Sunday, May 3, 2009

microbial contamination rates of pharmacy-compounded sterile preparations

Purpose. Using a multiple-step testing medium-risk-level compounding test procedure, the evaluation of two work-practice changes to determine if the changes could effectively reduce the potential for contamination occurrence was conducted.

Summary. Along with training and evaluation of aseptic sterile compounding techniques, each individual pharmacist and pharmacy technician at M. D. Anderson Cancer Center must successfully demonstrate aseptic preparation competency annually by performing the complicated multistep aseptic transfers of growth medium with no resulting growth of microorganisms. The multistep aseptic transfers are designed to simulate manual compounding of the most complicated medium-risk-level preparations anticipated as specified in the United States Pharmacopeia‘s chapter 797. An evaluation of two modest and simple work-practice changes was conducted: The use of bare hands and nonsterile gloves with only initial disinfection with 70% isopropyl alcohol (IPA) during years 1 and 2 (group A) was compared with the use of nonsterile chemotherapy gloves with initial and repeated disinfection with IPA for year 3 (group B) and the use of sterile gloves with initial and repeated disinfection with IPA for year 4 (group C). The process involved multiple discrete manipulations, including reconstitution of dry-growth medium; transfers of growth medium from vials and ampules using syringes, needles, a dispensing pin, and a filter straw; and transfers to an empty plastic i.v. bag. For groups B and C, significant reductions in contaminated samples were found compared with group A.

Conclusion. The use of protective chemotherapy gloves that were repeatedly disinfected with IPA decreased the contamination rate of pharmacy-compounded sterile preparations.

Index terms: Alcohols, isopropyl; Compounding; Contamination; Disinfectants; Gloves; Pharmacy; Sterile products

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