Meeting Minutes - Weekly Meeting

Held on 12 Dec 2006

December 12, 2006 Alfa Laval Biokinetics Inc.

Michael S. Moglia 7 Penn Center
1635 Market Street
Suite 1500
Philadelphia, PA 19103
USA
Tel +1 215-656-2500
Fax +1 215-561-4444
www.alfalaval.com

Alfa Laval- Biokinetics

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 Item # Item
Open / Discussion Items from Previous Meetings
1 Citadon/Word Document opening
errors
2 Compressed Air Generation/Gas
Manifold Documentation/ AHU
Operations Manual Clean Steam
Generation Manual
2A Testing and Balancing subcontract
is needed for generation of the IOQ
for the AHUs. Since the HVAC
system is in the process of being
balanced, this document must be
available.
3 URS Document Updates with
operational set points and ranges
Action Comment Responsibility Date
Problems still exist in Reliance 11 Dec 06
Citadon on the Reliance
end. Citadon contacted;
however, Citadon has not
responded. Contact emails
to Citadon to be forwarded
to M. Moglia.
M. Moglia to contact M. Moglia 11 Dec 06
Citadon to expedite
response.
Work around strategy to Reliance/Alfa Information
continue for issues with Laval
downloading/viewing
Citadon files.
Problems at Reliance Information N/A
transferring emails (emails
bounce back) email to be
sent to Alfa Laval when
Reliance email problems
corrected.
M. Moglia to contact M. Moglia 12 Dec 06
Citadon and notify that there
are problems using Citadon
at the Reliance site. Umesh
to be given as contact.
Hard Copies received at Reliance 13 Dec 06
Reliance.
Electronic Documents to be
issued to Citadon.
Note that document 13 Dec 06
generation (CTP, IOQ,
SOPs) for these systems
cannot proceed without
manuals
Compressed Air and Gas Reliance 13 Dec 06
Manifold documents past
due for posting. Will be
posted for 13 Dec 06
AHU and Clean Steam Reliance 15 Dec 06
Manual still not available.
Reliance to update of new
posting date.
Forward AHU contractor Umesh to locate 13 Dec 06
agreements for execution of TAB
testing and balancing subcontract.
reports at Reliance to Alfa Discuss with
Laval to use to develop IOQ Matthew
documents.
All final URS release Reliance 13 Dec 06
documents to be issued by
Wednesday13 Dec 06
Document schedule to be Information N/A
based on URS release of
the 13 Dec 06 and
Execution Log.
Execution Log to be issued Reliance 9 Dec 06
by Reliance on 9 Dec 06
Alfa Laval- Biokinetics
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Item # Item Action Comment Responsibility Date
Bioreactor URS documents Reliance 9 Dec 06
to be released.
All final URS release Reliance 13 Dec 06
documents to be issued by
Wednesday13 Dec 06
Startup Schedule Flowsheet Reliance to 13 Dec 06
issued. Alfa Laval had respond to email
concerns that it does not
include execution dates
requested more information
per C Dell Cioppia email.
Bioreactor URS documents Reliance 9 Dec 06
to be released on 09 Dec Updated to 13
06. Documents due to be Dec 06
released with remainder of
URS Documents on 13 Dec
06
4 CLIA Revision 2 Documents Up to date CLIA revision Information N/A
documents required for DQ
Documentation. To avoid
changes to current draft DQ
documents a CLIA Rev 2
schedule for the release of
documents is needed
CLIA, Rev 2, document Reliance 11 Dec 06
matrix detailing release of
updated CLIA Rev 2
documents per P&ID
updates
CLIA, Rev 2, document Information N/A
matrix detailing CLIA, URS,
CTP documents emailed to
Alfa Laval.

