With the RDC 197/2017, from 2019/12/29 on, it will no longer be allowed to use common refrigerators to store vaccines. They must be properly stored in chambers regulated by the Ministry of Health, which meet all the requirements described in the National Immunization Program Cold Network Manual.
With Biotecno equipment, the compliance with the law is simple, safe and guaranteed, as we follow the Good Manufacturing Practices determined by ANVISA, as well as many quality requirements, which guarantee safety and precision for correct storage.
For a better understanding of the importance of storage accuracy, see what ANVISA’s Cold Network Manual (Manual da Rede de Frio) says about the sensitivity of immunobiologicals to temperature variations.
“In the case of immunobiologicals, the sensitivity is directly related to the storage temperature pre-established by the producing laboratory to maintain chemical, physical and biological properties within the shelf life. (...)
Changing the storage temperature may compromise the immunogenic potency of the vaccine, as well as the characteristics verified and certified by the producing laboratory under certain ideal storage conditions: temperature, shelf life, humidity, light and others. (...)
Among the most common deficiencies reported by developed countries are: high temperatures during storage or transportation, exposure of vaccine adsorbed to freezing temperatures, uncontrolled refrigeration equipment, failures in readings and temperature records.”
Source: Ministério da Saúde – Manual da Rede de Frio do Programa Nacional de Imunizações. 5ª Edição. Available at http://www.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf