At UltraPure Systems, the focus is to build the high-purity piping systems that are used to manufacture some of the most sensitive and important products for Puerto Rico’s burgeoning pharmaceutical and biotech industry. Lorie Greenspan goes into the clean room to discover ways in which UltraPure delivers top-of-the-line products and service.
Cesar Roca knew he had a potentially booming industry under his belt, even though Chicago Bridge & Iron, the former parent of Roca’s UltraPure Systems, Inc., didn’t see the need to retain the pharmaceutical industry supplier.
Deciding to close the high-purity and process arm of its business, which also extended into the semiconductor arena, Chicago Bridge & Iron was ready to pull the plug in mid 2001 following the semiconductor fallout, but in the midst of Puerto Rico’s productive pharmaceutical arena, Roca’s operation was not only humming, but had burst out into a full-fledged melody. In just 18 months since commencing operations, Roca and the core team he put together, which included current Vice President Lucas Ramirez, saw the business go from a startup operation to 125 employees.
Knowing he was in the right place, Roca put some financing together and acquired the company on June 30, 2001. At the time, UltraPure Systems was a $12 million concern; currently the company is posting revenues exceeding $25 million.
Needless to say, Roca knew where the business was headed in Puerto Rico. Since, the company has performed manufacturing and installation work for some of the best-known names in the field: Eli Lily, Abbott Laboratories and Amgen, to name a few. Coupled with the tax advantages Puerto Rico offers as a commonwealth of the United States, and a local workforce that is highly skilled and well educated, Ultra-Pure Systems is experiencing a boom that shows no signs of abating.
Roca, now president and CEO, had been with the company since its founding in 1999 as a subsidiary of Chicago Bridge and Iron to solely service the pharmaceutical and biotech industries in Puerto Rico, which by all accounts, has become a major industrial sector for the island. According to statistics compiled by the Pharmaceutical Industry Association, the pharmaceutical industry generates more than 30,000 direct jobs in Puerto Rico, representing more than 25 percent of the work force in the manufacturing sector (approximately 120,000 jobs). All of this work trickles down to other markets, such as small business and professional organizations that provide ample goods and services in areas such as manufacturing components, food services, engineering, medical and legal services, banking services, insurance, transportation communication, tourism and others. This related business generates approximately 90,000 additional jobs in Puerto Rico. In addition, the pharmaceutical industry represents 25 percent of the Island Gross Domestic Product. In 2002, Puerto Rico exports in the pharmaceutical industry reached $32 billion, or 66 percent, of all island exports.
UltraPure’s slice of the pharmaceutical pie involves the manufacture and installation of high purity piping process systems – virtually all the infrastructure needed for certain processes within the pharmaceutical and biotech markets. “We install piping and equipment that will manufacture their product,” he explains further. “In pharmaceutical that entails pure water processes and clean utilities; in biotech, a lot of fluids and injectables, which is a liquid process.” High purity piping, Roca explains, is heavily FDA-regulated, promulgating voluminous documents that must show inspection and certifications at every step of the manufacturing and installation process.
“There are literally binders of documentation that need to be shown to the FDA and everything needs to be audited and validated,” Roca explains. “In a skid that takes thousands of components, there are volumes of documentation at the end.”
With Class 100,000 clean room capabilities, UltraPure can further lay claim to being the largest orbital welder in Puerto Rico, which is a computerized welding process that leaves the clean seam needed for the processing systems. The company’s expertise in fabrication and installing high-purity piping for gases, chemicals and water process systems for the pharmaceutical and biotech arena also extends to the following:
• sanitary process piping systems
• clean-in-place systems
• water for injection systems
• sterilize in-place systems
• pre-fabrication skids
• process/utility skids interconnect piping
• process waste systems
• process piping systems
• utility piping systems
• rigging and setting of skid, process, manufacturing and
“Pharmaceutical and biotech are growth industries that reach their peak in times of need,” Roca explains. “In the last few years biotech has peaked with the need for new and improved treatments and there has been a lot of research and development in this area. Now the industry is going toward gene and DNA research. In the bio-pharmaceutical industry, local growth is occurring because of tax advantages from the local government.
As a commonwealth, there are a number of incentives offered by the local government that makes Puerto Rico very attractive for businesses.”
UltraPure operates in two sites; one in Juncos measures 25,000 square feet and the other in Vega Baja totals 35,000 square feet. Currently, Roca is looking at a third facility in Puerto Rico with docking capabilities; the additional export capability, Roca estimates, will quadruple the company’s business in three years.
Ready when you are
In terms of trends, one of the biggest is in the delicate area of pre-fabrication of process piping spools and equipment fabrication and installation, a highly specialized job for which Roca expends a great deal of time, energy and money to ensure people receive the training necessary to complete installation on time and free of trouble.
“By pre-fabricating piping spools, skids and modules in a controlled shop atmosphere, we are able to provide our customers with very cost effective, high productive, schedule sensitive and unsurpassed quality results,” he explains.
To enhance this area of the business, UltraPure Systems has recently set in place a new modular systems division dedicated to the fabrication, installation and documentation of skidded and modular process systems for pharmaceutical and bio-pharmaceutical applications. The new division was established to expedite a customer’s speed to market by building skid systems and other various infrastructure components concurrently with the customer’s building construction. By doing this, the process equipment is ready for installation at the time the building is ready for occupation.
“When you construct a building a lot needs to be done before bringing in equipment,” he notes. “By building our systems at the same time they can bring in equipment faster. A customer can be up and running in the neighborhood of 25 percent quicker.”
The key to UltraPure’s success, by far, has been its commitment to proper training combined with stringent adherence to quality control, assurance and adherence to a set of standard operating procedures for bio-pharmaceutical process systems design, fabrication and installation.
“We continuously strive to provide the best quality solutions for our clients using the latest available technologies and equipment,” Roca says. “We’re able to bring together all aspects of the high purity piping business into one operation, which means our clients can come to us for a full bevy of services and feel confident that they’re dealing with a company that has a proven track record in the industry.”