Microbiological contamination (MC) within the Parenteral Nutrition (PN) isolator : multicentric survey on microbiological control practices.
(1) Pharmacy Unit, University Hospital Center, Limoges, France
Following MC within the isolator throughout 2018, a comparative study was carried out. The aim was to compare manufacturing and sampling practices with other Hospital Centers (HC) to standardize our practices.
Materials and Methods
A multicentric survey was carried out by mail through a web-based survey (Google Form®), from February 2019 to April 2019. This prospective study was carried out at 18 HC supposed to manufacture PN. Three items were studied (work environment, microbiological sampling and isolator cleaning).
Answer rate was of 83,3% (n=15). 60,0% (n=9) of PN mixtures were manufactured using an isolator, 33,3% (n=5) under a laminar flow hood and 6,7 % (n=1) by a contract manufacturing organization. 100% of units owned an isolator with nominat and 77,8% had an additional transfer. 88,9% of centers were automatized and sterilized by hydrogen peroxide. 53,4% (n=8) of microbiological samplings were carried out using swabs, 33,3% (n=5) used contact agar and 13,3% (n=2) used other tools. For units using only a nominat to sterilize (n=2), in 50,0% of cases, the hebdomadary microbiological sampling plan (MSP) was identical versus 77,3% for monthly cases. For units using a nominat and a transfer to sterilize (n=7), in 38,6% of cases the hebdomadary MSP was similar versus 57,1% for monthly cases. For automatized units (n=8), sampling regarding the automat was similar for 47,5% of hebdomadary cases versus 67,5% for monthly cases. In 2018, 88,9% of HC identified microbiological contamination (n=91), 66,7% (n=6) of HC used the same cleaning protocol, with daily disinfection and weekly detersive cleaning, 22,2% (n=2) used a daily mixture of disinfectant-(MDC) and 11,1% (n=1) used a daily detergent and a weekly MDC. The number of MC compared to the number of manufactured admixtures varies between 0% and 0,63%, the average rate being 0,21%. Main contamination sites were on gloves at 37,4%, in the finished goods airlock at 28,6%, on the waste bin lid at 25,3%, on manufacturing work surface at 6,6% and on others specifics sites at 2,2%. Following positive sampling, 87,5% of HC did a resampling and took corrective measures.
With a MC rate of 89%, PN centers are established to not be fault-free. MC rate is not correlated with yearly production volume. Thus, harmonization of cleaning and control practices, in accordance with the manufacturer, could allow a better and higher quality procedure.
Références bibliographiques principales
ASPEC, Le nettoyage et la désinfection : locaux et surfaces extérieures des équipements - Salles propres & environnements maîtrisés, Paris : ASPEC, 2015, 76p.