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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Provision of 100’s of TPD2-compliant toxicity / addictiveness monographs for “e-liquid” ingredients

Provision of 100’s of TPD2-compliant toxicity / addictiveness monographs for “e-liquid” ingredients

Background There has been recent rapid expansion in the market for non-tobacco products that deliver inhaled nicotine, most notably, electronic cigarettes. These do not involve burning processes, rather converting an e‑liquid, containing nicotine and other excipients, into a vapour that is inhaled by the user. It…

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Calculation of HCVs for a packaging leachable

Calculation of HCVs for a packaging leachable

Background Bibra was asked to calculate health criteria values (HCVs) for a potential leachable from packaging for an intravenous pharmaceutical. Client A pharmaceutical company. Project goals To consider the critical systemic toxicity data on the potential leachable and to calculate HCVs for short- and long-term…

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Update of health risk assessment and Expert reports for an OTC veterinary product regulatory submission

Update of health risk assessment and Expert reports for an OTC veterinary product regulatory submission

Background The client wished to market a prescription veterinary treatment for dogs as an over-the-counter (OTC) product and was required to submit an updated data dossier complete with expert toxicological assessment. Client A large European company developing insecticidal formulations for use as Veterinary or Biocidal…

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Health risk assessment of aromatic hydrocarbon extractables

Health risk assessment of aromatic hydrocarbon extractables

Background The company had commissioned extractables studies on a stopper, used as part of the closure for the storage of a drug product for injection. Bibra was supplied with a laboratory analytical report describing the results of such studies on the test item. Client A…

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Expert opinion on the dermal absorption of a plant protection product active ingredient

Expert opinion on the dermal absorption of a plant protection product active ingredient

Background The client manufactures a plant protection product (PPP) containing two active ingredients; both suspension concentrate and dilute preparations are marketed. The default dermal absorption value for an active ingredient is based on the concentration; on this basis a value of 75% was indicated for the…

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Biocompatibility assessment of nerve vessel retractors

Biocompatibility assessment of nerve vessel retractors

Background The company markets a range of nerve vessel retractors (NVRs), differing only in external colour, for use during surgical procedures. Biocompatibility data were limited to the raw material, a silicone polymer, with no such information on the pigments. Client A medical device manufacturer. Project…

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Immunological effects of e-cigarette aerosols

Immunological effects of e-cigarette aerosols

Background The client wished bibra to conduct a literature search and briefly summarise any papers relating to the immune effects of e-cigarette aerosols or liquids. Client A large international company specialising in inhalable nicotine delivery products. Project goals To gather the most relevant studies regarding…

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Health risk assessment of a potential wound dressing leachable

Health risk assessment of a potential wound dressing leachable

Client A leading manufacturer of advanced wound care products and medical grade materials. Background The client wished to add a certain antimicrobial compound into their wound dressings at a low ppm w/w concentration and so, taking appropriate precautions, asked bibra to assess whether or not…

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