Remediation Project for ALZA Corporation Creates Paradigm for Meeting European Union Regulatory Standards and Maintaining Business Continuity

Upgrading 40 processing rooms and building four new tableting suites within an existing validated facility without disrupting production, ALZA Corporation’s Building M1 team delivered much more than a project that also met new European Union (EU) criterion. The two-phase remediation is a great example of collaboration, trust and respect and is serving as a “test case” to help establish processes for ALZA’s future capital projects.

ALZA’s relationship with DPR began with Peter Nosler, who served as the project executive on Building M1 when it was originally constructed in 1988. The building was the first in a series of facilities that the leading provider of drug delivery solutions built on its Mountain View, CA, campus, according to Jim Simpson, executive director, Real Estate and Facilities for ALZA Corporation, a Johnson & Johnson company with more than 3,000 U.S. and foreign patents active or pending.

Throughout the years, the long-standing relationship has resulted in the completion of nearly 75 projects by DPR. Projects have ranged from minor-scale jobs, such as a projection screen and shade installation, to meatier technical endeavors like the recent remediation project that included the conversion of 6,000 sq. ft. of space into four tableting suites within Building M1 and upgrades to meet the new standards set by the United Kingdom’s Medicines Control Agency (MCA). In 2003, while the project was under construction, the MCA merged with the Medical Devices Agency to form the Medicines and Healthcare products Regulatory Agency (MHRA), the EU equivalent to the Food and Drug Administration (FDA).

“For ALZA to sell products in Europe, we had to meet the new requirements around how clinical development facilities are built, and the differences can be quite distinct from what they are in the U.S.,” said Simpson. “DPR did an outstanding job in responding to ALZA with a very fast-track process to meet our timelines for launching clinical trials in Germany and registering products in Europe.”

The M1 remediation also provided DPR with an opportunity to assist ALZA in enhancing various programs that better integrate construction with the company’s validation plan. For example, during the project, 140 Building Management System instruments were pre-calibrated, tracked, retired or post-calibrated, and a model tracking process was developed and initiated, which has become the calibration department’s primary tool for coordinating calibration work.

“We worked closely with the entire ALZA team to help define the approach, establish protocols and manage the validation effort, including coming up with a test plan and proving that the systems function the way they are supposed to,” said Mark Thompson of DPR.

Project Prognosis

Building M1 was put to the ultimate test when German auditors arrived. Following the inspection, the facility quickly received the requisite green light to produce products for distribution within the EU.

“The German inspectors were extremely complimentary,” said Simpson. “In fact, they made the general statement that this remediation project is a model of how they would like to see other pharmaceutical companies respond to similar types of upgrades.”

For the team working to remediate Building M1, addressing new standards was just one facet of the intricate facility project.

“The project was more like 40 smaller projects located in one large occupied building that needed to be completed while maintaining the delicate balance between schedule, budget and quality,” said Michael Magnano of Total Project Services. “We achieved all three, which is truly an accomplishment. Jerry Lamm, the facility manager, provided a strong vision from the end-user perspective and walked every room of the project to drive quality to a higher level. We also kept the facility up and running throughout the entire project.”

With work performed in two phases, DPR created a detailed Critical Path Method (CPM) schedule showing activity durations and sequence, general flow of work, and major milestones for every element of the project. The schedule also allowed for some leeway to marry ALZA’s production schedule with the overall construction plan and keep the momentum with crews as they shifted gears and moved from one area to another, sometimes with less than a day’s notice.

DPR also self performed the foundation of the tableting suites, drywall and framing, as well as had other subcontractor crews available throughout the project for increased flexibility, permitting teams to make progress in areas while steering clear of active production.

Simpson credits much of the project’s success to the team approach. “The project included 40 different areas and some 20 separate organizations and departments—each which had a vested interest in the reconstruction. The teamwork required to coordinate that kind of complex effort and the mutual respect shown to each other was outstanding.

“Project managers have often reported that one of the key attributes of DPR is its responsiveness to organizations and its flexibility. This is best illustrated with the recent M1 remediation project,” said Simpson.

Healthy Practices

Along with the remediation effort, DPR also completed the addition of four new tableting suites—building a facility within a facility. Semi-permanent walls were constructed around the 6,000-sq.-ft. perimeter of the construction zone to prevent contamination to the existing validated facility. Crews also had to demolish 6,000 sq. ft. of concrete and remove 200 yards of dirt below by hand to ensure accurate grading within the confined space. Even equipment delivery and preservation required artful orchestration, as air-handling units as large as the facility’s conference room had to be brought in through the front of the occupied building, stacked atop each other, and existing equipment was protected, modified or relocated.

“The project team successfully overcame all the challenges and finished both phases on time and within budget without sacrificing quality,” said Thompson. “The key factors for success in this model were the constant communication among all the groups within ALZA that were part of the project and that all of our priorities and goals were in alignment.”

Also of note was the safety record for the project: 107,000 contractor hours were performed with zero injuries or first aid incidents.

“Every morning for two years, a safety meeting was held at 6:30 a.m. to conduct pre-task planning of the day’s activities,” said Thompson. “Each individual had to think about the work they were about to perform, the tools they needed for individual tasks and determine all the potential hazards, which also helped in overall productivity as the work was thought through.”

DPR also expanded its Injury Free Environment program, which has resulted in one of the best safety records in the country, during the ALZA project to include environmental hazards and how materials are stored.

“A desire to do really good work and solve problems—that’s always been my perception of DPR, that’s where they shine,” said Simpson. “Many companies are in the game, but they don’t have the same kind of focus that DPR does. It always comes through … from Peter Nosler to the guy that’s breaking up the concrete, the culture surrounds the work and the value goes way beyond the breaking of the concrete; they are contributing to the greater good.”