Content microbial quality

To fulhll the monograph requirements with respect to the maximum allowed pyrogen content of about 0.25 endotoxin units per ml, the water used for distillation must be of very high microbial quality. 

If the drug is insufficiently soluble to allow delivery of the required dose as a solution (the maximum delivered dose for each nostril is 200 p,L), then a suspension formulation will be required. There are additional issues for suspension products, for example crystal growth, physical stability, resuspension, homogeneity and dose uniformity. Suspension products will also require information on density, particle size distribution, particle morphology, solvates and hydrates, polymorphs, amorphous forms, moisture and/or residual solvent content and microbial quality (sterile filtration of the bulk liquid during manufacture is not feasible). 

Definition of the API in terms of its critical quality attributes. Among the attributes that should be considered are chemical purity qualitative and quantitative impurity profiles physical characteristics such as particle size, bulk and tap density polymorphic forms moisture and solvent content homogeneity and microbial quality (if the product is susceptible to microbial contamination). 

Penas, E., Rrfas, J., Sidro, B., Vidal-Valverde, C. (2010). Impact of fermentation conditions and refrigerated storage on microbial quality and biogenic amine content of sauerkraut. Food Chemistry, 123, 143-150. http //dx.doi.Org/10.1016/j.foodchem.2010.04.021. 

A process, which considered the bio-oxidation of naphthalene compounds using naphthalenes-oxidizing bacteria, was applied for the treatment of gas oil. The quality of the product not only exhibited a sulfur content closed to specifications but also a high lubricity. Description on the used microbial strain was not provided [432],... 

Fig. 16.2 A 3-year on-farm comparison study in Switzerland where microbial activity in orchard soils (expressed as the ratio of microbial bound carbonmitrogen) was higher (low values indicate higher bacterial presence and activity) in organic (filled symbols) than in integrated (open symbols) managed orchards (same symbol shape = orchards in the same village), (a) A clear correlation between the Cmic Nmic ratio to phosphorus content of the fruit flesh was found which (b) in turn was correlated with the fruit quality index (including sugar and acidity content and fruit flesh firmness) P = phosphorus content of the fruit fresh in mg/kg dry matter.

After all the answers from the interviews had been uploaded, an expert analysed each supply chain for each of the seven defined criteria for quality and safety microbial toxins and abiotic contaminants potential pathogens natural plant toxicants freshness and taste nutrient content and food additives fraud social and ethical aspects. For example, an expert on freshness and taste would check each major step in a supply chain for tomatoes to determine if it fulfilled the definition of a CCP (HACCP, Principle 2) in relation to freshness and taste for this commodity. If the step was considered to be a CCP, the answers in the questionnaire that related to relevant substeps at this step would be reviewed, to assess the control procedures that were in use for this CCP. The expert would then fill in the text field, structuring the input to consist of the following points ... 

Monitor pyrogen and microbial content of feed water as the cleaning and depyrogenation effects are dependent from the water quality used during processing of the stoppers. 

ABC Pharmaceutical Industries routinely monitors the microbial content of the air, inanimate surfaces, personnel, water systems, and product component bioburden. Microbiological monitoring of these areas generally reflects on the efficiency of cleaning and sanitization procedures and employee practices. Continuous environmental monitoring provides the assurance that product is produced by a controlled process that will maximize the sterility and quality of the manufactured sterile product. 

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