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!!