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Part 2 – Eric Kastango and Abby Roth answer your questions about the Investigation and Remediation of Environmental and Personnel Sampling Excursions


This week, we continue our question and answer forum from our recent webinar, Investigation and Remediation of Environmental and Personnel Sampling Excursions. Today’s edition includes questions related to:

  • Environmental monitoring session requirements and locations
  • Cleanroom Cleaning

Environmental monitoring session requirements and locations

Should the air and surface testing occur under static or dynamic conditions?

Routine environmental monitoring must occur under dynamic operation conditions.  You must be able to show that your facility can remain in a state of control while work is being performed.  If you are having your certification company perform your sampling, they should not ask personnel to leave the area while sampling is taking place. Static testing has its place as when investigative sampling is required.

When you have a 24/7 operation, can you comment on best times for static/dynamic sampling?

Routine dynamic sampling can occur at any time, but it is best done towards the end of a shift as these are worst case conditions, especially for the surface sampling. 

How frequently do you recommend to do surface and air sampling?  Current USP says semi-annually, and revision says every month, what do you recommend?

Our recommendation is routine monthly air and surface sampling at set locations.  We also recommend that random gloved fingertip sampling and surface sampling be incorporated into the sampling plan and be done towards the end of the person’s compounding day.  These random samples provide information as to the aseptic technique of the person compounding.

Please comment on compounding assistive devices – sampling plan, frequency. Ex: Repeater pumps, TPN ACDs, workflow/guided compounding equipment, robots.

These items need to be sampled and need to be considered in the sampling plan. Large pieces of equipment in a PEC must have smoke pattern testing done to determine where work can be performed and how that piece of equipment is affecting overall air flow.

Which is recommended: Weekly, bi-weekly or monthly sampling?

The more you can sample the better.  If weekly sampling is something that your pharmacy can take on, it will provide you with a lot of data.  This data can be trended to see what is normal for your facility, both counts and types of growth, throughout the year. It can also prepare you for certain times during the year when know you can expect fungal recovery or higher than usual counts.

During the media fill test, Would you recommend to take a finger sample after compounding?

Yes, the gloved fingertip sampling that is part of a media fill competency would be done after the compounding was complete, but before the gloves are sprayed with 70% IPA.

We have had growth on our ante room ISO 8 sink. Is it required to test the sink area? Do you have any recommendations on cleaning and sampling as it seems it would have growth when we are washing our hands there

Sampling around the sink area is valuable, as the sink is definitely a potential source of contamination.  An air sample should be done in the vicinity of the sink and the surface should be done on the wall or the counter next to the sink.  Sampling in the sink is not valuable and you expect to find contamination there.  The idea to sample in an area where there might be standing water that could in some way affect the final CSP.

Is fungal surface testing required?

Although the chapter is not clear, any surface samples should also be incubated for fungal growth. 

What about testing in segregated compounding area?

According to USP, the segregated compounding are needs to be sampled.  The action levels are not applied and pathogenic organisms are not a concern.  Identifying any growth in this area is helpful when performing an investigation in the event the PEC is exceeded.

Cleanroom Cleaning

When is a triple clean required?

There is no requirement for a triple clean.  The term triple clean comes from the pharmaceutical manufacturing industry. This can be done after an EM excursion or at any other point the cleanliness of the space has been compromised.  Typically, a germicidal detergent is used twice followed by the use of a sporicidal agent. 

Are the cleaners broad-spectrum or do Pharmacies have to using specific cleaners based on what organism was recovered?

Cleaning requires a germicidal detergent and a disinfectant.  A sporicidal agent should be used weekly.  Different cleaning agents can be used based on the EM data, but in most cases, the agents listed above are sufficient.  Keep in mind that a deactivating/decontaminating agent would need to be used when cleaning hazardous drug areas.

I have heard that microbes do not develop resistance to antimicrobials in a clean room environment like they do in vivo. Is this correct?

Yes, this is correct.

How do you feel about sterile cleaning agents for us in a Class ISO 5 setting? Such as a germicidal or sporicidal agent. Current USP Standards do not require these cleaning agents to be sterile. Our disinfecting agent, Sterile-IPA is used as a final wipe in our Class ISO 5 settings. I am interested in your thoughts.

Cleaning agents other than IPA do not need to be sterile.  If the agent needs to be prepared with water, it is best practice to use sterile water to prepare it.

Can you further define “triple cleaning” eg. Consecutive days with different detergent/disinfectants?

Triple clean is full cleaning done three times right after one another.  It’s typically germicidal detergent x 2 and finish with a sporicidal. Some places will do a germicidal detergent, sporicidal and sporicidal. There actually is no research about this.  This is something that is commonly done in aseptic manufacturing, but the requirement is not documented anywhere.

At what point is the White Fog treatment indicated?

A decontamination of the space using vaporized hydrogen peroxide or chlorine dioxide should be used as a last resort.  In many cases, limiting the amount of material that is stored in the cleanroom, implementing a robust cleaning procedure and being sure all personnel are following good cleanroom behavior can get the space back into the state of control.

Some sporicidal agents indicate “residual activity” … up to 6 months. Should SIPA be used to disinfect after their application, or leave it on the surfaces that this solution was applied?

In a PEC, sterile IPA must be used after the sporicidal agent.  Sterile IPA does not need to be applied after the sporicidal agent in the SEC.  That being said, you must follow the manufacturer’s instructions for use.  Spore sporicidal agents can be corrosive and do need to be followed with agent.

Which cleaning solution best to use in high risk compounding area. Do you have any recommendations?

Cleaning a high risk area would be done in the same way as a low or medium risk area.  A germicidal detergent (EPA registered cleaner and disinfectant) that contains a surfactant must be used.  When cleaning the PEC, that must be followed by sIPA.  A sporicidal agent should be used either weekly in monthly in PEC.  Remember that a deactivating/decontaminating agent would be needed for HD areas.

What is your sporicidal of choice? We have been using Peridox, but my staff consistently complains of eye burning, coughing, etc. My worry is that it is creating non-compliance in my absence.

Peridox is a great option.  One way to use it is to pour some into a zip top bag with wipers, essentially creating your own presaturated wipes.  This helps cut back on the odor.  There are other sporicidal agents available, but many of them have the same odors.

A sporicidal agent we use monthly in PECs has additional information to be an effective deactivation, decontamination, cleaning and disinfection. Would this mitigate a triple clean? Would it eliminate a germicidal agent?

You cannot eliminate the germicidal detergent.  When cleaning a HD PEC you would first deactivate / decontaminate, then use the germicidal detergent, followed by sterile 70% IPA.  If your deactivating / decontaminating agent is also a germicidal detergent you would need to apply the agent twice.  A sporicidal agent should be included either weekly or monthly.

What is the benefit / importance of a 4 hour rest after cleaning?

A lot of particles are created during the cleaning process. It is important to give the room time to rest and allow the room to clean itself, through the use of the HEPA filters.  This helps to more easily identify if there are any issues with the engineering controls when you perform the static sampling.

Join us again next week for the final installment of our webinar Q and A session, when we’ll be answering questions about:

  • Organisms
  • Investigative, Media and Glove Fingertip Sampling
  • Pharmacies Doing Their Own Sampling
  • External Lab Requirements
  • USP 797 and USP 800 Management
  • General USP 797 and USP 800

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