Smart BioStorage

By Masy BioServices

Date: September 16, 2018

 

FP_Smart_Biostorage_1If your company or research organization is part of the growing pharmaceutical and biotechnology sector, at some point in the development process, you will likely be faced with the need for environmentally controlled storage. Whether your R&D department needs cold storage for samples under development, your stability department requires long-term test-sample storage, or your lab needs ongoing storage for seed product or clinical trial materials, you will face the quandary of finding a reliable and convenient climate-controlled facility accessible to your teams, or you may take on the challenge of building your own biorepository.

If you are like the majority of biopharma firms that Masy Systems has served for the past twenty years, your justification for biorepository storage arose from an initial critical need that had to be met “now,” rather than from a well-conceived long-range plan for storage. Perhaps after considerable trial and error, your R&D team discovered a sample that worked. They needed to keep it refrigerated, and a dorm-sized refrigerator on sale at your local department store served the purpose. Research continued, results were good, and a second refrigeration chamber was warranted, perhaps a more expensive one that required tighter temperature control. Soon your lab required more space so additional storage chambers could be accommodated.

At what point do you realize that this facility has become a biorepository? At what point do you recognize that its infrastructure is not appropriate for present and future needs? When do you realize that the site is not adequate, your power supply is not sufficient, there is no room for expansion, and you have no contingency plans for equipment failure?

Among the challenges inherent in developing and building your own biorepository are justifying the need for such a facility; planning for short-term and long-term capacity and a variety of storage conditions; and finding a location for it that will meet the demanding needs for uninterrupted electricity, back-up power, space for expansion, easy accessibility for those working with the materials to be stored, and ready access to the raw material suppliers and service personnel needed to maintain your facility.

Selection of equipment for your facility is ultimately the most important—and possibly the most costly—challenge. It is the one we will focus on here, because if you haven’t already reached the critical point in justifying the need for a biorepository, you should plan ahead for storage equipment needs. Make your initial purchases wisely so they can be incorporated into a long-range biorepository plan rather than coming to this juncture with the consequences of initial impulse equipment purchases.

The two primary considerations for your purchase of environmental chambers must be quality and serviceability to meet both your short-term and long-term storage needs. Cost should be the third concern, factored in only after the necessary levels of quality and service have been determined. Trading low initial cost for product failures, loss of samples, extra service expenses, and eventual equipment replacement costs will certainly lead to higher overall expense; and time and money spent on research may be entirely negated if your critical samples are lost.

Long-range planning is essential to obtain the best equipment value for the dollars invested. If you need a refrigerator now to store research samples, will the unit you purchase meet your needs when the product is developed and gets to the stages of stability testing and clinical trials? Will the unit meet GxP validation specifications for FDA and/or other government-required testing? Will the unit be large enough to store the additional volume of material you may need for later development stages?

The size and accuracy requirements of your unit should match your long-term needs. If your samples or product will be compromised if they freeze or thaw in the course of the defrost cycle, an ordinary freezer will not meet even your short-terms needs. If you only need to store a handful of research samples now, but you will need to keep many control or test samples at tighter temperature controls later, consider investing in a reliable unit that will meet both needs to begin with rather than buying a department store refrigerator now, replacing it later with a larger one, then replacing it again with an expensive, more tightly controlled laboratory unit. If you will need validated equipment with which you can achieve repeatable results in testing stages, then buy equipment that meets those specifications now rather than having to reinvent your storage options later. If more than one team of researchers or scientists will be using your climate-controlled equipment at various stages, talk to all of them and take all of their needs into consideration when determining your eventual equipment requirements.

Environmental storage chambers come in two varieties—reach-ins and walk-ins—each with their own power and space requirements, and with widely differing impacts on your facility’s resources. The type of unit best for you will depend on the amount of storage space you need over the long term, energy efficiency considerations, the size of the space you have available, and diversity of material and size of product that you will be storing.

If your product needs will never require more than a small amount of environmentally controlled space, consider a reach-in refrigeration unit that maintains the temperature you need. A typical 25 cubic-foot reach-in chamber will require approximately sixteen square feet of floor space and will run on a ¾-horsepower compressor. It may cost upwards of $175 per month in operational costs. If the samples or product you store in it cannot afford to be compromised by temperature excursions, then you should consider getting an additional unit so that when your primary unit fails, you have a back-up chamber ready and waiting.

Bear in mind that if your storage needs increase, adding a second, third, or fourth chamber will increase your energy and space needs exponentially. Not only does each unit have its own compressor adding to energy consumption, but you will need additional floor space for the units and for aisles, and your heat and air conditioning (HVAC) system will need to be adequate to protect them. Refrigerators generate considerable heat to keep their contents cold, and the more chambers running in a room, the hotter it will get and the more susceptible the units will become to failure if the external environment is not properly controlled.

A typical 800 cubic-foot walk-in chamber has a 10´ by 10´ footprint, runs on a 1½ h.p. compressor, and can have redundancy built into the unit, with two cooling units running in alternating time periods; if one fails, the other will continue operating, so no additional back-up chamber is needed. At a cost of approximately $20,000-25,000, it is a significant investment; but if your ultimate storage needs will warrant that much space, consider that it cost 90% less than the 32 reach-in units that would be required to meet the same cubic feet of storage space—and it will take up far less space and energy resources in your facility. Furthermore, the temperature of the external environment is of less concern, so the impact on your building’s HVAC system would be negligible.

With either type of chamber, redundancy is of paramount importance if the product and samples you are storing must stay at a specific temperature. In either case, you will need a backup generator to power your chambers—reach-in or walk-in—in the event of a power failure. Your whole infrastructure is important when considering the redundancies built into a biorepository including security for your high value investment; monitoring, reporting and notification; sample management; and quality control.

After comprehensive assessment of your biostorage needs, you may find that the type of system you require is outside your budget. If that is the case, offsite storage space in an independent biorepository that incorporates these best practices should be considered.

Building your own biorepository or choosing an offsite storage facility will be a costly investment, but if the proper planning is done in the early stages, it will save you time and money over the long-term and help ensure the success of your drug development and research when it gets to the clinical trial stage.

 


Appearing in the December issue of Future Pharmaceuticals Magazine

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