Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part B: risk control

Boom, F. A.; Ris, Judith M; Veenbaas, Tjitske; Brun, P.P.H. Le; Touw, Daan

doi:10.1136/ejhpharm-2019-002179

Cited by 9 publications

(21 citation statements)

References 4 publications

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“…The description of the risk reducing measures was derived from figure 2, 3 and 4 of part B. 5 The checklist was filled in by the principal investigator (F.A.B.) in consultation with the responsible staff.…”

Section: Original Researchmentioning

confidence: 99%

“…Most hospital pharmacies own a particle counter, but only one did quarterly non-viable particle counting at rest around the work zone ('at rest' and 'work zone': definitions are given in online supplemental file 1); this lack of counting is a shame because non-viable particle counting is a simple experiment, while the results will give valuable information about complying with the at rest criteria for airborne particles. 5 In hospital pharmacies 1, 8 and 9, videos about the risk of blocking first air by materials were used to find the correct position of materials inside LAF/SC. 11 The results of viable air sampling are already far below the MM limits of up to 10% at the start of the study and did not really change during the study period (see table 4).…”

Section: Airmentioning

confidence: 99%

“…This is not surprising because there are no distinct sources to contaminate the air inside LAF/SC. 5…”

Section: Airmentioning

confidence: 99%

“…Better results for glove prints are not only the result of more frequent glove disinfection, but also the result of more frequent worktop disinfection and better disinfection of materials with a non-sterile surface. 5 However, if all these improvements are not implemented, a result below the MM limit of up to 10% is also possible (see figure 2, hospital pharmacy 7). Possible explanations for this finding are a low surface bioburden of materials and/or concurrent disinfection of the gloves by the impregnated wipes used during the disinfection of materials and/or frequent glove changes.…”

Section: Operator's Handsmentioning

confidence: 99%

“…As mentioned in part B, sterile long-sleeved gloves will give the same protection as separate sterile gloves and sleeves. 5…”

Section: Operator's Forearmmentioning

confidence: 99%

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Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C: applying risk assessment and risk control in practice

et al. 2021

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Objectives To describe the application of the model described in part A and part B of this series of articles for risk assessment (RA) and risk control (RC) of non-sterility during aseptic handling. The model was applied in nine hospital pharmacies. Methods The starting point was an audit of each hospital pharmacy. The determined risk reduction and remaining risks were entered into a risk assessment model. The corresponding risk prioritisation numbers (RPNs) for each source of risk were calculated and these values were summed up to a cumulative RPN. Subsequently, all hospital pharmacies started an improvement programme, using the risk assessment as input. Results of aseptic process simulation (APS) and microbiological monitoring (MM) were also collected. The participants were informed about their progress of risk reduction and results of APS and MM during the study period. At the end of the study (about 4 years after the start), a final assessment was executed by using a checklist with risk reducing measures for each source of risk. Additional risk reduction and remaining risks were put in an RA and RC template and corresponding RPN values and a new cumulative RPN were determined. Results At the start of the study differences in cumulative RPN values were relatively small (from 630 to 825). At the end they were relatively great (from 230 to 725), which illustrates a different sense of urgency for reducing the risk of non-sterility. Of all the risk reducing measures, a yearly audit of all operators had the greatest impact on reducing the risk of non-sterility. Except for glove prints, there was no correlation between process improvement (lower cumulative RPN) and results of microbiological controls. Conclusion A systematic and science-based reduction of the risks of non-sterility can be done by using a checklist with risk reducing measures and an RA & RC template. Prospectively, the relevance of each risk reducing measure can be demonstrated by RPN calculations. Microbiological controls are an important part of the overall assurance of product quality. However, the results are less useful for assessing the risk of non-sterility.

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Section: Original Researchmentioning

confidence: 99%

Section: Airmentioning

confidence: 99%

“…This is not surprising because there are no distinct sources to contaminate the air inside LAF/SC. 5…”

Section: Airmentioning

confidence: 99%

Section: Operator's Handsmentioning

confidence: 99%

“…As mentioned in part B, sterile long-sleeved gloves will give the same protection as separate sterile gloves and sleeves. 5…”

Section: Operator's Forearmmentioning