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Flexible
container systems consist of plastic films, ports, tubing, fittings and
may contain ancillary components like filters, valves, etc. The performance
of a specific container system in a particular application depends primarily
on its underlying building blocks. All standard product contact materials
in HyClone BPCs tolerate up to 38 kGy (3.8 mRad) of gamma irradiation
without loss of integrity. In addition, standard product contact fittings,
tubing and film pass current applicable United States Pharmacopoeia (USP),
ISO and European Pharmacopoeia (EP) testing. Primary contact material gets
the full testing (USP 85, 87, 88, 661, ISO and EP) Whereas the Secondary contact only receives USP 88.
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Procedure |
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Description |
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Class VI
Biological Reactivity Tests in Vivo |
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Muscle
Implantation Study in the Rabbit |
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Systemic
Toxicity Study in the Mouse |
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Intracutaneous
Toxicity Study in the Rabbit |
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Biological
Reactivity Tests in Vitro-Cytotoxicity |
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Agar
Diffusion |
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Elution
Method |
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Bacterial
Endotoxin using Kinetic-LAL* |
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Based
on USP requirement for WFI |
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Physicochemical
Testing of Plastic Containers (Aqueous Extract) |
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Heavy
Metals |
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Buffering
Capacity |
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Non-Volatile
Residue |
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Residue
on Ignition |
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Physicochemical
Tests |
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Appearance |
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Initial
color of solution |
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Acidity |
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Alkalinity |
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Absorbance |
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Reducing
substances |
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Transparency |
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*Testing is performed on a routine basis
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