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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.
Endotoxin testing by using recombinant Factor C (rFC)
March 2021: As an alternative method for the Limulus Amebocyte Lysate (LAL) VelaLabs now offers endotoxin tests with recombinant Factor C-Test (rFC) – a fluorescence-based assay in a 96 well plate format. Pharmaceutical products and sales are growing and the demand of endotoxin testing increased. In the context of saving the horseshoe crap population VelaLabs has
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Tentamus launches its Spanish Website
The Tentamus Group is happy to announce the launch of the Tentamus website in Spanish featuring all analytical services and industries covered by Tentamus Group: Food & Feed, Agriculture & Environment, Pharmaceuticals & Medical Devices, Cosmetics as well as Agrosciences Services. The new website is aligned with the corporate identity of Tentamus Group and is
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Risk evaluation of nitrosamines in pharmaceuticals
As of October 2020, EMA and the national competent authorities are asking marketing authorisation holders for metformin-containing medicines to test their medicines before releasing them onto the market. The risk evaluation for chemical medicines should be completed at the latest by 31 March 2021 and 1 July 2021 for biological medicines. If a risk is
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Ethylene oxide residues still found in sesame seeds
Sesame seeds and sesame products have been recalled from the market many times in the recent past due to ethylene oxide residues. In a recent test, sesame seeds and foods containing sesame were tested and elevated levels of ethylene oxide were still detected in four of 44 products. Ethylene oxide is a pesticide used to
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Possible faults in vegan minced meat
Worldwide, more and more people live vegan, i.e. they avoid all animal products for various reasons. Therefore, the market for vegan meat alternatives such as vegan minced meat is booming, so that a bolognese or a chili can also be prepared vegan. Mineral oil components do not taste vegan as well In a
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How to Collect Samples for Pesticide Residue Testing
Now, before you even get to collecting itself, you will need to prepare adequately for it. Here are some of the things that you should consider. Personal Protection Equipment (PPE) – Since there is a very high chance of personal contamination, you will need to protect yourself by wearing appropriate personal protective equipment, including masks, gloves, and
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