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May 2011


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Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 25 May 2011 17:33:55 +0700
text/plain (203 lines)
Dear Mey, 
your explanation is really interesting, since I'm improving the URS for 
isolator now.
Did you use vaporized hydrogen peroxide as celaning method?
May I know what is the brand of your isolator? 

Warm regards,
Tryana Sinaga

PT Ferron Par Pharmaceuticals
Kawasan Industri Jababeka I
Jl. Jababeka VI Blok J - 3
Cikarang, Bekasi 17520
Telp. 021-898-33333
Fax. 021-898-33838

meylina frida <[log in to unmask]> 
Sent by: The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>
04/16/2011 11:13 PM
Please respond to
The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>

[log in to unmask]

Re: [PMFLIST] Practical demonstration on sterility test in Isolator

Dear Ramchandra,
I have experience in performing opened system in LAF and closed system in 
What's your main purpose of changing the working environment from LAF to 
isolator? Is it because some of your failure result of sterility test is 
identified mostly came from your environment or from your personnel? 
and what is your class background of isolator ?

I found many difficulties in doing sterility test in isolator.
1. You have to do validation on your cleaning procedure of your isolator. 
You must set the right cleaning procedure of isolator, because if you want 
to do cleaning process, you must open your isolator, and the problem is 
the possibility of contamination to your isolator from surrounding 
2. You must give special intention in process transferring
 of your sample, media & tools from pass through chamber to main chamber 
and main chamber to pass through chamber of isolator. I found it's very 
difficult, because the space of pass through chamber is limited. On the 
contrary, if you want to testing a lot of sample, you must consider the 
maximum sample, tools and sanitizing agent you want to insert to your 
isolator. The more you open the pass through to insert your sample and 
tools, the more the contamination will happen. Due to the limited space of 
pass through, I set the maximum sample of my sterility testing per shift 
is 4 sample. On the contrary, if i performed in LAF with B background, i 
can test maximum 8 sample per shift.
3. You must do validation of your analyst on performing sterility test in 
isolator. At the first time it's implemented, I have sterility failure on 
my test. The limitation of moving hand, taking sample with hand wearing 
gloves form pass through to main chamber can cost failure also. 

And if we're talking about efficiency, you will save a lot of money if you 
just bought closed system equipment rather that isolator. There's a lot of 
effort you must do.

I hope this answer your question.Good luck.

Thanks & Best Regards


--- On Wed, 4/13/11, Carol Lampe <[log in to unmask]> wrote:

From: Carol Lampe <[log in to unmask]>
Subject: Re: [PMFLIST] Practical demonstration on sterility test in 
To: [log in to unmask]
Date: Wednesday, April 13, 2011,
 8:23 AM

Is there any way you can get your sterility testing changed to a closed
system canister system.  An open pour method in a LAF is very risky; and
your odds of a better outcome in an isolator are much better.  However, 
isolator is not a sterile environment - it is highly disinfected.  You 
need to practice aseptic transfers and you really need to make sure all
surfaces have been disinfected - if you have contact points you have the
potential for microbial survival.  If you are planning on maintaining the
open pour method in the isolator, you may not get a better outcome than if
you changed to a closed system in a LAF.
Carol Lampe
Sr. Consultant, JMHAI

On Tue, Apr 12, 2011 at 10:22 PM, Ramchandra Tallu <
[log in to unmask]>

> Dear Karthic,
> We currently do sterility testing by - open funnel method in LAF. We are
> planning to procure Isolator for sterility testing.
> Regards,
> Ramchandra
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List
> [mailto:[log in to unmask]] On Behalf Of Karthic vasan
> Sent: Tuesday, April 12, 2011 7:21 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Practical demonstration on sterility test in
> Isolator
> Dear Ramachandra,
> How do you perform sterility testing - Open funnel method or closed
> concept.
> Regards,
> On 4/11/11, Ramchandra Tallu <[log in to unmask]> wrote:
> > Dear all,
> >
> >
> >
> > I want practical demonstration on performance of sterility test in
> isolator.
> >
> > Can someone share with me, if there are some presentations (slide 
> on
> > how to perform sterility test in isolator? What precautions to be 
> Or
> > from where I can download the same? Any reference?
> >
> >
> >
> > Looking forward to hearing your responses!
> >
> >
> >
> > Regards,
> >
> > Ramchandra
> >

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