FDA biocompatibility of a wound dressing, with subsequent risk assessment of a potential leachable

FDA biocompatibility of a wound dressing, with subsequent risk assessment of a potential leachable

Client A worldwide manufacturer of wound care products, who required a biological evaluation and biocompatibility assessment. Background The company markets adhesive and non-adhesive wound dressings that include a foam layer containing a polymeric antimicrobial agent. In order to meet the FDA requirements as a medical device,…

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Health risk assessments of extractables profiles allowed a client to make a safety-based choice between syringe types

Health risk assessments of extractables profiles allowed a client to make a safety-based choice between syringe types

Client A multi-national medical devices manufacturer. Background The company had commissioned extractables analyses on three different types of syringe intended for flushing of intravenous catheters/tubing with saline. A number of organic and inorganic extractables were detected. Project goals Bibra was asked to assess the possible…

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Health risk assessment of di-n-butyl phthalate as a potential leachable in an eye ointment

Health risk assessment of di-n-butyl phthalate as a potential leachable in an eye ointment

Client A pharmaceutical company in the far East. Background The company had commissioned extractables studies on a container-closure system (CCS) intended to store an eye ointment. The only extractable detected was di-n-butyl phthalate (DBP). Project goals Bibra was asked to assess the possible health risks…

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An accelerated aging study on a syringe – health risk assessment of leachables

An accelerated aging study on a syringe – health risk assessment of leachables

Client A multi-national medical devices manufacturer. Background The company had commissioned an accelerated stability (aging) study on syringes intended for flushing of intravenous catheters/tubing with saline. The leachables profile was examined after about 70 days at 60°C, conditions used to mimic normal storage for around…

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Biocompatibility skin irritation sensitisation two medical devices

Biocompatibility skin irritation sensitisation two medical devices

Client A medical device manufacturer. Background Two devices, intended to be used by children to self-administer a pharmaceutical, required a biocompatibility assessment in accordance with International Organization for Standardization (ISO) 10993 guidance. Project goals The toxicologists at bibra were asked to identify and summarise the…

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OEL considerations on an API and an intermediate

OEL considerations on an API and an intermediate

Client A pharmaceutical developer. Background Bibra was asked to consider whether an occupational exposure limit (OEL) for workers exposed to an active pharmaceutical ingredient (API) should be revised, and to derive a new OEL for a structurally-related chemical intermediate. Project goals To identify and review…

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Safe oral intakes for pharmaceutical excipients

Safe oral intakes for pharmaceutical excipients

Client A manufacturer of pharmaceuticals. Background Bibra was asked to consider the available toxicity data on two pharmaceutical excipients, and to propose tolerable oral intakes (i.e. health criteria values (HCVs)) for patients. Project goals To perform comprehensive literature searches on both excipients, identifying, where available,…

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Health risk assessments of priority metal contaminants in a silver sulphate wound dressing

Health risk assessments of priority metal contaminants in a silver sulphate wound dressing

Client A medical devices manufacturer. Background The company had identified a small number of metal contaminants in the silver sulphate component of a wound dressing that might (hypothetically) be leached from the dressing and transfer directly into the patients’ system (blood stream) following application to…

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Synthetic bone graft – a health risk assessment of degradants and a biocompatibility evaluation

Synthetic bone graft – a health risk assessment of degradants and a biocompatibility evaluation

Client A medical devices manufacturer. Background Accelerated stability studies conducted on the polymer matrix of a synthetic bone graft (implant) identified a number of degradants that might (hypothetically) be released directly into the patients’ system following implantation. The matrix is purely an implantation aid and…

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Health risk assessment of a polyester thread in a wound dressing

Health risk assessment of a polyester thread in a wound dressing

Client A medical devices manufacturer. Background The company manufactures wound dressings (for short-term use) that were found to contain, at very infrequent intervals, a joining polyester thread in one of the layers. Project goals Bibra was asked to assess the possible health impact of the…

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