Laboratory+commissioning+%26+validation+process

Laboratory commissioning and validation provides assurance that a biological facility is capable of meeting biosafety requirements.

DNV provides the commissioning service through a series of three project stages:

Stage 1 – Design verification: Review and risk assessment

Review of facility design will be carried out in order to verify the adequacy and compliance against requirements. This will include issues such as:
• Pathogen work envisaged
• Cost vs. flexibility/ capacity/ capability
• Equipment needs
• Number of groups/ workers sharing spaces and etc.

Risk assessment will be conducted to identify those critical areas/ issues and those that poise a risk to the integrity of the facilities during construction. The risk assessment will be recorded on specialised software (PHA-Pro 7) using existing tested templates and guidewords developed by DNV.

Stage 2 – Construction/installation verification
A commissioning plan will be produced with the input from the risk assessment. In this stage, DNV’s role and aim is to identify the necessary checks and tests to ensure that the individual components and systems of the facility are in line with the specified requirements and can function as stand-alone units and as part of an integrated facility system.

Regular site visits by DNV personnel would be necessary to ensure close monitoring and be available during the critical stages of the project.

Stage 3 – Certification
DNV will issue a certificate of conformance of laboratory commissioning and validation on the basis of our involvement throughout the project and satisfactory completion of:
• Verification that commissioning and validation was carried out and with acceptable results;
• Independent tests of facility containment integrity and safety systems;
• Verification of systems response to pre-determined failure modes;
• Review of facility-orientated SOPs (maintenance plans, operating manuals, etc.) and decontamination procedures.

DNV's role is critical in this regard as it provides a link between designers, contractors, suppliers and other groups throughout the whole process, giving the owner an independent assurance that the work is being carried out to the required specification and to an acceptable standard.

Contact us

DNV Singapore

Phone us

+65 6602 3826/+65 92338835

E-mail usbiorisk@dnv.com

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