Assessment of a chemical compound for possible future SVHC investigation

Assessment of a chemical compound for possible future SVHC investigation

Background Bibra was asked to assess the likelihood that a chemical used by the client in some of its syntheses might at some point in the future be identified as a Substance of Very High Concern (SVHC) in the context of the REACH regulations. Additionally,…

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Oral toxicity and skin sensitisation assessment of scar gels

Oral toxicity and skin sensitisation assessment of scar gels

Project goals Bibra was asked to evaluate the available data on the constituents of the two products with specific focus on their potential for skin sensitisation and subchronic oral toxicity. The aim was to determine whether testing of the products in laboratory animals for these…

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A review of the effects of ultrasound on food integrity and food safety

A review of the effects of ultrasound on food integrity and food safety

Background The client wished bibra to conduct a literature search and to briefly summarise any papers relating to the effects of ultrasound treatment on food safety and food integrity. Client A large international food company. Project goals To identify the most relevant studies regarding the…

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Biocompatibility and toxicological risk assessment of a “permanent” medical device

Biocompatibility and toxicological risk assessment of a “permanent” medical device

Background The client, who markets a wound dressing with existing EU approval for ‘prolonged’ use (24 hours – 30 days), wished to extend the approval to cover >30 days use. According to ISO 10993-1 guidelines, the wound dressing would then be classified as a ‘surface…

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Assessment of potential human health risks arising from the manufacture of a new licensed product in a shared manufacturing facility

Assessment of potential human health risks arising from the manufacture of a new licensed product in a shared manufacturing facility

Background The company intended to manufacture a new multi-ingredient pharmaceutical product at a shared manufacturing facility. Pharmaceutical good manufacturing practice (GMP) makes it incumbent on manufacturers of multiple pharmaceutical actives to ensure that cross-contamination of products does not present a health risk to patients. The…

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Health risk assessment of an excipient in an intravenously administered pharmaceutical product

Health risk assessment of an excipient in an intravenously administered pharmaceutical product

Background The client required qualification of the use of a nutrient-related compound as an excipient in an intravenously administered biological. Client An international pharmaceutical company. Project goals Bibra was asked to give an opinion on whether the presence of the excipient at the intended concentration…

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Provision of regular updates on the regulatory status of chemicals relevant to a client’s manufacturing process

Provision of regular updates on the regulatory status of chemicals relevant to a client’s manufacturing process

Background Regulatory information on chemicals is constantly changing and current awareness of a chemical’s regulatory status in the European Union and worldwide is key for responsible companies. Client A manufacturer of polymer products. Project goals To provide the client with a quarterly update on the…

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Responding to ECHA Evaluation draft decision for a UVCB

Responding to ECHA Evaluation draft decision for a UVCB

Background The client was sent a Draft Compliance Check Decision by ECHA, following an Evaluation, on one of their UVCB (Unknown or Variable Composition, Complex Reaction Products and Biological Materials) substances REACH registered at Annex X (in 2010). The REACH Standard Information Requirements (SIRs) identified…

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Biocompatibility and health risk assessment of a silver nanoparticle wound dressing

Biocompatibility and health risk assessment of a silver nanoparticle wound dressing

Background The client wished to market a new anti-bacterial dressing utilising nanoparticles of silver and intended to be worn for up to 30 days. Bibra was asked to assess a) the biocompatibility of the dressing and b) whether or not there would be any significant…

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Leachables in an intravenous buffer – a health risk assessment

Leachables in an intravenous buffer – a health risk assessment

Background The client was carrying out stability studies on a container-closure system (CCS) intended for long-term storage of an intravenous buffer that is added to various drug substances (in vials) immediately prior to administration to patients. Leachables data were available for various time points including day…

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