TEKNOLOGI SEDIAAN FARMASI

surface
surface treatment
treatment
test
DILA APRIANI

FARMASI
 Surface treatment
test
isamraF naaideS igolonkeT

Surface treatments are done to reinforce the strength of the external skin of the vial,
to reduce breakage and bump checks. This kind of treatment is done on the hot
bottles before they enter the annealing lehr. So called Hot-end treatment

Examples of hot-end treatment use:

Syrup bottles
Lightweight infusion bottles (type II)
Large vials for lyophilisation (this also requires the cold-end treatment)

Purpose of
surface
treatment

isamraF naaideS igolonkeT

To decrease the abrasion factor

between items to facilitate handling,

conveyance on production lines and

transportation by protecting the glass

against any risk of scratching. What it

all comes down to is to reinforce the

strength of the external skin of the vial,

to reduce breakage and bump checks.

 Types of
1. Surface treatment of

bottles through:

surface 2. Application of a metallic

isamraF naaideS igolonkeT

oxide layer (hot treatment)

treatment: 3. Application of a lubricating

layer (cold treatment).

Hottreatment
Hot treatment

THE GOAL IS TO FORM A LAYER

OF TIN OXIDE ON THE EXTERNAL

SURFACE OF THE BOTTLE BY

BURNING AN ORGANO-METALIC

COMPOUND.

Qualitycontrol
Quality control

EQUIPMENT MADE BY AGR TO MEASURE THE

THICKNESS OF THE TIN OXIDE LAYER ON THE

EXTERNAL SURFACE. RESULTS ARE REPORTED IN

CTUS (COATING THICKNESS UNITS).

MEASUREMENTS MADE IN QC LABORATORY

BASED ON SAMPLING DURING PRODUCTION

 Process
Process
validation
validation

DETECTION/QUANTIFICATION BY EXTRACTABLE

RESULTS: LESS THAN 7 ΜG PER BOTTLE.

Cold treatment
treatment

DAPPLICATION OF A LUBRICATING LAYER.

PRODUCT: SIMULSOL M52 (MONOSTEARATE- OR

POLYOETHYLENE GLYCOL-BASED)

WATER SOLUBLE

REDUCES THE ABRASION FACTOR, FACILITATES

SLIDING OF THE BOTTLES.