Virtual Pharmaceutical Engineering: Hands-On, Cost-Effective

Now that pharmaceutical industry outsourcing has produced "virtual" pharmaceutical companies, perhaps it's time for engineering services to develop along the same lines.

You've heard of drug firms consisting of "three guys (or gals) and three computers," where a central management firm oversees screening, discovery, testing, scaleup, and production–all performed offsite. Pharmaceutical plant engineering can benefit from the same decentralization, if the success of Syner/Tex, Inc. (York, PA) and its corporate partners is any indication.

Syner/Tex has formed project-specific alliances with other small engineering firms to deliver a broad range of pharmaceutical industry engineering services. One such collaboration, the "Qualification/Validation Alliance," involves Synertex and a nearby firm, Integrated Validation Services, Inc. (Chalfont, PA). Integrated has developed and executed more than 1,000 protocols on a wide variety of pharmaceutical and biological projects, including extensive computer validation using PLCs and DCS Systems. Integrated's client base includes Merck, Johnson & Johnson, SmithKline Beecham, Parke Davis and Warner Lambert.

Pharmaceutical and biological projects include installation qualifications, operational qualifications, process qualifications, and performance qualifications or validation master plans.

The other two alliances are:

• Barrier Alliance, with Advanced Barrier Concepts, Inc. (Cary, NC), specializing in vapor phase hydrogen peroxide sterilization. Advance Barrier has participated in the design, development, commissioning, qualification and validation of six sterile isolators in the US and overseas.
• Construction Alliance, with Integrated Mechanical Services, Inc. (Plymouth Meeting, PA) and Silas Bolef Co. (Norristown, PA). Integrated Mechanical has expertise in sterile and process piping; Silas Bolef specializes in controls, instrumentation, power wiring, and maintenance.

Pharmaceutical Online spoke with Mark Fazio, president of Integrated Validation and a big booster of the virtual engineering idea.

"We've put together an alliance of medium-sized pharmaceutical service companies, all with their own specialized expertise, as alternative to one-stop services," Fazio said. "The five companies involved have worked well together in the past, so we thought it would be a good idea to formalize our business relationship."

"Many of our clients don't think highly of turnkey project packages. For example, having the same company carry out construction and then oversee validation is analogous to the proverbial 'fox in the henhouse.' When one firm does everything, checks and controls are lost.

"In addition, smaller engineering and validation firms can be more flexible, offer faster response time, and build closer relationships with clients. We can compete with the larger firms on many fronts, and in effect the customer still gets a 'one-stop shop.' But since we're still separate companies, dividing up big projects is done more efficiently and cost-effectively.

Fazio points out that the principals at the alliance companies have worked for large engineering firms a the managerial level, "And we've all seen clients' frustration due to inflexibility or inability to respond quickly during a rapidly evolving project."

But what about economy of scale? It doesn't apply to large engineering projects, according to Fazio. "Large companies are substantially more expensive than our alliances because of high overhead. We're driven by multipliers, an engineering finance function, which is simply overhead added to actual cost. Our overhead is much, much smaller. We're also flexible in terms of cost. Many clients say 'I can only afford such-and-such,' so we do a lot of fixed-price jobs. Sometimes we lose money, but we're looking at long-term relationships where it washes out in the end. If a customer says they have one or two years' worth of work, I will lower my profit objective accordingly. Larger engineering company's can't do that because of their fixed overhead."

For more information: Mark Fazio, president, Integrated Validation Services, Inc., 225 Loch Alsh Dr., Chalfont, PA 18914. Tel: 215-997-3310 or 1-888-VALIDATE. Fax: 215-997-3312.