QUALIFICATION OF THERMO CONTAINERS | Amicum Pharma

QUALIFICATION OF THERMAL CONTAINERS

Ensure the stability of the cold chain during the transportation of pharmaceutical and medical products.

  • asd Installation Quality Check (IQ)
  • asd Operational Qualification (OQ) of the container
  • asd Testing under real transport conditions (PQ)
  • asd Preparation of documentation for audits and regulators

COMPREHENSIVE QUALIFICATION OF THERMAL CONTAINERS

We conduct a full cycle of qualification work for thermal containers used in pharmaceutical logistics, the medical field, and the transportation of temperature-controlled products. Our goal is to confirm that the equipment maintains a stable temperature during transportation and complies with GDP and other international standards. Specialists check the installation, functional capabilities, perform risk analysis, conduct tests in conditions as close to real as possible, assess temperature stability, the correct operation of cooling elements, and their placement scheme. The result is documented confirmation of the thermal containers’ compliance with requirements, a guarantee of safe product transportation, and minimization of risks during inspections.

What's included

Assessment of container installation and preparation (IQ)

Testing functionality and operating modes (OQ)

Performance Qualification (PQ)

Temperature testing and stability analysis

Development of protocols and complete documentation

What you get

Confirmation of temperature stability during transport

Guarantee of equipment compliance with international requirements and reduced risks during quality inspections

Optimal layout of cooling elements

Need advice?

Get answers to all your questions by phone. Our specialist will advise you free of charge.