EJPPS - A comparative study of a standard slit-to-agar sampler and a real-time bacterial detecto

  

ABSTRACT

A comparison is presented of data from simultaneous measurements of airborne particles by astandard slit-to-agar sampler (STA) and of fluorescent particles by a real-time bacterial detector, BioAerosol Monitoring System (BAMS) during an evaluation regarding emitted airborne particles of asurgical clothing system in a test chamber. Data from simultaneous orientating measurements ofairborne particles by a standard discrete particle counter are also discussed.The results show that in an environment with a low level of airborne particles including CFUs andman the only contamination source, there is a moderate correlation between the number of aerobicCFU and BAMS viable, i.e., fluorescence, particles, when the slit-to-agar sampler isregistering/collecting within its detection level.Different environments need simultaneous measurements by an STA in aerobic CFU/m3and by aBAMS in viable particles/m3to set up the correlation between the two methods.

KEY WORDS

Airborne particles, controlled environment, CFU, fluorescent particles, real-timemeasurements, viable particles.

INTRODUCTION

Orthopedic surgery is usually classified as infection-prone surgery and mostly performed inultraclean air operating rooms. Thus, maintaining a high-level of microbial air cleanliness(≤10CFU/m3) in the operating room is of high importance, see e.g., SIS TS 39:2015¹ and Whyte, Lytsy². The present guidelines for environmental microbial monitoring of air in the pharmaceutical industry(≤10CFU/m3) are provided in GMP guidance documents published by the EU and FDA^3,4.

Ultraclean air operating rooms for infection-prone surgery in hospitals and premises for asepticproduction of sterile pharmaceutical products have demands/requirements on high microbial aircleanliness during activity, both with a mean value of less than or equal to 10 CFU per m3.Real time monitoring has a great advantage over conventional monitoring because deviations can bedetected immediately.During conditions with very low concentrations of airborne viable particles, a simultaneousmeasuring study has been performed in a test chamber to compare the recoveries between astandard slit-to-agar sampler (STA), and Bio Aerosol Monitoring System (BAMS). Simultaneouslyorientating measurements were also performed with a standard discrete particle counter (DPC).

The Bio Aerosol Measuring System uses light scattering measurement according to the Miescattering principle to detect, quantify and measure the sizes of airborne particles. The BAMS alsouses laser induced fluorescence, which indicates the biological activity of the airborne particles todetermine if they are microbial or inert particles. The emitted fluorescence is measured using aphotodetector. The presence or absence of this fluorescent light is a direct indication of biologicalparticles. These fluorescent particles are often called viables.

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EJPPS Volume 29 Issue 1

A comparative study of a standard slit to agar sampler and a real time bacterial detector

REFERENCES:

1. Swedish Standard Institute, SIS -TS39:2015, Microbiological cleanliness in the operating room – Preventing airborne contaminants – Guidance and fundamental requirements, Stockholm, Sweden, SIS:2015. 

2. Whyte, W., Lytzy, B., Ultraclean air systems and the claim that laminar airflow systems fail to prevent deep infections after total joint arthroplasty, J. Hosp Infect. 2019: Sept 103 (1): e9-e15. 

3. European Commission, The Rules Governing Medicinal Products in the European Union, Volume 4; EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1 - Manufacture of Sterile Products, Brussels, Belgium, European Conimission:2022. 

4. Food and Drug Administration, Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, Rockville, MD, USA: FDA: 2004.