Fluid path - connectors

BioEndCap

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Overview

BioEndCap™ End caps with pull tab

BioEndCap is designed to terminate a disposable manifold until an in-process new sterile connection is to be made. Produced from DMF listed polypropylene compliant with FDA and USP Class VI and European Pharmacopoeia.

Features and benefits

Lot numbers molded in for full traceability
Unique pull-tab ensures easy removal of the cap
Suitable for sterilization by autoclave and gamma irradiation

Technical summary

Max. operating pressure	4 bar
Max. operating pressure	58 psi
Shelf life	5 years
Certification and compliance	ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI
TC Size	½-¾ TC - 1-1½ TC in

Technical Summary table lists features available within the range. See ‘Technical specifications’ tab for model specific information.

Specifications

Technical specifications

	BioEndCap
Max. operating pressure	4 bar
Max. operating pressure	58 psi
Fluid temperature range	5 to 40 °C
Fluid temperature range	40 to 104 °F
Operating temperature range	-5 to 40 °C
Operating temperature range	23 to 104 °F
Autoclave stability	121 °C 30 minutes
Gamma stability	50kGy
Shelf life	5 years
Certification and compliance	ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI
TC Size	½-¾ TC - 1-1½ TC in
Quantity	10 PCS

Materials of construction

Material

Natural PP

Validation

About the BioPure components validation guides

These components are manufactured and packed in an ISO 14644-1 Class 7 cleanroom from a DMF listed polypropylene compliant with FDA and USP VI. Product validation studies were performed on the post gamma irradiated BioPure components.

Evaluated for extractables using a multi-solvent approach to BPOG guidelines
USP Class VI compliant and Animal Derived Component Free (ACDF)
Raw material assigned FDA drug master number: DMF 9040 and fulfills requirements of European pharmacopoeia, 5th edition (2004) and supplement 5.8 (07/2007), monograph 3.2.2.
Suitable for sterilization by autoclave and gamma irradiation
Lot traceability
Precision compression between tube and fittings eliminates flow bypass and media entrapment

Validation summary guide

The summary guide summarizes the validation/qualification testing that has been carried out on BioPure components

View BioPure components summary guide - 379.5kb

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