Evaluation of Scan® 4000 Ultra-HD automatic colony counter
Junes, Heli (2021-04-13)
Evaluation of Scan® 4000 Ultra-HD automatic colony counter
(13.04.2021)
Julkaisu on tekijänoikeussäännösten alainen. Teosta voi lukea ja tulostaa henkilökohtaista käyttöä varten. Käyttö kaupallisiin tarkoituksiin on kielletty.
suljettu
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2021043028148
https://urn.fi/URN:NBN:fi-fe2021043028148
Tiivistelmä
Enumeration of colonies manually or automatically provides a principle method for monitoring microbiological purity. Automated colony counter has potential to bring many advantages into microbiological laboratory, including saving time, improved data integrity and ergonomics. To be able to introduce a computerized equipment, such as colony counter, into a GMP laboratory, the equipment must be validated to ensure accuracy, functionality, and suitability of the device. This thesis is conducted for the Microbiological quality control laboratory of Orion Oyj and in this thesis, equipment validation was conducted for colony counter Scan® 4000 (Interscience) by comparing it with the manual microbial enumeration, currently used in the laboratory.
Samples (N = 336) for the equipment validation were collected from ongoing analysis in the laboratory and some samples were also prepared for the purpose of this validation. Plates were analysed manually and automatically with Scan® 4000 in two ways: by allowing manual interventions (addition/removal of the colonies) and without manual interventions. Time spent on counting with all the methods was evaluated. Furthermore, image analysis was performed for a subgroup of samples to further understand the challenges in automated counting.
The mean difference between manual counting and Scan® 4000 was - 1.74 cfu, 95 % CI (-4.3, 0.9), r = 0.88 (p < 0.001). When the manual interventions were allowed while using Scan 4000, the mean difference was 0.3 cfu, 95 % CI (0.24, 0.87), r = 0.99 (p < 0.001). Time analysis showed that automated method saved time only as a stand-alone method.
Samples (N = 336) for the equipment validation were collected from ongoing analysis in the laboratory and some samples were also prepared for the purpose of this validation. Plates were analysed manually and automatically with Scan® 4000 in two ways: by allowing manual interventions (addition/removal of the colonies) and without manual interventions. Time spent on counting with all the methods was evaluated. Furthermore, image analysis was performed for a subgroup of samples to further understand the challenges in automated counting.
The mean difference between manual counting and Scan® 4000 was - 1.74 cfu, 95 % CI (-4.3, 0.9), r = 0.88 (p < 0.001). When the manual interventions were allowed while using Scan 4000, the mean difference was 0.3 cfu, 95 % CI (0.24, 0.87), r = 0.99 (p < 0.001). Time analysis showed that automated method saved time only as a stand-alone method.