The industrial design engineer develops a design based on data gathered during a plant visit. The engineer then returns to his / her office to produce the desired design. The design details produced are almost always more complex than a validation protocol. All of the pharmaceutical company’s confidential information is in the hands of the design engineer.

The validation effort begins by bringing validation specialists to the pharmaceutical facility. Part of the purpose of this approach is to have the company’s confidential information secure.

The validation specialist begins the validation effort by trying to discover what the design engineer had in mind when the system was designed. The specialist spends hours looking at equipment manuals and learning how to read P&ID’s so the protocols can be written to test the equipment and systems.

Orion Engineering, PLLC, developed the concept of REMOTE VALIDATION after twenty years of industrial design experience. This experience indicates that the pharmaceutical industry is not receiving the maximum possible return for its validation expenditures.

Orion Engineering believes that the validation process can be completed in the same manner as the original design.

The REMOTE VALIDATION approach utilizes the experience the design engineer has acquired to reduce the cost of the validation to a minimum.

If the facility is complete a validation trained engineer visits the plant to become intimately familiar with all aspects of the process and every item of equipment.

Although this seems an enormous task; it is one familiar to all design engineers and a commonly used approach throughout the specialty chemicals, fibers and other industries. The design for the pharmaceutical was not done in the pharmaceutical facility itself but at the engineer’s home office; why should the validation effort be different?

Just as in the case of the original design effort the engineer returns to his / her home office and "designs" and creates the validation protocols. A review by e-mail is possible to further reduce costs.

The typical validation project requires that the pharmaceutical company pay expenses for someone to sit in their plant and study the documents in order to prepare the protocols.

The REMOTE VALIDATION concept accomplishes the same end result by doing the work off site where no expenses are incurred.

For a simple project consisting of four [4] new equipment items requiring an IQ and an OQ for each, one [1] PQ and a History File, and assuming $70 per hour for a validation engineer, the equivalent of $115 per diem and equal hours by a trained validation engineer and a validation specialist. Travel expenses for the engineer are set at $0.36 per mile.

Orion will be happy to provide proposals as Time and Materials or lump sum.

Orion can prepare the protocols for your approval and your personnel can execute the protocols.

Orion’s staff of design engineers are Registered Professional Engineers in the mid-Atlantic states with significant validation experience. References on request.

Orion will be happy to provide resumes for all of our staff and the owners of Orion Engineering, PLLC.

Orion will be happy to provide a review of any documentation prepared by others.

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Last modified: 12/21/04