PMFLIST Archives

October 1999

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Harder, Joel" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 1 Oct 1999 09:32:56 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (128 lines)
Here is some information regarding what FDA thinks about contamination of
penicillian (obtained from their website):

*       i5 - March 99 HUMAN DRUG CGMP NOTES, ASCII Edition Attached

Can a facility that produced penicillin dosage forms be
decontaminated and renovated for production of non-
penicillin solid dosage forms provided there is no
further penicillin production in the renovated facility?
Reference: 21 CFR 211.42(d), Design and construction
features; 211.46(d), Ventilation, air filtration, air
heating and cooling; 211.176, Penicillin contamination;
FDA By-Lines #3, Nov.77, Procedures for the Detection of
Residual Penicillins in Drugs; 21 CFR 436.104 Penicillin
Activity; and FDA Guide to Inspections of Validation of
Cleaning Processes, July 1993.

Yes.  However, the decontamination process is extremely
difficult and we are unaware of any firm that has
successfully decontaminated a penicillin facility and
converted it to production of non-penicillin products.

Note that at section 211.176 the CGMP regulations require
that if a reasonable possibility exists that a non-
penicillin drug product has been exposed to cross-
contamination with penicillin, the non-penicillin product
must be tested for the presence of penicillin and not
marketed if detectable levels are found using the
codified method.  Such a reasonable possibility may be
present where decontamination has not been conducted
effectively.  That would put the responsible firm in a
position of having to test each and every lot of non-
penicllin product for the presence of penicillin.

In sum, while the CGMP regulations would not prohibit
decontamination and conversion, the difficulty of
cleaning up penicillin residues makes the chore daunting.

Contact for further info: Edwin Melendez, HFD-322, 301-
594-0095; e-mail; [log in to unmask] <mailto:[log in to unmask]>

Is there an acceptable level of penicillin residue in non-
penicillin drug products?

Reference: 21 CFR 211.176, Penicillin contamination; 21
CFR 436.104 Penicillin Activity; FDA By-Lines No.3,
Nov.77, A Review of Procedures for the Detection of
Residual Penicillins in Drugs.

Any detectable levels of penicillin residue are
considered violative because 21 CFR 211.176 indicates
that a non-penicillin drug product must not be marketed
if detectable levels of penicillin are found when tested
according to procedures specified in The Procedures for
Detecting and Measuring Penicillin Contamination in
Drugs.

The current analytical standard for demonstrating
adequate decontamination of facilities, separation within
the same building, or measurement of cross-contamination
is codified at 21 CFR 211.176 and 436.104 and has a limit
of detectability of 0.006 ppm (as Penicillin G using S.
Lutea) and a violative detection amount of 0.03 ppm.
Note that the latter amount reflects the method's limits
with respect to confidence and reproducibility and does
not represent a tolerance level.  This analytical
methodology is limited to the detection of Penicillin G
and ampicillin in a limited number of products listed in
the referenced method, not including other beta-lactam
antibiotics.  In situations where this methodology is not
workable, it is the firm's responsibility to develop,
validate, and use other methodology with similar
sensitivity.

Contact for further info: Edwin Melendez, HFD-322, 301-
594-0095; e-mail: [log in to unmask]; Dr. Richard
Adams, HFD-643, 301-827-5849; e-mail: [log in to unmask]

I am aware that there must be separate HVAC systems in-place to prevent the
transmission of penicillin and like compounds throughout a facility.
Without more detail as to the nature of the situation you are addressing, I
am uncertain how to further advise you.

Joel C. Harder
American Red Cross
Quality Assurance Associate for Process Equipment Validation
* v-mail: 703-351-5942
* e-mail: [log in to unmask]


-----Original Message-----
From:   Sherry Oxford [mailto:[log in to unmask]]
Sent:   Thursday, September 30, 1999 3:38 PM
To:     [log in to unmask]; [log in to unmask]
Subject:        [PMFLIST] Penicillin Contamination

Hi everyone!

Does anyone have experience with or know of good references concerning
penicillin (and other similar antibiotics) contamination within the
laboratory (chemistry and micro)?   How much of a problem is this?  I have
some knowledge of penicillin contamination within a manufacturing setting
(special handling, etc.etc.), but did not know of these types of compounds
being a serious issue within the laboratory if normal handling procedures
are
employed.

Any help or comments would be greatly appreciated!

Sherry Oxford
UDL Laboratories, Inc.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.



ATOM RSS1 RSS2