Like the name, these pharma grade films reflect the glow of pearls. With a brilliant shine and opacity, the Day Perle range complies with global regulations with respect to USP/EC guidelines. Available in a range of stunning colours, this category has revolutionized the PVC films market and is sought after by extremely discerning and quality conscious clientele.
Precious qualities that never fade :-
High aesthetic appeal
Excellent formability
In a myriad of attractive colours
Higher opacity
Superior sealing
Good impact strength
Active drug master filed with USFDA (DME No. 17354, Type III)
Complying to EEC/USP guidelines (current version)
Best barrier properties due to uniform thickness control
Applications :-
Capsules
Tablets
Fenoplast Films are Manufactured in a Controlled Environment Following Good Manufacturing Practices.
Technical Data :-
SL. NO.
CHARACTERISTICS
UNIT
METHOD
SPECIFICATION & REMARKS
1
Thickness Tolerance
MICRONS
DIN 53370
± 10% for <_200; ± 8% for 201 to 400; ± 4% for 401 to 700
2
GSM Tolerance
GM/M²
DIN 53352
± 10% for <200; ± 8% for 201 to 400; ± 4% for 401 to 700
3
Gloss (@20°C)
%
ASTM D 2457
Min. 85 for Transparent Film
Min. 65 for Opaque Film
4
Impact Strength
GM
ASTM D 1709
400 Min. for > 250µ
250 Min. for < 220µ
5
Dimensional Stability
(@ 140°C/10 min)
% MD
DIN 53377
-3.0 to -13.0(110 to 170µ), -3.0 to -10.0(171 to 200µ)
-3.0 to -8.0(201 to 250µ), -3.0 to -7.0(>250µ)
%TD
DIN 53377
0.5 to 6.0(110 to 170µ), 0.5 to 5.0(171 to 200µ)
0.5 to 4.0(201 to 250µ), 0.5 to 2.5(>250µ)
6
Tensile Strength at Peak
KG/CM²
ASTM D 882
_>500
7
Elongation at Peak Load (Jaw Separation Speed @20mm/min)
%
ASTM D 882
_>4
8
Density
GM/CM³
ASTM -D 792
1.4 ± 0.02
9
Vicat Softening Point
°C
ASTM -D 1525
74 ± 2
10
WVTR @ 38°C, 90% RH
GM/M²/24HR
ASTM F 1249
< 4.00(<_200µ); <3.75(>220µ)
11
OTR @ 23°C, 0% RH
CM³/M²/24HR
ASTM D 3985
< 12.00(<_200µ); <10.00(>220µ)
12
Toxicity
N/A
Current USP Method
Non - Toxic
13
Global Migration
PPM
2002/72/EC
< 10
14
RVCM Content
PPM
78/142/EEC
< 0.50
15
RoHS
PPM
94/62/EC
Complies
16
Other Defects
N/A
FPL/QA/STP-17
Free from Air Streaks, Dents, Hot Patches
These technical specifications and end-use recommendations are based on our observations and assessment.
Validating/optimizing the right grade may vary based on particular application, tooling and process conditions.