cert: 3907.1
Centrifuge Validation Services
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*IQ/PQ testing.
Installation Protocol (IP),
* Verification of proper installation
* Voltage check
* Equipment is leveled
* Vibration test to ensure the equipment is running smooth.
Qualifications for Centrifuge Devices
Centrifuges are high-speed rotation equipment that produce centrifugal force to separate substances
such as liquid for solid. As part of the validation process, I2S can provide an IQ, OQ and/or PQ.
* An IQ will provide assurance of proper centrifuge installation
* The OQ shows that operational specifications are met consistently
* A PQ verifies consistency in meeting performance requirements
The OQ and PQ centrifuge validation helps ensure that substances are being correctly processed
the manufacturing or laboratory research. The overall centrifuge validation process could also include the verifying
if a unit functions (e.g rotational speed) are in line with your performance objectives.
We offer centrifuge validation for bench, door and portable or mini centrifuges.
Ensuring manufacturers specifications, we perform:
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1. I2S service technicians will perform a preliminary inspection of the equipment to ensure the
centrifuge passes the validation.
2. I2S service tech will follow a service protocols that is based on the the validation requirements,
or they can use and existing protocols within your quality program.
3. We offer three services levels that are designed to meet your laboratory requirements.
a. Performance Verification (Basic level validation includes):
* thorough cleaning of the rotor.
* Validating the rotor speed.
* Validating the time of the centrifuge
* Centrifuge Validation the temperature
* Centrifuge Validation stickers are a fixed with service date and due date.
* Service report.
b. Performance Assurance
* thorough cleaning of the rotor.
* Centrifuge Validating the rotor speed.
* Validating the time of the centrifuge
* Centrifuge Validation the temperature
* Centrifuge Validation stickers are affixed with service date and due date.
* Calibration documentation showing the accuracy and precision for the calibration
showing the statues of the centrifuge and ensuring its running within your operation
procedure and GMP regulations and prepares your lab for audit.
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Qualifications for Centrifuge Devices
Centrifuges are high-speed rotation equipment that produce centrifugal force to separate substances
such as liquid for solid. As part of the validation process, I2S can provide an IQ, OQ and/or PQ.
* An IQ will provide assurance of proper centrifuge installation
* The OQ shows that operational specifications are met consistently
* A PQ verifies consistency in meeting performance requirements
The OQ and PQ centrifuge validation helps ensure that substances are being correctly processed
the manufacturing or laboratory research. The overall centrifuge validation process could also include the verifying
if a unit functions (e.g rotational speed) are in line with your performance objectives.