Pharmaceuticals and biospecimens are sensitive to temperature. This makes it complex to store and transport them. A small temperature variation of 2°C can ruin your pharmaceutical products totally. Besides temperature, there is a host of equally important factors that should be keenly observed. This is where a biostorage service facility comes in handy. It helps you eliminate the risk of damage. Storage conditions of pharmaceuticals is an integral part of pharmaceutical operation and should not be trivialized.
Biostorage maintains the quality of your product. When choosing a biological pharmaceutical storage facility you need a Solid Plan. This will help you eliminate problems that will hinder you from achieving critical innovations and discoveries. The plan should help you decide whether to go for an outsourced or onsite biostorage facility. For an onsite facility, you should carefully consider the cost of specimen, temperature monitoring systems, freezers, backup power systems, and sample management systems. You’ll also require skilled staff and security systems for your
products.
If this is too much for you, then outsourcing is your best deal. Top notch biostorage service providers offer storage services and cold chain logistics. They should have expertise in packaging, planning, and transporting materials that are temperature sensitive. Check whether the biostorage service provides necessary certification such as IATA certification, and adherence to HIPAA regulations. Choosing a biostorage facility that can accommodate changing needs should be a top priority. It should accommodate a bigger inventory if the need arises.
Below are important considerations when choosing for a biostorage facility.
Valid Processes
Biospecimen storage practices that are not well documented can erode the reliability of generated data. It’s, therefore, imperative that you seek services of biostorage service providers who use validated controls and robust process. You should store all biological pharmaceutical samples according to the industry’s guidelines. However, you should evaluate each product properly to determine the best condition it can handle. Enquire if the pharmaceutical storage facility integrates data from appropriate studies into their storage parameters.
Risk mitigation
Documented controls ensure that your organization’s biologics and pharmaceuticals are secure in case of accidents. The biospecimen should be well protected and monitored. This means that you should have an alarm response and backup power
ready.
Proper monitoring and Reporting
Remember, your organization has the mandate of adhering to the regulatory requirements of biospecimens. This means that you should be able to produce required audits and reports when need be. Therefore, you should choose a storage service provider that allows data access and reporting. This also helps to monitor access, inventory activities, and temperature.
Customized Needs
A suitable facility should tailor the pharmaceutical storage conditions according to the company’s needs. The needs of different companies vary significantly even if their products are similar. The storage temperatures vary for components such as proteins, stem cells, and DNA. An ideal pharmaceutical company will provide proper cold storage solutions to enhance sample management depending on what you’re storing. Some pharmaceutical materials may require cryogenic freezing. Your storage needs should be in line with pharmaceutical storage conditions.
Efficient Refrigeration
The temperature of the storage room is an extremely important consideration to ensure you preserve your goods properly. A good biostorage facility should have a high-quality refrigeration system. A suitable biological pharmaceutical facility should have eco-friendly systems that are not only effective but durable. The storage conditions for pharmaceuticals should provide optimum protection to your materials. Additionally, the facility should have a cold storage room service that is tailored to meet the size and temperature requirements.
Cost
One of the biggest concerns about outsourcing a biostorage facility is cost.However, while you will incur costs in having someone do the job for you,you will save in other areas. First, you benefit from best practices. The storage service provider may do a better job especially if they have superior technology and process. Here is another interesting bit. Outsourcing helps biotech and pharma companies to enhance operation efficiency, reduce cost and hence achieve better results for their business.
Security and Regulation
Regulation and security are one of the main reasons why business management outsources services altogether. Due to ever-changing biostorage regulations, it’s prudent to hire professional service providers. High security and temperature sensitivity is also a demanding task. Outsourcing a biostorage facility is therefore a better option.