Basic pharmacy terms/definations part 4

Write the full meaning of DOP & HEPA and its efficiency.

1.Write the full meaning of DOP & HEPA and its efficiency.

DOP  : Dioctyl Phthalate .Dioctyl Pthanate test is used to determine the integrity of HEPA filters.

%

HEPA: High Efficiency Particulate Air Filter (HEPA) is a filtering system. HEPA filter capable of retaining 99.97 percent of particles as small as 0.3 mm. It is a disposable, extended media dry type filter in a rigid frame.

Efficiency: 99.97

Air classification of clean room, gram +Ve & gram –Ve bacteria & Endotoxin

1.Write short note on gram +Ve & gram –Ve bacteria ? which one is more pathogenic ?

Gram +Ve Bacteria

Gram +Ve bacteria are those that are stained dark blue or violate by gram staining. This is  contrast to gram –Ve .

Gram –Ve Bacteria

Gram –Ve bacteria are those bacteria that do not retain crystal violate dye in the gram staining protocol.

Gram –Ve bacteria is more pathogenic than gram +Ve.

2.Write Air classification on cleanliness of parentral preparation.

Air Classification on cleanliness of parentral preparation

Grade            At Rest                       In Operation        

              Maximum permitted particles/ m3 = or above

               0.5 µ        5µ                0.5µ             5µ

Grade A  3500         0                 3500            0

Grade B  3500         0                 350000        2000

Grade C  350000    2000            3500000      20000

Grade D  3500000  20000              Not Defined

3.Mention Autoclave period and temperature.

Temperature : 121^{0 C}

Duration : 15 minutes

Pressure : 15 lbs Pressure/Square inch

4.What is the source of Endotoxin ? Write the source of Microbial Contamination of Product.

 

Endotoxin are bacterial dead cell or garbage.

 

Source of Endotoxin

Gram –Ve bacterial cell wall.

Source of microbial contamination of a product

Person, Water, Air, RM, Rubber stopper, Glass Vial and Garments