Fluid path - connectors

BioEndCap

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 moulded in for full traceability
  • Unique pull-tab ensures easy removal of the cap
  • Suitable for sterilisation by autoclave and gamma irradiation

Technical summary

Max. operating pressure4 bar
Max. operating pressure58 psi
Shelf life5 years
Certification and complianceADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
TC Size½-¾ TC - 1-1½ TC in

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

Specifications

Technical specifications

BioEndCap
Max. operating pressure4 bar
Max. operating pressure58 psi
Fluid temperature range 5 °C to 40 °C
Fluid temperature range 40 °F to 104 °F
Operating temperature range 23 °F to 104 °F
Autoclave stability121 °C 30 minutes 
Gamma stability50 kGy 
Shelf life5 years
Certification and complianceADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
TC Size½-¾ TC - 1-1½ TC in
Quantity10 PCS

Materials of construction

MaterialNatural 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 fulfils requirements of European pharmacopoeia, 5th edition (2004) and supplement 5.8 (07/2007), monograph 3.2.2.
  • Suitable for sterilisation by autoclave and gamma irradiation
  • Lot traceability
  • Precision compression between tube and fittings eliminates flow bypass and media entrapment

Download summary guide

BioEndCap validation summary guide

Validation summary guide PDF - 379,5kb

Request full validation guide

Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTS.

Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTS.

Literature

Brochures

  1. BioPure overview (EN).pdf
    PDF - 863,8kb

Datasheet

Other Resources

  1. 1 inch - 1½ inch TC BioEndCap technical drawing.pdf
    PDF - 185,9kb
  2. ½ inch - ¾ inch TC BioEndCap technical drawing.pdf
    PDF - 240,6kb

Order Information

Product codes

BioEndCap product codes

Part Number Size Flange Size Material
PPEC05000750 1/2" - 3/4" TC 1/2" - 3/4" Natural PP
PPEC10001500 1" - 1 1/2" TC 1" - 1 1/2" Natural PP

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