Qualifications

 Thermal Qualifications

• Qualification of sterilization by dry-heat or moist heat.
• Qualification of drying stoves or incubator stoves.
• Qualification of climatic room for accelerated aging studies.

• Qualification of refrigerators, freezers and laboratory ultralow temperature.
• Qualification of warehouses and areas of conservation samples.

 The service is adaptable to your needs depending on the particular situation of each team and consists of:

DQ Phase

For new tailored equipment, verifying at design level the compliance of the defined requirements of the user and the compliance of the applicable regulations in each case.

IQ Phase

After the installation, we check the proper condition, location, instrumentation, services, documentation, etc.

OQ Phase

Verification of the proper working of the equipment, according to the functional specifications expected (Functionality of the control panel, alarms, securities, tightness and adjustment / distribution of temperatures / humidity, including multipoint mapping variables to measure).

PQ Phase

Verification that the designed cycle works for the loads to process. In the case of sterilization equipment, we verify the deadlines reached in different points of the load. Optionally, we do microbiological studies with bio indicators.

METHODOLOGY

• Drafting of a qualification protocol, signed before starting the work • Performance of the verification described in the protocol • Analysis of the results and assessments of deviations • Writing a qualification report.

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