Fluid path - connectors

FlatBioEndCap

Overview

FlatBioEndCap™ - End caps for connectors

FlatBioEndCap is 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
  • Suitable for sterilisation by autoclave and gamma irradiation

Technical summary

Max. operating pressure4 bar
Max. operating pressure58 psi
Shelf life5 years
CertificationADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
TC Size½-¾ TC - 2½ TC in

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

Specifications

Technical specifications

FlatBioEndCap
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 -5 °C to 40 °C
Operating temperature range 23 °F to 104 °F
Autoclave stability121 °C 30 minutes 
Gamma stability50 kGy 
Shelf life5 years
CertificationADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
TC Size½-¾ TC - 2½ 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

Validation summary guide

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

View BioPure components summary guide - 379.5kb

Request full validation guide

Thank you for requesting our validation documentation. We have received your request and will respond within 48 hours.

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 (US).pdf
    PDF - 2.4mb

Datasheet

Other Resources

  1. 2½ inch Flat BioEndCap technical drawing.pdf
    PDF - 187.9kb
  2. 2 inch Flat BioEndCap technical drawing.pdf
    PDF - 176.6kb
  3. 1 inch - 1½ inch Flat BioEndCap technical drawing.pdf
    PDF - 169.9kb
  4. ½ inch - ¾ inch Flat BioEndCap technical drawing.pdf
    PDF - 181.1kb

Order Information

Product codes

FlatBioEndCap product codes

Part Number Size Flange Size Material
PPEC05000750FC 1/2" - 3/4" TC 1/2" - 3/4" Natural PP
PPEC10001500FC 1" - 1 1/2" TC 1" - 1 1/2" Natural PP
PPEC2000FC 2" TC 2" Natural PP
PPEC2500FC 2 1/2" TC 2 1/2" Natural PP

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