Top 5 benefits of Single-use bioprocess container - PowerPoint PPT Presentation

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Top 5 benefits of Single-use bioprocess container

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Bioprocess Bottles & PETCarboy PharmaTainer™ bottles and carboys meet today’s requirements for bio-manufacturing storage and transport. We believe these are the best rigid single-use containers available today for safe, trouble-free mini-bulk storage of biologics. – PowerPoint PPT presentation

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Title: Top 5 benefits of Single-use bioprocess container


1
Biofluid Focus
  • TOP 05 BENEFITS OF SINGLE-USE BIOPROCESS
    CONTAINERS

2
PharmaTainer PC
  • Single-Use  Bioprocess Containers
  • Bioprocess Bottles Carboys
  • PharmaTainer bottles and carboys meet todays
    requirements for bio-manufacturing storage and
    transport.
  • We believe these are the best rigid single-use
    containers available today for safe,
    trouble-free mini-bulk storage of biologics.

3
What Makes PharmaTainers Better
  • Features Benefits
  • Double-seal closure system leakproof sealing.
  • Traceability by lot tracks back to materials,
    operators, molding machine and related QC/QA
    records.
  • Traceability by serial number provides a method
    for single unit inventory tracking.
  • 2D optical code of serial number allows
    registration and control of individual units
    using an optical reader.
  • Expiration Date 5 years from date of
    manufacture.
  • Molded in ISO Class 5 environment Allows
    compliance with USP lt788gt Particulate Matter in
    Injections standard without any problematic
    cleaning steps.
  • Polycarbonate bottles are safe for use a -80C.

4
New, state-of-the-art molding facility
  • Molds only for biotechnology applications no
    confusion with multiple quality standards.
  • Leading edge molding technology precision
    molding with better control for high product
    quality and consistency.
  • Molding containers and closures full control of
    container sealing system, no variation imposed by
    outside vendors.
  • Validation CD a compilation of test reports,
    data sheets, drawings and other information to
    support the use of PharmaTainer products. This
    information is free, but is only provided under a
    non-disclosure agreement.

5
The Double-Seal Closure
  • PharmaTainer closures seal at two points on the
    inside of the neck and also on the top flat rim
    of the neck.
  • Tests have demonstrated that the closure system
    holds seal very well.
  • The seal inside the neck is readily achieved when
    applying the closure by hand.
  • Certain engagement of the rim seal requires
    application of a known amount of torque.

6
Packaging
  • PharmaTainer packaging has been designed to pass
    through 3 levels of increasing clean environments
    and each level of packaging is clearly labeled
    with product identity, lot number, expiration
    date and a radiation indicator dot.
  • The following packaging scheme is true for all
    PharmaTainer bottles and carboys
  • Carton 4mm corrugate, with top base protection
    sheets.
  • Carton Liner 50µ LDPE monolayer film bag, tape
    sealed.
  • Level 2 Pack 100µ LDPE monolayer film bag, heat
    sealed.
  • Sterile Barrier 120µ PE/PA/PE multilayer film,
    vacuum sealed.
  • The user may be confident that the products are
    sterile as long and the innermost bag holds its
    vacuum.

7
Imprint and Unit Traceability
  • PharmaTainer bottles and carboys have black
    printed volume scales and traceability
    information.
  • Graduations 2 in appropriate increments to
    recommended capacity.
  • Traceability Lot No., S/N, 2D S/N optical code,
    Expiration Date
  • PharmaTainer products are manufactured by Cellon
    SA serving biologics manufacturing customers
    since 1987.
  • PharmaTainer is a trademark of Cellon SA,

8
Contact Us
  • BIOFLUID FOUCS
  • Please feel free to contact us with any questions
    or requests.
  • E-mail info_at_biofluidfocus.com
  • Address
  • Biofluid Focus,  Inc.
  • 8207 118th Avenue
  • Largo, FL 33773
  • Contact
  • Phone - 1-727.437.7777Fax - 1-727-222-3398
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