Anonymous Press-Republican Plattsburgh Press Republican Sun Jan 09, 2011, 02:28 AM EST
sept Pak, a Malone-based manufacturer of sterile pharmaceutical vials and bottles, continues to prepare for a huge contract.
Asept Pak CEO Dr. Gary Hanley said the company has secured a five-year contract with Florida-based PharmaCaribe, which has developed FDA-approved products for treatment of cystic fibrosis and chronic obstructive pulmonary disorder. The contract calls for manufacture of 220 million vials per year.
Asept Pak was awarded a grant for up to $850,000 from Empire State Development Corp. to acquire a machine that would manufacture about 60 million vials per year. That's four times the capacity of each of the company's four other manufacturing machines.
It is expected to arrive in March, and would take 45 days to get up and running. It is expected to lead to the addition of about 60 jobs.
"For us, this is a rather tumultuous time as we prepare for the machine and ramp up this contract," Hanley said.
Asept Pak presently has 18 full-time staff and six temporary workers.
Terry Wiley, head of manufacturing at Asept Pak, said the company presently runs two shifts. It plans to go to three shifts sometime in January.
"We were very fortunate there were a wealth of very talented Wyeth people available," he said.
Hanley said that at its maximum level, the contract could result in 180 jobs total.
"We probably need five machines like the one we got a grant for," he said.
Asept Pak Vice President of Operations Sandy Hawkins said going to a third shift has other advantages.
"We don't have to start up and shut down the machines," she said.
Hanley said the concept for the company started in 2005.
With support from the Malone Economic Development Corp. and County of Franklin Industrial Development Agency, Asept Pak bought a former school building and 13 acres of land at 64 West St. The company did renovations and asbestos abatement, including creation of clean rooms and installation of a new air handling system, steam system and other pharmaceutical-grade equipment.
The most prominent was a water purification system to upgrade the village water supply to pharmaceutical-industry standards. The village water is sent to a holding tank.
Then, chlorine is removed and the water undergoes reverse osmosis and deionization treatments. The water is then stored and later ozonated.
"This is truly what makes it all work — the quality of the water," Hanley said.
Production started in 2008. One Canadian firm has increased its demand for Asept Pak products by 60 percent.
Asept Pak is also exploring interest for companies that produce opthalmic medications.
"That is ideally suited to this type of packaging," Hanley said.
Hanley said Asept Pak was able to obtain four Rommelag 3012M blow-fill-seal machines from pharmaceutical manufacturer AstraZeneca.
"The vials are cast as a (plastic) slab, molded, filled and sealed, all within the machine," Hanley said.
Wiley said that sterile environment drastically reduces the risk of contamination.
He said Justin Miller and Tim Miller have gained significant experience in operation of the blow-fill-seal machines. The sophisticated machines require knowledge of pneumatics, hydraulics and programmable logic controller interfaces.
The Rommelag machines are situated in clean room fill suites. The rooms are pressurized so that air can only flow out of the rooms.
Office space for the management ,team and administrative personnel is in the front of the building.
The company has its own quality assurance area, where testing helps ensure the products are sterile and free of defect.
Renovations also included creations of male and female locker rooms and a break room.
Asept Pak hired a contractor to bring the three-phase electric power supply through the building.
The shipping and receiving processes are both two-step stations. Materials are checked as they come into the building to make sure they meet specifications before moving to manufacturing areas.
Finished products are not shipped until the quality-assurance process is complete.
Hanley said he sees a bright future for Asept Pak.
"The number of products that are amenable to this technology will continue to grow and become more integral to the health-care industry as we grow," he said. "We see this technology getting bigger and bigger in the next decade or so."
Asept Pak's operation is ISO certified, so product can be shipped to Canada and Europe as well.
The vials and bottles come in sizes from .2 ml to 100 ml. They can be used to dispense product in either spray, pour or droplet form.
Asept Pak can package intranasal, opthalmic, saline, oral liquids, topical creams, gels and ointments, and over-the-counter and prescription pharmaceuticals.
"We can fill these with anything our customer wants to sell," Hawkins said.
Wiley said 2011 is going to be a milestone year in terms of company growth.
Their present location is expected to be filled before they can meet the maximum level of the PharmaCaribe. Hanley said they plan to look for room to expand in Franklin County as long as it can meet its contracts.
Possible sites include their 13-acre property, but they also like the Chateaugay Business Park.
"We're pretty well entrenched here for the next couple decades," Hanley said.
Hanley thanked Dennis Mullen, Peter Wuhl and Roseanne Murphy at Empire State Development for help in securing the grant.
He said the IDA, MEDCO and North Country Alliance were very helpful as well as patient as the company got started.