July 9, 2018

Microbial Contamination Focus Following Pathogen Outbreak


Burkholderia cepacia complex (Bcc) is a group of pathogenic bacteria that can pose a serious risk to immunocompromised individuals. These organisms are typically found in soil and water and can survive for prolonged periods in moist conditions. They can spread through person-to-person contact and are considered a serious risk in hospitals and healthcare environments.

In May 2018, a Skin Cleansing foam was recalled due to a Burkholderia cepacia outbreak across a number of U.S States. This leave-on personal care product was used in healthcare environments and caused serious infections in at least 16 individuals who were already hospitalised. A wider recall of other products manufactured by the same facility was enacted.

In another case legal action is currently underway in the US after 10 batches of an OTC pharmaceutical product were contaminated with Bcc, resulting in numerous infections, including the death of three infants. The source of the contamination was traced to the manufacturer’s water system.

Cosmetics and Personal Care Products can become contaminated with microorganisms through:

  • Contaminated raw materials, water or other ingredients.
  • Poor manufacturing conditions / inadequate cleaning procedures.

This contamination can then be exacerbated by:

  • Ingredients that encourage growth of microorganisms, without an effective preservative system.
  • Packaging that doesn’t protect a product adequately.
  • Poor shipping or storage conditions.
  • Consumer use, such as the need to dip fingers into the product.

While Bcc can be a particularly dangerous pathogen, it is much more common for products to be contaminated with organisms which may cause spoiling and deterioration. This can lead to customer complaints, reduced sales and loss of reputation.

MSL offer a full suite of integrated services to guard against microbial contamination – including:

  • New Product development testing to ensure preservative systems are adequate and stated durability periods are achievable.
  • QC batch release testing of finished products and ingredients.
  • Site audits and investigations to identify and remedy the sources of any contamination.

Should you require any of these services please contact Angela.Davies@msl.io.

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