USP 797 FAQ: What are the requirements for the use of sterile alcohol (IPA)?

I’ve heard a lot of questions about when to use IPA versus bleach or other cleaning/disinfecting agents. Here is what the USP FAQ page includes on the topic:

30. Can vials be cleaned with alcohol swabs or 70% IPA wetted gauze pads?

Alcohol swabs must be sterile. Sterile 70% IPA wetted gauze pads or other particle generating material shall not be used to disinfect the sterile entry points of packages and devices (see Cleaning and Disinfecting the Compounding Area).

31. Can nonsterile 70% IPA be used to disinfect surfaces other than those in the DCA (direct compounding area) of the primary engineering controls in the ISO Class 5, 7, and 8 areas?

Yes. The chapter requires that surfaces be cleaned with sterile water for irrigation or injection to remove any soluble residues with low-shedding wipes. This is followed by wiping with a residue-free disinfecting agent (such as sterile 70% IPA), which is allowed to dry before compounding begins. However, the Chapter does not require that the residue-free disinfecting agent be sterile.

33. How soon before going into the BSC (biological safety cabinet) do supplies need to be sprayed with sterile IPA?

If supplies are sprayed immediately before being introduced to the BSC the operator minimizes the risk of touch contamination that may occur if supplies are sprayed in advance.

34. We currently store syringes and needles in bins in the buffer area. Can we wipe every syringe down the day before and restock bins to get ready for the next shift or do we need to remove them from the buffer area? Do they need to be wiped immediately prior to use? Can we re-spray with sterile IPA in the buffer area?

Removing supplies from the buffer area on a daily basis is not required. If supplies are disinfected prior to use it minimizes the risk of touch contamination. Re-spraying with sterile IPA in the buffer area is acceptable.

35. Do you recommend spraying sterile IPA and wiping with something dry (like Texwipe) or using a pre-moistened sterile wipe? Does it matter?

Pre-moistened sterile IPA wipes are acceptable. Water-soluble residues can be removed with sterile water and low-shedding wipes. This is followed by wiping with a residue-free agent such as sterile 70% IPA which is allowed to dry.

37. Can bleach be used as appropriate cleaning agent and can diluted bleach be used exclusively as a disinfectant?

Bleach can be effective as a disinfectant but is inactivated by proteins. Bleach is not appropriate for disinfecting critical sites. Bleach is appropriate if followed by sterile 70% IPA wipe (see question #34) Consideration for the selection of cleaning agents should be given to the effect on surfaces and potential respiratory, skin, and eye irritation to the operator.

39. Are instant hand sanitizers adequate for use in the cleanroom?

Products for use in the clean room must be classified as a waterless, surgical hand antiseptic.

43. Are we required to use sterile IPA for everything, including cleaning carts before bringing them into the clean room or just for the actual compounding activities?

Sterile 70% IPA is required for critical sites. Other disinfectants may be appropriate for carts and other surfaces. Consider the effect on surfaces, material compatibility and the operator.


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