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 molded in for full traceability
  • Suitable for sterilization by autoclave and gamma irradiation

Technical summary

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 ‘Technical specifications’ tab for model specific information.

Specifications

Technical specifications

FlatBioEndCap
Autoclave stability121 °C 30 minutes 
CertificationADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
Gamma stability50kGy 
Quantity10 PCS
Max. operating pressure4 bar
Max. operating pressure58 psi
Shelf life5 years
TC Size½-¾ TC - 2½ TC in
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

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 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

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 WMFTG.

Literature

Brochures

  1. Bioprocessing industry (US).pdf
    PDF - 2.9mb
  2. BioPure overview (US).pdf
    PDF - 598.8kb

Datasheet

Other Resources

  1. ½ inch - ¾ inch Flat BioEndCap technical drawing.pdf
    PDF - 1.5mb
  2. 1 inch - 1½ inch Flat BioEndCap technical drawing.pdf
    PDF - 1.4mb
  3. 2 inch Flat BioEndCap technical drawing.pdf
    PDF - 1.5mb
  4. 2½ inch Flat BioEndCap technical drawing.pdf
    PDF - 1.5mb

Order Information

Product codes

FlatBioEndCap product codes

Part Number Size Flange Size Material
PEC050075FC 1/2" - 3/4" TC 1/2" - 3/4" Natural PP
PEC100150FC 1" - 1 1/2" TC 1" - 1 1/2" Natural PP
PEC-200-FC 2" TC 2" Natural PP
PEC-250-FC 2 1/2" TC 2 1/2" Natural PP

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