The sensitive and irreplaceable nature of biopharmaceutical samples make storage considerations an imperative factor when outsourcing. Whether required due to lack of space, infrastructure capabilities, or preference to allow for focus on critical materials, which biopharmaceutical storage facility to outsource with involves the consideration of several factors.
Choosing the right company is a complex process that starts with a comprehensive checklist to identify your current (and possibly even future) needs as well as how the cold storage facility aligns to guide your selection.
1. Compliance
Whether storing ingredients, final products, samples, or other substances, it is critical for pharma cold storage companies to follow all relevant federal and state regulations for the services they are performing, from storage of pharmaceutical products and biological specimens to transport and beyond. It is integral that a facility’s accreditations and certifications meet your storage requirements.
Biosample storage facilities should also conform to proper Current Good Manufacturing Practices (cGMP) and other guidelines stipulated by governing agencies, like the FDA. A reliable biopharmaceutical storage company will be open about their Standard Operating Procedures (SOPs) which outline their processes for handling, transporting, managing, storing, and monitoring.
2. Industry Expertise
Having guidelines and rules in place is essential, but these processes need to be carried out by a reliable team. Biological sample storage employees should be highly trained in protocols and company SOPs to ensure proper storage, handling, and more.
Additionally, facilities with highly trained experts may be able to acquire additional accreditations and certifications before you need to begin storing critical materials.
3. Safety and Security
Biopharmaceutical storage facilities need sufficient security because they also act as essential data centers. Such data centers should have robust security systems including necessary video cameras, alarm response systems, and magnetic character readers allowing only those authorized to access samples.
Facilities should also be safeguarded from all hazards, along with disaster and emergency preparedness plans in place. Preparedness should be built into the facility design and employee procedures – including backup generators that kick on as soon as they sense power loss.
4. Temperature and Climate
Biological and pharmaceutical materials need varying levels of storage temperatures to avoid degradation and loss of specimen integrity. Depending on your needs, you may require a pharma cold storage company with one or multiple temperature range areas including:
- Cryogenic (-150°C to -196°C)
- Ultra-Low Temperature (-70°C to -100°C)
- Freezer (-20°C to -40°C)
- Refrigerated (+2°C to +8°C)
- Controlled Room Temperature (+20°C to +25°C)
- Ambient (+15°C to +30°C)
- ICH Stability (+25°C to +40°C)
- Custom temperatures
In addition to temperatures, climate control is crucial to prevent damage in biosample storage and accuracy during stability storage testing since unsuitable levels of humidity can negatively impact the rate at which chemical reactions occur.
5. Flexibility and Customization
Not all institutions and companies require the same conditions for their biopharmaceutical storage as not all deal in the same products. Excellent facilities are flexible and can tailor their services to particular requirements and are ready to adapt quickly.
For example, the same conditions will be different for DNA preservation or even cryobiology. Any reputable facility should be able to cater to your needs, have seamless customer services, and the ability to connect to senior management to properly straighten matters out.
6. Inventory Management System
Inventory systems control and manage all of the samples that have been stored within the biological sample storage facility. These management systems cover all of the processes that are involved in receiving, handling, storage, and retrieval of all the samples within the facility.
A biopharmaceutical storage institution needs to have a robust monitoring and inventory management system that provides full access to the conditions of your sample at any time. This guarantees safety and keeps you in control of your samples.
7. Sample Monitoring
Pharma cold storage companies should have temperature control software installed to track and regulate the minute changes that may occur within the cold storage boxes. Since most pharmaceutical samples are sensitive to even slight temperature changes, even the change of around 2°C could have a devastating impact on the sample.
24/7/365 temperature monitoring should be guaranteed while also ensuring that there are automatic temperature change detectors which will notify of slight temperature changes of less than 1°C.
8. Cold Chain Logistics and Management
Seven out of ten leading pharmaceutical products require temperature-controlled transportation, which is why pharma cold chain logistics play an integral role in cold storage. Proper cold chain shipping ensures you do not compromise on the integrity and potency of your products.
In order to develop a plan, it is vital to work with a cold storage company with cold chain management and logistics know-how to develop and execute precise transport with contingency planning to reduce risks.
9. Location and Shipping Lanes
While deciding, verify the place you are considering for storing materials is in a location that will be convenient for you when you need to get access to them. A biopharmaceutical storage facility’s proximity to shipping lanes is crucial. To easily transport samples to and from your location, determine if the company is near airports and major roads to allow for quick and effective sample transfers.
You don’t want to have to face a long drive to access your business materials, especially if you get a great last-minute opportunity, there is inclement weather, or if you need to frequently access samples.
Choosing Biopharmaceutical Storage
Taking your time to select the right firm for your biopharma temperature storage needs can be vital because picking the wrong company may lead to massive losses of expensive products.
As a global leader in cGMP-compliance with facility locations near major metropolitan areas and within 30 minutes of Newark Liberty International Airport, SciSafe has been operating for over 15 years and provides secure biopharmaceutical storage in a variety of temperature ranges, 24/7/365 continuous monitoring, cold chain logistics, and beyond to meet client’s unique needs. Contact our team of experts to learn more about our cold storage services.