The canister of the meter dose inhaler (MDI) is the primary packaging material for drug delivery as an aerosol. It is made of stainless or aluminium. The well of the canister comprises a laminate that comprises strengthening layer which comprises a strengthening material selected from the group consisting of aluminium, brass, copper, chromium, chromium oxide, iron, tin, and steel sandwiched between two metal layers which comprise a metal selected from the group consisting of aluminium brass, copper, chromium, iron, tin, and steel.
The Canister for use in meter dose inhalers (MDI)especially a canister that may contain and dispense pressurized formulations of pharmaceutical substances in propellant for example hydrofluroalkane propellants. It contains a nitrile valve (meter valve). it is a complete set connected to the actuator. meter dose inhaler is divided into parts the actuator, canister, and meter valve.
so, the important part of the canister we testing below some parameter
Table of Contents
1. Description
14ml or other 10ml, 17ml, 19 ml aluminium non-anodized plain canister
2. Dimension
- Body Diameter: Select 5 samples in stock sample measure Body Diameter with a calibrated Vernier caliper. One by one take the reading and note down the reading.
- Total Height: Select 5 samples in stock sample measure total height with a calibrated Vernier caliper. One by one take the reading and note down the reading.
- Collar Height: Select 5 samples in stock sample measure Collar height with a calibrated Vernier caliper. One by one take the reading and note down the reading.
- Internal bore diameter: Select 5 samples in stock sample measure the internal bore Diameter with a calibrated Vernier caliper. One by one take the reading and note down the reading.
- Neck Diameter (ext.): Select 5 samples in stock sample measure Neck Diameter with a calibrated Vernier caliper. One by one take the reading and note down the reading.
- Collar Diameter: Select 5 samples in stock sample measure collar Diameter with a calibrated Vernier caliper. One by one take the reading and note down the reading.
- Body Height: Select 5 samples in stock sample measure Body height with a calibrated Vernier caliper. One by one take the reading and note down the reading.
3. Concentricity
The canister specifies outer diameter and inner diameter measurements with concentricity requirements,
The Concentricity of a Canister Is Defined as a Measure of the Constancy of the wall thickness at a canister as such, concentricity controls a central axis derived from the median points of the part measured in cross-section.
That means if concentricity were “perfect” then wall thickness between the inner and outer diameter would be the same in every cross-section, at every point around the diameter of the canister.
This result was generated from vendor COA 0.15 maximum
4. Over Flow Capacity
Select 5 samples in the stock sample. Fill with water in over flow label. Transfer the measuring cylinder, and measure the water in ml, remains canister repeat the procedure, and note down the reading.
5. Weight of the canister
take the 5 samples. Measure with the help of analytical balance take the weight one by one and record the reading.
6. Wall thickness
Select the sample cut the sample at a middle point and divide it into two parts. It’s measuring the sample wall thickness with the help of a digital micrometer. Take readings one by one and note down the reading
7. Surface treatment
a canister contains hydrofluoro alkane (HFA)-Based propellants are widely used in modern metered–dose inhalers (MDI), due to their lack of hazardous and environmentally damaging effects. However, an HFA’s active pharmaceutical ingredients can interact with the canister substance causing deposition of the the drugs to the canister wall, or interact with the solution the solution causing degradation and resulting in increased impurity levels.
In modern times many surface coatings have been developed. They are applied on the surface of the canister and nitrile valve components. These coatings are protected from product degradation and deposition.
8. Base deflection Pressure
the base deflection pressure of the canister measures the ability to bear a given elevated pressure without any leakage on the base of the canister.
This result was generated from vendor COA >15.8 Bar.
9. Brust pressure
the burst pressure of the sample is the pressure that the “pressure” the canister can handle before rupturing or bursting the sample.
Environmental condition and the canister’s inner and outer diameter. The canister stress (ultimate tensile strength or yield strength) factor is involved the determining the burst pressure of the sample.
This result generated from vendor COA >18.6 Bar
10. Check for contamination
free from dirt foreign matter or any other contamination both inside and outside
I am Maneesh Maurya a professional pharmaceutical blogger from India having rich experience in the pharmaceutical Quality control field.
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[…] material. inhaler packaging of the actuator is used in meter dose inhalers. It has three parts, a canister, a metering valve, and an actuator. The meter-dose inhaler actuator for pressurized aerosol […]