Pharmaceutical or biological research samples, vaccines, and biological reagents such as antibodies and enzymes need specialized storage. These materials are essential in research and development, and they aid in the making of cures. Sometimes research institutions, hospitals, pharmaceutical, and Bio-Tech Companies lack the necessary storage capacity to keep their bio-specimens, reagents, and vaccines safe and potent. It’s in such circumstances that commercial bio-repositories and pharmaceutical storage facilities become essential.
But before your establishment can go out there looking for reliable pharmaceutical storage or bio-bank, here are some essentials that you’ll need to consider to find an excellent facility.
COMPLIANCE TO PROCEDURES AND PHARMACEUTICAL STANDARDS
A reliable bio-repository or pharmaceutical storage facility should follow all federal and state regulations on the storage of pharmaceutical products, biological specimens, and reagents. Sample storage facilities in this business should also conform to proper manufacturing processes (GMP) and all other guidelines stipulated by agencies such as FDA, which control issues relating to pharmaceuticals, foods, and supplements. Such entities should comply with all rules, regulations, and protocols that pertain to the manufacture and storage of pharmaceutical products, medical devices, bio-specimens, and supplements.
Such entities should also have ideal Standard Operating Procedures (SOPs), which govern sample preparation, monitoring, storage, and management. The privacy of involved individuals who contribute bio-specimens to RandD efforts should also get protected under the Health Insurance Portability and Accountability Act (HIPAA), which is a Privacy Rule.
BIO-BANK OR PHARMACEUTICAL STORAGE FACILITY MANAGEMENT SYSTEM
Operating a pharmaceutical storage facility or a bio-repository needs lots of safety, ethical, and legal considerations that need a robust computerized system to manage the flow of data and information. A bio-banking or pharmaceutical storage facility software is a necessary element in any establishment in this area because it helps in harmonizing and standardizing the procedures that relate to operations in this field.
There are many software options out there, and it’s prudent that your business conducts a comprehensive evaluation of the software systems out there to get the ideal choice that can help manage such facilities. Typical systems should work parallel to the SOPs, and they should be compliant and automated.
IDEAL FACILITIES SHOULD HAVE ALL FORMS OF SAFE STORAGE TEMPERATURES
Biological and pharmaceutical materials and products need varying levels of storage temperatures. An ideal facility should at least have the capacity to store stuff at all levels of storage temperatures to avoid degradation and loss of specimen integrity. The perfect storage temperature for a given reagent or bio-sample varies with the kind of sample, solution suspension, the period of storage, and the sample’s use.
As such, your chosen storage facility should have all forms of storage that can suit different levels of temperatures. In ideal storage, such as the Sci-Safe facility you should get room temperature storage (15ºC to 27ºC), refrigerated storage (2ºC to 5ºC), freezer storage (-20ºC), ultra-low freezer storage (-80ºC), and
cryogenic freezer storage (-150ºC to -190ºC).
SAFETY AND STABILITY
Pharmaceutical and bio-repository storage facilities need sufficient security and backup because they also act as essential data centers. Such centers should have enough security and safety for their backup systems and the specimens that they hold. All storage facilities should have robust security systems and facilities that get safeguarded from all hazards.
A ROBUST COLD CHAIN LOGISTICS SYSTEM
Any bio-repository or pharmaceutical storage facility should have all the necessary equipment and devices to ship samples safely. The integrity of bio-specimens can get compromised with great ease if they don’t get handled well. As such, you should work with a facility with a proper and robust cold chain logistics system.
The U.S. holds 45% of the world’s global pharmaceutical market, and you’ll need more global insights to handle such a sector. Even with all the technical capacity, knowledge, and know-how, it still may be challenging to handle institutions and individual entities that seek the services of bio-repositories or pharmaceutical storage facilities. To get the best facility, you also need to have excellent customer service and knowledge. When you get done with all the pros, always check the customer service quality, and you may get the best of what you’ll need.