Compounding Sterile Product
Inspections Bring ‘Ah Ha’ Moments
While learning USP standards, a few other “ah ha” moments
were discovered by Board investigators. These tips might be
helpful for the sterile compounder to review.
♦♦When compounding sterile products, sterile gloves are
to be used as opposed to simply spraying with isopropyl
alcohol (IPA).
♦♦Alcohol is to be sterile IPA.
♦♦The waterless alcohol-based surgical hand scrub, used to
disinfect hands during the hand hygiene process, should
have “persistent activity.”
♦♦Straight from USP 35 Chapter <797> Appendices,
“. . . Sterile 70% IPA wetted gauze pads or other particlegenerating
material shall not be used to disinfect the
sterile entry points of packages and devices. . .”
♦♦When cleaning and disinfecting the compounding area,
eg, laminar flow hoods, etc, “items shall be removed from
all areas to be cleaned, and surfaces shall be cleaned by
removing loose material and residue from spills, e.g.,
water-soluble solid residue are removed with Sterile
Water (for injection or irrigation) and low-shedding
wipes. . .”
♦♦And last but not least, regarding bulk or unformulated
drug substances and added substances or excipients
(also known as API or active pharmaceutical ingredient),
compounding facility personnel shall mark the date
received on the packaged ingredient. And, if a package
does not have a supplier’s expiration date listed on the
package, the product is only to be used for one year from
the date received unless tested for purity and quality as
stated in USP Chapter <797>.
quoted from here
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