Packaging Materials Specification at the Hospital (according DHQ Hospital in Pakistan)

INTRODUCTION:

A container closure or packaging system refers to the sum of packaging components that together contain and protect the dosage form.

The suitability of a container closure system for a particular pharmaceutical product is proven by full shelf life stability studies.

Packaging materials must comply with the requirements of official books, law, market needs, finance available and customer needs. Selection of immediate containers in an important issue and its compatibility with the product is checked and evaluated. Other packaging components are selected according to the parameters as mentioned above.

DETERMINATION OF PACKAGING MATERIAL SPECIFICATIONS:

Purpose:                                                                                                             

To determine whether the packaging material meets the official requirements or not.

1.     60ml Amber Colored Bottle For Ibuprofen Oral Suspension.

Glass bottles are usually subjected to following testing:

·         Length, diameter (both internal and external), width:

These parameters are measured with the help of measuring scale vernier caliper and compared with the standard one.

·         Glass used in drug packaging is exposed to following tests:

·         Powdered glass test:

Performed on crush grains of specific size using 0.02N H₂SO₄

·         Water attack test:

Performed on whole container and only on type-2 glass.

·         Opening and closing of lid:

It is checked by applying the caps on the bottles.

·         Volume fill:

Volume fill of the containers is checked by filling them water any other liquid and compared with the standard

·         Light transmission test:

The USP (United States Pharmacopeia) test for light transmission (USP <661>) is an accepted standard for evaluating the light transmission properties of a container.

·         Heavy metals:

Detection limit 1 parts per million.

·         Residue on ignition:

Detection limit 1 mg

·         Buffering capacity:

Detection limit pH 1-14

·         Absorbance of light

·         Acidity/alkalinity (determined by titration) that can be imparted by glass into the formulation.

·         Compatibility with the product

·         Reducing substances

·         Toxicity testing(biological testing for toxicity and carcinogenicity in animals)

 2) Cap for amber colored bottles:

            Caps are checked for their;

·         Length and diameter(outer and inner)

·         Diameter of plastic used

·         Consistency in shape, color and weight

·         Tests on plastic materials(compatibility and toxicity testing done only during selection phase)

3) Label on immediate container, unit carton and leaflet:

At work checking is employed on labels, unit carton, leaflets, or any other printed materials provided in the pack. At work must comply with the requirements of ministry and internal standards. Materials for packing are checked visibly for;

·         Product name

·         Generic or chemical name of the product or ingredients

·         Manufacturing license no.

·         Composition required

·         Color and graphics on the carton and label

·         Directions for storage and usual dose product name, generic name, directions for storage and dose written in Urdu.

·         Retail price

·         Logo of the company along with address.

·         Slogan if any.

·         Material is also checked for any flaw in writing, over printing or smudging

·         Functional test: opening and closing of the pack is checked

·         Height, width and length of label, unit carton and leaflet. These parameters are measured with the help of measuring scale and vernier caliper and compared with the standard one.

·         Grammage of the paper/card or board used:

Grammage may be calculated by the following formula;

All the above parameters must meet the internal standards of the company and drug labeling and packaging rules.

BOTTLE SPECIFICATIONS:

Length
Width
Inner Diameter
Outer Diameter
Diameter Of Base
Volume Fill
Average Wt.

CAP SPECIFICATIONS:

Length
Width
Inner Diameter
Outer Diameter
Average Wt.
Thickness
Screw

LABEL SPECIFICATIONS:

Length
Width
Grammage
Art work

CARTON SPECIFICATIONS:

Length
Width
Grammage
Art work

LEAFLET SPECIFICATIONS:

Length
Width
Grammage

ART WORK SPECIFICATIONS:

Brand name
Generic name
Batch no.
License no.
Manufacturing date
Expiry date
Composition
Directions for storage
Usual dose
Retail price
Logo of the company