Zaans Medical Center, Zaandam, The Netherlands
Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
Eur J Hosp Pharm. 2021 Jan;28(1):38-41. doi: 10.1136/ejhpharm-2018-001672. Epub 2019 Jun 12.
To develop methods for surface bioburden determination of ampoules and vials to be used in the validation of the disinfection procedures and in routine monitoring of ampoules and vials.
The surface bioburdens of ampoules and vials are determined before and after disinfection by contact plates and total immersion.
The mean surface bioburdens of non-disinfected ampoules and vials taken straight from the original boxes are 2.4 and 5.01 cfu (total immersion; n = 20), and 0.97 and 0.94 cfu (contact plates; n = 60). The mean surface bioburdens of ampules and vials after disinfection by wiping are 1.15 and 7.50 cfu (total immersion; n = 20), and 0.12 and 0.10 cfu (contact plates; n = 60). The high number of cfu on vials (total immersion) indicate hidden cfu around the neck not removable by wiping and not detected by contact plates. Total immersion needs special laboratory facilities and is expensive (about €50 a sample). Therefore, it is less appropriate for use in routine monitoring. However, because of the high recovery, it is the method of choice for the validation of the disinfection procedure. Surface bioburden determination by contact plates is relatively simple. Non-flat surfaces cannot be reached, but the recovery from the touched flat part of the surface is high (around 50%). The recovery from swabs is low (around 10%). Another disadvantage of swabs is the laboratory work after sampling. We therefore advise contact plates for routine monitoring. To get a reliable value of the mean surface bioburden at least 30 samples need to be examined.
Total immersion is the method of choice for the determination of the effectiveness of a disinfection procedure for ampoules and vials. Contact plate is the method of choice for routine monitoring of the surfaces of ampoules and vials.
开发安瓿和小瓶表面生物负荷测定方法，用于验证消毒程序，并常规监测安瓿和小瓶。
通过接触平板和全浸法测定消毒前后安瓿和小瓶的表面生物负荷。
直接从原始包装中取出的未消毒安瓿和小瓶的平均表面生物负荷分别为 2.4 和 5.01 cfu（全浸法；n = 20）和 0.97 和 0.94 cfu（接触平板；n = 60）。经擦拭消毒后的安瓿和小瓶的平均表面生物负荷分别为 1.15 和 7.50 cfu（全浸法；n = 20）和 0.12 和 0.10 cfu（接触平板；n = 60）。小瓶（全浸法）上的高 cfu 数表明，颈部周围有无法通过擦拭去除且接触平板无法检测到的隐藏 cfu。全浸法需要特殊的实验室设施且昂贵（每个样本约 50 欧元）。因此，它不太适合常规监测。但是，由于回收率高，它是消毒程序验证的首选方法。接触平板法进行表面生物负荷测定相对简单。无法接触非平面表面，但从接触的平面部分的回收率很高（约 50%）。棉签的回收率较低（约 10%）。棉签的另一个缺点是采样后的实验室工作。因此，我们建议在常规监测中使用接触平板。为了获得可靠的平均表面生物负荷值，至少需要检查 30 个样本。
全浸法是测定安瓿和小瓶消毒程序有效性的首选方法。接触平板法是常规监测安瓿和小瓶表面的首选方法。
