Pharmaceutical Bioburden Testing

Abstract

Manufacturing of pharmaceutical products, whether small molecules or biotherapeutics such as oligonucleotides, monoclonal antibodies, recombinant proteins, vaccines, and blood and plasma products are under regulatory control which demands various safety, efficacy and quality measures. This overview focuses on bioburden and microbial contamination detection, which are critical to overall pharmaceutical product safety. Not only the pharmaceutical products but also the entire manufacturing process from incoming raw materials to fill/finish and final product is tested. Bioburden and microbial detection are also required for process validation, cleaning validation, aseptic operation, qualification of water systems, and personnel monitoring. Included in this overview are the considerations necessary for successful microbial detection as well as some common procedures that are currently used in industry. Since standard industry methodologies rely on microbial growth as part of bioburden testing, a huge lag time exists between sampling and reporting. Therefore, a review of newer, more rapid methodologies is presented. Although newer technologies exist, regulatory hurdles still have to be overcome. As pharmaceutical companies continue to adopt newer technologies for their regulatory filings, there is no doubt that these rapid technologies will become suitable alternatives.

The Use of Microbiological Quality Control Techniques Adopted in a Human Tissue Bank

“…Microbial load (bioburden) of all samples was quantitatively/qualitatively examined to determine the number of microorganisms present on a given surface and/or product 9,10 . For this purpose, a fragment of bone tissue was stored for 24 hours at 37°C in 50 mL of sterile 0.9% Saline solution.…”

O Uso de Técnicas para Controle de Qualidade Microbiológico Adotadas em um Banco de Tecidos Humanos

“…Empregou-se ainda, para todas as amostras produzidas no período, o exame quantitativo/qualitativo de carga microbiana (bioburden), sendo esse capaz de definir o número de micro-organismos presentes em determinada superfície e/ou produto 9,10 . Para esse fim, um fragmento de tecido ósseo foi armazenado por 24 horas a 37°C em 50 mL de SF 0,9% estéril.…”