Pharmaceutical Cold Storage - ULT Freezers
Pharmaceutical Cold Storage – ULT Freezers
With a temperature range of -45°C to -86°C, an ultra-low temperature freezer (ULT freezer) is used for the storage of drugs, enzymes, chemicals, bacteria and other samples.
Find out more about ULT freezers in our article ‘What Is An Ultra-Low Temperature Freezer?’
This article will look at the use of ULT freezers in the pharmaceutical industry and some of the specific applications that are involved.
The Pharmaceutical Industry
The pharmaceutical industry refers to the field of work that discovers, develops, produces and markets drugs for use as medication to be administered to patients with the aim to cure or alleviate symptoms.
Pharmaceutical companies are subject to a variety of strict laws and regulations governing the patenting, testing, safety, efficacy and marketing of drugs. To ensure that medicines distributed to retail pharmacies and other persons entitled to sell products to the general public are of the appropriate quality, they must be manufactured in licensed facilities that comply with the principles and guidelines of good manufacturing practice (GMP) and good distribution practice (GDP).
Good manufacturing practice (GMP) refers to the minimum standard that a medicines manufacturer must meet in their production processes. Products must:
- Be of consistent high quality
- Be appropriate to their intended use
- Meet the requirements of the marketing authorization (MA) or product specification
Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.
Therefore, the equipment used in production laboratories, such as ULT pharmaceutical freezers, must be of the highest quality in order to assist users to comply with such regulations.
The Use Of Pharmaceutical Cold Storage And Freezers
In pharmaceuticals, refrigeration is vital for the sub-zero temperature storage of medicines, vaccines, samples and other sensitive materials. Precision, consistency and hygiene are therefore vital factors that every piece of equipment within this section are configured to achieve.
The following specific applications require the use of a ULT pharmaceutical freezer…
- Vaccine and Antibiotic Storage
Certain vaccines and antibiotics must be stored in a ULT pharmaceutical freezer. For example, all varicella-containing vaccines should be stored between -50 ° C and -15 ° C, and kept continuously frozen until administration. Other vaccines such as the measles-mumps-rubella (MMR) vaccine can also be stored in ULT freezers.
Proper storage is crucial because it ensures these medicines are safe and effective. Improper storage can lead to wastage of expensive products and the high cost of revaccination. An example of this was in Ventura County in 2017, when 23,000 patients were given vaccines that had not been properly stored. As a result, over a thousand of the patients had to be revaccinated which was extremely costly.
- Biological Samples
ULT pharmaceutical freezers are essential for the proper storage of biological samples such as blood, plasma and tissues, which may be required for pharmaceutical research.
This is because ultra-low temperatures prevent the degradation of nucleic acids, proteins, endocrine molecules, and many other biological molecules. They have been shown to maintain the viability of numerous biological assays and reagents through long-term storage. When samples are stored at ultra-low temperatures, it is important to consider freeze-thaw protocols. Cells typically preserve best when frozen slowly (about 1ºC a minute), but thawed quickly (such as in a water bath).
For example, plasma must be stored at less than or equal to -18ºC until it is thawed. Freezing preserves the blood and plasma and its critical components and keeps a steady supply of life-saving transfusions available.
Discover Froilabo’s ULT Freezers
At Froilabo, we produce a wide range of ultra-low temperature freezers that are ideal for use within the pharmaceutical industry. You can view these products here.
All manufacturing processes for Froilabo products are subject to ISO 9001 and ISO 13485. We guarantee you products meeting high standards of quality and quality to support you in your medical and pharmaceutical applications.
Furthermore, for pharmaceuticals it is critical that the ULT freezer is being maintained at the correct temperature. Therefore, Installation Qualification (IQ) and Operational Qualification (OQ) certification services are extremely important to provide assurance that the freezer is working correctly.
Find Out More
If you would like to find out more about ULT pharmaceutical freezers or to inquire about a product or service, please don’t hesitate to contact a member or our team today . We look forward to being of assistance.
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