Challenging our aseptic skills using more-rigorous media-fill tests

Kastango, Eric S

doi:10.2146/ajhp110670

Cited by 6 publications

(4 citation statements)

References 4 publications

(3 reference statements)

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“…Some sources of contamination can be controlled to secure the compounding of these preparations. The risk reduction requires trained staff, aseptic technique, adequate environment and adequate disinfectant product [15,16]. The revised version of United States Pharmacopeia Chapter 797 about pharmaceutical compounding -sterile preparations describes procedures to secure activity and minimize the risk of contamination of PN bags [17].…”

Section: Discussionmentioning

confidence: 99%

Differences in Disinfection Protocols of Raw Material Vials Intended for the Production of Parenteral Nutrition Mixtures

Cros

Bordenave

et al. 2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractBackgroundPreparation of parenteral nutrition (PN) mixtures is performed in a controlled atmosphere area (CAA) under a laminar flow hood. In 2014 and 2015 quality controls have revealed contaminations of PN bags by Bacillus. The different products used to avoid this contamination were Aniosurf premiumMethodsFive protocols have been tested by varying the disinfection step: hydrogen peroxide (H2O2) or sodium hypochlorite (immersion or spray), ethanol (non sporicidal) only by immersion. Prewash and aerosolization steps remained unchanged. For each series, a quantity of 30 vials have been prewashed, then disinfected according to the tested protocol, and finally aerosolized. In order to quantify the effectiveness of disinfection 10 vials were sampled using contact plates at every step of treatment.ResultsMicroorganisms were found after ethanol disinfection (n=4) and aerosolization (n=2). No germs were found when hydrogen peroxide or sodium hypochlorite were used. The atmospheric rates of H2O2 were 0.2 ppm by immersion and 0.8 ppm by spray, these values are below the recommended value level (1 ppm).ConclusionsThis study has validated the use and effectiveness of these disinfecting products. Taking into account the efficiency and ease of use for staff, immersion has been preferred to spray and hydrogen peroxide to sodium hypochlorite.

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Section: Discussionmentioning

confidence: 99%

Differences in Disinfection Protocols of Raw Material Vials Intended for the Production of Parenteral Nutrition Mixtures

Cros

Bordenave

et al. 2017

Pharmaceutical Technology in Hospital Pharmacy

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“…While all compounding personnel who fail a media-fill challenge test must be reinstructed and reevaluated, a 0% failure rate for human operators does not represent a realistic and consistently reproducible goal. 4 In addition, it might put a false sense of safety that overall technique is appropriate when media-fill tests are negative. Of further concern is the improbable, yet commonly reproducible incidence of absolutely no contamination when media-fill challenge tests are performed within an ISO Class 5 environment.…”

Section: Introductionmentioning

confidence: 99%

“…3 Previous researchers have expressed concern regarding the reliability of this risk level and sensitivity of media-fill challenge testing. 4 Media-fill challenge testing of compounding personnel can only prove personnel have the ability to compound one or more sterile preparations at a specific point in time. Statistically speaking, ISO recommends that at least 3000 products be compounded to detect with 95% confidence a contamination rate of 0.1% (1:1000), the minimum sterility goal for aseptic compounding.…”

Section: Introductionmentioning

confidence: 99%

Evaluating the Sensitivity of a Media-Fill Challenge Test Under Various Situations as a Reliable Method for Recommended Aseptic Technique Competency Assessment

Moody¹,

Eckel²,

Amerine³

2015

Journal of Pharmacy Technology

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Background: Microbial contamination of compounded medications is a serious concern within hospital pharmacies as it can lead to severe patient injury. The United States Pharmacopeia <797> mandates that pharmacy personnel responsible for preparing compounded sterile preparations must annually demonstrate competency in aseptic technique by performing a media-fill challenge test. Objective: The purpose of this study is to evaluate the sensitivity of a commonly used mediafill test through proper and improper compounding techniques. Methods: Two aseptically trained pharmacy technicians performed media-fill challenge testing by carrying out 5 separate manipulations 5 times each for a total of 25 trials. Sterile vials, syringes, and intravenous bags were prepared. The first manipulation followed best-practice aseptic technique and sterile compounding procedures. Each of the following 4 manipulations removed one aspect of best-practice aseptic technique. The prepared products were incubated at 20°C to 25°C. A positive result for microbial contamination is indicated by visible turbidity within the vials, syringes, and intravenous bags at the following check points: 24 hours, 72 hours, 7 days, 14 days, 21 days, and >30 days. Results: Twenty-five trials, each containing 10 distinct admixtures, resulted in a total of 250 compounded preparations. No single preparation showed signs of turbidity, sedimentation, or visible microbial growth at any of the 6 checkpoints yielding a 0% contamination rate. However, the positive controls inoculated with bacteria did have positive microbial growth results. Conclusion: A more sensitive test needs to be developed to provide assurances that all poor aseptic practices are detected in compounding personnel.

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“…Therefore, media-fill tests should simulate the aseptic conditions and procedures as close as possible and should also represent worse conditions and the highest risk level to be expected during normal preparation. 4 In the industrial manufacture of licensed medicinal products, media fills are generally accepted to validate aseptic manufacturing. Few reports about media fill simulation tests to validate aseptic preparation in hospital pharmacies are found in the literature.…”

Section: Introductionmentioning

confidence: 99%

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes

Krämer

Federici

Kaiser

et al. 2014

J Oncol Pharm Pract

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Extensive media-fill tests simulating manual and automated preparation of ready-to-use cytotoxic injection solutions revealed the same level of sterility for both procedures. The results of supplemental environmental controls confirmed that the aseptic procedures are well controlled. As there was no difference in the microbial contamination rates of the media preparations depending on the extent of cleaning and disinfection of the robot, the results were used to adapt the respective standard operating procedures.

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Challenging our aseptic skills using more-rigorous media-fill tests

Cited by 6 publications

References 4 publications

Differences in Disinfection Protocols of Raw Material Vials Intended for the Production of Parenteral Nutrition Mixtures

Differences in Disinfection Protocols of Raw Material Vials Intended for the Production of Parenteral Nutrition Mixtures

Evaluating the Sensitivity of a Media-Fill Challenge Test Under Various Situations as a Reliable Method for Recommended Aseptic Technique Competency Assessment

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes

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