The laminated pouch is directly connected with pharmaceutical drugs so, it is a primary packaging material. It is double-sided laminated, with two or three sheets of the laminated pouch available in a cold pouch or thermal pouches.
Laminated pouches are different from traditional lamination in that the air tight seal protects the contact of the pouch by preventing moisture and other foreign material from entering the lamination cover.
It plays an important role in packaging pharmaceutical products so its quality checks some given parameters,
Table of Contents
1. Description:
plain three-layered structure made of polyester laminated with aluminium foil which in turn is laminated low-density polyethylene film
2. Identification of contact layer
This test is performed by FTIR instrument, selected sample of sufficient quantity laminated pouch. Its contact layer is the LDPE layer then taken LDPE reference standard, scan standard, and sample scan graph are plotted. is compared with the standard to sample the same 3800-650cm-1 wavelength.
The corrected spectrum of the specimen exhibits major absorption bands only at the same wavelength as the spectrum of the low-density polyethylene reference standard.
3. Dimension
Width: selected 5 samples from a sample lot. Measure width with the help of a measuring scale. Take reading and note it down.
Length: selected 5 samples from a sample lot. Measure Length with the help of a measuring scale. Take reading and note it down.
4. Grammage of laminated pouch
selected the 5 samples of the laminated pouch. Cut the sample 10 x 10 cm or 5 x 5 cm with the help of a GSM plate. I have taken the weights one by one at analytical balance.
Grammage = weight of sample x 100 or 400 (if the sample cut 10 x 10 cm or 5 x 5 cm)
5. Sealing width
selected 5 samples from a sample lot. Measure the sealing width with the help of a measuring scale. Take reading and note it down
6. Light Transmission
Select a sample of laminated Pouch cut circular section from two or more areas of the laminated pouch and wash and dry them, avoiding scratching the surface, and mount them in the apparatus as described for glass.
Place the section in the spectrophotometer with its cylindrical axis parallel to the place of the slit and approximately centered concerning the slit. When properly placed, the light beam is normal to the surface properly placed, the light beam is normal to the surface of section and reflection losses are at a minimum.
The laminated pouch’s observed light transmission is a transparency of not more than 10% at any wavelength range from 290 to 450nm.
7. Check for contamination
the pouch shall be free from many adhered dust black particles, blister in lamination as well as sealing delamination of layers and foreign matter
8. Color scheme & text matter
if the laminated pouch is printed then we compare the sample with shade card or artwork
I am Maneesh Maurya a professional pharmaceutical blogger from India having rich experience in the pharmaceutical Quality control field.
