BETHESDA, MDWhat exactly is the definition of an isolator system? If you were to go to five different manufacturers in the parenteral drug and pharmaceutical industry and ask that question you might get five different answers.
But PDA, a science and technology organization for the pharmaceutical industry, hopes the draft of its isolator systems technical report is the first step in providing a unified definition within the industry.
Created in response to the skyrocketing use of isolators in the pharmaceutical industry, the technical report “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products” provides the ABCs of isolator systems. From definitions of the different types of isolators used in pharmaceutical manufacturing and functional specifications to facility requirements and user requirements, the report walks step-by-step through the process of setting up a safe and effective isolator manufacturing environment.
“There are hundreds, maybe even thousands of potential applications for this report,” says Jim Agalloco, president of Agalloco & Associates, an independent consulting firm based in Belle Mead, NJ, which helped write the document. “The equipment is coming into widespread use in the industry and it is appropriate to provide some kind of guidance about how the equipment is used.”
Gary Partington, technical sales representative for Carlisle Barrier Systems, a New Lisbon, WI-based manufacturer of isolators, feels the time is right for the kind of guidance provided by the report. “There is definitely a level of potential users out there who aren't isolator savvy,” he says. The result has been widely varied methods of using isolators as well as large variations in the quality of equipment available.
The report provides definitions of the range of isolators in use today. “So this serves as a guideline for companies to use,” said Partington. “Now instead of just saying to vendors they want an isolator, they can say what they need it to do and what they want to put in it. That makes a big difference.”
Tom Burns, lead scientist for the sterility lab at Eli Lilly and Co., Indianapolis, thinks there are other practical reasons to developing the guidelines. ” I think that any time the industry can provide consistency, it helps the (government) agencies when they come in and audit. They can see that the industry is working its way toward some kind of standard,” he says.
Agalloco agrees with that assessment. “There was a growing confusion among manufacturers in the sense the (government) regulators were setting the tone and there was no sense within the industry of what we, as an industry, should be doing.”
In addition to helping end-users of isolators, the report should also help isolator vendors develop products that meet the needs of end-users across a variety of applications. “Our hope is that this will help raise the standards of all of the equipment put out by all the companies in the industry,” says Partington.
The PDA is still accepting comments from interested parties prior to releasing a final document. Agalloco says the report could be finalized as early as mid-year, though he would prefer to keep the comment period open longer.
“I always think it is better to hold open the comment period,” says Agalloco.
“I'd rather wait a little longer and get all the comments than stop taking them just to get it done.”
For more information on the technical report, contact PDA on the Web at www.pda.org.