Topic of lecture:

Parenteral drugs in ampoules.Ampoules glass.

Plan

1. Ampoules as vessels for injections solutions.

2. Manufacturing of ampoules.

3. Ampoules glass. Properties and clasification glass.

4. Quality of ampoules.

Vessels for injection drugs are subdivided into 2 groups:

1. for single-use, containing a fixed amount of a drug intended for single-pass injection (ampoules, carpules, syringes-ampoules);

2. multidosed, providing an opportunity of multiple takeoff for fixed amount of a preparation from a vessel not breaking its sterility (bottles, vials, containers).

Ampoules are glass vessels of various capacity and shape, consisting of an extended main part (a body), which

contains medicinal substances, and 1-2 capillaries, intended to filling and emptying

of ampoules.

These are thin-walled glass containers which, after filling, are sealed by fusion of the glass.

Capillaries may be equal and with reduced width (with a pinch).

Ampoules often made of colorless glass, sometimes – of yellow or colored glass.

In pharmaceutical industry the most widespread ampoules have the capacity of

1, 2, 3, 5 and 10 ml; 20 and 50 ml ampoules are used in veterinary.

The most reasonable are the ampoules with a pinch since because the liquid cannot get into a capillary out from ampoule body that is important at soldering and opening of ampoules.

Types of ampoules according types filling and structure:

Ampoules of vacuum filling:

VPO - opened, vacuum filled, with a pinch;

VO - opened, vacuum filled, without a pinch;

Ampoules of spray {syringe} filling:

SO -spray {syringe} filled, opened;

SOB - syringe filled, bell-mounted, opened;

C – coupled

G - for glycerin.

Multy-dose vessels is the vials for infusion solutions in containers of 50, 100, 250, 500 ml capacity, obtained from glass or polymeric materials.

Perspective vessels for infusion solutions are flexible containers made of polyvinylchloride.

Glass is a solid alloy of silicates, oxides of metals and some salts.

An ampoule production is carried out on glass factories & made of glass tubes (glass rods) - a tubes of 1 to 1,5 meters long with fixed internal and external diameters.

Ampoule glass brands: UG -1, NG-1, NG-3, Ng-2.

LPNG -1 – light protecting properties

ABF-1 – without oxides - B2O3

Type of glass:Colourless glass is highly transparent in the

visible spectrum.

Coloured glass is obtained by the addition of small amounts of metal oxides, chosen according to the desired spectral absorbance.

Neutral glass is a borosilicate glass containing significant amounts of boric oxide, aluminum or alkaline earth oxides. Due to its composition neutral glass has a high thermal shock resistance and a very high hydrolytic resistance.

Parameters of the quality of glass rod: conicity,

wall thickness deviation,

linearity,

an ovality,

curvature,

pollution washability,

should be no mechanical inclusions, air bubbles.

Requirements for ampoule glass:

1. Transparency - for visual and optical control of mechanical impurities; 2.Colourlessness - to detect the discolouration of the solution and mechanical inclusions; 3. Easy fusibility - it is necessary for quality soldering; 4. Thermal stability - to resist a collapse at quick temperature variations; 5. Chemical stability securing the protection of medicinal substances and other constituents, 6. Glass resistance against lixiviation.

Requirements for ampoule glass:

7. Mechanical strength - for withstanding stresses at ampoule machining transportation and storage.

8. Friability - needed for easy opening of ampoule capillary.

9. Specific surface of glass contacting with a solution as the greater is its value, the chemical resistance of glass should be the higher.

Stages of the ampoules manufacturing:

1. Production of the glass rods

2. Calibration of glass rod (Fillipin Device)

3. Washing of the rod

4. Drying of the rod

5. Ampoules are made of a glass rod on rotor glass-forming automatic or semi-automatic devices of various firms.

Ways of washing rod:1. Chamber method

2. Ultrasonic method

3. Contact-ultrasonic method

Drying of a glass rod is carried out with hot filtered air in a tunnel drier.

Preconditioning of ampoule for filling up includes the following operations:

1. Opening of capillaries (Rezepin device)

2. Annealing of ampoules (Special furnaces)

3. Ampoule quality control

3. Washing

4. Drying and sterilization of ampoules (A tunnel drier)

Internal strains (residual stress) is the formed at the manufacturing of ampoules. Disproportion of bond length between molecules of glass alloy is reason of the forming residual stress.

Microcracks at extreme factors (high temperature, quick temperature change, vibration, etc.) are created because internal strains (residual stress).

The stress relief is carried out with the help of ampoule

annealing in special furnaces.

Process of annealing consist of:

1.Heating ampoules or vials to the temperature close to softening of glass,

2.Their exposition at this temperature during 7-10 minutes,

3.Gradual cooling to the room temperature .

Quality of the ampoule glass and ampoules is evaluated by the following

parameters:1. Water-resistance

2. Alkali resistance

3. Absences of the residual stresses

4. Thermal resistance

5. Chemical stability

6. Light protecting properties

7. Visual control of ampoules

8. Relative run-out of an ampoule capillary

9. Rotundity deviation of ampoules