Skip to main content

PROCEDURE FOR DETERMINATION OF THE FILLED VOLUME OF VIALS.

 DETERMINATION OF THE FILLED VOLUME OF VIALS:

v  Procedure
§  Precautions:
§  Use protective hand gloves.
§  Ensure that the limit of fill weight/volume of the vial is given in the respective BMR.

v  Operation:
v  By weight Method:
§  Keep the weighing balance on the vibration free table.
§  Switch on the weighing balance.
§  Ensure that the pan of weighing balance is completely cleaned.
§  Ensure weighing balance is showing ‘zero’ reading.
§  Ensure that the weighing balance is calibrated.
§  Keep the filled unsealed vial on the pan of weighing balance.
§  Note down the position of the filled vial on the filling Machine.
§  Remove all solution from the vial.
§  Ensure that the solution is completely removed out.
§  Again weigh the empty vial after removing solution.
§  The weight of the solution would be the difference between the weight of the unsealed filled vial and empty vials.
§  The weight of the solution should be within the range.
§  Discard the vial after checking the volume.


v  By Volume Method:
§  Take out the filled vials from the machine conveyor/ rack before sealing and note down the position of vials.
§  Pour all the solution of filled vials in a calibrated measuring cylinder.
§  Check the lower meniscus of the solution and note down in the Batch Manufacturing Record.
§  If it is out of limit, correct immediately.

v  Abbreviations and Definitions
o   SOP   : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
o   PD      :            Production
o   LAF    :            Laminar Air Flow      
o   BMR   :           Batch Manufacturing Record
o   IPQA   :           In-Process Quality Assurance



Comments

Popular posts from this blog

GRANULATION PROCESS

GRANULATION PROCESS: Granulation process :-  It is a process in which the  powder particles are made to adhere to form larger, multi particle entities called granules.  A dough mass is prepared to form the granules.

CINNAMON AS ANTI MICROBIAL AGENT

Hands are primary mode of transmission of microbes and infections. Through hand hygiene a simple and least expensive means of prevent health care associated infections specially derived from environmental surfaces. The present research was aimed to evaluate the antimicrobial efficacy of Cinnamon oil extract found that it showed better antimicrobial activity. Also the research was carried out to formulate and evaluate the Hand wash gel containing Cinnamon oil. The anti-microbial activity of the formulated hand wash gel was tested against Escherichia coli, Staphylococcus aureus, Bacilius subtilis and pseudomonas vulagaris by spread plate techniques and the results obtained were compared with standard antibiotic.

WONDER DRUG FAKE OR REALITY ?

1938: Di-ethyl stilbestrol (DES) was created. DES was the first synthetic estrogen ever synthesized; it was cheap to produce, more potent than natural estrogen, and could be taken orally. In the rush to make and market DES, Eli Lilly became one ofthe drug's major manufacturers. In America alone there were 267 drug companies that made and distributed DES and other similar synthetic estrogen because it was un-patented and easily produced.No controlled studies were ever conducted by the drug companies to determine the effectiveness or safety of DES for use during pregnancy, even after some scientists started questioning its efficacy in the 19505. As early as 1953, research revealed that DES did not work that DES actually brought about higher rates of premature birth and infant mortality yet DES continued to be prescribed to pregnant women for decades.