Equipment Compliance Verification

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Validation of isolators for the manipulation of radiopharmaceuticals, laminar flow hoods for aseptic manipulation and of radiopharmaceutical synthesis cells.

An isolator is a confined environment with a suitable degree of microbiological and particulate protection where high contamination risk operations may be carried out such as aseptic preparation of pharmaceuticals and radiopharmaceuticals.

The laminar flow hood enables performance of aseptic handling assuring a low microbial contamination risk due to the operator and the surrounding environment.

A synthesis cell of suitable pharmaceutical grade represents a useful tool for preparation of injectable radiopharmaceuticals.

Validation is the documented verification of equipment compliance with the acceptance criteria established by the contracting authority which has clear ideas of the equipment purpose.

Can the supplier test inspection substitute the validation? Absolutely NOT! During test-inspection, the supplier verifies that the system installed operates properly from an electromechanical point of view, therefore depending upon the same supplier’s specific acceptance criteria. Verification that the installed system reaches specific environmental contamination levels, for instance, is up to the end user who will have clearly different acceptance criteria.

Verification of microbiological and particulate contamination is the heart of the validation process. It enables the documented demonstration of the environmental contamination compliance with the standards in force. In fact, this compliance cannot be disregarded if the quality of the product handled inside of the equipment is to be guaranteed.

How else could one discover that the laminar flow hood absolute filter was perforated during installation of the equipment? Or that the air flow is not perfectly laminar and that therefore the equipment is not safe? Or that the isolator is not up to standard because the gaskets do not form a perfect seal? The only method available to avoid such unpleasant surprises is validation!

The results of validation activities are gathered and documented in protocols and final reports to be presented to the inspecting authority during periodic inspections.

Validation of areas classified as Pharmaceutical Grade C or D

Environmental conditions of areas set up for the synthesis and/or the handling of radiopharmaceuticals constitute a critical operational aspect and must be suitably verified. Controlled contamination environments are divided into different classes depending on the level of contamination. Class A is defined as an environment with a reduced particulate contamination and no microbial contamination. As the contamination progressively increases the cleanliness level decreases passing through class B, C and D. Validation enables the verification of area compliance to the acceptance criteria established by Good Manufacturing Practices.

Verification of the air treatment system functional parameters (e.g., over-pressures, hourly renewal, absolute filter integrity) and of microbiological and particulate contamination level of the air and the surfaces in the room guarantees proper functionality of the system.

The results of validation activities are gathered and documented in protocols and final reports to be presented to the inspecting authority during periodic inspections.

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