Supporting a major flavouring manufacturer and supplier with all aspects of their 2018 REACH registration obligations

Supporting a major flavouring manufacturer and supplier with all aspects of their 2018 REACH registration obligations

Client A global company manufacturing and supplying a large portfolio of flavouring and fragrance substances. Background EU manufacturers or importers of substances at tonnages of 1-10 and 10-100 per annum are required, under the REACH regulation, to submit a registration dossier of information on each…

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Preparation of hazard and risk assessments on a number of ingredients in oral healthcare products

Preparation of hazard and risk assessments on a number of ingredients in oral healthcare products

Client A major multinational provider of oral healthcare products. Background Bibra scientists were asked to assess the health risks to consumers associated with exposures to various ingredients in a range of oral healthcare products. Project Goals Review the available toxicological data on relevant chemicals, and…

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Health risk assessment of elements leaching from a filter used in deep fat fryers

Health risk assessment of elements leaching from a filter used in deep fat fryers

Client The UK manufacturer of a ceramic oil filter. Background Bibra was asked to assess the health risks, to consumers of fried foods, posed by 14 elements potentially leaching from a ceramic filter added to cooking oil in deep fat fryers. Project Goals Calculate worst-case…

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Selection of key extractables for leachables study

Selection of key extractables for leachables study

Client A pharmaceutical product manufacturer Background Analytical headspace studies, extractables studies (using solvents) and a stressed leachables study had been carried out on a single dose, prefilled syringe system used to store and deliver (by subcutaneous injection) a drug to stimulate neutrophil production in patients…

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Literature searches for toxicity data on key compounds

Literature searches for toxicity data on key compounds

Client A large international speciality chemicals company Background Toxicity and safety information is constantly being generated and added to the published literature, and current awareness of what is known about a compound’s toxicity profile is key for responsible companies. With decades of experience, bibra toxicologists…

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Health risk assessment of extractables from a bulk vaccine container

Health risk assessment of extractables from a bulk vaccine container

Client A pharmaceutical product manufacturer Background Extractables and headspace studies had been carried out on a container-closure system (polycarbonate bottles/HDPE caps) used to store a bulk vaccine product. The vaccine is administered by intranasal spray. Theoretically, in actual use, the detected extractables could become leachables…

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Health risk assessment of three leachables

Health risk assessment of three leachables

Client A pharmaceuticals company Background After 2 years of storage, three leachables were detected in a drug product that is administered by inhalation to patients aged as young as 6 years. Bibra was asked to assess whether the leachables might pose any significant health risks…

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Health risk assessment of several vaccine impurities

Health risk assessment of several vaccine impurities

Client A global biotherapeutics pharmaceutical company Background Several degradants had been identified and quantified in a vaccine product, and the client required an independent assessment of the potential health risks to patients that these impurities might pose following vaccination. Project goals To provide the client…

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Health risk assessment of an e-cigarette composition change

Health risk assessment of an e-cigarette composition change

Client An e-cigarette manufacturer Background A change to an e-cigarette stick configuration had led to an increase in the total weight of components based on a particular polymer. In the absence of a leachables study on the modified stick, bibra was asked if the safety…

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Actavis

Actavis

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