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.

Basic pharmacy terms/definations part 3

Empty Capsule Shell Weight & Capsule fill volume / weight capacity according to the density of the powder.

Dimensional Specification:

The following specifications apply to Capsugel hard gelatin capsules.

Weight:

The average capsule weight of an order is estimated by a representative sample average of 100 capsules falling within the limits given bellow:

(values in mg for one capsules)

Size	Target (mg)	Limits (mg)
000	163	150 – 176
00	122	112 – 132
0 el	112	103 – 121
0	96	86 – 105
1	77	69 – 85
2	62	56 – 68
3	49	44 – 54
4	39	36 – 44
5	27	24 - 36

A moisture content of 14% to 14.5% is assumed upper and lower limits are given at the 99.9% confidence level.

In empty hard gelatin capsule production wall thickness is carefully monitored and controlled by the regulation of gelatin solution viscosity. However, since the physical properties of raw gelatin are not constant. Solution density may vary and affect the resultant capsule weight. Therefore the above target weight should not be used as tare weights in capsule filling samples from the actual batch being filled should be taken as tare weights.

Capsule capacity:

The average capsule volume and filled capsule weight capacity for typical powder dose densities is as follows:

Capsule Size	Capsule Volume ML of Water	Capsule weight capacity in mg
		Powder dose density
		0.6 g/cc	0.8 g/cc	1.0 g/cc	1.2 g/cc
000	1.37	822	1096	1370	1644
00	0.95	520	760	950	1140
0 el	0.78	458	624	780	936
0	0.68	408	544	680	816
1	0.50	300	400	500	600
2	0.37	222	296	370	444
3	0.30	180	240	300	360
4	0.21	126	168	210	252
5	0.13	78	104	130	156

The above data are to be considered as approximations since filling product variables and filling machine type can significantly affect the capsule weight capacity.

What is training ? What are the functions of Qualified and key personnel in a Pharmaceutical Industry ? 

Basic pharmacy terms/definations part 2

Rheology, Viscosity, Shearing Stress, Dispersed System, Colloidal Dispersion, Colloids & Coarse Dispersion.

Rheology:

Rheology is the study of the flow and deformation properties of the matter.

Viscosity:

The viscosity of a fluid is its resistance to flow or movement.

According to flow, fluids are of two types. They are:-

1.       Newtonian Fluids &

2.       Non- Newtonian Fluids.

1.       Newtonian Fluids:- Liquids which follow Newton’s law of viscous flow are known as newtonian’s liquids.

2.       Non-Newtonian Fluids:- Liquids which do not follow Newton’s law are known as non-newtonian fluids.

Example: Colloidal dispersion, emulsions, suspensions and ointments.

Shearing Stress:

The force per unit area F/A required to bring about flow is called the “Shearing Stress”

·         The flow properties of Non-Newtonian Materials are three types. They are:-

1.       Plastic flow

2.       Pseudo plastic flow

3.       Dilatants flow.

Dispersed System:

A dispersed system is defined as a system in which one phase, the dispersed phase, is distributed uniformly as particles throughout another phase, called the sispersion medium or continuous phase.

Colloidal Dispersion:

If the particles have a size ranging from 1 nm to 1 µm, which is dispersed in the continuous phase, this system is called colloidal dispersion.

Colloids:

The particles have a size ranging from 1 nm to 1 µm is called colloids.

Because of their large surface area, colloids show greater efficiency for absorption or adsorption.

 

Coarse Dispersion:

The size of the dispersed particles ranging from 1 µm to 100 µm, which is dispersed in the continuous phase, this system is called coarse dispersion.

Basic pharmacy terms/definations 1

Tonicity, Isotonic solutions, Hypotonic solutions, Hypertonic solutions, Interface, Surface, Absorption, Adsorption, Surface tension, Solubilization, Polymorphism

Tonicity:

Tonicity is measure of the osmotic pressure of two solutions separated by a semi permeable membrane.

Isotonic solutions:

Two solutions are said to be iso-osmotic or isotonic if they exert the same osmotic pressure when separated by a semi permeable membrane.

Example: 0.9 % solutions of NaCl is said to be isotonic solutions.

Hypotonic solutions:

Solutions with osmotic pressure lower than that of the body fluids or of 0.9% NaCl solution are called hypotonic solution.

Hypertonic solutions:

Those solutions having a higher osmotic pressure than the body fluids or of 0.9% NaCl solutions are called hypertonic solution.

Interface:

The boundary between two phases is generally described as an interface.

Surface:

When one of the phases is a gas or a vapor and the other a liquid or solid, the outer space of the phases which is contacted or exposed with the outer space of other phases is called surface of that phase.

Absorption:

Absorption is the incorporation of a substance in one state into another of a different state.

Adsorption:

Adsorption is the adhesion of atoms, ions, biomolecules or molecules of gas, liquid, or dissolved solid particles to a surface.

Surface tension:

Surface tension is a property of the surface of a liquid that allows it to resist an external force.

Solubilization:

The process by which water insoluble or partly soluble substances are brought into aqueous solution by incorporation into micelles is termed as solubilization.

Polymorphism:

Polymorphism is the ability of a compound(or element) to crystallize as more than one distinct crystalline species with different internal lattices.

or

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