The efficiency test For HEPA filters uses a monodispersed aerosol of 0.3 micron sized particles and assesses filter media. Downstream readings represent an average over the entire filter surface. Efficiency tests are not intended to test for filter leaks. A single probe reading equivalent to 0.01 percent of the upstream challenge would be considered as…
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form.Classification of clean room:Clean rooms in pharma industry are arias which are specially designed to reduce and eliminate, particulate and microbial contamination in environment in aria used for manufacturing of pharmaceutical dosage forms, especially parenteral dosage forms which are required…
Do you know ? Nearly all drugs recalled due to nonsterility or lack of sterility assurance in the period spanning 1980-2000 were produced via aseptic processing. Aseptic process is very important aspect of pharmaceutical products which are required to be sterile and othere method of sterilisation can not be adapted. Cellular products , which require…
Following are some key abstract points form FDA’S guidance for sterile dosage form manufacturing this has listed follwing guidlines for Building and facilities for Sterile Dosage form . 21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed…
We are providing some terms and their meanings , definations which you all may be aware of , eventhough looking at increasing demand for them as referance on a single page , we are happy to publish them over this post today. We are also going to start a series of training documents for pharmaceutical proffesionals and students who keep intrest…
Dear readers in today’s post we are providing a very important document for our readers working in pharmaceutical regulatory affairs ,and for Pharmaceutical technology , Pharmacy students across the world. 1.The cheke list for ANDA submission. 2 E BOOK on biochemistry experiments in pharmacy courseOur E-Book is written by Pharmacy students and is having real…
In analyzing the materials for their protein content the Kjeldahl’s method is employed. In the Kjeldahl’s method nitrogen and not protein is determined most protein contain about 6% nitrogen by we so that 16 mg of nitrogen = 100 mg of protein. The nitrogen value is therefore multisided by 6.25 (100/16) to get the wt.…
It is based on the measurement of unstable blue co lour produced by vitamin A soln in an anhydrous alcohol free chloroform and a sat a soln of antimony dichloride in anhydrous alcohol free CHcl3 maximum absorpn is observed around 620 nm. The blue co lour is very unstable and is necessary to determine within…
To estimate blood (or serum) cholesterol by Lieberman-Buchan reaction. Acetic anhydride reacts with cholesterol in CHCI3 soln to produce a characteristic blue green co lour. The exact nature of chromospheres is not known but the reaction probably includes etherification of hydroxyl group in the 3 – posn as well as other in the mol. Cholesterol…
How to Do Chromatographic Separation Of Purin BasesChromatography is an analytical method and technique of separation in which the ingr. Are separated on basis of their difference in migration in a system of two phases. One is fixed on a stationary phase and other is a mobile phase. The difference in migration rates of ingr.…