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BPC Components

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.

 

Test Procedure   Description
USP <88>
 
> Class VI Biological Reactivity Tests in Vivo
 
Muscle Implantation Study in the Rabbit
Systemic Toxicity Study in the Mouse
Intracutaneous Toxicity Study in the Rabbit
USP <87>
 
> Biological Reactivity Tests in Vitro-Cytotoxicity
 
Agar Diffusion
Elution Method
USP <85>
 
> Bacterial Endotoxin using Kinetic-LAL*
 
Based on USP requirement for WFI
USP <661>
 
> Physicochemical Testing of Plastic Containers (Aqueous Extract)
 
Heavy Metals
Buffering Capacity
Non-Volatile Residue
Residue on Ignition
ISO 10993-4
 
> Hemolysis
EP <3.2.2.1>
 
> Physicochemical Tests
 
Appearance
Initial color of solution
Acidity
Alkalinity
Absorbance
Reducing substances
Transparency

*Testing is performed on a routine basis

Components Section Navigation
> Components
  Film
  Ports, Tubing, and Fittings

 

 

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