GSK sell the one plant to Dr. Reddy !

GlaxoSmithKline and Dr. Reddy’s Laboratories have signed an agreement under which, GSK will transfer ownership of its penicillin manufacturing site in Bristol, TN, and rights for the Augmentin and Amoxil brands in the U.S. to Dr. Reddy’s. GSK will retain the existing rights for these brands outside the U.S. The transaction is expected to close in 1H11. Financial terms were not disclosed.

Abhijit Mukherjee, president of Dr. Reddy's Global Generics Business, said, “We are excited about this acquisition, as it allows us to enter the U.S. penicillin-containing antibacterial market segment and serve the needs of our customers and patients through manufacturing capabilities that did not previously exist within Dr. Reddy’s. This acquisition is in line with our strategy to significantly scale up our generics business in North America while providing an opportunity to explore additional synergy with our other businesses.”

“The sale of this site and divestiture of these products in the U.S. are a positive step forward for this manufacturing facility. The Bristol site has had a long and successful history with GSK. This sale will enable the facility to continue to provide oral penicillin-containing antibacterial products to meet the needs of patients in the U.S., and will allow GSK to focus resources on our newer portfolio of differentiated products,” said Jean-Paul Reynaud, senior vice president of antibiotics and emerging markets supply for GSK.

Courtesy : CP

Happy Reading !

Degradation, Contamination, Cross-contamination & Mixing !

                  

Degradation, Contamination, Cross-contamination & Mixing!

“Degradation”

Biodegradation is the chemical breakdown of materials by a physiological environment. The term is often used in relation to ecology, waste management and environmental remediation (bioremediation). Organic material can be degraded aerobically with oxygen, or anaerobically, without oxygen. A term related to biodegradation is biomineralisation, in which organic matter is converted into minerals. Biosurfactant, an extracellular surfactant secreted by microorganisms, enhances the biodegradation process.

Biodegradable matter is generally organic material such as plant and animal matter and other substances originating from living organisms, or artificial materials that are similar enough to plant and animal matter to be put to use by microorganisms. Some microorganisms have a naturally occurring, microbial catabolic diversity to degrade, transform or accumulate a huge range of compounds including hydrocarbons (e.g. oil), polychlorinated biphenyls (PCBs), polyaromatic hydrocarbons (PAHs), pharmaceutical substances, radionuclides and metals. Major methodological breakthroughs in microbial biodegradation have enabled detailed genomic, metagenomic, proteomic, bioinformatic and other high-throughput analyses of environmentally relevant microorganisms providing unprecedented insights into key biodegradative pathways and the ability of microorganisms to adapt to changing environmental conditions.

“Contamination”

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.

“Cross-Contamination”

Contamination of a material or product with another material or product.

 “Mixing”

Mixing is a process of combining or blending of components into one mass or mixture. In other words it is a process to add (an ingredient or element) to another:

Happy Reading !

For Web Masters: Other key words & site addresses used in common search activity

This summary is not available. Please click here to view the post.

general Key words

This summary is not available. Please click here to view the post.

This summary is not available. Please click here to view the post.

Food Grade Plastic

                             FOOD GRADE MATERIAL

 

"Food grade material" basically means any material which when it comes in contact with food or is the area near food is unlikely to contaminate food with harmful materials above the FDA allowed limit (in PPM or parts per million).

 

For instance, propylene glycol can be used as a lubricant under certain circumstances, and is even used as a food additive within limits. It has very low toxicity, therefore a high PPM is allowable, but you wouldn't want to actually drink the stuff. If you're going to use it in a manufacturing process for food you have to be able to show that using it will not result in a concentration above the allowable PPM. 

 

Some but not all plastics are allowed in food handling and manufacturing. The determination whether they are allowable includes several variables, including how toxic that material is, under what circumstances (besides just concentration) it is more (or less) toxic, and how much of the material is likely to end up in the food. Some materials outgas -- that is they emit gases as a result of how they are created or how they break down after being created or how they are affected by the environment in which you place them (a hot environment, for example, or one with a specific chemical in it that is not especially compatible with another material) -- and other materials slough off molecules as they meet abrasion or other materials. The method of use may have something to do with it ... if an abrasive environment is employed then materials which might slough high amounts of molecules have to be considered carefully for their effect (the level of toxicity).

 

 

Happy Reading !

