Installation verification example

The IQ is often the first validation activity completed when the lyophilizer arrives at the final installation site. Implementation of the protocol may begin as the lyophilizer is being installed. For example, verification of the electrical wiring and piping may be accomplished as part of the assembly activities. The appropriate approach to completing the IQ is dependent on the specific circumstances of the project. 

If you conduct trials on parts and materials to prove reliability or durability, these can be considered to be verification tests. For example, you may test metals for corrosion resistance or hinges for reliability in the laboratory and then conduct validation tests under actual operating conditions when these items are installed in the final product. 

FIGURE 5-13. Example of Project Plan Sections on Installation and Verification and Financial Controls ... 

The installation should now be formally verified. A tabular example of such verification is provided in Figure 2. This should be followed by a verification statement that the instrument was successfully installed in accordance with the Installation Checklist, above, and signed by the installer. 

The performance verification of Karl Fisher apparatus should include checks for the accuracy and precision of the instrument. The linearity of the instrument should be determined at installation. The first step is to standardize the instrument (see Section 14.3.2) pure water is sufficient for this purpose. Sodium tartrate dihydrate standard (water content 15.66 0.05%) can be used to assess the accuracy, precision, and linearity of the instrument. Typically, one would measure the water content of at least five samples, over the intended instrument user range. For example, the water content of sodium tartrate dihydrate samples that were 65 mg (ca. 10 mg H20), 195 mg (ca. 30 mg H20), 325 mg (ca. 50 mg H20), 455 mg (ca. 70 mg H20), and 650 mg (100 mg H20) could be determined. Calculate the percent water to assess the instrument s accuracy. The results should be within 98 to 102% of 15.66% water. Determine the % RSD of the percent water found to assess the precision of the instrument. The % RSD should be less than or equal to 1%. Finally, plot the expected water content versus the percent water content to assess the linearity of the instrument s response. A correlation coefficient (r) value of 0.999 or greater is acceptable. 

The protocol must include the clarified purpose of each item, such as design verification and installation qualification. For example, the purpose of cleaning validation is to avoid any contamination. 

For example of medium-speed anemometer verification, dismantle the pitot tube and the compensated micro-manometer showed in Fig. 1, have the anemometer to be verified installed in the axis of the medium-speed segment in the wind tunnel with other arrangements remained. 

Tbe 3rd Amendment to the lET Regulations in Appendix 6 gives a schedule or checklist of examples of items requiring inspection during the initial verification of the installation, including ... 

The final step in the validation process is the PQ, which is the verification of the suitability of the installation for the intended purpose in the production process. Often quality control of the finished product is involved in carrying out the PQ. An example is the measurement of the homogeneity of a mixture that is produced by a mixing machine. The PQ is performed by the user. When all the above-mentioned steps are completed, the equipment is qualified and can be used in a preparation process. 

As an example, Borja et al. (1999) presented a verification study using the recordings from accelerometer arrays installed at the Lotung Large-Scale... 

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