SUMITOMO BAKELITE CO., LTD.
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PTP (press-through-pack) materials for pharmaceutical blister films
SUMILITE® VSS/VSL E SUMILITE® NS E SUMILITE® FCL

Hygiene and non-toxicity of each sheet

Hygiene and non-toxicity of each sheet

PTP (press-through-pack) materials for pharmaceutical blister films, SUMILITE® VSS/VSL/NS are comprised of highly hygienic materials in specific formulations and layer structures. Furthermore, the materials are manufactured under stringent quality controls in accordance with GMP (Good Manufacturing Practice). As shown in the following table, each grade conforms to the Japan MHW Notification No.20, 1982, the JHPA (Japan Hygienic PVC Association) PL standards and JHOSA (Japan Hygienic Olefin and Styrene Association). Also, most of the grades except for a limited number of sheets are registered with the Food and Drug Administration in the USA.
Article No.
Japan MHW
Notification No.
20, 1982
JHPA (Japan
Hygienic PVC
Association)
PL standards
JHOSA
(Japan Hygienic Olefin
and Styrene Association)
FDA Drug
Master File
VSS-1104
Conforms
Registered
Conforms
Registered
VSS-F110
Conforms
Registered
Conforms
Registered
VSS-F120
Conforms
Registered
Conforms
Registered
VSS-1104-UV-3
Conforms
Registered
-
-
VSS-F110-UV-3
Conforms
Registered
-
-
NS-3450
Conforms*
-
Conforms
Registered
NS-3451
Conforms*
-
Conforms
Registered
VSL-4501
PVC resins used for VSL are registered with JHPA PL standards; polyethylene resins are also registered with JHOSA PL standards, and polyvinylidene resins conform to Japan MHW Notification No.20, 1982
Registered
VSL-4510-B
Registered
VSL-4601-N
Registered
VSL-4603
Registered
VSL-4610-N
Registered
* Conformity limited to PTP use.