Analysis of bioburden - Microbial enumeration tests
Background
The term bioburden is used to describe how many microorganisms are present on or in a medical device or sterile barrier system. The bioburden shows the sum of microorganisms from various sources including raw materials, manufacturing processes, cleaning, packaging and other things that come into contact with the product. Bioburden analyzes are carried out, among other things during:
- Validation and requalification of sterilization processes.
- Routine monitoring for control of manufacturing processes.
- Monitoring raw materials, product components or packaging.
- Assessment of the efficiency of cleaning processes
- Overall environmental monitoring program.
Methods
High demands are placed on the handling of the samples as one may neither introduce new microorganisms nor kill those that may be present in the liquid or on the surface before the analysis has been carried out. Micans applies proven methods and has strict routines in the laboratory to ensure the greatest possible reproducibility in sample handling, which is guaranteed by our accreditation according to ISO 17025:2018 for microbiological studies, Micans' laboratory follows the OECD principles of good laboratory practice (GLP), ENV / MC / CHEM (98) 17.
Micans analyzes bioburden by quantitatively determining the number of viable microorganisms; aerobic bacteria, yeast and mold. We develop a customized method that is first validated with different microorganisms; some methods also require that a correction factor be determined. When microorganisms are found, we can offer characterization of the microbes found.
Micans analyzes bioburden for customers who, among other things, manufacture dressing materials, lenses, in vitro fertilization products, ceramic and metallic implants and probiotics. Customer satisfaction is very high, partly because our customers can audition on site in our laboratory and participate in the design of their bioburden analyses. At Micans, customer relations are personal and always open to discussion, suggestions and questions.
The assignments are performed according to:
- SS-EN ISO 11737-1:2018 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products
- USP <61> Microbiological examination of nonsterile products - Microbial enumeration tests
- EP 2.6.12 Microbiological examination of non-sterile products: Microbial enumeration tests
Contact us at analys@micans.se for more information.
Micans' laboratory is:
ISO 17025: 2018 (SS) accredited by Swedac (id 10351)
ISO 9001: 2015 certified by A3 cert (id 1565)
SO 14001: 2015 certified by A3 cert (id 1565)
For details, see Quality and environment
MICANS' laboratory complies with OECD principles of good laboratory practice (GLP), ENV / MC / CHEM (98) 17
