-site storage space through outsourcing as highlighted in these examples.
Moving long term samples / retain storage
Long term or retain samples may have no pulls on them and are required to be stored for the full shelf life + 1 year, which could be 36-60 months. These samples take up a lot of space and often do not need to be stored physically on-site, as there is no testing. Outsourcing these samples to Q1 Scientific allows you to keep the more day to day stability / R&D samples in your own on-site chambers where you have local access.
Outsourcing certain conditions
Moving more awkward conditions can make sense, as the Q1 Scientific offering flexes with your requirements.
For example, to make your stability storage more efficient on-site it may make more sense to store your 40°C/75% studies with Q1 Scientific. 40°C/75% studies typically last 6 months, so the capacity of a 40°C/75 chamber will vary hugely. You might need a large walk in for 3 months which then sits idle for 6 months after. However, this chamber must always be maintained via calibrations, mappings and PMs even when not in use.
Outsourcing your stability storage to save time and money
Do you already have your own stability storage chambers? It may still be beneficial to store your samples with Q1 Scientific. When your chambers are nearing maximum capacity, you can rent temporary storage space with Q1 Scientific rather than expanding your own facilities.
There are many benefits to outsourcing your stability storage including:
- Saving money by not having to invest in floor space, new equipment, staff and training.
- Saving time through not having to plan, build, map and validate a new chamber.
- Saving staff resources through not having to carry out daily inspections, monitoring, validation, calibration and preventative maintenance checks.
Through outsourcing your stability storage to Q1 Scientific you can free up CAPEX and staff resources to spend on other core tasks. In addition, Q1 Scientific can provide:
- A back-up or redundancy space for your samples in case of equipment break-down or emergencies in your sample storage process.
- Dual storage allowing the safe storage of your samples in two locations to lower the risk of unforeseen interruptions to your stability storage process.
- Custom stability conditions and studies that may not be available at your facility including Thermal Cycling and Photostability Testing.
See how easy it is to move your samples to Q1 Scientific:
How can Q1 Scientific help you?
Q1 Scientific offer a complete stability sample management service and can organise and secure your sample inventory. We offer:
- ICH compliant and non-ICH stability storage chambers which are monitored 24/7, 365 days of the year and have built-in safeguards
- Custom conditions to meet the specific storage requirements of any project
- Fully validated systems and equipment
- A monitoring and alert system and emergency back-up generators
- A complete stability study sample management service with sample receipt and return documentation along with notifications for scheduled pulls for testing
- A secure cloud-based documentation solution for your sample management
- Temperature controlled transfer and transport
- Access to a team of highly experienced pharmaceutical industry experts who are trained in recording cGMP compliant data
With tightly controlled temperatures and humidity rates at our spacious cGMP facility, we can store and manage any samples over the full life cycle of your stability plans.
To discuss how we can help with increasing your stability storage space contact the team today.