OSELYA YUT LLC provides cold chain validation for medical facilities, laboratories, pharmacy warehouses, and pharmaceutical logistics. We provide documented evidence that the equipment and processes consistently maintain the required temperature range under real operating conditions — in line with quality and audit requirements.
Why validation is needed
Validation is needed to:
- prove that vaccines, plasma, blood, reagents, and samples are stored correctly;
- establish justified settings (setpoints, alarms, limits, sensor placement);
- pass internal controls, donor inspections, and quality audits;
- reduce the risk of write-offs, spoilage, and claims caused by temperature deviations.
What we validate
- medical refrigerators and freezers (including vaccine, laboratory, and reagent units);
- plasma freezers, cold rooms/chambers, and storage facilities/warehouses;
- thermal containers/cool boxes and transport solutions (as needed);
- temperature monitoring and alarm systems (as part of process control).
Work format (turnkey approach)
We structure validation as a clear process with a predictable outcome:
- Preparation and plan approval
- define target temperatures, use scenarios, and critical points;
- agree on the protocol, schedule, and site requirements.
- Qualifications (if required)
- IQ/OQ: verification of installation, basic functions, settings, and alarms;
- prepare equipment for correct testing (setpoints, placement, staff briefing).
- Temperature mapping / PQ
- sensor placement and measurements in operating modes;
- stability analysis, “hot/cold” spots, and temperature recovery time;
- recommendations on optimal loading and placement.
- Report and documentation package
- final report with conclusions and compliance against acceptance criteria;
- measurement records, charts, tables, deviations, and CAPA (if applicable);
- operational recommendations and revalidation frequency.
What you receive
- a clear conclusion: whether the system meets requirements and under which conditions;
- an evidence base for management, audits, and inspections;
- practical recommendations: setpoints, alarms, sensor placement, loading rules;
- an option to subscribe to revalidation once a year / once every two years (depending on the task and risk level).
When revalidation is needed
We recommend revalidation in the following cases:
- equipment relocation or changes to the room/ventilation;
- repairs, component replacement, firmware updates, or setpoint changes;
- changes in use conditions (different load, different product);
- periodically — as part of the quality system.
Why “OSELYA YUT”
- 30+ years of experience in medical equipment and cold chain solutions;
- we understand real-world conditions in healthcare facilities and pharma logistics;
- structured workflow: protocol → measurements → analysis → report → recommendations;
- service support and on-site visits across Ukraine.
How to prepare (short checklist)
To ensure validation goes smoothly, it is recommended to:
- provide access to the premises and equipment at the agreed time;
- ensure stable power supply and the ability to work without outages;
- agree on operating modes (setpoints/ranges/alarms);
- appoint a responsible contact person on the customer’s side.
Need validation or a consultation?
Write to us — we’ll recommend the optimal scope of work and prepare a protocol and a commercial proposal for your site.