In general, what are some concerns manufacturers of bulk drug products have when storing and transporting product at ultra-low temperatures.
Product loss is the main concern for drug manufacturers. This occurs when the system used to store product is breached in some way. Breakage of the storage container or cracking of the tubing attached to the bag or bottle used to store product are the most common causes of lost product.
Alex Kakad, AdvantaPure Product Marketing Manager
Is there advice a vendor of cold-storage and transport solutions can give to a pharmaceutical manufacturer to make this process as easy as possible?
Make sure that the components used in low temperature storage and transport packaging are capable of withstanding the temperatures to which they will be subjected.
As a supplier/vendor of products designed for just this process, what technologies and expertise can you offer to a pharmaceutical manufacturer? What sets you apart from other vendors?
AdvantaPure has a range of product solutions that were designed specifically for low temperature bulk drug storage and transport.
We have a line of tubing and LIM (liquid injection molding) products that can withstand temperatures far below standard silicone products used in the bioprocess market. Our tubing material, for example, has a glass transition temperature of -109 °C (minus 109 Celsius) which is far below temperatures required for bulk drug storage. We also have complete solutions including bioprocess bag and bottle closures that utilize this new technology.
As the pharmaceutical industry increasingly becomes more global in nature, how can you help a manufacturer navigate through increasingly stringent and varying regulations regarding shipping and storing products internationally?
One recent development in the bioprocess space is the attempt by BPOG (BioPhorum Operations Group) to standardize extractables testing for materials used in drug production and storage. Our new tubing and LIM products, as all our products, are being tested to the full BPOG extractables testing requirements.
Finally, looking ahead, do you see any industry trends developing that will significantly affect the storing and transporting of ultra-low temperature drug product, and if so, how will you position your company to meet the needs of your current and future clients?
As drug companies look at storing more bulk drug product for longer periods of time, they are challenged with trying to better utilize their freezer space. Rather than having a clam shell or secondary container to protect the bag in which they’re storing product, they want the primary container and all components to be capable of withstanding ultra-low freezer temperatures. This allows them to not only better utilize their freezer space but, also allows them to move and manipulate product safely at low temperatures and decreases the risk of product loss.