5 Schedule for release of all pending Schedule to be issued for Information N/A
document which is in the ALB CTP, IOQ and PQ
scope documents (SOP
documents excluded).
Schedule based on
Execution Log and URS
release date of 13 Dec 06
Document Schedule release Alfa Laval 15 Dec 06
for CTP, IOQ and PQ
documents excluding SOP
documents
Umesh is in disagreement Information N/A
to point 5. States execution
log is not needed to update
document release schedule.
Execution to be per start up
and commissioning
schedule.
Reliance to email Start up Reliance 12 Dec 06
and commissioning
schedule.

Alfa Laval- Biokinetics

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Item # Item
6 SOP issue schedule for manual
available (Loaded)
Equipment/system
7 Operation/Process Set Point and
Ranges/URS documents
Action Comment Responsibility Date
Request for Alfa Laval Alfa Laval 15 Dec 06
document release schedule
of DQ, CTP and IOQ
documents for end of
December.
Umesh requested original Alfa Laval 12 Dec 06
scope document from Jan
06. Alfa Laval to email.
SOP schedule based on Alfa Laval Projected 18
execution log release. Dec 06
Release one week from
execution log release
No changes
Set points and parameters Information N/A
that are currently in the
documentation do not
accurately depict the
operation of the equipment.
Ranges supplied are
typically full ranges of the
instrumentation and not the
intended operation ranges.

ALB expressed their

concerns regarding
execution problems,
deviations and errors
resulting from the inclusion
of incorrect process
parameters
Umesh is aware of the Information N/A
situation and instructed Alfa
Laval to continue
developing documents
based on the supplied
information or to make an
educated guess at
parameters, even through
these may not be the actual
operation parameters
No Changes
8 CTP Comments Comments for issued Draft Reliance 12 Dec 06
CTP document shall be
reviewed with schedule of
document turnaround
issued on Tuesday, 12 Dec
06
No Changes

Alfa Laval- Biokinetics

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Item # Item Action Comment Responsibility Date
9 SAT SAT information not Information N/A
available in Citadon or to
Reliance.
ALB expressed concerns
with this. In keeping with
the strategy of leveraging
commissioning, the SAT
documents are needed for
ALB to complete meaningful
CTP documents.
The CQMP Strategy based
on CTP utilizing SAT
testing. Not having
complete resource
documentation will cause
punch list items during CTP
execution, and additional
work in the field.
Umesh instructed to update Information N/A
documents per Reliance
comments and without the
complete documentation
available to Alfa Laval with
the understanding that
duplicate testing may occur
or that additional testing
may be required in the field.
No Changes
10 Media and Buffer URS/DQ approval URS, post URS, DQ Report Reliance 09 Dec 06
on 12/9 document approvals will be
approved on 09 Dec 06
3 documents received for Information N/A
Media CTP
Alfa Laval to continue to Alfa Laval 12 Dec 06
update documents. More
documents to be issued on
12 Dec 06.
Transfer testing not Information N/A
included in CTP 3110.
Transfer Panel TP-3109 is
part of V-3100 system and
transfer testing involving
TP-3109 placed in CTP for
V-3100.
11 Media and Buffer CTP and IOQ Media and Buffer CTP and Alfa Laval 11 Dec 06
documents for approval IOQ document to be issued
for approval per Reliance
comments on 11 Dec 06
No Changes
12 Nitrogen IOQ Header For approval document had For Information N/A
errors in the header. Error
isolated to one document
No Changes
13 Meeting Minutes/Next Meeting Today’s meeting minutes to Alfa Laval 12 Dec 06
be issued to Reliance for 12
Dec 06
Next meeting on 19 Dec 06. Information N/A
6pm Navi Mumbai/7:30am
Philadelphia

Alfa Laval- Biokinetics

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Attendees:

Reliance ALB
Umesh Baikunie Michael S. Moglia
Nithin Choudhary Christina Dell Cioppia
Ganesh Dash
Other-Umesh to provide name

Distribution
Matthew Bishop ALB Project Team
Umesh Baikunie

Alfa Laval- Biokinetics

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