 

F0 VALUE

F0 VALUE

F0 is the equivalent exposure time at 121.11°C of the actual exposure time at a
variable temperature, calculated for an ideal micro-organism with a temperature
coefficient of destruction equal to 10.

"F0 means the equivalent amount of time, in minutes at 121°C or 250°F, which has been delivered to a product by the sterilization process". For the calculation of it, "a z-value of 10°C or 18°F is assumed; the term z-value means the slope of the thermal death time curve and may be expressed as the number of degrees.... required to bring about a tenfold change in the death rate".

In practice, the knowledge of the temperature values as the continuous function of elapsing time is not available, and F0 is calculated as follows:

Fo = D t log10 (Ta-Tb/Z)

where:

۸ t - Cycle time at a particular temperature
Ta - Actual temperature
Tb - Actual cycle temperature (i.e.110 degree) or base temperature
Z = 10.0 Degree centigrade

Happy Reading !

D- Value & Z-Values

D VALUE

Many kinds of microbes are pathogens, meaning they are capable of causing disease to other organisms. Sterilization processes, such as exposure to heat, destroy these pathogens. D-value refers to decimal reduction time - The time required at a certain temperature to kill 90% of the organisms being studied. Thus after an organism is reduced by 1 D, only 10% of the original organisms remain. The population number has been reduced by one decimal place in the counting scheme. Generally, each lot of a sterilization-resistant organism is given a unique D-value. When referring to D values it is proper to give the temperature as a subscript to the D. For example, a hypothetical organism is reduced by 90% after exposure to temperatures of 300 degrees Fahrenheit for 2 minutes, thus the D-value would be written as D_300F = 2 minutes. D-value determination [1] is often carried out to measure a disinfectant's efficiency to reduce the number of microbes, present in a given environment.

Z Value

Z-value of an organism is the temperature, in degrees Fahrenheit or Celsius, that is required for the thermal destruction curve to move one log cycle.It is the reciprocal of the slope resulting from the plot of the logarithm of the D-value versus the temperature at which the D-value was obtained.It may be simplified as the temperature required for one log reduction in the D-value.While the D-value gives us the time needed at a certain temperature to kill an organism, the z-value relates the resistance of an organism to differing temperatures. So, the z-value allows us to calculate a thermal process of equivalency, if we have one D-value and the z-value. So, if it takes an increase of 10°F to move the curve one log, then our z-value is 10. So then, if we have a D-value of 4.5 minutes at 150°F, we can calculate D-values for 160°F by reducing the time by 1 log. So, our new D-value for 160°F is 0.45 minutes. This means that each 10°F increase in temperature will reduce our D-value by 1 log. Conversely, a 10°F decrease in temperature will increase our D-value by 1 log. So, the D-value for a temperature of 140°F would be 45 minutes.

Courtesy : http://en.wikipedia.org/

Happy Reading !

What is Bowie-Dick Test ??

Hi,

This is a common question while reading sterilization processes. Here writing in a very simple understandable logic & concepts for the Topic.

The Bowie-Dick Test is an indicator having the special purpose of evaluating the efficiency of dynamic air removal sterilizer systems.

In this test the indicator is being place with the load for sterilization. It is important to note that the Bowie-Dick Test is not to be considered as a biological performance test. It is intended only to alert the user that the air removal system has deteriorated in performance and should be corrected before sterilization problems occur as indicated by a biological indicator failure.

Interpretations of Bowie-Dick test are based on experience with the individual sterilizer, the Bowie-Dick Test pack itself, and knowledge and background concerning how this test works and the factors influencing a successful outcome.

Few Bowie-Dick Test packs are easier to interpret than other available because the visual assessment of pass/fail criteria is subjective and not quantitative. Different shades of gray (or black) may not be easy to detect. Precise differences in shading and uniformity of the observed results may not be obvious for all.

 Refer figure-1 for proper understanding of Bowie Dick Test

Happy Reading !

ICH Q-7

ICH Q-7

Please use below mentioned link to get ICH Q-7 for ready reference purpose only.

http://www.4shared.com/document/eCdJ86ZO/Q7_A.html

Free download Jai Ganesh Aarti,

Jai Shree Ganesh !!

To download the aarti please use below link.

http://www.4shared.com/audio/fSW_UgBL/037_Jai_Ganesh_Deva.html

Password = 100