Thursday, March 6, 2014

MUST READ Tennessee Board of Pharmacy Compounding Sterile Product Inspections Bring 'Ah Ha' Moments

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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