October 14, 2003

FDA

Mr. Rick Friedman

7520 Standish Place

Rockville, MD 20855

## Sent via: fdadockets@oc.fda.gov 

### Re: Docket number: 2003D-0382

Dear Rick,

I think FDA has done an admirable job in development of the new "Sterile
Drug Products Produced by Aseptic Processing", Rev 08/22/03.

#### The following is one editing point to the document that places FDA in the position of favoritism or endorsement of a product type. This should be avoided as such endorsement of a commercialized product places the possibility in the reader's mind that they must use this product.

FDA has specified in Line 1254:

1252. Active Air Monitoring

1253

1254. **The method for assessing the microbial quality of air should
      involve the use of *active ***

1255. **devices such as slit to agar samplers, those using liquid
      impingement and membrane (or gelatin) filtration, and centrifugal
      samplers**.

First, this statement is commercialization of the slit to agar sampler
that is a registered trademark by the Matteson Garvin Corporation.
Secondly, the other methods are listed as liquid impingement, membrane
(or gelatin) filtration and centrifugal samplers. This is also
commercialization as the gelatin filtration process is patented by the
Sartorious Corporation and the centrifugal sampler calls for the use of
the RCS by the Biotest Corporation. Thirdly, this writing DOES NOT
include the listing of active air samplers used in the industry and show
favoritism.

Overall, the addition of the word, "impactor type" completes the list as
this includes the forgotten Sterilizable Microbial Atrium (SMA), the
Surface to Air Sampler (SAS) and the Mass 100 EM Science sampler.

Technically, the listed methods in the document are not the best methods
in the industry to use in aseptic process and cannot be use within the
isolator. The Slit to Agar is a very old method whereby moving parts
cannot be sterilized. The liquid impinger and filtration methods have
been nearly fazed out due to handling issues of the sample and the
showing of false positives. The gelatin filtration is very limited in
it's use. And the centrifugal samplers disturb laminar airflow patterns.

**References:**

1.  Please refer to USP \<1116\> whereby an accurate and complete list
    of microbial air samplers is found.

2.  Please refer to ISO 14698 whereby no sampling method is named by
    name. Rather a validated system is called for.

3.  Please refer to the Orange Guide whereby no sampling method is named
    by name

4.  Please refer to the US Government's Small Business and Agriculture
    Regulation Enforcement Fairness Pact whereby endorsement requires
    three reviewed bids.

Again, I think you have the workings of a great document and I wanted to
brig to light this one small deficiency of the document. Personally, I
would not list sampler types but rather that the samplers need to be
"**tested, validated and qualified as part of a change control
process**". This way you do not show government favoritism in your
writings.

Please let me know how I can assist.

Sincerely,

**Art Vellutato, Jr.\
**V.P. Technical Support Operations\
Veltek Associates, Inc.\
1039 West Bridge Street\
Phoenixville, PA 19460-4218\
Tel: (610) 983-4949 X 110\
Fax: (610) 983-9494\
[http://www.sterile.com](http://www.sterile.com/)\
Artjr@sterile.com