Adapting temperature controlled strategies for biologics

Adapting Temperature Controlled Strategies for Biologics

Ursula VĂŠrtiz, MBA

Agenda • Temperature Controlled strategies • Case of study : Temperature Controlled Strategies for National Hospitals in Peru, from Distribution Center to the patient.

• New challenges • Benefits

Temperature Controlled Strategies Q U A L I F I C A T I O N OQ PQ IQ

Risk assesment Mapping Main Process, Volumes, Distance

Select Strategy

Design system

Distribution routes ( Temperature Assesment, distance, steps) Define Parameters for Monitoring and Alarms

Training

Technology and Connectivity available

Redundancy support SOFTWARE VALIDATION, (Connectivity, Instructions, etc.)

Training

C O N T I N G E N C Y P L A N

Temperature Controlled Strategies 1. Establish temperature controlled strategies based on risk assessment.

- Cost strategy - 100% control during all the process - Define routes or point of control 2. Packaging : Use suppliers available (local or regionals) - Adapting T / H devices - Adapting packaging - Adapting devices for other industries 3. Connectivity (software/intranet/internet) 4. Temperature map based on worse case.

5. Transportation available (air, land routes)

Case of study : Temperature Controlled Strategies for National Hospitals in Peru, from Distribution Center to the patient.

Pharmacie

Distribution Center Temperature Control Centralize using Remote information Online Alarm - program

Hospital Warehouse

Temperature Control Dataloggers for Remote populations Because of connection limitations

Case of study : Temperature Controlled Strategies for National Hospitals in Peru, from Distribution Center to the patient.

Centralize control

Remote population

New Challenges  Integrate warehouse technology for biologics :  Use of RFID for monitoring shipments  Monitoring shipments and warehouses online and centralize  Integrate transportation system and customs

0 Excursion!

100% traceability!

Adapting Temperature Controlled Strategies for Biologics BENEFITS     

Reduce risk of excursion Integrate technologies Guarantee good service level Delivery on time! On quality ! Cost correct!

NEVER BRAKE COLD CHAIN!!