Pharmaceutical Microbiology Insights

Bowie-Dick test has been widely used in pharmaceutical industries for the vacuum sterilizers. This test developed by J.H. Bowie and J.Dick. Bowie-Dick test is also called dynamic air removal test. This test is performing to verify heat penetration inside the chamber. Bowie –Dick test applied that the pressure and vacuum pulses. Sufficient to remove the entrapped air so as to facilitate The purpose of pressure and vacuum pulse is to effectively remove air (condensation gases) from the chamber because air is a bad conductor of heat. Bowie-Dick test demonstrates proper air removal from the chamber of a pre-vacuum autoclaves. If air pockets are present inside the chamber the it would be verify difficult to sterilize the load. Pockets of a cool air act as a barrier that prevents steam from penetrating the load. Therefore, the air must be removed by a vacuum. Heat penetration can be checked by observing EN ISO 11140 Class-2 chemical indicator (Specific test indicator or Bow...

Vacuum leak test is also called chamber integrity test. Vacuum leak test verify the any leakage in autoclave. Performed in daily once (first cycle). As per guideline HTM -2010 Vacuum leak test should be performed  on weekly once. Vacuum leak test is a critical test because verify the chamber leakage. Vacuum leak test applied the vacuum inside the chamber and wait for reach the vacuum as per set point (NLT -600 bar). After reach vacuum as per the set point hold the vacuum ten minutes. After ten minutes release the vacuum . Calculate leakage as per formula. After that check the results whether autoclave chamber leakage is within the limit or not. If there is any leakage in the autoclave chamber or leakage is exceeding the limits it means there might be chance of entering non-sterile air inside the chamber. When vacuum break happens, air enter inside the chamber through the 0.22 micron filter which is located on the unloading side of the autoclave. There is no chance of...

Accuracy:    Is also called "Precision". It means the quality or state of being correct or precise. It is calculated as follows.                   Accuracy or Precision = Measured value / Theoretical value   X 100% Example  :    20 µl  = 20 mg  (or) 20000ug ( or) 0.02g                      1.        19.8 µl          2.        19.6 µl          3.        19.7 µl          4.        19.9 µl Average (Mean )  = 19.75 µl 19.75 µl = 19.75 mg =20-19.75/20 X 100 = 20-19.75 = 0.25     0.25/20  X 100 = 1.25 =100-1.25 =98.75 Accuracy  value must be   99 to 101 %

Different types of sterilization methods used in pharmaceutical industries. Moist heat, dry heat and membrane filtration methods are used in majority of companies.  For example in case of moist heat sterilization there are three basic parameters we need to check during sterilization process. These are temperature, pressure and time. Any process would be called successful if all these parameters are met. So, to monitor these parameters in sterilization process we require chemical indicators. Chemical Indicator classifications to understand performance parameters and tolerances of various Chemical Indicators. The appropriate Chemical Indicator can then be used to obtain the information needed to determine the effectiveness of the sterilization process. Chemical Indicator for the sterilization process being monitored. ISO 11140 are classified in to six groups. Ø   Class -1     Process indicators (tape roll, label) use  with individual indi...

Autoclaves mainly used for sterilization process. Autoclave Sterilization temperature at 121 0 C for 15 to 20 minutes depending on the size of the load and the contents. Sterilization in an autoclave is most effective when the organisms are either contacted by the steam directly. Under these conditions, steam at a pressure about  15 PSI. attaining temperature (121 0 C) will kill all organisms. The autoclave was invented by   Charles Chamberland in 1879.  This process ensure the 3 parameters Related: Classification of Chemical Indicators            1.        Physical  : Pressure, temperature and time recording devices.            2.        Chemical :  Indicators that change color after being exposed to specific temperatures, such as              temperature sensitive tape.     ...

Micropipette  requires to  calibration, this process is known as pipette calibration. Pipette calibration mainly two types             1.        Gravimetric method             2.        Colorimetric method 1.        Gravimetric Method. Gravimetric method based upon water gravity. Under a constant temperature and atmospheric pressure and relative humidity, the density of distilled water is constant. When determining the volume of water, the accuracy of measurements is effected by ambient temperature, atmospheric pressure and relative humidity. These factors are usually combined to give the Z factor, used in calculation of volume of water.   Calibration Process: Calibrate the micropipette in a vibration free room at a constant temperature of distilled water between 20 to 25 0 C. Use analytic...