Partnership in service
To the Editor:
The article, “Cleanroom product distributors fill niche,” (CleanRooms, Dec. 1997, p. 21) was well researched and presented. As a manufacturer of gloves, with cleanroom gloves our main business, Phoenix certainly relies on its distributors for on-the-spot service to our end users.
I do take issue with your position that “manufacturers are reluctant to stockpile inventory in valuable warehouse space.” It is standard operating procedure for Phoenix to carry one month back-up inventory for its end-users. In fact, users such as Advanced Micro Devices, IBM and Texas Instruments require such of us. Distributors carry many items other than gloves and we don`t transfer our responsibility to them. We feel our relationship is a partnership in service to the end user.
Best regards and thank you for interesting articles.
Edward W. Gallagher, Sr.
President and CEO
Phoenix Medical Technology, Inc.
Andrews, SC
Misleading photo
To the Editor:
I am writing in reference to an article published in the January 1998 Life Sciences Supplement, in which a clear inference is made concerning the intended use of a product that could have dangerous ramifications for potential users.
The article, “Biological Safety Principals Enhance Contamination Control,” (Jan. 1998, p. 10) although describing precisely the features, characteristics, and precautions associated with the field of biological safety, does include a misleading photograph of a Stackhouse Cleanroom Helmet “Shield” System. The system, illustrated and manufactured by Stackhouse, is intended for use in a non-hazardous cleanroom setting only, and not in conjunction with biological applications.
As the manufacturer of the illustrated shield system, previously sold to Dryden Engineering under a private label, I feel it is important that you are aware of this issue and are in possession of the correct information to pass along to your readers.
Stackhouse is primarily a medical device company and in addition to being the pioneer in helmet system technology for over 20 years, Stackhouse is also the world leader in helmet filtration systems for medical and industrial applications. The shield system shown in the article, now distributed directly to the market by Stackhouse as the Freedom Shield Cleanroom Helmet System, is intended for use in applications where the product/environment requires protection from the user. This system will not protect a user from the environment, i.e., airborne contaminants, hazardous, and in this case the experiment. Stackhouse does, however, manufacture systems that will accommodate some biosafety applications.
There is also the issue of compliance with FDA regulations. As a medical device manufacturer, we are strictly governed by said regulations and are familiar with the restrictions they impose upon various sectors of commerce. Although the microelectronics industry is not regulated by the FDA, the pharmaceutical and to some extent the biotech industries are. I bring this to your attention because the particular configuration of shield system referenced does not have a 501(k) for use in the applications referenced. The FDA is very clear as to what can and cannot be inferred when referencing a governed device and they are swift in their action to correct any non-compliance. This point needs to be emphasized.
Please bear these points in mind when publishing future articles referencing this type of product. As I am sure you will agree, it is our responsibility to provide the industry with accurate information ensuring a high level of safety and accountability where ever possible.
Simon Johnson
Marketing Manager, Stackhouse
Palm Springs, CA