Analysis of Pharmaceuticals Packaging Materials

SOP for Analysis of Packaging Materials

This SOP is applicable to all packaging materials under
retest due in warehouse at (Pharmaceutical Company Name). Concerned Store
personnel shall be responsible for intimating Quality control about the retest
due.

SOP for Analysis of Packaging Materials

1.0 PURPOSE

To provide the procedure for the analysis of packaging
materials.

2.0 SCOPE

Covers all the packing materials used in the factory.

3.0 REFERENCE

      IP & In House.         

4.0 RESPONSIBILITY

      Q.C. Chemist.

5.0 ACCOUNTABILITY

     Quality Control Manager.

6.0 PROCEDURE

6.1 OPERATION

6.1.1 Sample packing materials as per sampling of Packaging
Materials

6.2 ANALYSIS

Check the following for various packaging components:

6.2.1 CARTONS

6.2.1.1 Check the entire supply

6.2.1.2 Design (As per approved art work)

6.2.1.3 Text (As per approved art work)

6.2.1.4 Color (As per approved by Marketing)

6.2.1.5 Improper pasting

6.2.1.6 Cartooning

6.2.1.7 Dirty appearance and any other abnormality

6.2.1.8 Dimensions

            a) Length (As per approved art work)

           b) Width (As per approved art work)

           c) Height (As per approved art work)

6.2.1.9 Packaging Code Number

6.2.1.10 Printing

6.2.1.11 Holding of strips/blisters

6.2.1.12 Grammage (GSM)

Procedure

Cut and perfect square piece of 10cm*10 cm or 5 cm *5 cm or
less, as per the size of packaging material and weigh. Calculate Grams per
sq.meter as per the formula

                                Wt. in mg *100
*100

    GSM       =   
———————————————–

                        
Width in cm x length in cm *1000

6.2.2 LABELS

6.2.2.1 Check the entire supply

6.2.2.2 Design (As per approved art work)

6.2.2.3 Text (As per approved art work)

6.2.2.4 Color (As per approved by Marketing)

6.2.2.5 Defective cutting

6.2.2.6 Deviation from actual color shade

6.2.2.7 Printing

6.2.2.8 Dimensions:

            a) Length (As per approved art work)

           b) Width (As per approved art work)

6.2.2.9 Grammage (GSM): follow step no. 5.2.1.12

6.2.2.10 Gumming for sticker labels:  Paste few stickers on to the PP containers,
leave the containers at 37°C for 6-8 hours. 
Observe for quality of gum.

6.2.3 ALUMINIUM FOIL

6.2.3.1 Check condition of the entire supply.  Observe the general condition of the supply
received and check width of every stripe roll.

6.2.3.2 Design (As per approved art work)

6.2.3.3 Text (As per approved art work)

6.2.3.4 Color (As per approved by Marketing)

6.2.3.5 Width (As per approved art work)

6.2.3.6 Printing

6.2.3.7 Packaging Code Number

6.2.3.8 Grammage (GSM): 
follow step no. 5.2.1.12

            a) Aluminum

           b) Polythene
lining

Separation of polythene lining from aluminum:  Cut at least three pieces from three
different strip rolls. Make them smooth by gentle rub with diluted nitric acid
or toluene.   Cut a piece of same
dimension from each and weight.  Put all
three pieces in a beaker filled with diluted nitric acid or toluene, warm up
the beaker and remove polythene lining from each.  Dry and weight each piece, difference in
weight is the   weight    of the polythene lining. Calculate GSM.

6.2.3.9 Peel Test:

Take the piece of cellophane tape and paste on a printed
matter and wait for 45 seconds. Remove the cellophane tape from foil and record
the observation. The printing matter should not peel off with cellophane tape.

6.2.4 CORRUGATED BOXES

6.2.4.1 Check the entire supply

6.2.4.2 Improper pasting

6.2.4.3 Dirty appearance and any other abnormality

6.2.4.4 Dimensions

            a) Length

            b) Width

            c) Height

6.2.4.5 Formation of Boxes

6.2.4.6 Suitability: 
Put the cartons in the shipper, meant for packing and close the shipper.
It should hold the specified number of cartons.

6.2.4.7 Grammage (GSM): follow step no. 5.2.1.12

6.2.5 POLYPROPYLENE BOTTLE

6.2.5.1 Check the entire supply.

6.2.5.2 Description.

6.2.5.3 Bottle Design.

6.2.5.4 Total Height.

6.2.5.5 Body Diameter.

6.2.5.6 Neck Diameter.

           a. Outer Diameter.

           b. Inner Diameter

6.2.5.7 Color shade – check color shade variation

6.2.5.8 Filled Volume

6.2.5.9 Average weight of 20 bottles

6.2.5.10 Weight variation

6.2.5.11 Holding of 30 bottles with caps in a WW box.

6.2.6 CAPS

6.2.6.1 General condition of the supply

6.2.6.2 Description

6.2.6.3 Color

6.2.6.4 Design and Monogram

6.2.6.5 Diameter in mm outer & inner

6.2.6.6 Average Weight

6.2.6.7 Individual Weights

6.2.6.8 Weight variation

6.2.6.9 Fitting of caps on the bottles

6.2.7 PACKAGE INSERT

6.2.7.1 Check the entire supply

6.2.7.2 Design (As per approved art works)

6.2.7.3 Text (As
per approved art works)

6.2.7.4 Colour (As per approved color swatch)

6.2.7.5 Printing

6.2.7.6 Dimensions

           (a) Length

           (b) Breadth

5.2.7.1 Improper cutting

5.2.7.2 Packaging Code No

5.2.7.3 Grammage (GSM): follow step no. 5.2.1.12

5.2.8 PVC/PVDC FILM        

5.2.8.1 General condition of the supply

5.2.8.2 Description

5.2.8.3 Color

5.2.8.4 Thickness

5.2.8.5 Width

5.2.8.6 Physical defects if any

5.2.8.7 Grammage (GSM): follow step no. 5.2.1.12

            a) PVC

            b) PVDC

Test for PVDC: Place a drop of cold pyridine on the surface
of PVDC film side followed by a drop of 5% Sodium hydroxide in Methanol.
Appearance of brown to black colour indicated the presence of PVDC.

5.2.8.8 Element tests

For Vinyl chlorides: The films containing two basic elements
chloride and nitrogen can be distinguished by Beilstein copper wire or Greiss
reagent methods. For Chlorine copper wire is heated and wiped across the sample
and then replaced in the flame. Green flame indicates presence of chlorine and
the film can either be PVC, PVDC on one or both sides further identification of
above film can be carried out by Liebermann-Sctorch –Morawski test, in which
sample is placed on a spot plate, covered with few drops of acetic Anhydride
and a drop of concentrated sulphuric acid is added. The colours in liquid and
on film are observed for an hour.

      Colour             Film

1. Blue (Slow)     PVC

2. Yellow (Slow)  PVDC

Now to confirm the absence of nitrogen, the film together
with manganese dioxide is heated in combustion tube for 2-3 minutes. The tube
is covered with filter paper dampened with Greiss reagent. None colour on
filter paper confirms the absence of nitrogen.

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