02-21-2013 08:11 PM - last edited on 02-25-2013 08:06 AM by HeatherQ
Also want to confirm - the chapter says that surfaces in the LAFW, etc, are cleaned and "This shall be followed by wiping with a residue-free disinfecting agent such as sterile 70% IPA, which is alowed to dry..." It does not specify cleaning and disinfecting agents for work suraces in the ISO 7 & 8 areas. During the Webinar, you said that a "germicidal detergent" should be used on all surfaces daily. Does this include the inside of the hood? Is that in the chapter and I am not seeing it? Could you give an example of a germicidal detergent that would be appropriate for use in the hood?
I have used Lysol IC or Quatsyl in past lives. Those products are quaternary ammonium agents. I attached Appendix II from the chapter.
As found in the chapter:
"Cleaning and Disinfecting the Compounding Area
Environmental contact is a major source of microbial contamination of CSPs. Consequently, scrupulous attention to
cleaning and disinfecting the sterile compounding areas is required to minimize this as a source of CSP contamination.
The cleaning and disinfecting practices and frequencies in this section apply to ISO Class 5 (see Table 1) compounding
areas for exposure of critical sites as well as buffer areas, ante-areas, and segregated compounding areas.
Compounding personnel are responsible for ensuring that the frequency of cleaning is in accordance with the requirements
stated in Table 3 and determining the cleaning and disinfecting products to be used (see Appendix II). Any organizational
or institutional policies regarding disinfectant selection should be considered by compounding personnel. All cleaning and
disinfecting practices and policies for the compounding of CSPs shall be included in written SOPs and shall be followed by
all compounding personnel.
The selection and use of disinfectants in healthcare facilities is guided by several properties, such as microbicidal activity,
inactivation by organic matter, residue, and shelf life (see Appendix II). In general, highly toxic disinfectants, such as
glutaraldehyde, are not used on housekeeping surfaces (e.g., floors, countertops). Many disinfectants registered by the
EPA are one-step disinfectants. This means that the disinfectant has been formulated to be effective in the presence of
light to moderate soiling without a pre-cleaning step.
Surfaces in LAFWs, BSCs, CAIs, and CACIs, which are intimate to the exposure of critical sites, require disinfecting more
frequently than do housekeeping surfaces such as walls and ceilings. Disinfecting sterile compounding areas shall occur on
a regular basis at the intervals noted in Table 3 when spills occur, when the surfaces are visibly soiled, and when microbial
contamination is known to have been or is suspected of having been introduced into the compounding areas."
02-21-2013 08:11 PM - last edited on 02-25-2013 08:05 AM by HeatherQ
Would you allow the germicidal detergent to dry, then wipe off with alcohol?
02-22-2013 07:41 AM
While sterile IPA is required in the ISO Class 5 environment and on gloved hands, is sterile IPA required in the ISO Class 7 or 8 areas for disinfecting tables, carts, chairs, etc.? --> You are correct. Sterile alcohol is important to use on the critical sites.
In addition, must sterile alcohol in a closed spray system be used? --> If you purchase sterile alcohol, the manufacturers typically use a closed spray system but a good question to ask when you purchase the product.
02-22-2013 07:46 AM
Q: Do you have a preference between modular cleanrooms and purpose-built cleanrooms (contractor-built)?
A: I have worked with both systems and it depends on many different factors.
Q: Can you comment on BUD for products like Vial-to-Bag, Add Vantage, etc... (hooking vials to minibags).
A: This question has been answered in other posts on this forum. Refer to the package insert or copy of the chapter re: answer.
Q: Should non-sterile pads be used in Hoods? CSP Buffer rooms? Some come in cardboard without any other protective packaging
A: Sterile alcohol shall used in the ISO Class 5 to disinfect the critical site. I don't understand the question re: cardboard.
04-29-2013 12:35 PM
04-29-2013 01:10 PM
Yes, you want to be in your cleanroom doing nonpatient compounding (doing a media fill would be a good activity) during certifcation to show that your rooms can maintain a state of control under dynamic operating conditions.
04-29-2013 01:21 PM
1. At my facility we are doing air impaction sampling using vertically placed paddles once a month. We get our hoods certified every 6 months and I believe that they also do air impaction sampling as part of certification. In the webinar: You recommended against the use of setting plates/paddles as part of the air sampling. No benefit in doing the air impaction sampling with paddles?
Using paddles is employing a gravimetric method of air sampling and is NOT volumetric air sampling. Using a vertically standing paddle is not going to let particles settle properly on the surface. I don't believe there is any benefit to this sampling because it is not consistent with the requirements of the chapter.
2. I couldn't find anything on USP797 on doing fingertip sampling after completion of compounding. Is this no longer a requirement? We are doing fingertip sampling for new compunders x3 and then annually as part of the garbing competency.
Fingertip sampling is still a requirement and nothing in the chapter has been changed or deleted since 2008. You are doing fingertip sampling properly according to the chapter. You can make the annual fingertip sampling part of the garbing competency or media fill. Either way would be a good tool to evaluate your staff.
04-29-2013 01:24 PM
According to the chapter: CSPs include any of the following: Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are administered to patients: aqueous bronchial and nasal
inhalations, baths and soaks for live organs and tissues, injections (e.g., colloidal dispersions, emulsions, solutions, suspensions), irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants. All of these compounded sterile preparations need to be sterile.
My response is that the two conditions you described require the final CSP to be sterile.