Second Generation Celsius-Pak Frame Qualification Executive

Second Generation CelsiusCelsius-Pak Frame Qualification Executive Summary
Introduction
The second generation (2G) of Celsius-Pak frame is a refinement of the first-generation
Celsius Frame. It is expected that the Celsius-Pak frame 2G will follow the same use
pattern as the first generation including assembly, filling, pressurization, freezing, storage,
shipping, thawing, and draining. This document describes the testing that was done to
demonstrate that the second generation of Celsius-Pak frame conforms to the established
product requirements.
Qualification testing was conducted at the Sartorius Stedim Biotech facility in Concord,
California from July 2008 to October 2008.
Differences between 1G and 2G
The following table is a summary of changes made to the Celsius-Pak frame 2G:
Feature
Description
Bumpers
Four foam bumpers were added to the top of the frame in order to
cushion the Celsius-Pak during tip-over impacts and during endto-end impacts. The Celsius-Pak frame 2G provides a high degree
of survivability to a tip-over test.
Bag Profile
The geometry of the plastic frame end was altered to follow the
contour of the ice block when frozen. In this way, the ice block is
supported during shocks and cannot shear away from the frame.
Additional Ribs
New ribs across the foot and the tubing channels provide increased
robustness. The transverse ribs have also been reinforced and
reshaped to provide greater robustness.
Integral Handle
Instead of a separate stainless steel handle, the Celsius-Pak frame
2G has handles that are molded in to the frame end. The handles
include a notch to guide the bag rod into the bag rod channel.
Aseptic
Connector
Pocket
The Celsius-Pak frame 2G design has a pocket for an aseptic
connector located at the base of the frame end. This pocket
provides future support for a Celsius-Pak with a Sartorius Stedim
Biotech Opta aseptic connector and long drain line.
Remove Sharps
The Celsius-Pak frame 2G design eliminates sharps that were
present on the first design. In particular, the pass-through’s for the
transverse ribs have been eliminated.
Improved
The first design had three different fasteners and required two
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Feature
Assembly
Description
different tools for assembly. The Celsius-Pak frame 2G design has a
press-in plastic fastener for the bumpers and a single type of
stainless steel fastener; only one tool is required for assembly.
Rod Ends
The 2G design has metal-on-metal at the ends of the rods so that
there is no possibility of the fasteners pulling through the plastic
frame end.
FINDINGS
The following table summarizes the outcome of qualification testing against the product
requirements.
Req#
Conclusion
Pass / Fail
Notes
1
Accommodation of
existing 8.3L and
16.6L Celsius-Paks
Pass
2
Liquid height
equivalence
Pass
3
Headspace pressure
equivalence
Pass
4
Frame end material
equivalence
Pass
5
Compatibility with
Celsius freeze-thaw
modules
Pass
6
Compatibility with
accessories
Fail
The current Celsius Shipper is not
compatible. However, the deviation is
accepted since a new version of the
shipper is developed.
7
Assembly with hand
tools
Pass
A total of 12 Celsius-Pak frame 2G were
assembled and disassembled several times
in both 16.6L and 8.3L configurations. As
expected, assembly of the new frame
requires only a 5/16” hex socket.
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Req#
Conclusion
Pass / Fail
Notes
8
Robustness during
normal use
Pass
At least 54x16.6L Celsius-Paks and
12x8.3L Celsius-Paks were frozen and
thawed in Celsius-Pak frame 2G. All were
bubble tested at approximately 200mbarg
(3 psig) and inspected for damage. All
passed the bubble test.
9
Frame end contoured
to ice block shape
Pass
10
Aseptic connector
pocket
Fail
The deviation is accepted since the frame
end will support the Opta connector.
11
Sharps removed
Pass
On the first generation of frame there are
three pass-through’s where the injection
mold tool left a notch along the bag
centerline. These notches were absent
from all 2G frame ends tested.
12
Tip-over survival
Pass
A total of 18 tip-over tests were
performed, including 12x16.6L and 6x
8.3L Celsius-Paks. The tip angle was found
to be between 15° and 20°. Elapsed time
between removal from freezer and
impact on concrete was less than 1
minute.
13
End-to-end impact
survival
Pass
It was verified that the foam bumpers are
the contact surfaces between the tops of
two frames in an end-to-end impact.
14
Integral handle
Pass
The Celsius-Pak frame 2G end features a
molded-in handle. The handle is
contoured to the curve of the hand for
better ergonomics.
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Req#
Conclusion
Pass / Fail
Notes
15
Recess for adhesive
label
Pass
A rounded rectangular recess measuring
58.4mm x 9.4mm (2.30” x 0.37”) is
located at the exterior face of each frame
end at the top of the handle. The recess is
of sufficient depth to protect a label.
However, no self-adhesive materials have
been found that can withstand multiple
freeze-thaw cycles.
16
Freeze/thaw
equivalence
Pass
A total of 40x16.6L Celsius-Paks were
frozen and thawed in Celsius-Pak frames
2G. Effective Frreze Time and Nominal
Freeze Time decreased by 3.3% and 4.5%,
respectively. Standard deviations are
comparable.
CONCLUSION
The Celsius-Pak frame 2G was tested to demonstrate conformance with the established
product requirements.
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