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HISTORY OF A PHARMACEUTICAL PROJECT

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 companyís 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 companyís 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&IDís so the protocols can be written to test the equipment and systems.

REMOTE VALIDATION

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.

BENEFITS

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

bulletLower overall cost
bulletLower expense costs to pharmaceutical company
bulletNo "stranger-in-my-plant" effects
bulletLess work for plant training personnel
bulletReduced risk of injuries to "outsiders"
bulletNo need for offices for outsiders

HOW IT WORKS

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 engineerís 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.

HOW DOES THIS SAVE US MONEY?

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.

HOW MUCH CAN WE SAVE?

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.

 

ITEM

TIME ALLOWANCE

IQ preparation

40 hrs.

IQ Execution

15 hrs.

OQ Preparation

40 hrs.

OQ Execution

20 hrs.

PQ Preparation

60 hrs.

PQ Execution

40 hrs.

History File

40 hrs. Total

 

RESULTS:

ITEM

STANDARD

REMOTE

Protocol Preparation, Execution and History File

$43,400

$43,400

Expenses

$8,967

$3,362

Totals

$52,367

$46,762

Savings

$5600

Savings equals $600 per protocol.

NEED AN ACCURATE COST ESTIMATE?

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

OTHER MONEY SAVING OPTIONS

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

WORRIED ABOUT QUALITY?

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

Worried about our level of expertise?

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

Worried about the technical competence of some of your third party validation specialists?

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

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Last modified: 12/21/04