ISO 14644-7 open for comment
04/01/2001
Hank Hogan
MOUNT PROSPECT, IL—In late February, the ISO Technical Committee 209 (TC 209) released a draft standard of ISO 14644-7, also known as "Separative Enclosures (clean air hoods, glove boxes, isolators and minienvironments)." The 51-page document, albeit a draft, will assist in developing standard operating procedures for those times when something smaller than a full cleanroom is needed.
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Matthews: The draft is 95 percent technically complete.
The draft international standard (DIS) is going through a five-month comment phase, with a cutoff date of July 22, 2001. During that time, the industry can prepare comments on the breadth of the document to the various national ISO technical committees.
"[ISO 14644-7] would provide a context of the minimum requirements, but it's not going to be a design document," says Dave Ensor, the convener for the working group that produced ISO 14644-7.
What the standard will do is provide a framework to tie various industries together. For instance, an isolator in pharmaceutical production is analogous to a minienvironment in semiconductor manufacturing.
The isolator and the minienvironment share some common characteristics, whereas they both separate the operator from the product by a barrier. However, the pharmaceutical isolator needs to be sterilized on a more frequent basis in preparation for stringent FDA approval.
Because the ISO document is still in a draft phase, Richard Matthews, chairman of TC 209, says it's a case of buyer beware. The draft means that the document is 95 percent technically complete, but there may yet be changes. Still, Matthews notes the draft can be useful in various areas, such as contractual negotiations.
"Legally, an ISO document at the DIS stage can be used as a reference document in a business transaction," he says.
In the U.S., the Mount Prospect, IL-based Institute of Environmental Sciences and Technology (IEST) will handle comments. The IEST also happens to be a source for purchasing the draft document. Other sources include Geneva-based ISO itself and the American National Standards Institute in New York.
All remarks will be taken into account before the final standard is produced, voted on and published. That process is expected to take about a half year.
ISO 14644-7 should be official in early 2002.