Microbial environment of the manufacturing plant

Mulhall, Richard; Schmidt, E. K. H.; Brannan, Daniel K.

doi:10.3109/9781420003321-3

Cited by 2 publications

(1 citation statement)

References 14 publications

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“…Prior to the introduction of these control measures, the cosmetics industry and medical field experienced high numbers of infections caused particularly by the presence of Gram-negative organisms in such products [7]. In recent years, however, the safety record for personal care products has been excellent and infections resulting from contaminated products are rare, with many of the reported cases occurring in hospitalized individuals [3].…”

Section: Introductionmentioning

confidence: 99%

Microbiological risk assessment for personal care products

Stewart

Parker

Amézquita

et al. 2016

Intern J of Cosmetic Sci

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Regulatory decisions regarding microbiological safety of cosmetics and personal care products are primarily hazard-based, where the presence of a potential pathogen determines decision-making. This contrasts with the Food industry where it is a commonplace to use a risk-based approach for ensuring microbiological safety. A risk-based approach allows consideration of the degree of exposure to assess unacceptable health risks. As there can be a number of advantages in using a risk-based approach to safety, this study explores the Codex Alimentarius (Codex) four-step Microbiological Risk Assessment (MRA) framework frequently used in the Food industry and examines how it can be applied to the safety assessment of personal care products. The hazard identification and hazard characterization steps (one and two) of the Codex MRA framework consider the main microorganisms of concern. These are addressed by reviewing the current industry guidelines for objectionable organisms and analysing reports of contaminated products notified by government agencies over a recent 5-year period, together with examples of reported outbreaks. Data related to estimation of exposure (step three) are discussed, and examples of possible calculations and references are included. The fourth step, performed by the risk assessor (risk characterization), is specific to each assessment and brings together the information from the first three steps to assess the risk. Although there are very few documented uses of the MRA approach for personal care products, this study illustrates that it is a practicable and sound approach for producing products that are safe by design. It can be helpful in the context of designing products and processes going to market and with setting of microbiological specifications. Additionally, it can be applied reactively to facilitate decision-making when contaminated products are released on to the marketplace. Currently, the knowledge available may only allow a qualitative or semi-quantitative rather than fully quantitative risk assessment, but an added benefit is that the disciplined structuring of available knowledge enables clear identification of gaps to target resources and if appropriate, instigate data generation.

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Section: Introductionmentioning

confidence: 99%

Microbiological risk assessment for personal care products

Stewart

Parker

Amézquita

et al. 2016

Intern J of Cosmetic Sci

View full text Add to dashboard Cite

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Bacillus cereus in personal care products: risk to consumers

Pitt¹,

McClure

Parker

et al. 2015

Intern J of Cosmetic Sci

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SynopsisBacillus cereus is ubiquitous in nature and thus occurs naturally in a wide range of raw materials and foodstuffs. B. cereus spores are resistant to desiccation and heat and able to survive dry storage and cooking. Vegetative cells produce several toxins which on ingestion in sufficient numbers can cause vomiting and/or diarrhoea depending on the toxins produced. Gastrointestinal disease is commonly associated with reheated or inadequately cooked foods. In addition to being a rare cause of several acute infections (e.g. pneumonia and septicaemia), B. cereus can also cause localized infection of post-surgical or trauma wounds and is a rare but significant pathogen of the eye where it may result in severe endophthalmitis often leading to loss of vision. Key risk factors in such cases are trauma to the eye and retained contaminated intraocular foreign bodies. In addition, rare cases of B. cereus-associated keratitis (inflammation of the cornea) have been linked to contact lens use. Bacillus cereus is therefore a microbial contaminant that could adversely affect product safety of cosmetic and facial toiletries and pose a threat to the user if other key risk factors are also present. The infective dose in the human eye is unknown, but as few as 100 cfu has been reported to initiate infection in a susceptible animal model. However, we are not aware of any reports in the literature of B. cereus infections in any body site linked with use of personal care products. Low levels of B. cereus spores may on occasion be present in near-eye cosmetics, and these products have been used by consumers for many years. In addition, exposure to B. cereus is more likely to occur through other routes (e.g. dustborne contamination) due to its ubiquity and resistance properties of spores. The organism has been recovered from the eyes of healthy individuals. Therefore, although there may be a perceived hazard, the risk of severe eye infections as a consequence of exposure through contaminated near-eye cosmetics is judged to be vanishingly small. It is unlikely that more stringent microbiological standards for near-eye cosmetics will have any impact on the risk of severe eye infections caused by B. cereus, as these are not linked to use of personal care products.R esum e Bacillus cereus est une bact erie largement r epandue dans la nature et est pr esente naturellement dans une grande vari et e de mati eres premi eres et de produits alimentaires. Les spores de B. cereus sont r esistantes aux op erations de d eshydratation et de chauffage et sont capables de survivre au stockage a sec et a la cuisson. Les cellules v eg etatives produisent plusieurs toxines qui peuvent provoquer des vomissements et/ou des diarrh ees (selon la nature des toxines produites) lorsque elles sont ing er ees en quantit e suffisante. Les maladies gastro-intestinales sont couramment associ ees avec des aliments r echauff es ou cuits de mani ere inad equate. En plus d'être une cause rare de plusieurs infections aigu€ es (comme la pneumonie ou la septic emie), ...

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Microbial environment of the manufacturing plant

Cited by 2 publications

References 14 publications

Microbiological risk assessment for personal care products

Microbiological risk assessment for personal care products

Bacillus cereus in personal care products: risk to consumers

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