Helvic Laboratories has changed its name to Tentamus Pharma UK Limited.
Please visit the new website at www.tentamus-pharma.co.uk
A Medical Device is any instrument, apparatus, appliance, software, material or other article intended to be used for a medical purpose and must be proven as safe and effective. …more
Ensuring every batch of life saving drug or vaccine is free from microorganisms or contamination is the responsibility of every pharmaceutical manufacturer and the expectation of every patient . …more
Biologic molecules differ from SMDs with regard to size, complexity and processing. Ensuring adequate controls of bioburden and endotoxin limits are critical to ensuring patient safety. …more
Cosmetics, personal care and cleaning products need to be effective yet dermatologically and environmentally harmless. …more
Helvic is an independent contract testing laboratory that has been providing microbiology analysis to the pharma sector since 2010.
Helvic is a pharmaceutical microbiological testing laboratory with a difference. Our passion is to offer industry leading Quality and Customer Service coupled with competitive prices.
We are committed to being best in the industry. Contact us to see how we can drive down your costs while offering market leading quality and service.
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
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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
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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
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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
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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
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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
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