MicroMol GmbH

Testing laboratory in Karlsruhe, Germany

Verified

MicroMol was founded in 1996 and belongs to the Tentamus group since 2018. Offering analysis in molecular biological, microbiological and cell biological context the accredited lab works under GMP or non-GMP conditions depending on customer´s needs. MicroMol works for the phamaceutical industry, for biotech companies, for medical device producers and as CRO.

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Microbiology
Cell biology incl. biocompatibility analysis (ISO 10993)
Molecular Biology
Speciality Bacteriophage works

Specification of Services

Test areas

Testing > Material Analytics > Chemical Testing > Medical > Appliances Testing > Medical > Workplace Hygiene Testing > Pharma > Drugs

Offered test methods / services

ADA ADME ASTM Biokompatibilitätsprüfung DIN Hautirritation Hautsensibilisierung In-vitro Legionellen OECD PK-analysen Raumluft Sterilität USP Umgebungsüberwachung VDI-Lüftungsregeln Zellbank Zellproliferation bacteriphages bakteriophagen efficacy hygiene mikrobiologie phagen phages potency zytotoxizität

Available machines / laboratory equipment / devices

ELISA Elispot FACS MSD Mesoscale PCR Western Blot q-PCR

Test objects / materials

Arzneimittel Bedarfsgegenstände Haut Medizinprodukt

Certifications / authorizations / supported regulations

GMP-Standard; (Good Manufacturing Practice)

Testing Standards

Accreditations for Testing Standards

ACCRED. BODY

ACCRED. STANDARD

DAkkS DIN EN ISO/IEC 17025

Supported Testing Standards

Testing Standard

Description

AA 36
AA 444
AA 481
AA 610
AA 636
AA 85
AES 10/11-07/11
AES 10/3-09/00
API 20
API 50
ASU 00.00-107
ASU L 00.00-20
DIN 10198-1
ASU L 00.00-22
ASU L 00.00-33
ASU L 00.00-32
ASU L 00.00-107
ASU L 00.00-33
ASU L 00.00-54
ASU L 00.00-55
ASU L 00.00-56
ASU L 00.00-88/1
ASU L 00.00-88/2
ASU L 01.00-37
ASU L 06.00-32
ASU L 06.00-43
ASU L 06.00-35
Bestimmung der aerob wachsenden Milchsäurebakterien in
ASU L 06.00-39
ASU L 06.00-43
ASU L 10.00-10
ASU L 80.00-3
Bestimmung des Oberflächenkeimgehaltes auf Einrichtungs-und
DIN EN ISO 10523
Water quality - Determination of pH (ISO 10523:2008); German version EN ISO 10523:2012
DIN EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
DIN EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013
DIN EN ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
DIN EN ISO 10993-5
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
DIN EN ISO 11731
Water quality - Enumeration of Legionella (ISO/DIS 11731:2015); German and English version prEN ISO 11731:2015
DIN EN ISO 11731-2
Water quality - Detection and enumeration of Legionella - Part 2: Direct membrane filtration method for waters with low bacterial counts (ISO 11731-2:2004); German version EN ISO 11731-2:2008
DIN EN ISO 11737-1
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009
DIN EN ISO 11737-2
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009
DIN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
DIN EN ISO 14698-1
Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003); German version EN ISO 14698-1:2003
DIN EN ISO 15883-1
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014
DIN EN ISO 1622
Water quality - Determination of the threshold odour number (TON) and threshold flavour number (TFN); German version EN 1622:2006
DIN EN ISO 16266
Water quality - Detection and enumeration of Pseudomonas aeruginosa - Method by membrane filtration (ISO 16266:2006); German version EN ISO 16266:2008
DIN EN ISO 16649-2
Mikrobiologie von Lebensmitteln und Futtermitteln - Horizontales Verfahren für die Zählung von β-Glucuronidase-positiven Escherichia coli - Teil 2: Koloniezählverfahren bei 44 °C mit 5-Brom-4-Chlor-3-Indol-β-D-Glucuronid (ISO 16649-2:2001)
DIN EN ISO 19458
Water quality - Sampling for microbiological analysis (ISO 19458:2006); German version EN ISO 19458:2006
DIN EN ISO 21528-2
Microbiology of the food chain - Horizontal methods for the detection and enumeration of Enterobacteriaceae - Part 2: Colony-count method (ISO/DIS 21528-2:2014); German version prEN ISO 21528-2:2014
DIN EN ISO 27888
Wasserbeschaffenheit; Bestimmung der elektrischen Leitfähigkeit (ISO 7888:1985); Deutsche Fassung EN 27888:1993
DIN EN ISO 38404
DIN EN ISO 5667-01
Wasserbeschaffenheit - Probenahme - Teil 1: Anleitung zur Erstellung
von Probenahmeprogrammen und Probenahmetechniken
DIN EN ISO 5667-1
Water quality - Sampling - Part 1: Guidance on the design of sampling programmes and sampling techniques (ISO 5667-1:2006); German version EN ISO 5667-1:2006
DIN EN ISO 5667-3
Water quality - Sampling - Part 3: Preservation and handling of water samples (ISO 5667-3:2012); German version EN ISO 5667-3:2012
DIN EN ISO 5667-5
Wasserbeschaffenheit - Probenahme - Teil 5: Anleitung zur Probenahme von Trinkwasser aus Aufbereitungsanlagen und Rohrnetzsystemen (ISO 5667-5:2006)
DIN EN ISO 6222
Water quality - Enumeration of culturable micro-organisms - Colony count by inoculation in a nutrient agar culture medium (ISO 6222:1999); German version EN ISO 6222:1999
DIN EN ISO 7899-2
Water quality - Detection and enumeration of intestinal enterococci - Part 2: Membrane filtration method (ISO 7899-2:2000); German version EN ISO 7899-2:2000
DIN EN ISO 9308-1
Water quality - Enumeration of Escherichia coli and coliform bacteria - Part 1: Membrane filtration method for waters with low bacterial background flora (ISO 9308-1:2014); German version EN ISO 9308-1:2014
ISO/TS 15883-5
Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
L 169
L 189
OECD 431
OECD TG 439
In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method,
SOP 185
SOP 34
SOP 537
SOP 600
SOP 610
SOP 644
VDI 6022
RODAC- Platten (Caso-, Sabouraud-, Malz-, Blut-, MacConkey- Abklatschplatten) / Tupferabstriche

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Lab location:

76149, Karlsruhe, Germany

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