Hammarplast Medical

Validation

We perform process validation according to an agreed process validation plan. Process validation is carried out in conjunction with injection moulding, blow moulding, ultrasonic welding, bag sealing and sterilization.

Validation is broken down into three phases:
1. Installation Qualification (IQ)
2. Operational Qualification (OQ)
3. Performance Qualification (PQ)

These three protocols are used to define tests that will demonstrate that the process consistently and repeatedly produces the desired product.

1. Installation Qualification (IQ)
This protocol insures that the system/equipment and its components are installed correctly and to the original manufacturer’s specifications.
Calibration of major equipment, accessory equipment, and/or utilities should be performed in this step as well.

2. Operational Qualification (OQ)
This step proceeds after the IQ has been performed.
In the OQ, the process window is tested and challenged.
 
3. Performance Qualification (PQ)
This phase tests the ability of the process to perform over long periods of time within tolerance deemed acceptable.
PQ is performed on the manufacturing process as a whole. Individual components of the system are not tested individually.

4. Validation Report (VR)
Validation report is prepared and presented to the customer.
Written consent from the customer / Quality Department releases products for delivery.


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