Presentation on Parenteral products: Clarity test

Presented by

Fatima- tuz- zohora NadiId-11346002

Azamu shahiullah prottoyId- 11146018

PARENTERAL PRODUCTS

PARA- OUTSIDEENTERON- INTESTINEParenteral preparations are sterile, pyrogen-free liquids (solutions, emulsions, or suspensions) or solid dosage forms containing one or more active ingredients, packaged in either single-dose or multidose containers. They are intended for administration by injection, infusion, or implantation into the body.

Quality control

• Sterility testing

• Pyrogen test

• Clarity test

• Leakage test

Clarity Test• Clarity is tested by visual inspection of containers under

light and against a black and white background.

• Instrumental methods of evaluation is based on the principles of light scattering, light absorption and electrical resistance which are used to count particle and particle size distribution.

• Unwanted mobile insoluble matter other than gas bubbles are present in the given product.

• It may be dangerous when the particle size is larger than R.B.C. and may block the blood vessel.

Particulate Matter

• Matter of biological or non-biological origin.

• With observable length, width, and thicknesse.g., bacteria, fungi, dust, dirt, fibers, plastic,rubber, lint etc.

• It may be any matter, mixed accidentally during manufacturing in the parenteral product which does not belong to the product.

• Particulate mater may be tiny pieces of lint, glass, dust, rubber, metal fibers, hair, microbes or unidentified and can make the product impure, unclean or unfit for use.

Sources of Particulate Matter

• Material arising from the drug: undissolvedsubstances and trace contaminants etc.

• Material arising from vehicle or added substances: These may include those material not filtered out during a clarification process before to filling the final container.

• Materials present in the final container: Material already present in container and which were not removed by rinsing prior to filling.

• Materials falling by chance into the final container during the filling process.

Sources of Particulate Matter

• The container or closures which may be deposited in the produce during sterilization, e.g. carbon black, whiting, zinc oxide and clay.

• Packaging components: Including glass, plastic, rubber, I/V administration sets, etc.

• Environmental contaminants: Including air, work tops, insects’ parts.

• Processing equipments: Including glass, stainless steel, rubber, or filter fiber, etc.

• Personnel: Including skin, hair, and clothing etc.

Particle Size

• A person with 20/20 vision under inspection conditions is able to detect particles of size range 40 – 50 μm. However, it is universally accepted that the particles size of 50 μm is detected visually by an unaided eye.

• Particle size greater than 7 μm diameter is considered to be more threatening. Pulmonary capillary are approximately 7 μm in diameter, thus particle of this much size entrapped in vascular bed resulting in multiple pulmonary infarction.

Identification of Particulates

1. Microscopy.

2. X-ray powder diffraction.

3. Mass spectroscopy.

4. Polarized light spectroscopy.

5. Scanning electron microscopy (SEM)

Methods of Monitoring

1. Coulter- current method

2. Visual method

3. Light scattering and light absorption

4. Light blockage method

Coulter- current method

• This is a destructive test.

• Large errors in measuring flakes and fibers are expected.

• This test is not recommended by FDA for parenterals.

• High Accuracy (HIAC) Instrument is based on light blockage principle. The test is highly effective for counting the both solid and liquid suspended particles. The instrument is calibrated easily and the test is recommended by USP. This is destructive test method and is expensive.

Coulter- current method

2. Visual method

3. Light scattering and light absorption

4. Light blockage method

Methods of Monitoring