MINDEN - A Carson Valley developer of medical products is turning to technology in establishing its own manufacturing plant that will compete with major producers throughout the industry.
The husband and wife who formed DARJA Laboratories 13 years ago believe that the technology will let them do something better than anyone else can - pay attention to the details.
"The way a little 'mom-and-pop' lab has been able to attract large companies is because we've gone into more detail than the large ones can," said James B. McCord, who sells the lab's products to such distributors which then sell it under their brand names.
"With our new system, the integration of the automated equipment and software controls, we'll take our documentation to the extreme."
Since DARJA produces medical products, that documentation is important.
"Out attention to detail can help prevent lawsuits. It's important to document that we have done everything possible to prevent harm or negative impact to our customers," McCord said. "Large companies have a zero tolerance for negative reactions, because they are seen as having 'deep pockets.'" in law suits.
McCord, who has a doctorate in college administration and is a retired college dean, is married to DARJA president Darlene McCord, whose doctorate is in biochemistry. They formed DARJA in Dana Point, Calif., then moved it to the Airport Business Park in Douglas County six years ago.
Now, after contracting with other companies to manufacture products designed by Darlene, DARJA is building a 90,000-square-foot plant at the industrial park to house the most advanced product manufacturing line in the industry, he said.
Al Shankle Construction of Minden is building the new facility. The architectural designer is Archeion of Orange County, Calif., Ratheon Corp. was engaged to design the manufacturing line.
"To the best of my knowledge, we'll be the only contract manufacturing plant in the country with an automated plant, Food and Drug Administration drug and device licenses and all three ISO (international qualify control standards) certifications," McCord said.
He said that the computerized plant will be electronically linked to the facility's three laboratories so records of every test and quality control step will be maintained.
"There would be 75-125 pages of hard copy in FDA batch records for each run, but we'll be able to download it all on to a diskette in seconds. It will show who sanitized the mixer ports, who test-swabbed them to verify they were sanitized, who did the weighing of ingredients."
He said the manufacturing plant will have dock-to-dock automation - ingredients go in at one end and sealed cases of a packaged product come out the other, all controlled by computers with employees monitoring and maintaining the system but not actually making the product.
Before those ingredients go in, though, every one gets tested for quality and purity. The testing continues at sample points during the process and the final product is also tested.
"We do all that testing in-house, then turn around and hire an independent third-party lab to test it again," McCord said. "We use ACTA Laboratories out of Southern California, the best in the country, because independent testing is seen as more reliable."
Anticipating the opening of the plant, DARJA is expanding from about 16 employees to about 47 during the next 18 months. Because the United States has only one university that teaches process chemists, the McCords turned to other countries in recruiting qualified chemists.
Marie Dibon, who also has a doctorate in pharmacy as well as chemistry, came to the Carson Valley from France; Karen Tkaczyk was recruited from Scotland, and Deline Anderson was brought from the Philippines, McCord said. Two other chemists are moving from France later in February.
Once the production system is running, McCord said, the company will be able to accept contracts to manufacture medical products for other companies. He said the system will produce liquid products ranging from very thin materials through thick creams or gels and package them in bottles or tubes. The system will also mix dry products, which would be packaged elsewhere.
