Information on aseptic processing, barrier isolation, environmental monitoring, sterility testing and vaporized hydrogen peroxide.

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Welcome to the ETIC Q&A Archive – Below you will find some of the questions we have been asked. Click on the link after the question to see our answer.

Need to design a chamber to sterilize stainless steel carts with VHP. Chamber dimensions are 5x6x6. Two doors, one to class 100, one to class 10,000. Must be validatable. Any feedback?

This is a question concerning a tunnel that is part of an isolated filling system. Is the sterilization zone required to be monitored for particulate? What frequency is the sterilization zone expected to be monitored? Is the monitoring completed prior to heating the air? Is the monitoring completed after the air temperature is at set point?

I work for a large pharmaceutical company in a global capacity responsible for isolation. I have visited your website but could not find anything on Rapid Transfer Ports or other high containment transfer devices. Do you manufacture your own RTP Ports or use those of other manufacturers? If you only use other manufacturers products, which have you used successfully?

Does the room where the isolator is located need to be monitored for temperature and RH? How important is it? The detergen for the Isolator cleaning: do we have to use the ones recommended in the manual or can we use the ones currently used in our firm?

How are isolators being used in manufacturing drugs used for clinical trials?

Have you published a paper on VHP "D" values of B. stearo inoculated on substrates? If so, where could I find it?

Have you performed any recent work using VHP as a decontaminant and not as a steriliant? My company is looking to use if for a project where we are trying to replace conventional decontamination methods and are looking to see if anyone else has used this before.

We are thinking of using VHP as a room change over between campaigns. Conventional change-over (ie paraformaldehyde or triple decon) would be extremely painful. However,we are not certain what expectations the agencies (FDA, CBER or CDER) have had using new technology (VHP) for room decon (not sure if any agencies have seen the packages yet).

For example, the industry requirement for sterilization is pretty well defined (at least my company seems to think so from their experience with isolators). One issue we are struggling with is all the various material surfaces in the suite. We have to compare the relative resistance of organisms on all the materials in the isolator/barrier and use the worst case material. Is there the same expectation for the decontamination of a suite?

Is there a value or percentage of sterility false positive rate that is the pharmaceutical industry standard (0.1%, 0.5%)?

I am responsible for adding an isolator for sterility testing into the microbiology lab. I know very little about this new technology. Where do I start?

My client received an FDA 483 for not having a monitor installed in their isolator. They have purchased and installed a Guided Wave monitor and are concerned that the data collection software is not compliant with 21CFR11. The monitor has an RS232 connection. What hardware and software would you recommend and is it compliant with 21CFR11?

We are a research and development facility within the pharmaceutical industry. We have a potential upcoming project involving handling cyto toxic drug substances. I am interested in any information you can provide about equipment needed to ensure the safety of our employees and stability of the sample material.

Are there any companies that fill dry, sterile antibiotic powders into a bag in a barrier? If so, how do they get the bags in and out?

My company does not plan to have either non-particulate or quantitative air sampling in our sterility test isolator. Our isolator system consists of a soft-wall autoclave interface isolator connected to a softwall double 1/2 suit test isolator with a hard wall transfer isolator which are "hard" piped to the VHP generator.

I have a few questions on my isolator validation / use:

1. Is any monitoring required for the autoclave interface?     Before VHP cycle?

2. Since we are working in normal room air, not nitrogen, is     anaerobic monitoring needed?

3. I had some of the Merckoquant peroxide strips show the     presence of H2O2 in VHP'ed small ophthalmic ointment     (1g) tin tube with plastic lid containing DI water. The growth     promotion of the same tubes containing media fill were     inoculated before VHP with <30cfu the USP organisms,     Saureus, Paeruginosa, Ecoli, Bsubtilis, C.albicans, A.niger     and M.luteus, in quadriplicate. All VHP'ed tubes show growth     after the same time of incubation as non-VHP control     tubes. All of the tubes were in the same VHP transfer cycle.     The growth promotion tubes were production media filled     tubes, the peroxide tubes were filled with ~1mL DI water,     the end hand crimped. All tubes are the same (no change     in construction).

Can I justify that the concentration of the H2O2 in the tubes was at a low enough concentration not to interfere with the samples since the satisfactory growth promotion of the organisms was not affected by the H2O2 as observed with the detection of growth in the VHP'ed and non-VHP'ed?

Can a Laminar Flow Hood (LFH) be used for small-scale sterility testing (R&D Lab) instead of an isolator?

How long is the validation process, on average, for the isolator barrier?

In a Clinical Fill isolator, we have a hold time of 3 days - as shown by the Environmental Monitoring. I wanted to confirm that when we extend the hold time, that each of the extended Environmental Monitorings ends in a media fill. Rationale - is the media fill serving as the best type of increased environmental monitoring to show the hold time is acceptable? Is there a rationale for backing off from the validated hold time other than to have a 'buffer'? That is, having data showing a hold time of one month, but stating the validated hold time is 2 or 3 weeks.

Do you know of a way to determine peracetic acid vapor concentration? I have seen test strips for liquid concentration but nothing that is compatible with isolators.

In general, could you please describe how a microbiological isolator, for use with bacterial cultures works?

How do you accurately measure the concentration of hydrogen peroxide in the sterilization chamber? Is the sensor manufactured by ABI or someone else?