Member of Tentamus - Visit Tentamus.com

TentaMedix becomes official testing laboratory for medical devices

Karlsruhe: Animal free biomcompatibility testing of medical devices achieved ZLG recognition – Succesful Re-Accreditation according to ISO 17025:2018 On the 18th of December 2019 the Tentamus company TentaMedix GmbH received the official recognition document and listing by ZLG as testing laboratory according to the guideline 93/42 EWG, 90/385/EWG and DIN ISO/IEC 17025 for biological and
... Continued

MicroMol becomes TentaMedix GmbH

Karlsruhe: TentaMedix is pleased to announce the new company name On the 11th of November 2019 the Tentamus company MicroMol GmbH has changed its name to TentaMedix GmbH. TentaMedix will continue MicroMol’s business concept in offering sophisticated and accredited microbiological and bioanalytics in the field of  Biological Risk Assessment especially in the field of Biological
... Continued

Renewed GMP certificate for MicroMol

Extension of the certificate for amino acid analysis (Ph. Eur.2.2.56) and the absence of bacteriophages In August 2019, MicroMol has been inspected by the local regulatory GMP authority under the national inspection programme in connection with its activity according to the German Drug Law. After successful completion of the inspection MicroMol has extended its certificate
... Continued

Creamedix becomes part of MicroMol and the Tentamus Group

Karlsruhe/ Weingarten (Germany), 04.07.19  The medical device testing laboratory Creamedix in Weingarten, Germany, is joining MicroMol in Karlsruhe and thus also the Tentamus Group. Dr. Dominik Herzog, Managing Director of MicroMol GmbH announced the move in Weingarten. “We are very pleased to welcome Creamedix on board of MicroMol and Tentamus. Creamedix’ strong expertise in biocompatibility
... Continued

GMP Audit successful

Tentamus GMP-audits are an important tool to assure the services of the pharmaceutical labs. One lab conducting an audit at another lab is very helpful to overcome organizational blindness and to harmonize processes and mainly results. MicroMol welcomed the auditors from VELA-labs in Vienna and from BLS in Bad Kissingen. It was a very effective
... Continued

New efficacy test for veterinary disinfectants

Laboratorio Control, a reference partner of numerous companies for the analysis of biocidal products, implements a new efficacy test for disinfectants used on the skin in the veterinary industry.   > NEW PHASE 2,2 SKIN TEST FOR VETERINARY INDUSTRY (PT3). PR standard NF EN 17422:2019. The launch of this new quantitative surface efficacy test focuses
... Continued

In which foods are furan and its methyl analogs present?

In a recent recommendation, the European Commission calls for the determination of furan and methylfurans. These are process contaminants that form in food during thermal treatment. Consumers ingest furan particularly through coffee and cereal-based foods, but young children are also exposed to furan through jarred or canned ready-to-eat foods. According to the European Food Safety
... Continued

Laboratorio Control expands ENAC scope in food and animal feed

Laboratorio Control continues with its work plan focused on offering a wide range of analytical services under ENAC accreditation.   On this occasion, Laboratorio Control expands the ENAC scope in food and feed with the accreditation of mould and yeast count by culture according to ISO 21527-1 and 21527-2. Moulds and yeasts are one of
... Continued

Adalimumab – blockbuster & never ending story

Resolved patent disputes With Abbvie and Alvotech having solved their patent disputes, market entry for new biosimilars for adalimumab applicable for various indications might speed up. The patent protection of the originator product  Humira ® has expired in the EU in 2017, though due to complex patent claim development and market launch of non-component material
... Continued

Shock for manufacturer of substance-based medical devices

Long awaited, widely feared and stunningly received: The newly published MDCG document 2022-05 poses already suspected and yet very considerable challenges to medical device manufacturers of substance-based medical devices. While the Medical Device Regulation (MDR) 2017 still supported and thus legitimised this type of medical device with the official designation of „substances and combinations of
... Continued

Available NOW: Metals speciation for Inorganic Arsenic

There are two different forms of arsenic: organic and inorganic- and Columbia Labs tests for both. Inorganic arsenic is highly toxic and is therefore a public health concern; the organic form (commonly found in fish and seafood) is less harmful. The main source of exposure to inorganic arsenic is food; particularly grain-based processed products such
... Continued

Updated Analysis: Allergen Testing: More Savings, More flexibility

Allergen testing at Columbia Labs just got more affordable. Columbia Laboratories now offers allergen testing as either qualitative or quantitative, to cut costs and encourage routine monitoring. Allergens infiltrate the food supply at several control points, so routine testing of products AND their environment is KEY to keeping them out of your product line. Allergens
... Continued

Infusion from coffee leaves – Authorization as novel food

On occasion of the current discussions in DIN Tea, we would like to inform about „coffee leaf tea“. In addition to coffee cherry pulp (see News from 02-2022), the European Union has authorized an infusion from coffee leaves as a novel food (traditional food from a third country) in the EU. This product can already
... Continued

Laboratorio Kudam obtains Norovirus and Hepatitis A analyses accreditation

Laboratorio Kudam obtains ENAC accreditation for Norovirus and Hepatitis A testing in certain foods and bottled water. Tests are performed using the real-time PCR technique. Laboratorio Kudam continues its commitment to quality and the continuous improvement of all its analytical services and has therefore extended its ENAC accreditation for the following microbiological tests in food
... Continued

New Management at bilacon GmbH

For more than 30 years, bilacon has been supporting customers in the field of food, feed, food supplements and cosmetics with an extensive, accredited analytical spectrum. bilacon combines the competences of sensory, instrumental, chemical-physical, and microbiological analysis under one roof and answers all questions concerning the safety of your products. In April 2022, the management
... Continued

Tentamus Labor in Ihrer Nähe