Sterilization control

WHAT TESTS DO WE OFFER?

We perform the sterilization process effectiveness control analysis according to

1. procedury metodycznej opracowanej w Laboratorium Mikrolab w oparciu o normy PN - EN ISO 11138 i PN - EN ISO 14161

We offer control of the sterilization process using biological indicators:

1. intended for control of steam sterilization - indicator saturated with a spore suspension of Geobacillus stearothermophilus ATCC 7953
2. designed to control sterilization with dry hot air - indicator saturated with a suspension of highly resistant spores of the strain Bacillus atrophaeus ATCC 9372
3. other biological tests and indicators on request

WHO DO WE DIRECT OUR SERVICE TO?

Mikrolab provides services to control the sterilization process using biological indicators, e.g. for:

1. dental offices
2. Healthcare facilities
3. Pharmacies
4. Aesthetic Medicine Clinics
5. Tattoo studies
6. beauty salons
7. other

LEGAL REQUIREMENTS:

Issues related to the sterilization of medical devices and the control of the sterilization process are regulated by the following legal acts:

1. PN EN ISO 17665-1; Sterilization of healthcare products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices.
2. PN-EN ISO 11138-7; Sterilization of products used in healthcare. Biological indicators. Guidelines for the selection, use and interpretation of results.
3. PN-EN ISO 11138-1; Sterilization of products used in healthcare - Biological indicators, general requirements.
4. Act of 5 December 2008 on preventing and combating infections and infectious diseases in humans (Journal of Laws of 2013, item 947).

OUR CERTIFICATES AND AUTHORIZATIONS:

Mikrolab has a GMP Certificate approved by the Chief Pharmaceutical Inspector.

Mikrolab has been approved by the State Sanitary Inspection for water testing. The test results are honored by the Sanitary and Epidemiological Stations.

Mikrolab has a research laboratory accreditation certificate issued by the Polish Center for Accreditation, accreditation number AB 1531.

WHY CONTROL THE STERILIZATION PROCESS?

Control of the effectiveness of sterilization processes is carried out, e.g. using biological indicators. Biological indicators provide a direct assessment of the biocidal effectiveness of sterilization. They confirm that during the sterilization process all microorganisms, both vegetative forms and spores (spores), were destroyed. The control of the sterilization process is performed to check whether the device is operational and whether the appropriate conditions have been maintained for more effective sterilization, i.e. temperature, time, load size. Documentation on the control of the sterilization process is required by the control authorities.