Some chemotherapy drugs are part of the thermolabile group. These oncological drugs require strict temperature control in their conservation and handling in order to preserve their physical and chemical efficacy and stability. Conservation must be carried out at a specific temperature, with a narrow range of minimum and maximum, between 2 ° C and 8 ° C. If not stored correctly, thermolabile undergoes changes and deterioration that can lead to a setback in cancer treatments. Instability due to poor preservation can also lead the drug to a state of toxicity.
RDC 220/2004 approves the Technical Regulation for the functioning of the Antineoplastic Therapy Services (STA), which sets out the requirements for its operation. Regarding the conservation of drugs used in ED (Antineoplastic Therapy, or Chemotherapy), RDC 220/2004 determines:
Annex I, 6.5.1.
In the case of medications that require special temperature conditions, there must be a temperature record and control to prove compliance with the requirements.
Annex III, 6.1.
All TA must be conserved and transported at a temperature that guarantees physical and chemical stability.
All the requirements of temperature conditions and records of RDC 220/2004 are met with the adoption of Biotecno intelligent conservation chambers - technology that guarantees the safe storage and integrity of thermolabile oncology.
In addition, RDC 304/2019 has specific regulations on the storage of thermolabels. To help you, we have prepared a Digital Guide on RDC 304/2019, already updated with RDC 360/2020. Download it now on our website and always count on Biotecno to assist you in adapting to the correct storage of medicines, oncology, vaccines, samples and blood.
Source: www.cff.org.br