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Burkholderia cepacia complex (BCC) isolates are causes of healthcare-associated infection, especially in relation to contamination of aqueous inhalers and some intravenously administered products. The bacterial species can cause opportunistic infections in vulnerable individuals, especially those with cystic fibrosis (CF)
Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…
Recent technological advances are enabling manufacturers to move away from equipment that must be sterilised or consumables that are recycled or pose a risk with their transfer into cleanrooms, towards the adoption of disposable and single-use sterile items. This article considers the advantages of implementing single-use technology and outlines a…
An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.
Water is widely used in pharmaceutical manufacturing – either as a raw material, as an ingredient, or as a final product. Water is also used for rinsing equipment or for the preparation of disinfectants and detergents...
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…
Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to…
