How to organize the real temperature mode control of the bulk quantity of temperature-unstable immune-biological medications delivered against the Contracts.

1. Manufacturer informs the Client about the readiness to meet commitments against Contract (after the medications are manufactured and sales permit is ready).
2. After Client or Client’s inspector arrives to the storage of Manufacturer the medication sampling starts. It requires sending samples into the special laboratory of Standardization and Quality Control to make quality verification test. The other part of medications should be placed in the cooling chambers. Then they should be sealed by Client’s seal. The temperature modes inside cooling chambers are controlled with the documentary monitoring instruments against Contract.
3. If the laboratory of Standardization and Quality Control decision is positive, the Client’s inspector goes to the Manufacturer and places temperature monitoring instruments in each thermo-container with medications. The instruments with threshold from 2°C to 8°C are placed on the bottom and under the cover of the thermo-container.
4. Client’s inspector seals each thermo-container with Client’s seal and goes to the destination address.
5. Medications (that are delivered to the final destination) in thermo-containers are placed in the cooling room. Then the registered information from the thermo-indicators (temperature monitoring instruments) is reading to the PC in the presence of the Supplier. The information in shape of tables and graphs is added to the Acceptance Certificate of the supplied medications. The results of registering in real time and calendar are transferred to the Manufacturer of medications.
6. The medications delivered with the temperature mode violations should be accepted to temporary Client’s storage or should be returned to the Manufacturer by mutual arrangement. The delivery of the new lot of medications is by the premises chain.
7. The costs regarding the presence of Client’s inspector in the Manufacturer storage defrays Client.
8. The costs regarding the temporary storage of medications that are delivered with violations defrays Supplier.
9. To control the temperature modes inside the thermo-containers could be used:
• Electronic thermo-indicators and thermo-registers, that are working in calendar and real time with accuracy of ±0,5°C in the temperature range from 0°C to 10 °C, in the temperature range from -20°C to 20 °C with accuracy of ±1°C. The discrete interval of registration should be not more than 30 minutes;
• Electronic single/multy-use thermo-indicators with accuracy of no less than ±1°C in the temperature range from 0°C to 10 °C, in the temperature range from -20°C to 20 °C with accuracy of ±2°C. The discrete interval of registration should be not more than 30 minutes. The application of these instruments is possible on the bottom and under the cover of thermo-containers to define temperature violations.
In Russia to control temperature mode we use electronic two-threshold (2°C,8°C)multy-use thermo-indicator TI-2 and electronic six-threshold (-10°C, -1°C, 1°C,9°C,11°C,20°C)single-use thermo-indicator.