Catalogs >
Sartorius Group >
continuous air monitoring

continuous air monitoring
6Pages

Catalog excerpts

Application Note February 2019 Keywords: continuous air monitoring, clean room, gelatin filter, MD8 Airscan®, EU GMP Guideline Annex 1 Continuous Microbial Air Monitoring in Clean Room Environments Claudia Scherwing1, Jasmin Bunke2 1. Product Development Lab Consumables Microbiology, Sartorius Stedim Biotech, Göttingen, Germany 2. Product Management Lab Essentials Microbiology, Sartorius Lab Instruments, Göttingen, Germany * Correspondence E-Mail: kai.nesemann@sartorius.com Abstract Environmental monitoring is an important part of quality assurance for the production environments of sterile pharma ceutical products. Especially for aseptic filling lines where products are filled without a terminal sterilization step it is of utmost importance for product safety and thus an essential part of the quality control strategy. Such ISO 5 graded manufacturing environments are required to have < 1 colony-forming unit (CFU) per m³ of air. A typical method for monitoring contamination of air is to actively draw air and filter it through special gelatin filters. According to Annex 1 to the EU GMP guide a minimum sample volume of 1 m³ of air should be taken per sample location. Considering an 8 hours work shift 1 m3 is a too low sample volume to reliably judge the air quality of the manufacturing environ ment. One approach to improve product safety would be the implementation of a continuous air monitoring covering the complete production process (at multiple sampling points). Unlike agar plates, which would dry out during long-term sampling, the Gelatin membrane filters can be used for the whole 8 h period. Human intervention, such as change of agar plates, could then be avoided, thus lowering the risk of secondary contaminations to nearly zero. Find out more: www.sar

Open the catalog to page 1

Introduction The following study aimed to establish whether a continu ous sampling (and multisampling point assay) provides effective monitoring for the entire production process (8 h) by determining whether trapped organisms can withstand long-term drying stress with unaltered recovery. This study examined the recovery and viability of micro organisms captured on gelatin filters during 8 h of filtration with HEPA-filtered air from a laminar flow hood, using the MD8 Airscan® system. Stressed and unstressed filters were compared with parallel-run reference filters as controls. The CFU were...

Open the catalog to page 2

The study examined whether the viability of microorgan isms on gelatin filters was maintained during the long-term filtration of filtered air. The expression “filtered air” describes the ISO 5 HEPA-filtered air of the used Class 2 biological safety cabinet. Figure 1 shows the mean CFU/m3 on test (gold bar, mean = 69 colonies, sd = 51 colonies) and reference filters (grey bar, mean = 64 colonies, sd = 32 colonies). A mean difference of 5 CFU/m3 (not statistically significant according to the paired T-test) was found, but observed no general trend upon comparison of test and reference filters...

Open the catalog to page 3

Comparison of CFU on the paired test and reference gelatin filters Figure 2: Comparison of CFU on the paired test and reference gelatin filters. No statistically significant difference in the growth of micro organisms on test versus reference filters could be observed. Figures 3 and 4 show a representative soybean-caseindigest agar medium plate with microbiological flora grown on the paired test (left) and reference filters (right). This visual impression shows that the microbiological population found on the test and reference filters is comparable. The genus identification data from a...

Open the catalog to page 4

Cocci 91 % Yeast 3 % Mold 3 % Gram - 3 % Sporeforming 0 % Staphylococci 0 % This study aimed to examine if gelatin filters manufactured by Sartorius Stedim Biotech GmbH are qualified for long-term (eight hours [8 h]) air sampling in production environments in the pharmaceutical industry. Specifically, if microorgan isms collected on gelatin membranes can survive long-term filtration with filtered air. The 8-hour filtration period is rep resentative of a typical work shift on an aseptic filling line. The focus of the study aimed to establish whether longterm air filtration decreased the...

Open the catalog to page 5

Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0 For further contacts, visit Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. Status: 10 | 2020

Open the catalog to page 6

continuous air monitoring 6Pages

Catalog excerpts

All Sartorius Group catalogs and technical brochures

continuous air monitoring
6Pages