Microbial purity

An entirely different type of contamination arises from the presence of microbiota in a product. As in the case of chemical contamination, compendial requirements for microbiological purity exists. Pharmacopoeial standards vary from country to country, and manufacturers must use the specifications and kill times that meet local requirements. As of this writing, the criteria in the British Pharmacopoeia are more stringent than those estabUshed by the CTFA, which are stricter than those in the United States Pharmacopoeia. In order to meet commonly accepted standards of microbial purity, manufacturing faciUties must be periodically cleaned and all products that can support microbial growth must contain an effective preservative (6). 

When stored in glass containers, the solution becomes very pH sensitive therefore, preparations using sorbic acid as a preservative should be tested for their microbial purity after prolonged periods of storage. 

Microbial quality, methods of examination of microbial purity . 

Committee on Microbial Purity, Validation and Environmental Monitoring of Aseptic Processing, J. Parenteral Sci. Tech., 44(5) 272-277 (1990)... 

Water purification, storage and distribution equipment are operated in such a manner so as to ensure a reliable source of water of appropriate chemical and microbial purity. 

The control of samples of starting materials, finished products and. if necessary, intermediates, includes a test for identity, analysis, purity, or potency, microbial purity, apyrogenicity and other properties determining the quality. Section 25.4 remains in effect. 

Cutaneous preparations cmitent, homogeneity, appearance, particle size, chemical purity, microbial purity. 

Suppositories content, mean weight, content uniformity, appearance, microbial purity. 

Features Indigestible high chemical and microbial purity pleasant mouthfeel Regutatory DAB, Ph.Eur., NF, JP compliances kosher Properties Wh. powd. 50 pm particle size neutral flavor and odor bulk dens. 320 g/l water-binding capacity 255% pH 5.5-7.0 (10% susp.) 99.5% act. 

Optically Active PO. The synthesis of optically pure PO has been accompHshed by microbial asymmetric reduction of chloroacetone [78-95-5] (90). (3)-2-Meth5loxirane [16088-62-3] (PO) can be prepared in 90% optical purity from ethyl (3)-lactate in 44% overall yield (91). This method gives good optical purity from inexpensive reagents without the need for chromatography or a fermentation step. (3)-PO is available from Aldrich Chemical Company, having a specific rotation [0 ] ° 7.2 (c = 1, CHCl ). 

Favorable polymer physical properties include water solubiUty and sample purity. Environmental conditions to consider in evaluating biodegradabihty are temperature, pH, moisture, oxygen, nutrients, suitable microbial population (fungal, algae, bacterial), concentration, and test duration. 

A Corynebacterium propinquum microbial cell catalyst was employed to convert acrylonitrile to ammonium acrylate, where the final concentration of product was 10-20% and the concentration of unconverted acrylonitrile was <30 ppm [81], The ammonium acrylate solution was concentrated to 40-60% by falling film evaporation, the resulting solution acidified, and the acrylic acid extracted with diethyl ether at 0-10 °C to obtain high-purity acrylic acid. 

In contrast to asymmetric oxidation of unsymmetrical sulfides with chiral peracids, microbial oxidation usually gives much better results. Thus, optically active phenyl benzyl sulfoxide was prepared by oxidation of the parent sulfide via fermentation with Aspergillus niger, NRRL 337, with 18% optical purity (42). Similarly, asymmetric... 

As with traditional aseptic filling, in order to comply with pharmaceutical GMP, it is important to minimize contamination at all stages of manufacture. Raw materials should be of a high quality and tested for microbial contamination. Water used for product manufacture should be of low bioburden and high purity (preferably water-for-injection quality, although this requirement is dependent upon the nature of the product being manufactured). 

Several microbial alcohol oxidoreductases can catalyze the stereoselective oxidation of GLD. Quinohaemoprotein ethanol dehydrogenase of Acetobacter pasteurianus is able to oxidize stereospecifically (S)-GLD to (l )-glycidic acid in racemic GLD [41,42 ]. When washed cells of A. pasteurianus were incubated with 4.8 mg ml" of racemic GLD, (1 )-GLD was obtained, with an optical purity of 99.5% e. e. and 64% conversion. 

It has been estimated that up to 30 000 litres of water is required to support the production of 1 kg of a recombinant biopharmaceutical produced in a microbial system. It is not surprising, therefore, that the generation of water of suitable purity for processing is central to the... 

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