Validation, a concept originating in the field of research, enables the examination and assessment of whether something actually fulfills the function it is intended to perform. The notion has been borrowed from the sphere of research and has been implemented in many domains, including process equipment, computer support systems, HighTech, and more. Naturally, validation was lent also to the fields of laboratories, production floors, and clean rooms. The validation process verifies the laboratory, clean room, or production complex when they are completed and examines whether the planning and construction allow the operation for which these facilities were established.
Validation during the construction of clean rooms and laboratories
Clean rooms and laboratories are designated rooms with a strictly controlled environment. Laboratories and clean rooms are in high demand and may be used on a frequent or a long-term basis for various purposes. Clean rooms are used in the fields of chip development, where any change in the environment can impair the development and production of the chip, food industry, FoodTech, pharmaceuticals, medicine, and more. Every field or product has distinct requirements and specifications. Therefore, the laboratories and clean rooms used for the development or manufacturing of products must be meticulously tailored to the specific product. Sometimes, even if a company already has a laboratory or a clean room, it needs to set up a new laboratory or clean room only because it is developing a new product. This is why the specification, definition, construction, and development of clean rooms is a very precise and complex enterprise. It involves initiating, planning, and executing tens and perhaps hundreds of details in an accurate and rigorous manner that is adapted to the specifications of the product and the process for which the laboratory or clean room is established. The most important part of the construction of these laboratories or clean rooms is validating that the laboratory or clean room indeed meets all the requirements and is capable of serving the product development over time, year after year.
How is a laboratory or clean room validated?
Validation is a process in itself that consists of multiple checks and tests, at the end of which the lab or clean room is validated and certified as meeting all the defined requirements. Performing validation tests and certifying laboratories or clean rooms requires the work of professionals with extensive and rich experience. Enginity consists of experts in the design, construction, execution, supervision, and testing of clean rooms and laboratories. The company has expertise in the process of validating clean rooms and laboratories, at the end of which the customer knows for certain whether the laboratory or clean room can be used, based on the specified requirements, or whether anything needs to be rectified before it can be used. We accompany the client throughout all stages of the validation process, including adjustments. If an amendment document is obtained, we accompany the customer to address the gaps and perform additional validation until the facility is fully validated.
