Validating Critical Utilities

This is meant to be a summary of the validation of critical utilities referencing from the source below.

2The validation of utilities used in a production facility can often times present itself as an overwhelming task. The initial effort should be focused on the definition of the project scope and plan layout. The first step in distinguishing the scope of work is the identification of all utilities. This is then followed by the evaluation of the criticality and risk to product of each utility. Identification of the criticality of the utility then dictates the testing required by each system, whether it be no commissioning required, commissioning only, or full commissioning and qualification. This step in the process is often performed through the answering of a series of yes or no questions with regards to the utility. For example “Does the utility support GMP activities” or “Does the utility come in direct contact with the product, or product contact surfaces?”  Answering yes to such questions would indicate greater levels of testing being required.

Once system criticality is identified the framework for the validation effort is identified. Commissioning and Qualification plans or strategies are to be generated defining how each system is to be commissioned and qualified, the type(s) of protocols to be employed and identification of entities or groups who will be performing tasks, and engaged in approval of documents. These plans should be developed by cross-functional teams, each with their own roles and responsibilities necessary to ensure an acceptable project result.   Lastly the actual commissioning and qualification of the system(s) is performed. At this stage the previously defined critical process parameters are to be verified within approved documents ensuring that the system does and will continue to perform as intended. 1

Required specifications and design elements such as (but not limited to) material of construction, verification of welds and welder qualification, cleaning, passivation if necessary, P&ID verification, proper installation and identification of equipment, and pressure testing are verified within the installation portion. Typical operational testing of utilities include verification and challenge of operational SOPs, verification of instrument calibration, power loss and recovery, radio and electromagnetic interference and PLC environment verification (if applicable), alarms and interlocks, and sequence of operations verification. The final performance qualification portion of the testing often entails a period of intense sampling, followed by a long-term sampling phase. Typical testing parameters for gas distribution utilities such and compressed air and nitrogen may include verification for absence of water and oil, atmospheric dew point, microbiology for total count, particulates, and makeup or purity. For water and clean steam systems typical parameters include sampling for microbiology for total count, conductivity, endotoxin, and total organic carbon (non-condensable gasses, dryness fraction and super-heat for clean steam). From the end of this phase forward ongoing activities should be employed to ensure the validated state is maintained. This may include continued assessment of minor changes or enhancements to the system viewed in a cumulative effect, review of changes due to preventative maintenance and calibration, equipment or system modifications, and periodic monitoring of utilities throuh continued sampling.

Reference

Agalloco, James; Carleton, Frederick; Validation of Pharmaceutical Processes, Third Edition; 2008. – Maynard, David, ”Validation of Critical Utilities”

Written By: Alex Khaw, Managing Consultant

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