Analysis of bioburden - Microbial enumeration tests

Background

The new regulations, Ordinance on Medical Devices (MDR) came into force on 26 May 2021. The change places increased and clearer requirements on manufacturers for users to have access to safe and effective products. What is also new is that importers and distributors are covered by the new legislation. Absence of microorganisms in and on medical devices is a common requirement. Our bioburden analyzes are based on ISO 11737-1: 2018 Sterilization of medical devices - Microbiological methods Part 1: estimation of the number of microorganisms on products.

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 at:

Validation and requalification of sterilization processes.
Routine monitoring for control of manufacturing processes.
Monitoring raw materials, components or packaging.
Assessment of the efficiency of cleaning processes
Overall environmental monitoring program.

Methods

Major demands are placed on the handling of the samples without killing possibly present microorganisms or to introduce new ones. Micans applies proven methods and has strict procedures in the laboratory to ensure maximum reproducibility in sample handling, which is guaranteed by our accreditation according to ISO 17025: 2018 for microbiological studies. Micans laboratory comply with the OECD Principles on Good Laboratory Practice (GLP), ENV/MC/CHEM(98)17.

Micans analyzes the bioburden by quantitatively determining the number of viable microorganisms; aerobic bacteria, yeast and mold. Micans develops a customized method that is first verified with five different microorganisms; some methods also require that a correction factor be determined. When microorganisms are found, we can offer characterization of found microbes.

Micans analyzes the bioburden by quantitatively determining the number of viable aerobic microorganisms, yeasts and molds for customers who, among other things, manufacture dressings, lenses, products for in vitro fertilization, ceramic and metallic implants and probiotics. Customer satisfaction is very high, among many things because our customers can make auditions on site in our laboratory and participate in the design of their bioburden analyzes. At Micans, customer relationships are personal and always open for 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
ISO 11737-2:2019, Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO/TS 13004:2013, Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD

as well as relevant sections from the United States Pharmacopeia USP and European Pharmacopeia, including:
USP <61> Microbiological examination of nonsterile products - Microbial enumeration tests
USP <1113> Microbial characterisation, identification, and strain typing
USP <1117> Microbiological best laboratory practices
USP <1229.3> Monitoring of bioburden
USP <1229.10> Radiation sterilization
EP 2.6.12 Microbiological examination of non-sterile products: Microbial enumeration tests
EP 2.6.13. Microbiological examination of non-sterile products: Test for specified micro-organisms
EP 2.6.1 Sterility

Mican's laboratory is:

ISO 17025: 2018 (SS) accredited by Swedac (id 10351)
ISO 9001: 2015 certified by A3 cert (id 1565) I
SO 14001: 2015 certified by A3 cert (id 1565)

For details, see Quality and environment

MICAN's laboratory complies with OECD principles of good laboratory practice (GLP), ENV / MC / CHEM (98) 17