LAB-TEST LLCEquipment validation and qualification
We check equipment and premises at every stage — from the technical specification to operation under load — and document evidence that they meet GMP requirements and your specifications.
Ready for audit
Instead of assurances, the inspector gets records: what was checked, which instruments were used and what the results were.
Reliable test results
A chamber can hold the set temperature near the sensor and drift in the corners. Qualification shows how the whole working volume behaves.
Tested failure modes
We test alarms and failure modes in advance, not during a real breakdown.
Four stages — from design to operation
Design qualification
Before purchase, we check the technical specification and the supplier's offer against the process requirements: ranges, accuracy and installation conditions.
Installation qualification
We verify that the equipment is installed and connected according to the manufacturer's documentation, and that its built-in measuring instruments hold a valid calibration.
Operational qualification
We test operation across the full stated range: reaching set points, holding parameters accurately, and triggering of alarms and interlocks.
Performance qualification
We confirm that under routine conditions and with a real load the parameters stay stable throughout the entire working cycle.
Laboratory and test equipment
- Thermostats and incubators
- Sterilisers
- Heating and cooling chambers
- Climatic chambers
- Biological safety cabinets
Premises
The working areas where the equipment operates:
- Temperature
- Humidity
- Distribution across the working area
- Stability over time
Application
You send the form with a list of equipment, a description of the premises and the method the qualification is performed against.
Protocol
We agree the stages, acceptance criteria, timing and price — before any work starts.
Testing
We carry out the checks at your site, measuring parameters with calibrated instruments.
Report
We issue a report with the results in Ukrainian, or in Ukrainian and English. If the characteristics do not match those declared, we state the values actually obtained.
Calibration without a third-party contractor
We calibrate the measuring instruments built into the equipment ourselves — within our accreditation scope, certificate No. 40036. Thermostats, sterilisers and heating and cooling chambers are already covered.
Send a validation request
Fill in the form and send it to 7838535@ukr.net — we will reply with terms, timing and price.
What to include- The method the application is submitted against
- Brief: the address and characteristics of the premises — size, number of floors, walk-through or not
- A list of measuring instruments and equipment in the premises — name, type, serial or inventory number